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1Arnfred B, et al. BMJ Open 2022;12:e051147. doi:10.1136/bmjopen-2021-051147

Open access

Group cognitive behavioural therapy
with virtual reality exposure versus
group cognitive behavioural therapy
with in vivo exposure for social anxiety
disorder and agoraphobia: a protocol for
a randomised clinical trial

Benjamin Arnfred ,1 Peter Bang,1,2 Carsten Hjorthøj ,1,3
Clas Winding Christensen,1 Kirsten Stengaard Moeller,1 Morten Hvenegaard,1
Lone Agerskov,1 Ulrik Krog Gausboel,1 Ditte Soe,1 Peter Wiborg,1
Christopher Ian Schøler Smith,1 Nicole Rosenberg,1 Merete Nordentoft1,4

To cite: Arnfred B, Bang P,
Hjorthøj C, et al. Group
cognitive behavioural therapy
with virtual reality exposure
versus group cognitive
behavioural therapy with in
vivo exposure for social anxiety
disorder and agoraphobia:
a protocol for a randomised
clinical trial. BMJ Open
2022;12:e051147. doi:10.1136/

► Prepublication history and
additional supplemental material
for this paper are available
online. To view these files,
please visit the journal online

Received 26 May 2021
Accepted 24 November 2021

For numbered affiliations see
end of article.

Correspondence to
Dr Benjamin Arnfred;
[email protected] regionh. dk


© Author(s) (or their
employer(s)) 2022. Re- use
permitted under CC BY- NC. No
commercial re- use. See rights
and permissions. Published by

Introduction Anxiety disorders have a high lifetime
prevalence, early- onset and long duration or chronicity.
Exposure therapy is considered one of the most effective
elements in cognitive behavioural therapy (CBT) for
anxiety, but in vivo exposure can be challenging to access
and control, and is sometimes rejected by patients
because they consider it too aversive. Virtual reality allows
flexible and controlled exposure to challenging situations
in an immersive and protected environment.
Aim The SoREAL- trial aims to investigate the effect of
group cognitive behavioural therapy (CBT- in vivo) versus
group CBT with virtual reality exposure (CBT- in virtuo) for
patients diagnosed with social anxiety disorder and/or
agoraphobia, in mixed groups.
Methods and analysis The design is an investigator-
initiated randomised, assessor- blinded, parallel- group
and superiority- designed clinical trial. Three hundred
two patients diagnosed with social anxiety disorder and/
or agoraphobia will be included from the regional mental
health centres of Copenhagen and North Sealand and
the Northern Region of Denmark. All patients will be
offered a manual- based 14- week cognitive behavioural
group treatment programme, including eight sessions
with exposure therapy. Therapy groups will be centrally
randomised with concealed allocation sequence to either
CBT- in virtuo or CBT- in vivo. Patients will be assessed
at baseline, post- treatment and 1- year follow- up by
treatment blinded researchers and research assistants.
The primary outcome will be diagnosis- specific symptoms
measured with the Liebowitz Social Anxiety Scale for
patients with social anxiety disorder and the Mobility
Inventory for Agoraphobia for patients with agoraphobia.
Secondary outcome measures will include depression
symptoms, social functioning and patient satisfaction.
Exploratory outcomes will be substance and alcohol use,
working alliance and quality of life.
Ethics and dissemination The trial has been approved by the
research ethics committee in the Capital Region of Denmark.

All results, positive, negative as well as inconclusive, will be
published as quickly as possible and still in concordance
with Danish law on the protection of confidentially and
personal information. Results will be presented at national
and international scientific conferences. The trial has obtained
approval by the Regional Ethics Committee of Zealand (H-
6- 2013- 015) and the Danish Data Protection Agency (RHP-
2014- 009- 02670). The trial is registered at ClinicalTrial. gov
as NCT03845101. The patients will receive information on
the trial both verbally and in written form. Written informed
consent will be obtained from each patient before inclusion in
the trial. The consent form will be scanned and stored in the
database system and the physical copy will be destroyed. It is
emphasised that participation in the trial is voluntary and that
the patient can withdraw his or her consent at any time without
consequences for further and continued treatment.
Trial registration number NCT03845101.

Strengths and limitations of this study

► The present study will be the first large randomised
clinical trial to investigate virtual reality exposure
therapy for social anxiety disorder and agoraphobia
in group therapy.

► The present study is very closely integrated with
clinical practice, making results highly transferable
to similar real- life settings.

► Mixing patients with social anxiety disorder and ag-
oraphobia in the same therapy groups have never
been investigated systematically, which may con-
found the interpretation of results.

► Because the study is embedded in an outpatient
hospital setting, the intervention was designed to
be flexible. This increases the ecological validity
but also the risk of systematic bias in treatment

2 Arnfred B, et al. BMJ Open 2022;12:e051147. doi:10.1136/bmjopen-2021-051147

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Social anxiety disorder is characterised by paying attention
to oneself in an exaggerated manner and having marked
fear of being negatively evaluated by other people.1 2
Agoraphobia is characterised by avoidance or enduring
with dread, situations in which escape is perceived diffi-
cult or where help might not be available in the event
of a panic attack, panic- like symptoms or incapacitating
symptoms such as loss of bladder and/or bowel control.1 3
Both social anxiety disorder and agoraphobia are associ-
ated with marked functional consequences.1 In Denmark,
anxiety disorders represent the costliest disease burden
in terms of lost production, due to their early onset, long
duration and high prevalence.4

The first- line treatment for social anxiety disorder and
agoraphobia is cognitive behavioural therapy (CBT) with
exposure therapy.5 6 Several meta- analyses have found
that patients with social anxiety disorder and agoraphobia
respond well to CBT with exposure therapy, provided in
individual as well as group format.7–10 Exposure therapy
aims to change expectations and emotional responses
associated with feared stimuli, by exposing the patient to
the stimuli and challenging the patients’ expectancies of
the likelihood and consequences of a feared outcome.11
However, in clinical practice, in- vivo exposure stimuli can
be difficult to access and control and patients or therapists
sometimes reject the treatment, because they consider it
too aversive or too logistically demanding.12–14

Virtual reality exposure therapy for social anxiety disorder and
Virtual reality (VR) technology allows the user to experi-
ence virtually mediated environments that are perceived
as real or almost real, due to multisensory stimulation and
blocking of real- world sensory input. Numerous possibili-
ties for psychological intervention using VR are currently
being researched owing to its immersive quality.15 16 As a
therapy tool, VR is most widely used to perform Virtual
Reality Exposure Therapy (VRET),16 17 either as a stand-
alone treatment, for example,18 or integrated into a CBT
treatment, for example.19

The use of VR allows flexible and controlled exposure
to challenging situations in an immersive and safe envi-
ronment. Therefore, using VRET can mitigate the chal-
lenges of in- vivo exposure therapy by producing greater
user acceptance and access to situations that would other-
wise be too difficult to control, too resource- intensive to
find and/or have unacceptable confidentiality risks.15 19 20
Based on this, VRET may improve the efficacy and cost-
effectiveness of psychotherapeutic interventions for
anxiety disorders.

Recent reviews and meta- analysis of VRET, either as a
standalone treatment or combined with cognitive inter-
ventions, conclude that VRET is more effective than wait-
list and placebo control and equally as effective as first- line
treatment controls for anxiety disorders.21–23 However, in
one meta- analysis, the authors find significantly worse
treatment effects of VRET for social anxiety disorder,

when compared with control groups that received equal
amounts of in- vivo exposure.24 It has been suggested that
it is more difficult to produce VRET environments for
social anxiety disorder, as compared with other phobic
disorders because human interaction is complex and
therefore difficult to realistically recreate25 which may
explain these results. Accordingly, the same meta- analysis
found no significant difference in treatment efficacy for
CBT with VRET versus CBT with in- vivo exposure for
agoraphobia and specific phobia.24

In general, there is a scarcity of high- quality randomised
clinical trials evaluating the use of VRET for social anxiety
disorder and agoraphobia.16 26 27 For social anxiety
disorder, there are five trials published, the largest having
97 participants.18 19 28–30 For agoraphobia, there are six
trials published, the largest having 80 participants.31–36 All
in all, the evidence base for using VRET compared with
in- vivo exposure for social anxiety disorder and agora-
phobia remain small. Therefore, larger studies that capi-
talise on the unique qualities of VRET are needed.

VR exposure in group therapy
VRET has never been investigated in a group format.
Group therapy for social anxiety disorder and agoraphobia
is popular in outpatient settings because it has similar
treatment efficacy37–39 and is proposed to have better cost
efficiency, compared with individual therapy.37 39 However,
the claim of cost efficiency for social anxiety disorder is
disputed, at least in a UK mental healthcare setting.40
Beyond that, therapeutic interpersonal processes such as
peer learning and modelling has been suggested to be
a distinct benefit of group therapy,41 42 though this has
never been systematically evaluated for mixed anxiety
groups. A suggested drawback of group CBT compared
with individual CBT is that in- vivo exposure in group
therapy is restrained by the logistics of managing several
patients simultaneously, leading to comparatively less
individualised exposure exercises.43 44

The use of VRET in group therapy may therefore be
especially beneficial, since it should allow for individual-
ised exposure, as well as a greater amount of exposure
therapy because less time will be spent on logistical issues
(transport, planning, waiting, and so on), while at the
same time retaining the proposed benefits of the thera-
peutic interpersonal processes and cost- efficiency.

Treatment of social anxiety disorder and agoraphobia in the
Danish mental health system
In the Danish mental health services, patients with social
anxiety disorder or agoraphobia as their primary diag-
nosis are generally offered group CBT. To reduce wait
time, patients with these diagnoses are treated in the
same therapy groups, generally referred to as ‘mixed
anxiety groups’ or ‘phobia groups’. These mixed anxiety
groups are considered to be as effective as diagnosis-
specific groups, due to the overlap in symptoms and diag-
nostic criteria,45 high degree of comorbidity,46 as well as

3Arnfred B, et al. BMJ Open 2022;12:e051147. doi:10.1136/bmjopen-2021-051147

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recent evidence of the acceptable treatment efficacy of
CBT- based transdiagnostic therapies.47

However, it is worth noting that the pragmatic mixed
anxiety group format has never been systematically eval-
uated and that the official treatment recommendation
remains diagnoses- specific CBT delivered in group or
individually.48 To maximise the study’s clinical represen-
tativeness, as defined by Shadish et al,49 the treatment
structure in the present study, including the comperator,
will mimic the treatment offered by the Danish mental
health services.

Aim and objectives
In summary in- vivo exposure is considered effective,
but can be challenging to perform. VRET may alleviate
these challenges. However, the usefulness of VRET for
social anxiety disorder and agoraphobia remains unclear.
Larger studies that capitalise on the benefits of VRET are
needed. Group therapy may be one way to capitalise on
the benefits of VRET because it could allow for more indi-
vidualised exposure exercises. Mixed anxiety groups are
commonly used in Danish mental healthcare to reduce
wait time, but have not been systematically evaluated.
The treatment, inclusion and exclusion criteria described
in the present study match the eligibility criteria for
treatment and treatment format of the Danish mental
healthcare system to maximise transferability of results to
clinical practice.

Therefore, the SoREAL trial aims to evaluate the treat-
ment efficacy of VRET in mixed anxiety CBT groups
(CBT- in virtuo) compared with mixed anxiety CBT groups
where exposure therapy is performed in- vivo (CBT- in

Thus, in the SoREAL trial, the following hypotheses’
will be tested:

Primary hypothesis
1. Post- treatment, patients treated with CBT- in virtuo will

have a lower level of anxiety symptoms compared with
patients treated with CBT- in vivo, measured as total
scores on the Liebowitz Social Anxiety Scale (LSAS)
for patients with social anxiety disorder and the
Mobility Inventory for Agoraphobia (MIA) for patients
with agoraphobia converted to the percentage of max-
imum possible (POMP) scores and averaged within
treatment arms.

Secondary hypotheses
1. One year after treatment, patients treated with CBT- in

virtuo will have lower levels of anxiety symptoms com-
pared with patients treated with CBT- in vivo.

2. Post- treatment and 1 year after treatment, patients
treated with CBT- in virtuo will have lower levels of fear
of negative evaluation compared with patients treated
with CBT- in vivo.

Overall, we believe that the SoREAL trial will contribute
with knowledge about the efficacy and feasibility of VRE
for treating social anxiety disorder and agoraphobia in

a clinical outpatient setting. The results of this trial may
guide future applications of VR in clinical settings across
a wide breadth of use cases.

This article was written in accordance with the Standard
Protocol Items: Recommendations for Interventional
Trials (SPIRIT) 2013 explanation and elaboration: guid-
ance for protocols of clinical trials.50 The SPIRIT Check-
list was followed and the SPIRIT flowchart was used (see
online supplemental file 1 and figure 1).

The SoREAL trial is embedded directly into five outpa-
tient clinics offering group CBT for social anxiety
disorder and agoraphobia. These clinics are part of the
Danish mental healthcare system. To be eligible for treat-
ment in these clinics, patients must be referred by their
primary care physicians to a Centre for Visitation and
Diagnosis in their area, where their symptomatology will
be assessed. At the Centre for Visitation and Diagnosis,
they must be referred to one of the five outpatient clinics
involved in the study. At the outpatient clinic, the patient
will again be clinically assessed, and a diagnosis and treat-
ment plan will be formulated. If social anxiety disorder
and/or agoraphobia is considered the primary diagnosis
for the patient, they will be asked if they are interested in
getting more information about the trial. If they consent
to it, their contact details will be given to a researcher,
who will invite them to an interview concerning the study.

Mini International Neuropsychiatric Interview (MINI),
V. 7.0 for DSM- 5 will be used to screen for diagnosis.
Psychometric analyses of the MINI have demonstrated
acceptable test–retest and inter- rater reliability.51 52 Diag-
nostic screening is sufficient due to the thorough assess-
ment from both Centre for Visitation and Diagnostics and
the outpatient clinics which must have confirmed social
anxiety disorder or agoraphobia as the primary diagnosis
of the patient, for the patient to be eligible for the study.
If eligibility is confirmed, informed consent is acquired
(see online supplemental file 2, for a model consent
form). Patients who cannot or will not participate in the
study will be offered treatment as usual, which is identical
to the control group treatment. Inclusion and exclusion
criteria were based on the eligibility criteria for receiving
the treatment package in Danish outpatient clinics.

Inclusion criteria
1. Fulfilling diagnostic criteria for social anxiety disorder

and/or agoraphobia.
2. Age 18–75 years.
3. Sufficient knowledge of the Danish language.
4. Informed consent

Exclusion criteria
1. Alcohol or drug dependence

4 Arnfred B, et al. BMJ Open 2022;12:e051147. doi:10.1136/bmjopen-2021-051147

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Five psychotherapeutic outpatient clinics are involved in
the study. All patients referred to these clinics with the
relevant diagnosis, who also agree to be contacted, will be
invited to an interview about their potential participation.
Each of the clinics provide treatment for approximately
30 patients with social anxiety disorder and/or agora-
phobia every year. Thus we anticipate that 450 patients
will be eligible for the trial during a 3- year recruitment
period. We expect a high eligibility rate, due to the previ-
ously mentioned assessment procedures the patients will
have completed. We also expect a high acceptance rate,
due to the novel use of VR technology and the use of a
control group that is identical to the treatment they would
be offered if they refused participation. See figure 2 for a
flow diagram of the SoREAL trial.

Treatment format
The treatment for social anxiety disorder and agora-
phobia offered at the outpatient clinics must follow the
national guidelines for the treatment of these disorders.
The guidelines are encapsulated in specified ‘treatment

packages’. For social anxiety disorder and agoraphobia,
this package contains:

► 1 hour of assessment.
► 1 hour of individual therapy in preparation for group

► 1 hour of psychometric testing.
► 14 sessions of 2 hours of group therapy
► 1.5 hours of next of kin involvement
► 1 hour of pharmacological treatment planning with a

► 2.5 hours coordination with social services, relapse

prevention and follow- up meetings.
Not all of this is necessary for every patient, but every

patient can receive every part of the package, should they
want to. The treatment in the present study must live up
to the standards of the national guidelines. Patients are
not allowed to be in any other form of psychotherapeutic

The therapeutic intervention is manual- based cognitive-
behavioural CBT group adapted from the approach of
Turk et al53 and Graske and Barlow54 with worksheets

Figure 1 Overview of data collection. CBT, cognitive behavioural therapy.

5Arnfred B, et al. BMJ Open 2022;12:e051147. doi:10.1136/bmjopen-2021-051147

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from Rosenberg et al55 and inspiration from Bouchard
et al.56 The treatment will consist of 14 weekly 2- hour
group sessions following the manual to ensure equal
and uniform treatment for every patient throughout the
study. The manual allows flexibility to ensure clinically
representative conditions.49 For example, it is allowed to
change the order of the sessions if it is considered bene-
ficial for the group and multiple exercises are optional.
However, the time dedicated to exposure is fixed in both
groups. Concurrent psychopharmacological treatment is
allowed in both intervention arms.

Groups will consist of 8–9 patients with social anxiety
disorder and/or agoraphobia as their primary diagnosis,
and every session will be led by two trained clinicians (ie,
psychologists, psychiatrists or psychotherapists) with prac-
tical experience in CBT and in vivo exposure. Throughout
the course of the study, the clinicians involved will treat
both CBT- in vivo and CBT- in virtuo groups. Medical
consultation, acute individual sessions, supplementary
social counselling and physical therapy are possible in
both intervention arms. In both intervention arms, the
sessions dedicated to exposure are scheduled from the
fifth to the eleventh session with approximately 45 min
of exposure in each session. From the fifth session and
onwards, all patients in both interventions will have
in- vivo exposure as homework. The cognitive therapy
strategies used in the non- exposure sessions (first four
and last two therapy sessions) are as follows: (1) intro-
duction to CBT; (2) psychoeducation about anxiety and
cognitive restructuring of dysfunctional assumptions and
beliefs; (3) shifting self- focused attention and modifying

cognitive distortions; (4) developing an understanding
of safety behaviour and the rationale of exposure; (5)
evaluation, discussion and feedback on the use of patient-
acquired techniques; and (6) relapse prevention. In
both conditions, the exposure exercises aim to develop
adaptive responses to anxiety- provoking situations, rein-
force cognitive restructuring by framing exercises as
behavioural experiments (though these were limited by
the non- interactive medium), train attention exercises,
train general cognitive strategies (eg, identifying negative
automatic thoughts) and train social skills. See tables 1
and 2 for an overview of the content of the CBT sessions
for both conditions.

In the in virtuo condition, exposure will take place
during 8 out of the 14 group sessions, as in the CBT- in
vivo condition. Patients will be exposed to VR situations,

Figure 2 Flow diagram of the SoREAL trial. CBT, cognitive
behavioural therapy.

Table 1 Group cognitive behavioural therapy manual
session overview for social anxiety disorder and

Session Content


Case conceptualisation, psychoeducation on
CBT, treatment goal, introduction to treatment

1 Psychoeducation about anxiety, CBT anxiety

2 Psychoeducation about anxiety, registration of
thoughts, feelings, behaviour and introduction to
cognitive restructuring.

3 Psychoeducation and exercise:
cognitive bias, attention and self- focus, repetition
about cognitive restructuring, attention exercises.

4 Psychoeducation about exposure therapy,
optionally, an introductory exposure exercise.

5 Exposure therapy.

6 Behavioural experiments in exposure exercises.

7 Repetition of the methods presented so far,
additional attention/mindfulness exercise linked
to exposure.

8 Conversational skills and small- talk exposure

9 Introduction to core beliefs, additional exposure

10 Repetition of core beliefs, resources and skills,
additional exposure exercises.

11 Exposure therapy, out of the clinic.

12 Repetition and evaluation of methods learnt/used
so far, revising problem–goal list.

13 Evaluation, discussion and feedback on the
different methods used by each patient.

14 Maintenance and relapse prevention, review of
skills, review of progress and future goals, plan
for continued exposures, relapse prevention

CBT, cognitive behavioural therapy.

6 Arnfred B, et al. BMJ Open 2022;12:e051147. doi:10.1136/bmjopen-2021-051147

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which are relevant to them, and which they are motivated
to engage in. Patients in CBT- in virtuo condition will be
assigned in vivo exposure homework between sessions in
the same way as the CBT- in vivo group.

Fidelity to the treatment manual
The intervention is manual- based, which improves the
standardisation of the treatment. Fidelity to the treat-
ment manual will be assessed through a self- report ques-
tionnaire answered by the clinicians at five different
time points throughout each group treatment. The
questionnaire (and the timepoints when it is delivered)
are designed to correspond to the treatment manual.
This type of fidelity measurement has proved useful and
adequate in trials where the effect of treatment is tested.57

The VR headsets will also record statistics of the use of
the 360o films. This data show which specific scenes were
watched and how much and can be matched to the indi-
vidual patient. This data will be used to keep track of the
VR usage throughout the study to see how well it matches
the treatment manual.

Treatment completion and discontinuation
Criteria for treatment completion, partial treatment and no
treatment were based on clinical guidelines for writing
epicrisis as well as discussions within the research group.

► The attendance of 0 or more group therapy sessions
will be coded as ‘treatment completion’.

► The attendance of between four to nine group therapy
sessions will be coded as ‘partial treatment’.

► The attendance of less than four group therapy
sessions will be coded as ‘no treatment’.

Treatment will be discontinued if participants do not
show up to treatment 3 weeks in a row and cannot be
contacted after multiple attempts by the therapists. Partic-
ipants who have their treatment discontinued will still be
included in the statistical analysis.

VR equipment
The patients receiving the in virtuo exposure will be
immersed using an Oculus Go head- mounted display,
enabling viewing of 360° spherically camera- recorded
VR environments. The VR scenarios will thus be high-
resolution 360° stereoscopic films, that are played around
the viewer. For audio, the patients will use high- quality
sound- blocking headphones. For ease of use, the indi-
vidual videos will be administered from an app that has
been designed to be as intuitive to operate as possible.
The patient will only have to put on the headset, adjust
the focus and choose the desired environment by looking
at it in the app. 360° video was chosen because it gives the
most photorealistic visuals, while also being the cheapest
to produce. The downside is that it does not allow direct
user interaction (eg, the viewer cannot affect the environ-
ment in any way). To circumvent this, there are multiple
junctions throughout the films where the actors will talk
directly and unsolicited to the viewer (eg, greetings,
common questions), while also allowing time for the
viewer to respond. The actors respond in a generic way to
the actions of the viewer. Unsolicited and direct referral
from a virtual environment seems to be an essential factor
in triggering realistic responses to it.58 Though the non-
interactability of the environment limits the flexibility of
behavioural experiments, it does not make them impos-
sible. For example, it is still possible to hypothesise about
internal states (eg, ‘I will clam up if I have to present in
front of people’) and identify and challenge negative
automatic thoughts.

VR scenarios
Thirteen VR exposure scenarios relevant for social anxiety
disorder and agoraphobia were chosen for the CBT- in
virtuo condition. The 13 scenarios are as follows:

Table 2 Group CBT manual session overview for social
anxiety disorder and agoraphobia with VRET

Session Content


Case conceptualisation, psychoeducation on
CBT, treatment goal, introduction to treatment

1 Psychoeducation about anxiety, CBT anxiety

2 Psychoeducation about anxiety, registration of
thoughts, feelings, behaviour and introduction to
cognitive restructuring.

3 Psychoeducation and exercise:
Cognitive bias, attention and self- focus,
repetition about cognitive restructuring, attention

4 Psychoeducation about exposure therapy,
introduction to VRET.


6 Behavioural experiments in VRET.

7 Repetition of the methods presented so far,
additional attention/mindfulness exercise linked
to VRET.

8 Conversational skills and VRET.

9 Introduction to core beliefs, additional VRET

10 Repetition of core beliefs, resources and skills,
additional VRET exercises.

11 VRET combined with in- vivo out- of- the- clinic
exposure exercises.

12 Repetition and evaluation of methods learnt/
used so far, revising problem–goal list.

13 Evaluation, discussion and feedback on the
different methods used by each patient.

14 Maintenance and relapse prevention; review of
skills; review of progress and future goals; plan
for continued exposures; relapse prevention

CBT, cognitive behavioural therapy; VRET, virtual reality exposure

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1. Standing in line in a supermarket.
2. Being in a crowded shopping centre
3. Attending a party.
4. Attending a formal meeting and giving a presentation
5. A job interview.
6. Small talking/discussing in a university canteen with

young adults
7. Small talking/discussing in a canteen in a work

8. Entering an auditorium
9. Leaving your apartment

10. Waiting for and taking the bus
11. Crossing a bridge
12. Taking an elevator
13. Taking a commercial aeroplane

Each scenario has four to six scenes of increasing diffi-
culty as well as a neutral scene to familiarise patients
with the VR setting. All scenes skip to a looping version
of a scene in the same environment after being played,
to allow patients to achieve within- session habituation if
needed. See online supplemental file 3 for screenshots
and descriptions of the individual scenes, as well as links
to view a selection of the scenes online. All identifiable
persons depicted in the virtual environments are paid

Patient and public involvement: development of VR scenarios
and manual
The pilot phase was a continuous iterative process
between the developers of the VR media, CBT- trained
clinicians and a panel of patients with social anxiety
disorder and/or agoraphobia. The process lasted approx-
imately 16 months (12 for social anxiety disorder environ-
ments and 4 for agoraphobia) and consisted of regular
meetings following each scenario’s initial filming wherein
the patients saw the VR scenario in question. Their expe-
rience (eg, anxiety level provoked from the films, the
validity of the scenarios) was then used as a starting point
for a discussion of further development and alterations
to the scenarios. Towards the end of the development of
the scenarios and application to launch them, two clini-
cians tested the usability of VRE in a group format. The
clinicians and patients then gave further feedback on the
films and the delivery of the exposure in the group. This
guided the initial draft for a group CBT manual with VRE
for social anxiety disorder and agoraphobia.

MINI V.7.0 for DSM- 5 will be used to screen for diagnosis.
At the inclusion interview, all modules but P will be used
to assess diagnostic eligibility. At the baseline interview, all
modules but P will be used to assess diagnosis and detect
comorbidity. At the post- treatment interview, all modules
but P will be used to assess diagnosis and detect comor-
bidity. At the follow- up interview, all modules but P will be
used to assess diagnosis and detect comorbidity.

Outcomes and sample size calculation
We originally designed the trial around inclusion of only
patients with social anxiety disorder, basing the sample
size calculation on the following parameters on the LSAS:
with alpha=0.05, 80% power, and an expected SD of 21,
302 patients would be required to detect the minimal
relevant difference of 6.8 on the LSAS total score between
the groups.

On deciding to expand the diagnostic criteria for
inclusion to also include patients with agoraphobia, it
was necessary to change our primary outcome measure.
For patients with agoraphobia, we primarily rate symp-
toms using MIA. To include both patients with social
anxiety disorder and patients with agoraphobia, we
thus decided to recalculate scores on these two scales to
POMP as described below. Since the sample size calcu-
lation for LSAS was based on a Cohen’s d=0.33, we also
set the minimum clinically relevant difference on MIA,
and by extension on the POMP, to d=0.33. Consequently,
the required sample size remained unaffected by this
change of primary outcome measures and is thus still 302
patients. See figure 3 for power calculations on secondary

Primary outcome
Total scores on the LSAS for patients with social anxiety
disorder and the MIA for patients with agoraphobia
measured pretreatment, post- treatment and at 1- year
follow- up converted to the POMP and averaged within
treatment arms. POMP calculations can bring differently
measured items to the same metric and do not change
the multivariate distribution and covariance matrix of
the transformed variables. Therefore, scales transformed
with the POMP method can be used to examine mean-
level differences between groups.59–61 Using POMP-
transformed scores on two different measures of phobic
anxiety makes it possible to include patients with different
primary diagnoses in the same analysis, thus, avoiding the
need for approximately double the number of partici-
pants to reach a sufficient sample size. The downside of
this method is that differences in the sensitivity of the
outcome measures and potential differences in treat-
ment effect between patients with social anxiety disorder
and agoraphobia, which has been observed in diagnosis-
specific treatment,62 are also averaged out, thus possibly
skewing results.

Social anxiety disorder symptom severity will be
measured using a danish version of the LSAS. LSAS
assesses 24 situations typically feared by individuals with
social anxiety disorder, rated on anxiety and avoidance,
divided into subscales of performance anxiety and social
situations. It has acceptable psychometric properties.63
Agoraphobia symptom severity will be measured using a
danish version of the MIA. The MIA assesses avoidance of
26 situations typically feared by patients who were agora-
phobic.64 The MIA has demonstrated excellent psycho-
metric properties and has been validated in multiple
languages, including Swedish.65 66

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Secondary outcomes
► Depressive symptoms measured pretreatment, post-

treatment and at follow- up as total scores on the
Hamilton Depression Rating Scale, 6 item version
(HAM- 6).67

► Fear of negative evaluation measured pretreat-
ment, post- treatment and at follow- up with the Brief
Version of the Fear of Negative Evaluation Scale

► Work and social adjustment measured pretreatment,
post- treatment and at follow- up with the Work and
Social Adjustment Scale (WSAS).69 70

► User acceptability and satisfaction of treatment meas-
ured post- treatment with the Client Satisfaction Ques-
tionnaire (CSQ). The CSQ is an 8- item scale loading
to one factor of satisfaction with mental healthcare

► Quality of life measured pretreatment, post- treatment
and at follow- up with the WHO Well- Being Index,
five items (WHO- 5). It is considered a very sensitive
outcome measure as it does not incorporate nega-
tive quality of life, that is, distress, and has no ceiling

► Treatment response on social anxiety disorder symp-
toms measured as LSAS below 50 or a 15 points drop.

► Treatment response on agoraphobia symptoms meas-
ured as MIA below 2 or a 0.5 points drop.

► Remission of social anxiety disorder symptoms meas-
ured post- treatment and at follow- up as LSAS below
2573 and not qualifying for social anxiety disorder as
measured using the MINI.

► Remission of agoraphobia symptoms measured post-
treatment and at follow- up as MIA below 1.5 and not
qualifying for agoraphobia as measured using the

Explorative outcomes
► Social functioning measured with Personal and

Social Performance Scale74 (PSP) pretreatment, post-
treatment and at 1- year follow- up.

► Substance and alcohol use measured with timeline
followback75 (TLFB) pretreatment, post- treatment
and at 1- year follow- up.

► Self- belief of coping measured with General Self
Efficacy76 pretreatment, post- treatment and at 1- year
follow- up.

Figure 3 Power calculation for secondary outcomes in the SoREAL trial. LSAS, Liebowitz Social Anxiety Scale; MIA, Mobility
Inventory for Agoraphobia; VR, virtual reality.

9Arnfred B, et al. BMJ Open 2022;12:e051147. doi:10.1136/bmjopen-2021-051147

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► Working alliance measured with the Working Alliance
Inventory77 (WAI) post- treatment.

► Social anxiety symptoms in patients with social anxiety
disorder, measured with the LSAS pretreatment, post-
treatment and at 1- year follow- up.

► Agoraphobia symptoms in patients with agoraphobia,
measured with the MIA pretreatment, post- treatment
and at 1- year follow- up.

Other measures
► Unwanted negative side- effects induced by immer-

sions in VR (commonly referred to as cybersickness)
will be measured with the Simulator Sickness Ques-
tionnaire78 (SSQ) at the end of VRE sessions.

► Deterioration and adverse effects of psychotherapy
on social anxiety disorder symptoms measured post-
treatment and at follow- up as a 6.8+point increase in
total LSAS score. Patients who have deteriorated will
be interviewed about their experiences in therapy.

► Deterioration and adverse effects of psychotherapy on
Agoraphobia symptoms measured post- treatment and
at follow- up as a 0.3 point increase in total MIA score.
Patients who have deteriorated will be interviewed
about their experiences in therapy.

► The experience of social presence, as described by
Lee,79 will be measured after each VR exposure session
with a scale consisting of nine questions rated on a
1–7 Likert scale. This scale was developed specifically
for this trial because existing scales are too specific for
the VR equipment and content they were developed
for. Social presence is measured instead of the more
general construct of presence, because it has been
theorised to be a critical element in the effective use
of VRE for socially related fears.80 81

Data from medical report
The following data will be retrieved from the partici-
pants’ medical report with consent, only if the participant
cannot remember it:
1. Number of previous hospitalisations for mental health

conditions or medical conditions.
2. Use of mental health services during the follow- up pe-

3. Current and previous psychopharmacological medica-

4. Attendance rate of the CBT treatment.

Setting of assessment
Assessment will take place at the outpatient clinics where
the patients also receive treatment. Self- report ques-
tionnaires (MIA, FNES, CSQ, WAI, WSAS, WHO- 5) will
be answered by following a link sent to the patient’s
email address, which the patients can access either on a
personal device or on one of the clinic’s computers. If
preferred by the patient, the self- report questionnaires
can be filled out on printed copies of the scales while
at the assessment interview. MINI, LSAS, PSP, HAM- D6
and TLFB will be administered by trained researchers

and research assistants. After each session with VRE,
specific questionnaires (Social Presence & Simulator
Sickness Questionnaire) will be administered by the clini-
cians delivering the intervention. If necessary, due to the
global COVID- 19 pandemic, assessment interviews will be
performed via telephone.

Randomisation is performed by randomising each
therapy group, 1 week before the first treatment session.
This means that no patient is included while their treat-
ment allocation is known. The randomisation is done
with a hidden allocation sequence generated from www.
sealedenvelope.com and is centralised and handled with
the randomisation module in Research Electronic Data
Capture (REDCap) by a project manager uninvolved in
the data collection. Block sizes will be unknown to the
outcome assessors and clinicians. The factor for strat-
ification is the treatment site. Allocation tables will be
handled by external researchers with no affiliation with
the project. An email of the group’s assigned randomisa-
tion will be sent to the team leaders organising the logis-
tics of the interventions in the psychotherapeutic clinics.
Assigned randomisation of the groups will be stored by
the research team data manager. The randomisation
code will be stored at REDCap.

The assessors are blinded when interviewing at
pretreatment, post- treatment and at follow- up. Should
unblinding occur, another researcher will perform the
assessment. Blinded researchers will perform analysis
and draft conclusions. There are no circumstances where
unblinding of the assessors is permissible.

Data collection methods and management
See figure 1 for an overview of data collection. Self-
reported data will be collected through surveys sent via
REDCap or filled out on paper. Assessors are trained in
the interview instruments and will do regular coratings
of recorded interviews. Inter- rater reliability of clinician-
rated outcome measures will be calculated throughout
the trial. The interviewers will import data from the
assessments directly into the electronic Case Report
Form using the data entry system REDCap.82 REDCap is
an electronic data capture tool hosted at Center for IT,
Medico and Telephony (CIMT) in the Capital Region
of Denmark. For non- self- report measures, data will first
be captured on paper and then entered electronically.
REDCap complies with Danish legislation (the Act on
Processing Personal Data) due to it having both compre-
hensive user rights and access control management
and a complete audit trail on all data transactions. The
data from individual patients are tied to a unique serial
number. Assigned researchers and Good Clinical Practice
(GCP) monitors will be the only people who can access
the database. Non- electronic data will be stored locally
in secure archives. Data will be exported from REDCap

10 Arnfred B, et al. BMJ Open 2022;12:e051147. doi:10.1136/bmjopen-2021-051147

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without personal identifiers. Data will be exported to all
well- known software packages: SPSS v. 28, SAS v. 15.2,
Stata v. 17, R v. 4.1.2. and stored on a secure network drive
under the control of CIMT. A data manager will ensure
that all variables are correctly defined with variable and
value labels. All derived variables will be correctly defined,
and algorithms will be kept in individual files. All data will
be scrutinised to identify errors in data entry. The sponsor
and the principal investigators ensure that data are stored
at least 10 years after the trial is ended.

Statistical methods
The analysis will all be from intention- to- treat. All
included patients will also be included in the analyses.
All statistical tests of significance will be two- tailed. The
primary outcome analysis will be an intention- to- treat
analysis. Missing data will be handled by multiple impu-
tations (m=100). As predictors in the imputation model,
we will select variables if they are independent predictors
of the outcome or predictors of missing data (p<0.05 in
a univariate model). Each group will have imputations
done separately. Analysis of covariance will be used to
calculate any significant results between the two groups,
using the baseline value and the stratification variables.

The continuous variables will be imputed with linear
regression. Binary variables will be imputed with binary
logistic regression. Multinomial variables will be imputed
with multinomial logistic regression. Ordinal variables
will be imputed with ordinal logistic regression. For every
type of variable, we will perform 100 imputations.

All distributions will be assessed for normality using
visual inspection of histograms and Q–Q plots. If not
normally distributed, variables will be log- transformed,
and if unsuccessful, a non- parametric test will be used.

For dichotomous outcomes, we will perform multiple
logistic regressions with treatment as usual as reference
and stratification variables as covariates after having
imputed missing values using a logistic regression model.

A trial protocol, including a plan for statistical proce-
dures, has been published at wwwclinicaltrialsgov/ct2/
show/NCT03845101. This will ensure that the SoREAL
trial is conducted and analysed as planned. Possible devi-
ations and reasons for those will be described in publica-
tions. All data published will be verified for authenticity
by controlling for internal inconsistency. All results, posi-
tive, negative as well as inconclusive, will be published as
quickly as possible and still in concordance with Danish
law on the protection of confidentially and personal
information. Results will be presented at national and
international scientific conferences. Lastly, results will be
presented at relevant mental health centres in Denmark.

Data monitoring and auditing
Like in GCP monitoring, an independent committee
will check the following data for the included patients:
informed consent, inclusion and exclusion from

intervention, serious adverse events and severe adverse
reactions. It will be checked whether there is a link
between trial allocation and the serious adverse events
and severe adverse reactions.

In the clinical setting, the clinicians will register adverse
events and adverse reactions and report all serious adverse
events and severe adverse reactions to the sponsor. Other
events or side effects will be collected from patient files
and registers. International Conference on Harmoni-
zation of Technical Requirements for Registration of
Pharmaceuticals for Human Use, Good Clinical Prac-
tice guidelines define serious adverse events and serious
adverse reactions. The patients in the SoREAL trial are
ensured by Danish law and the patient care regulation.
Every patient in the SoREAL trial will have access to their
results of the trial if they wish to. The clinicians will not
have access to data collected from assessments done by
the researchers.

Trial status
Inclusion began on 4 February 2019. Inclusion is expected
to stop on 4 June 2023. Inclusion was delayed by approxi-
mately 3 months due to the COVID- 19 pandemic.

Author affiliations
1Copenhagen Research Center for Mental Health – CORE, Mental Health Center
Copenhagen, Copenhagen University Hospital, Copenhagen, Denmark
2Department of Biomedical and Clinical Sciences, Linköping University, Linkoping,
3Department of Public Health, University of Copenhagen, Copenhagen, Denmark
4Department for Clinical Medicine, Faculty of Health and Medical Science, University
of Copenhagen, Copenhagen, Denmark

Contributors Authorship is this based on the Vancouver guidelines. All authors
have read, revised and approved the manuscript. MN and NR had the original
idea for the trial. MN wrote the application for the NovoNordic Foundation and is
the PI of the trial. CH generated the allocation sequence, carried out the power
calculations and will be responsible for supervising the statistical analyses. NR
was responsible for the non- experimental content of the CBT. CWC, KSM, CISS, PB
and BA directed the development of the VR films. CWC, KSM, UKG, DS, PW, BA and
PB developed the manual and guidelines for using VRET in group therapy. MH was
responsible for outcome measures. BA and PB developed the Social Presence Scale
and fidelity measures. BA set up randomisation, built and manage the database
and is responsible for all participant assessment, including training and managing
research assistants.

Funding MN and NR initiated the project. MN applied to Novo Nordisk Foundation,
and the SoREAL trial was granted 5.000.000 DKK [NNF17OC0027780]. MN and
NR have no affiliation to the Novo Nordisk Foundation. MN, PB and BA applied to
TrygFonden and the trial was granted an additional 3.517.500 DKK [ID: 146169].
MN, PB and BA have no affiliation to TrygFonden. The project is entirely independent
of the Novo Nordisk Foundation and TrygFonden and therefore, the funding body
plays no role in the design of the study, the collection, analysis and interpretation
of data and in writing the manuscript. Nor will the Novo Nordisk Foundation or
TrygFonden play any role in future publications that may derive from the project.

Competing interests None declared.

Patient consent for publication Not applicable.

Provenance and peer review Not commissioned; externally peer reviewed.

Supplemental material This content has been supplied by the author(s). It has
not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been
peer- reviewed. Any opinions or recommendations discussed are solely those
of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and

11Arnfred B, et al. BMJ Open 2022;12:e051147. doi:10.1136/bmjopen-2021-051147

Open access

responsibility arising from any reliance placed on the content. Where the content
includes any translated material, BMJ does not warrant the accuracy and reliability
of the translations (including but not limited to local regulations, clinical guidelines,
terminology, drug names and drug dosages), and is not responsible for any error
and/or omissions arising from translation and adaptation or otherwise.

Open access This is an open access article distributed in accordance with the
Creative Commons Attribution Non Commercial (CC BY- NC 4.0) license, which
permits others to distribute, remix, adapt, build upon this work non- commercially,
and license their derivative works on different terms, provided the original work is
properly cited, appropriate credit is given, any changes made indicated, and the use
is non- commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

Benjamin Arnfred http://orcid.org/0000-0002-3064-8460
Carsten Hjorthøj http://orcid.org/0000-0002-6943-4785

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82 Harris PA, Taylor R, Thielke R, et al. Research electronic data capture
(REDCap)- A metadata- driven methodology and workflow process for
providing translational research informatics support. J Biomed Inform

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BY-NC. No commercial re-use. See rights and permissions. Published by

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  • Group cognitive behavioural therapy with virtual reality exposure versus group cognitive behavioural therapy with in vivo exposure for social anxiety disorder and agoraphobia: a protocol for a randomised clinical trial
    • Abstract
    • Background
      • Virtual reality exposure therapy for social anxiety disorder and agoraphobia
      • VR exposure in group therapy
      • Treatment of social anxiety disorder and agoraphobia in the Danish mental health system
      • Aim and objectives
      • Primary hypothesis
      • Secondary hypotheses
    • Methods and design
      • Recruitment
      • Inclusion criteria
      • Exclusion criteria
      • Feasibility
      • Treatment format
      • Fidelity to the treatment manual
      • Treatment completion and discontinuation
      • VR equipment
      • VR scenarios
      • Patient and public involvement: development of VR scenarios and manual
      • Assessment
        • Diagnostics
        • Outcomes and sample size calculation
        • Primary outcome
        • Secondary outcomes
        • Explorative outcomes
        • Other measures
      • Data from medical report
      • Setting of assessment
      • Randomisation
      • Blinding
      • Data collection methods and management
      • Statistical methods
        • Dissemination
        • Data monitoring and auditing
        • Safety
      • Trial status
    • References

Treatment Retention Among Patients
Participating in Coordinated Specialty Care
for First-Episode Psychosis: a Mixed-Methods

Jane E. Hamilton, PhD, MPH
Devika Srivastava, PhD
Danica Womack, BS
Ashlie Brown, MEd
Brian Schulz, MEd
April Macakanja, MEd
April Walker, BA
Mon-Ju Wu, PhD
Mark Williamson, MD
Raymond Y. Cho, MD, MSc


Young adults experiencing first-episode psychosis have historically been difficult to retain in
mental health treatment. Communities across the United States are implementing Coordinated

Address correspondence to Jane E. Hamilton, PhD, MPH, Department of Psychiatry and Behavioral Sciences, McGovern
Medical School, University of Texas Health Science Center Houston, 1941 East Road, Suite 1204, Houston, TX 77054,
USA. E-mail: [email protected]

Mon-Ju Wu, PhD, Department of Psychiatry and Behavioral Sciences, McGovern Medical School, University of Texas
Health Science Center Houston, Houston, TX, USA.

Devika Srivastava, PhD, Harris Center for Mental Health and IDD, Houston, TX, USA.
Ashlie Brown, MEd, Harris Center for Mental Health and IDD, Houston, TX, USA.
Brian Schulz, MEd, Harris Center for Mental Health and IDD, Houston, TX, USA.
April Macakanja, MEd, Harris Center for Mental Health and IDD, Houston, TX, USA.
Mark Williamson, MD, Harris Center for Mental Health and IDD, Houston, TX, USA.
Danica Womack, BS, Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX,

April Walker, BA, Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston, TX, USA.
Raymond Y. Cho, MD, MSc, Department of Psychiatry and Behavioral Sciences, Baylor College of Medicine, Houston,


Journal of Behavioral Health Services & Research, 2018. 415–433. c) 2018 National Council for Behavioral Health. DOI

Retention in First Episode Psychosis Treatment HAMILTON ET AL. 415

Specialty Care to improve outcomes for individuals experiencing first-episode psychosis. This
mixed-methods research study examined the relationship between program services and treatment
retention, operationalized as the likelihood of remaining in the program for 9 months or more. In
the adjusted analysis, male gender and participation in home-based cognitive behavioral therapy
were associated with an increased likelihood of remaining in treatment. The key informant
interview findings suggest the shared decision-making process and the breadth, flexibility, and
focus on functional recovery of the home-based cognitive behavioral therapy intervention may
have positively influenced treatment retention. These findings suggest the use of shared decision-
making and improved access to home-based cognitive behavioral therapy for first-episode
psychosis patients may improve outcomes for this vulnerable population.


Approximately 100,000 adolescents and young adults in the United States (U.S.) experience
first-episode psychosis (FEP) each year.1,2 Early intervention with evidence-based treatment is
recommended for clinical and functional recovery for individuals with FEP.3,4 Research supports
the effectiveness of FEP interventions that include low doses of atypical antipsychotic
medications,5,6 cognitive behavioral therapy (CBT),7–10 family education and support,11–13 and
supported employment and education.14,15 Two elements of early intervention in FEP that are
distinct from standard mental health care include early detection and phase-specific treatment.16

The implementation of effective early interventions for FEP can potentially improve patient
outcomes and reduce the burden of illness associated with psychotic disorders. Coordinated
Specialty Care (CSC) is a recovery-oriented treatment program for individuals experiencing FEP.1

Young adults experiencing FEP have historically been difficult to engage and retain in ongoing
mental health treatment.17 Approximately one third of young adults experiencing FEP delay
treatment for 1 to 3 years.18 Once in treatment, the majority of FEP patients drop out within the
first year of care.18 Causes for this alarmingly high rate of early disengagement from treatment
include poor therapeutic alliance, mistrust of the system, and poor insight into the need for
treatment.17 Treatment disengagement has been shown to result in poor clinical outcomes including
symptom relapse and psychiatric hospitalization.17 Thus, FEP interventions seeking to improve
treatment engagement and retention have the potential to improve clinical outcomes for this
vulnerable group. Research suggests that specialized FEP programs are more successful in
engaging young people in mental health services compared to routine care.19 Additionally, FEP
patients participating in specialized FEP clinics remain in treatment longer compared to those in
standard community clinics.20 To engage and retain FEP patients in treatment, CSC utilizes a team-
based approach and offers a continuum of evidence-based services within a framework of
collaborative treatment planning21 and shared decision-making.1,22 The CSC program aims to
personalize treatment for patients to meet recovery-oriented goals focused on developmental

In 2015, a CSC pilot program was implemented at a community mental health clinic in a large
urban area. An evaluation of the pilot program found that the majority of patients who participated
in the CSC pilot project (n = 129) were retained in mental health treatment for 9 months or more,
compared to 72 days on average for patients participating in standard treatment at another safety-
net clinic within the same mental health system. Compared to the continuum of services CSC
patients participated in, standard treatment patients only participated in psychiatric medication
management and case management services. To compare treatment lengths of stay, treatment as
usual patients were randomly identified from a clinic sample (n = 1503 eligible controls) and
matched with CSC patients for age, gender, and psychotic symptom severity. Because the
relationship between CSC service participation and treatment retention remains underexplored, the

416 The Journal of Behavioral Health Services & Research 46:3 July 2019

current study expands upon prior research by examining treatment retention operationalized as the
likelihood of remaining in the CSC program for 9 months or more.


Study design

This mixed-methods study examined utilization data for continuously admitted CSC patients and
interview data from interviews conducted with CSC providers after the program was fully
implemented. This study was approved by the University of Texas Health Science Center Houston
Institutional Review Board (IRB) by expedited review and approval.

Setting and population

The study data were obtained as part of the program evaluation of the CSC program
implemented at a safety-net psychiatric outpatient clinic in a large urban area. The following
eligibility criteria were established for participation in the CSC program:

� Received a qualifying diagnosis (or initiated psychiatric treatment) for a psychotic disorder
within the previous 2 years: schizophrenia spectrum diagnosis, major depressive disorder with
psychotic features, or bipolar disorder with psychotic features;

� Be between the ages of 15–30;
� Be uninsured (cannot be enrolled in Medicaid or commercial insurance); and
� Agree to participate in 7 h per month of CSC services.

Coordinated Specialty Care

The CSC program in the current study was implemented as a comprehensive wrap-around
program designed to meet the individualized needs of patients experiencing FEP. 23 The program
incorporated the core concepts of the Prevention and Recovery in Early Psychosis (PREP(®)
program including a focus on early, evidence-based, person-centered, phase-specific, integrated,
continuous, and comprehensive care).24 Clinic-based CSC services included pharmacotherapy with
a psychiatrist trained in FEP treatment. Home-based services included CBT, supported employment
and education, case management, and peer support.

Pharmacotherapy Each patient enrolled in the CSC pilot program was followed by a psychiatrist
specializing in early psychosis recovery. Pharmacotherapy included the use of lower medication
dosages, establishment of medication adherence practices, monitoring for evolving or changing
psychopathology, emphasis on patient functioning, development of healthy lifestyle habits, and
ensuring optimal metabolic and cardiovascular health through regular primary care services in
coordination with the patient’s psychiatric care.25 Shared decision-making was used to guide
interactions between the CSC psychiatrist and patient.26

Home-Based Cognitive Behavioral Therapy Home-based CBT was delivered by a licensed
master’s level psychotherapist with current Texas certification in CBT. The CBT intervention
provided within the CSC program targeted the following domains: illness management, medication
adherence, residual symptoms, trauma, substance use, life skills, and social/occupational/
educational functioning.

Retention in First Episode Psychosis Treatment HAMILTON ET AL. 417

Supported Employment and Education Home-based supported employment and education
services were delivered by an employment and education specialist utilizing a manualized
intervention to assist patients with reentering the workforce or enrolling in school.

Case Management Home-based case management services were provided by a rehabilitation
clinician who assisted patients in accessing community resources and supports and to navigate the
criminal justice system. Specific linkages to medical and social services included primary care
coordination, food stamp application assistance, and housing program application assistance.

Peer Support A FEP-trained peer support specialist participated as a CSC team member and
provided ongoing support to CSC patients. Using shared decision-making, peer specialists worked
with CSC patients to identify treatment options and to explore treatment preferences.

Patient Assessments Each CSC patient was assessed at program admission and every 90 days
during treatment by a CSC clinician who completed a functional assessment, the Adult Needs and
Strengths Assessment (ANSA).27,28 As part of the ANSA, patient functional improvement and the
severity of each patient’s psychosis/thought disturbance were assessed by a psychotherapist for
each CSC patient to plan for ongoing behavioral health needs. To tailor CBT interventions, two
validated measures of psychotic symptoms, the Positive and Negative Syndrome Scale (PANSS)29

and the Brief Psychiatric Rating Scale (BPRS),30 were administered at intake and after 9 months of
service participation. To improve program implementation fidelity, the study investigators
conducted ten onsite PANSS and BPRS assessment trainings with the psychotherapists from
June 2015 through January 2016. Inter-rater reliability was established during four trainings and
ranged from 70 to 85%.

Study protocol, measurements, and outcome measures

To systematically examine predictors of treatment retention for CSC patients, Andersen’s
Behavioral Model of Health Services Use was used to select study variables and to organize the
study findings. The Andersen model conceptual framework includes factors shown in a number of
studies to explain variation in health service use among vulnerable populations.31,32 In adapting the
framework for the study, the association of factors of these types with remaining in the CSC
program for 9 or more months was examined. Treatment retention for 9 months or more was
established as the outcome measure as this time point allowed for three completed ANSA
functional assessments by CSC providers. The research questions for the study were:

1. Do predisposing factors including the patient’s age, gender, or race/ethnicity differentially
predict treatment retention for FEP patients?

2. Do enabling factors including the type of mental health or social support services
differentially predict treatment retention for FEP patients?

3. Do need factors including the patient’s primary psychiatric diagnosis and psychotic symptom
severity differentially predict treatment retention for FEP patients?

Predisposing, enabling, and need factors identified in prior research as being associated with the
utilization of mental health services and treatment retention were included as predictors in the
multivariate analysis. In the Andersen model, predisposing (characteristics of the individual, i.e.,
age, sex, race/ethnicity), enabling (system or structural factors that make health service resources

418 The Journal of Behavioral Health Services & Research 46:3 July 2019

available to the individual), and need (clinical) factors are posited to act independently or together
to influence patterns of healthcare utilization and outcomes for individuals with SMI.32,33 The
predisposing factors examined included age,33–38 sex,36,37and racial/ethnic minority status.38–42

The enabling factors examined included CSC service components (home-based CBT, supported
employment and education, case management, and peer support).5–15 The need factors examined
included primary psychiatric diagnosis and psychotic symptom severity. 37,42–46 The conceptual
model for the study shown in Fig. 1 was adapted from prior research using the Andersen
framework. 47–50

Data analysis

Quantitative Treatment retention was examined for all continuously admitted CSC patients
between November 1, 2014, and June 30, 2016. Chi-square tests of homogeneity and independent t
tests were calculated to determine whether differences in predisposing, enabling, and need factors
between remaining in CSC treatment for 9 months or more or discontinuing treatment were
statistically significant (p G 0.05; p G 0.001) for categorical and continuous variables, respectively.
To examine the influence of the factors in the Andersen model on treatment retention, logistic
regression analysis was used for predictive modeling. Treatment retention was dichotomized as a
binary outcome variable: discontinuing treatment/remaining in treatment. Unadjusted analyses
were conducted to examine the relationship between each predictor variable and treatment
retention. To estimate the odds of treatment retention, a logistic regression model was fitted using
block-wise entry of variables. Block-wise entry of variables enabled the contribution of
predisposing, enabling, and need variables to be examined separately as blocks as done in prior
research using the Andersen model to examine psychiatric service utilization.48–50 Prior to
conducting the multivariate analysis, the appropriate diagnostic checks were completed to ensure
the model fits sufficiently well and to check for influential observations impacting the estimates of
the coefficients. Age was moderately positively skewed, and a square root transformation was
undertaken.51,52 The sample was examined for data entry mistakes and for missing data. All data
were complete and no data entry mistakes were identified; therefore, data for all 129 patients were
included in the analyses. The multivariate model was examined for multicollinearity by examining

Figure 1
Andersen Behavioral Model of Health Services Use

Retention in First Episode Psychosis Treatment HAMILTON ET AL. 419

Predisposing Factors

Need Factors

Enabling Factors

Case Management

Peer Support



Primary Diagnosis
Psychosis Symptoms


the variance inflation factors (VIFs) for all the variables in the model. All VIFs were less than 2.0,
indicating multicollinearity did not affect the variance of the model.53 The fit of the logistic model
was examined using the Omnibus tests of model coefficients, the classification table, the Hosmer-
Lemeshow goodness-of-fit test, and the Cox/Snell and Nagelkerke pseudo r-squared (R2). Due to
the small sample size (n = 129) and the number of predictors included in the multivariate model
(n = 9), bootstrapping with random sampling with replacement was utilized to validate the model.
Bootstrapping, a Monte Carlo simulation technique, allows assigning measures of accuracy to
sample estimates.54,55

Qualitative To supplement the quantitative analysis findings, nine key informant interviews were
conducted with CSC providers who had first-hand knowledge of CSC program services and
patients. Interview participants included two CSC clinical team leads, one psychiatrist, three CSC
psychotherapists, one supported employment and education specialist, one rehab clinician, and one
peer support specialist. Grounded theory was utilized as a conceptual framework for identifying
themes and generating a theoretical explanation for treatment retention within the CSC
program.56,57 The key informant interviews were designed to obtain detailed information across
four domains including (1) CSC program characteristics and resources; (2) CSC program
implementation successes and barriers; (3) patient engagement, utilization, and medication
adherence; and (4) factors affecting patient clinical and functional outcomes. All key informant
interviews were conducted using a semi-structured interview instrument (Table 1). The key
informant interviews were conducted in person by the study principal investigator (PI). A research
assistant assisted with the key informant interviews by observing the interviews, taking notes, and
asking additional questions to ensure interview data quality. The only participant not interviewed in
person was the peer support specialist, who was on bereavement leave and participated in a
telephone interview with the PI. Prior to beginning each interview, informed consent was obtained
for each participant, who was informed that anything they said during the interview would be held
in the strictest confidence and they would not be quoted directly. Participants were told if they
chose not to participate in the interview, their decision not to participate would not be disclosed to
their employer. Participants were given the opportunity to ask any questions or voice any concerns
prior to being asked the first interview question. All interviews were recorded and transcribed. The
interview data was aggregated, and a coding rubric was developed to code interviews. Two of the
investigators (J.H. and D.W.) used an iterative, open-coding approach to identify major themes in
the key informant interview data.58 Each investigator worked independently when coding the
interview data and was blinded to the coding used by the other investigator until the coding process
was completed. The inter-coder agreement for two coders using Krippendorff’s alpha was 90% (−
0.039) for n = 40 cases (36 agreements, four disagreements).59 Disagreements in coding were
resolved through negotiated consensus, refining, and finalizing the coding structure. During the
indexing process, the coders documented how many times a particular response to an interview
question was made by an interviewee to identify themes and underlying theoretical constructs. The
final indexed text providing a listing and frequency of the codes mentioned in the interview text
(overall, within each interview, and across interviews) is presented in Table 2. Across interviews, if
a particular comment was made only once, then the comment was not included. If a response was
made by two interviewees, then it was reported as an issue raised by a few interviewees. If a
response was made by three interviewees, then it was reported as an issue raised by several
interviewees. If an issue was raised by five or more interviewees, then it was reported as an issue
raised by the majority of interviewees.60 Using grounded theory to guide the termination of the
data analysis, saturation was defined as the point at which no new codes were occurring in the
data61 and as the point at which a complete range of theoretical constructs was fully represented by
the data.62 Member checking was conducted to improve the quality of the interpretation and to

420 The Journal of Behavioral Health Services & Research 46:3 July 2019

Table 1
Semi-structured interview instrument

Domain One: CSC Program Characteristics, Resources and Services
1) What program services and/or characteristics do you think were most effective in
contributing to patient success?

2) What aspects of the program, if any, had less impact on patient success?
3) Which program resources were most helpful in achieving program success and why?
4) Were there resources you needed that weren’t available? Yes/No
5) If yes, how could we improve access to resources?
6) Do you think all the needed services were offered to patients? Yes/No
7) If not, are there any additional services that you would recommend?
Domain Two: Challenges and Benefits of Implementing the CSC
8) What are the factors that led to beneficial outcomes of the program? Please comment on
each outcome below.
a. Patient clinical improvement
b. Patient functional improvement
c. Treatment Adherence/Engagement
d. Reduced hospitalizations
e. Obtaining Employment
f. Maintaining Employment
g. Education
h. Housing
i. Primary Care Coordination
9) What were the main challenges you faced implementing CSC?
10) What resources would help in resolving challenges to implementing CSC?
11) Please describe factors that contributed to patient discontinuation of services/unplanned

Domain Three: Patient Engagement, Utilization, and Treatment Adherence
12) Please describe how patient engagement in CSC services was successful.
13) What are ways that you would recommend to improve patient engagement?
14) What contributed to low SES scores (poor engagement) in each of the following domains:
a. Engagement
b. Collaboration
c. Help-seeking
d. Treatment adherence
15) To what extent were barriers to engagement due to each of the following and how could
they be addressed:
a. Clinical factors (e.g. clinical symptoms/cognitive functioning)
b. Social factors (e.g. poverty, unemployment, lack of other resources)
c. Program characteristics (e.g. program design)
d. System features (e.g. health insurance policy such as patients obtaining Medicaid or
commercial insurance)

16) Overall, how would you describe your patients’ consistency with attending scheduled

17) What do you believe are the most prominent reasons for patient drop-out?
18) What services are patients missing out on upon being discharged due to enrollment in
Medicaid or commercial insurance?

Domain Four: Factors Affecting Patient Clinical and Functional Outcomes
19) What have been challenges regarding each outcome below?

Retention in First Episode Psychosis Treatment HAMILTON ET AL. 421

validate the qualitative analysis findings.63 To protect participant confidentiality, aggregated
interview data was provided to participants for the purpose of verifying the plausibility of and for
obtaining feedback on the findings. 64,65 The researchers triangulated emerging insights with
patient interview data obtained from two semi-structured interviews conducted as part of the CSC
program evaluation.66 The major themes that emerged from the analysis of the key informant
responses are described in the BResults^ section.


Sample characteristics

During the study period, 129 patients were enrolled in CSC services, and 76 (58.9%) were
retained in treatment for 9 or more months. The majority of CSC patients were male (58.9%) and
African American (53.9%). While the CSC program was developed for patients diagnosed with
emerging schizophrenia, a substantial proportion of the patients served within the CSC program
were diagnosed with major depressive disorder with psychotic features (25.6%) or bipolar
disorder with psychotic features (20.9%). While all CSC patients were followed by the CSC
psychiatrist, additional CSC services were offered to patients through a shared decision-making
process. Most patients chose to participate in case management (79.8%) and home-based CBT
(57.4%); however, less chose to participate in supported employment and education (33.3%), and
peer support services (22.5%). A full listing of sample characteristics is included in Table 3.

Statistical analysis

To test the hypothesis that predisposing, enabling, and need factors differentially predicted
treatment retention, a logistic regression model with block-wise entry was conducted. The final
adjusted analysis included all 129 continuously admitted patients. On adjusted analysis, among
predisposing factors, male gender became significantly associated with the odds of being retained
in CSC services for 9 or more months. Compared to females, males were three times more likely
to be retained in treatment (adjusted odds ratio [aOR] = 2.989, 95% confidence interval [CI] =
1.154 to 7.742, p = 0.024). Among enabling factors, participating in home-based CBT remained
significantly associated with the odds of treatment retention. Compared to patients who did not
participate in home-based CBT, patients who participated in home-based CBT were 7.3 times
more likely to be retained in treatment (aOR 7.278, CI 2.803 to 18.900, p G 0.001). The explained
variance of the total model containing all significant predictor variables by Cox/Snell and
Nagelkerke pseudo R2 was 0.293 and 0.395, respectively. The Hosmer and Lemeshow goodness-

a. Patient clinical improvement
b. Patient functional improvement
c. Treatment Adherence/Engagement
d. Reduced hospitalizations
e. Employment
f. Education
g. Housing
h. Primary Care Coordination
20) Do you have any patient stories you can share where the patient’s course of illness
worsened after being discharged from CSC due to obtaining Medicaid or commercial

422 The Journal of Behavioral Health Services & Research 46:3 July 2019

Table 2
Listing and frequency of the codes mentioned in the interview text

Code frequency within semi-structured interview data

Code Mentioned

within same

Number of

Multidisciplinary team approach
Multidisciplinary teamwork 26 6 7
Offering multiple layers of support
(wrap-around services)

7 2 5

Collectively reinforcing treatment
engagement and medication adherence

14 3 8

Working together to provide
educational and vocational support

10 4 5

Weekly treatment team meetings 2 – 2
Improved staff awareness of patient
clinical issues and engagement

3 2 2

Emphasizing patient functioning 4 – 4
Collectively reinforcing life skills 7 – 7
Reinforcing trust and connection
between patients and other providers
(therapeutic alliance)

9 2 7

Provider flexibility
Small caseloads 3 – 3
Same-day appointments for patients
in crisis

5 2 3

Creative therapy methods to improve

8 3 5

Providing opportunities to re-engage 2 – 2
Working evening and weekend hours 4 – 4
Overwhelmed with multiple providers
and services (team-based services)

5 – 5

Taking on responsibilities beyond
traditional roles

8 2 6

Adapting the CBT curriculum
for CSC

11 3 5

Addressing patient engagement

10 2 9

Providing psychoeducation 8 4 5
Teaching life skills 7 2 6
Shared decision-making
Program philosophy 3 – 3
Patients choosing services
and providers

5 – 5

Peer support 2 – 2
Patient communication about 3 – 3

Retention in First Episode Psychosis Treatment HAMILTON ET AL. 423

of-fit test indicates a good model fit (χ2 = 7.256, degrees of freedom [df] = 8, p = 0.509). The
Omnibus test of model coefficients was highly significant, also indicating that the full model as a
whole fits significantly better than the null model and the independent variables predicted the
dependent variable well (χ2 = 44.738, df = 9, p G 0.001). The classification table was examined for
each block in the logistic regression model. The overall percentage of cases for which the
dependent variables were correctly predicted was 58.9% in the null model and 76.7% in the full
model. Both male sex (beta [β] = 1.095, CI 0.177 to 2.420, p = 0.020) and participation in home-
based CBT (β = 1.985, CI 1.098 to 3.595, p = 0.001) were significantly associated with treatment
retention in the bootstrap analysis. Thus, the significant findings for these predictor variables in
the multivariate model were validated in the bootstrap analysis. While not a significant predictor
in the multivariate analysis, African American race became a marginally significant predictor in
the bootstrap analysis (β = − 1.285, CI − 3.115 to 0.015, p = 0.047). Among predisposing,
enabling, and need factors, in the adjusted analysis, the largest change in pseudo R2 occurred with
the addition of the second block of enabling factors (R2 increase = 0.312) followed by the first
block of predisposing factors (R2 increase = 0.054). The smallest change in pseudo R2 occurred
with the addition of the third block of need factors (R2 increase = 0.029). A full listing of the
results of the unadjusted, adjusted, and bootstrap analyses is presented in Table 4.

Table 2

Code frequency within semi-structured interview data

Code Mentioned

within same

Number of

values and preferences
Patient-centered and individualized
(meeting patients where they
are at)

12 3 3

Readiness for program participation 7 5 4
Patient engagement barriers
Negative symptoms of psychosis 4 2 3
Prior trauma 3 – 3
Stigma 4 – 4
Lacking insight 7 2 5
Substance use 12 5 6
Criminal justice issues 2 – 2
Low intellectual functioning 3 – 3
Family conflict and lack of support 13 3 4
Limited social support 17 4 4
Poverty/lack of basic resources 9 2 7
Change in insurance status 15 14 6
Change in employment status 3 2 2
Housing instability/homelessness 6 5 5
Medication non-adherence 21 6 8

424 The Journal of Behavioral Health Services & Research 46:3 July 2019

Grounded theory

Four major themes were drawn from the key informant interviews: (1) multidisciplinary team
approach, (2) provider flexibility, (3) shared decision-making, and (4) patient engagement barriers.

Multidisciplinary Team Approach Across program services, providers reported that the
multidisciplinary team approach within CSC enabled them to offer multiple layers of support to
patients. According to a CSC provider, Bworking as a multidisciplinary team, we are able to
reinforce trust and connection between patients and other providers on the treatment team.^
Multiple providers reported using the team-based approach to address patient medication adherence
and improve functioning. A few providers identified weekly treatment team meetings as beneficial
in increasing their awareness of patient clinical issues and engagement problems. A theme emerged
among providers that the emphasis on patient functioning was a strength of the CSC program, and
through multidisciplinary teamwork, they could collectively reinforce life skills to improve patient
functioning. One patient reported that the CSC program helped her Bsee other options and gain
independence.^ Working with her CSC treatment team, she reported reaching her psychotherapy
goals to reduce hopelessness and suicidal thoughts and finding a medication regimen that worked.

Table 3
CSC sample characteristics

Characteristic Total N (%) Treatment retention
≥ 9 months N (%)

Chi-square (df) p value

Sex 3.612 (1) 0.057
Male 76 (58.9) 50 (65.8)
Female 53 (41.1) 26 (49.1)
Age (years) – 0.922
Age mean (SD) 23.14 (3.35) 23.12 (3.32) –
Race/ethnicity 7.527 (2) 0.023*
Non-Hispanic White 55 (42.6) 33 (60.0)
African American 69 (53.5) 43 (62.3)
Other race/ethnicity 5 (3.9) 0
Primary diagnosis 4.962 (2) 0.084
Schizophrenia spectrum 69 (53.5) 40 (58.0)
Bipolar disorder with
psychotic features

27 (20.9) 12 (44.4)

Major depressive disorder
with psychotic features

33 (25.6) 24 (72.7)

Intervention component
Home-based CBT 74 (57.4) 58 (78.4) 27.164 (1) 0.000**
Case management with a
rehab clinician

103 (79.8) 67 (65.0) 7.943 (1) 0.005*

Supported employment
and education

43 (33.3) 30 (69.8) 3.139 (1) 0.076

Peer support 29 (22.5) 23 (79.3) 6.429 (1) 0.011*

*p G 0.05
**p G 0.001

Retention in First Episode Psychosis Treatment HAMILTON ET AL. 425


































































































































































426 The Journal of Behavioral Health Services & Research 46:3 July 2019

Provider Flexibility The majority of CSC providers reported that provider flexibility was critical
to engaging and retaining FEP patients in CSC services. Across CSC services, providers reported
that their small caseloads enabled them to focus on engaging CSC patients in treatment. To help
patients avoid psychiatric hospitalization, several providers reported scheduling same-day
appointments with patients in crisis. Multiple providers reported using creative methods including
art therapy, role-playing, and outside activities to engage CSC patients. For patients who were not
engaging, providers reported Btrying to give patients the opportunity to re-engage.^ During the
interviews, several providers reported calling patients at night and on weekends to check in with
them to faciliate re-engagement. To keep patients engaged after their functioning improved,
providers reported working evening and weekend hours to accommodate patient work schedules.
For patients who were overwhelmed working with multiple CSC providers, the psychotherapists
provided case management and vocational support in addition to psychotherapy to reduce the
number of providers working with the patient. One provider reported Bwe all do case
management.^ A theme emerged among providers that they would take on responsibilities beyond
their traditional roles to meet patient needs. When asked what CSC program characteristics were
less helpful, the psychotherapists described difficulties working with patients with elevated
negative symptoms of psychosis and explained how more flexibility was needed when working
with CSC patients than was provided in the CBT curriculum they were using. Additionally, the
majority of CSC providers raised concerns that patients with substance use issues, who were lower
functioning intellectually, or who had families who were unsupportive seemed to do less well in the
CSC program overall. Both patients reported that the flexibility of their psychotherapists helped
them remain in treatment during housing and job transitions. Additionally, they reported that
setting goals and problem solving with their psychotherapist helped them get better. One patient
reported that before participating in psychotherapy, BI was having a difficult time opening up to
people, and now I am able to think more positively and be a better parent.^ The other patient
reported that the CSC team Bmakes me feel I am not forgotten…everybody on the team is really
flexible, meets me where I am at, helps me to get connected, and live independently.^

Shared Decision-Making A perception emerged among providers that the shared decision-
making philosophy of the program increased program retention because patients could choose
which program services to participate in and which providers to work with. A few providers
discussed how peer support specialists, who had personal experiences with mental illness and
recovery, were instrumental in engaging CSC patients in shared decision-making. One provider
reported that the shared decision-making philosophy of the CSC program Ballowed patients to have
a say and gave them options on choosing what services they wanted.^ Another provider reported
that shared decision-making enabled Bpatients to be honest and up front with what they want to do
from the start.^ One patient reported that within the CSC program, BI am the driver of my
treatment…I am more open now… I am able to talk a lot now.^ While the majority of providers
described the shared decision-making model within the CSC program as Bpatient-centered and
individualized,^ the majority of providers also reported that some patients were Bnot ready^ for
involvement in treatment decisions and were Btoo acute^ for the CSC program.

Patient Engagement Barriers Providers identified multiple reasons for patient disengagement
from the CSC program including substance use, criminal justice issues, obtaining commercial
insurance or Medicaid, obtaining social security disability, obtaining a job, or moving out of the
area. When asked about factors contributing to poor engagement, a few providers reported that
prior traumatic experiences and stigma surrounding mental illness impeded help-seeking among
some patients. Multiple providers reported that CSC patients lacked insight into their mental illness

Retention in First Episode Psychosis Treatment HAMILTON ET AL. 427

and benefitted from psychoeducation. Several providers reported that some CSC patients were
living with family members who were not supportive of their recovery and were in denial of their
mental health conditions. A few providers suggested an intervention targeting family members was
needed to improve patient engagement and medication adherence. Several additional factors were
identified as contributing to patient disengagement. One provider reported Bsome patients have
significant environmental stressors…they lose jobs and relationships and they get evicted from
their homes.^ Another provider reported Bpatients can be stable for months and then stop taking
their medications.^ While the patients acknowledged experiencing family conflict and significant
environmental stressors prior to CSC program participation, they discussed how CSC program
services enabled them to obtain employment, improve relationships with family members, and feel
better about their lives.


In the study, the majority of CSC patients (59%) were retained in treatment for 9 or more
months, which contrasts previous research findings.18 The study findings are particularly salient
given the challenges of treatment retention among FEP patients. In the adjusted analysis, male
gender and participation in home-based CBT were associated with an increased likelihood of
treatment retention. The finding that males were more likely to be retained in treatment is
interesting, as prior research has consistently associated male gender with treatment discontinu-
ation.34,36,67–69 In the CSC program, 59% of CSC patients were male. While one of the
psychotherapists was male and many of the male patients were referred to him for psychotherapy,
prior research has not found gender matching in counseling settings to improve retention rates.70

The block of enabling factors explained more of the variation in treatment retention than
predisposing or need factors. The finding that patients participating in home-based CBT were
approximately seven times more likely to be retained in CSC treatment for 9 or more months is
encouraging as FEP patients have been shown to obtain both clinical and psychosocial benefits
from CBT.71 Among the domains targeted within the CBT intervention, the majority of CSC
providers reported that medication adherence was critical to retaining patients in the CSC program.
CSC providers discussed strategies for improving medication adherence during weekly treatment
team meetings that each provider could reinforce separately with the same patient. Working as a
team, the psychiatrist and psychotherapists reinforced medication adherence strategies used by the
CSC case manager with patients including the use of medication fill boxes for organizing
medications. Additionally, the psychotherapists reported addressing medication adherence through
discussion of residual symptoms of psychosis. The study findings raise the question as to why case
management, supported employment and education, and peer support were not significantly
associated with being retained in treatment in the adjusted analysis. As suggested in prior research
reviews,71 three characteristics of the CSC home-based CBT intervention, including its focus on
breadth, functional recovery, and flexibility, may have been particularly helpful in retaining patients
in the CSC program. First, the focus of the CBT intervention on multiple domains may have been
especially beneficial for CSC patients. Research has found CBT approaches for the FEP population
that only emphasize one area of concern such as psychotic symptoms have the greatest benefit in
the short term (within 90 days).72,73 Second, the focus of the CSC CBT intervention on functional
recovery may have improved the longer-term prognosis of the patients participating in the CBT
intervention compared to patients who did not participate in CBT.70,73–75 Because individuals
experiencing FEP are at risk for lagging behind their peers in reaching developmental milestones,
CBT interventions that emphasize improvements in social/occupational/educational functioning are
recognized as important components of FEP interventions.76,77 Finally, the flexibility of the
individually tailored CBT intervention provided within the CSC program is consistent with FEP
best practices, given the heterogeneity of early psychosis.78 In particular, CSC psychotherapists

428 The Journal of Behavioral Health Services & Research 46:3 July 2019

reported that case consultations during FEP training were beneficial in tailoring CBT interventions
for patients who needed more flexibility. It is also possible that the provision of CBT in patient
homes positively influenced the impact of this service component on treatment retention by
increasing access to evidence-based psychotherapy for a difficult to engage population. Because
past studies examining the effectiveness of CBT with FEP patients have been primarily conducted
as randomized trials in clinical settings,79 additional effectiveness studies are needed to examine
the impact of home-based CBT on FEP outcomes.

During the study period, 18 CSC patients (14%) were admitted to a psychiatric hospital while
participating in CSC services. The providers identified several factors during the key informant
interviews that could be related to the low rate of psychiatric hospitalization including the
scheduling of same-day appointments for patients in crisis and calling patients at night and on
weekends to check in with them to facilitate re-engagement. While CSC patients who participated
in case management were 3.5 times more likely to be retained in treatment in the unadjusted
analysis, the relationship disappeared when adjusting for other factors in the multivariate model.
Due to the high level of needs within the CSC patient population, providers from other CSC
program services were also providing case management to CSC patients. Accordingly, the impact
of case management on treatment retention may be more difficult to elucidate. While participation
in supported employment and education was not significantly associated with treatment retention in
the unadjusted or adjusted analyses, 43 patients (33.3%) obtained employment while participating
in CSC and 27 patients (20.9%) enrolled in school. During the key informant interviews, the CSC
psychotherapists reported discussing life goals and conducting mock interviews during CBT
sessions. In cases where a patient discontinued services because of employment, dropout from the
program may be an indicator of a successful outcome and warrants further exploration.
Interestingly, peer support was not significantly associated with treatment retention in the
unadjusted or adjusted analysis. While not a part of the original RAISE model, peer support
models are becoming increasingly popular with both patients and providers.80 The key informant
interview findings suggest peer support services were popular with other CSC providers and were
perceived as beneficial in improving patient outcomes.

Among individuals with FEP, shared decision-making is increasingly promoted as a preferred
approach for providing person-centered care.17,80,81 The use of shared decision-making within the
CSC program may have positively influenced treatment retention. According to the shared
decision-making model, a provider’s role is to educate patients about available treatments, to
acknowledge and help clarify their preferences and values, and to empower them to take an active
role in the decision-making process.80 While each CSC patient participated in 7 h of services per
month, the types of services (CBT, case management, supported employment and education, peer
support) varied according to the preferences and treatment goals of the individual patient. To help
clarify values and preferences, a peer specialist met with each CSC patient during program
enrollment to share personal experiences with mental illness, provide patient education, and elicit
any concerns about participation in the CSC program. Thus, the study findings may indicate a need
for further development and testing of best practices in the use of shared decision-making by peer
support specialists to identify effective approaches within this service delivery component.

The strengths of the study include the diverse sample of patients continuously admitted to an
evidence-based program implemented in a real-world setting. Additionally, while the CSC program
was developed in the northeastern U.S., the current study was conducted in a large urban area in the
southern U.S. Accordingly, the study findings increase the generalizability of the effectiveness of the
CSC program in additional U.S. regions. Another strength of this study is the inclusion of patients in the
CSC program who were diagnosed with bipolar disorder with psychotic features or major depression
with psychotic features, which expands generalizability to individuals with affective psychoses.

Study limitations include limited patient interview data. Due to patient transportation barriers
and work schedules, only two key informant interviews with patients were conducted for the

Retention in First Episode Psychosis Treatment HAMILTON ET AL. 429

program evaluation. Additionally, both of the patients interviewed were treated by the same
psychotherapist, who transported her patients to the interviews. Another limitation included only
obtaining interview data for female patients, even though male patients were more likely to be
retained in treatment for 9 months or more. Because a different semi-structured interview
instrument was used to conduct the patient interviews, the data were included in the qualitative
analysis for triangulation but were not included in the initial indexing process. Accordingly,
member checking with CSC providers was conducted to validate the qualitative analysis findings.
Limitations of the study also include the implementation of the CSC program at only one clinic.
Hence, the study findings may be unique to provider practices at the clinic and/or to the FEP
population served by the clinic. However, because the patients served within the CSC program
were referred across the region served by the public mental health system, the patients are
representative of FEP patients served within a safety-net system. To increase generalizability at the
system level, future effectiveness research on the CSC program should be conducted within larger
systems of care. Another study limitation includes limiting CSC enrollment to uninsured patients,
which limits generalizability to this population. The requirement that CSC patients be uninsured
was a result of Texas public policy. This policy requirement was recently changed, and individuals
with Medicaid and commercial insurance are now able to participate in the CSC program in Texas.


This study is novel in examining treatment retention among FEP patients participating in the
CSC program in a real-world setting within a public mental health system. The block of enabling
factors was the strongest predictor of treatment retention compared to predisposing and need
factors. The findings provide preliminary evidence of the benefits of participating in home-based
CBT for improving treatment retention for FEP patients. Among predisposing factors, male gender
was associated with an increased likelihood of treatment retention, which contrasts with previous
research findings. The addition of a male therapist to the treatment team may have increased patient
engagement for some FEP male patients. Additionally, the use of the shared decision-making along
with the high overall treatment retention rate has important implications for FEP treatment.

Implications for Behavioral Health

The use of shared decision-making and improved access to home-based CBT for FEP patients, a
population at high risk for treatment dropout, may be needed to improve outcomes for this
vulnerable population. Future studies can investigate the necessity of the home-based context for
CBT delivery, perhaps making it more impactful or simply enhancing accessibility, or whether
CBT administered in a more traditional outpatient setting could be equally effective. Findings from
such investigations would inform decisions regarding the setting of CBT, including considerations
of impact on the time and budget required. The presence of male therapists on the CSC treatment
team as well as the use of several innovative strategies (shared decision-making and peer support)
suggests opportunities for adapting interventions for FEP patients to increase treatment retention.
Additionally, the emphasis on patient functioning is a strength of the CSC program as individuals
experiencing FEP are at risk for lagging behind their peers in reaching developmental milestones.

Compliance with Ethical Standards

This study was approved by the University of Texas Health Science Center Houston Institutional
Review Board (IRB) by expedited review and approval.

Conflict of Interest The authors declare that they have no conflict of interest.

430 The Journal of Behavioral Health Services & Research 46:3 July 2019


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Retention in First Episode Psychosis Treatment HAMILTON ET AL. 433

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  • Analysis
    • Abstract
    • Introduction
    • Methods
      • Study design
      • Setting and population
      • Coordinated Specialty Care
      • Study protocol, measurements, and outcome measures
      • Data analysis
    • Results
      • Sample characteristics
      • Statistical analysis
      • Grounded theory
      • Discussion
    • Conclusion
    • Implications for Behavioral Health
    • Compliance with Ethical Standards
    • References

An Investigation into the Feasibility of Intensive Cognitive

Behavioural Therapy

A thesis submitted to The University of Manchester for the
degree of Doctor of Clinical Psychology

in the Faculty of Biology, Medicine and Health


Lauren Hampson

School of Health Sciences
Division of Psychology and Mental Health

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Table of Contents

Figures and Tables ………………………………………………………………………………………. 5

Table of Appendices ……………………………………………………………………………………. 6

Word Counts ………………………………………………………………………………………………. 8

Overall Abstract …………………………………………………………………………………………. 9

Declaration ………………………………………………………………………………………………. 10

Copyright Statement ………………………………………………………………………………….. 10

Acknowledgments …………………………………………………………………………………….. 11

Dedication ……………………………………………………………………………………………….. 12

Introduction to Paper I ……………………………………………………………………………. 13

Paper I Systematic Review ………………………………………………………………………. 14

1. Abstract ……………………………………………………………………………………………….. 15

2. Introduction ………………………………………………………………………………………….. 16

2.1 Mental Health and Psychological Distress ………………………………………………. 16

2.2 Cognitive Behavioural Therapy …………………………………………………………….. 17

2.3 Components of Cognitive Behavioural Therapy ………………………………………. 18

2.4 Clinical Guidelines for Delivery of CBT ………………………………………………… 19

2.5 Intensive CBT ……………………………………………………………………………………… 21

2.6 Review Aims ………………………………………………………………………………………. 22

3. Method …………………………………………………………………………………………………. 23

3.1 Review Protocol ………………………………………………………………………………….. 23

3.2 Search strategy ……………………………………………………………………………………. 23

3.3 Inclusion Criteria …………………………………………………………………………………. 25

3.4 Quality Assessment ……………………………………………………………………………… 25

3.5 Analysis of Studies ………………………………………………………………………………. 26

4. Results …………………………………………………………………………………………………. 28

4.1 Description of Papers …………………………………………………………………………… 28

4.2 Quality of Studies ………………………………………………………………………………… 34

4.3 Participants …………………………………………………………………………………………. 36

4.4 Characteristics of Intensive CBT …………………………………………………………… 36

4.5 Effects of Intensive CBT ………………………………………………………………………. 37

4.6 Long Term Follow Up ………………………………………………………………………….. 43

4.7 Acceptability ………………………………………………………………………………………. 43


5. Discussion ……………………………………………………………………………………………. 45

5.1 Summary of Evidence ………………………………………………………………………….. 45

5.2 Strengths and Limitations ……………………………………………………………………… 48

5.3 Clinical Implications and Future Directions ……………………………………………. 50

5.4 Conclusions ………………………………………………………………………………………… 52

6. References ……………………………………………………………………………………………. 53

Introduction to Paper II …………………………………………………………………………… 62

Paper II Research Study ………………………………………………………………………….. 63

1. Abstract ……………………………………………………………………………………………….. 64

2. Introduction ………………………………………………………………………………………….. 65

3. Method …………………………………………………………………………………………………. 69

3.1 Study Design ………………………………………………………………………………………. 69

3.2 Participant Sample ……………………………………………………………………………….. 69

3.3 Inclusion Criteria …………………………………………………………………………………. 69

3.4 Recruitment ………………………………………………………………………………………… 70

3.5 Procedure ……………………………………………………………………………………………. 72

3.6 Measures …………………………………………………………………………………………….. 72

3.7 Intervention ………………………………………………………………………………………… 75

3.8 Data Analysis ……………………………………………………………………………………… 77

3.9 Ethical Approval ………………………………………………………………………………….. 78

4. Results …………………………………………………………………………………………………. 80

4.1 Demographic and Clinical Characteristics ………………………………………………. 80

4.2 Feasibility Outcome Measures (Hypothesis One) …………………………………….. 80

4.3 Clinical Outcome Measures (Hypothesis Two) ……………………………………….. 84

5. Discussion ……………………………………………………………………………………………. 87

5.1 Acceptability and Feasibility …………………………………………………………………. 87

5.2 Clinical Outcome …………………………………………………………………………………. 90

5.3 Strengths and Limitations ……………………………………………………………………… 92

5.4 Further Clinical and Research Considerations …………………………………………. 93

6. References ……………………………………………………………………………………………. 95


Introduction to Paper III ……………………………………………………………………….. 102

Paper 3: Critical Reflection Paper ………………………………………………………….. 103

Overview …………………………………………………………………………………………………. 104

1. Paper I: Systematic Review …………………………………………………………………… 105

1.1 Rationale for the Review …………………………………………………………………….. 105

1.2 Scoping and Database Searching………………………………………………………….. 106

1.3 Quality Appraisal ………………………………………………………………………………. 107

1.4 Synthesising Results …………………………………………………………………………… 108

1.5 Limitations ………………………………………………………………………………………… 108

1.6 Clinical Implications and Future Directions ………………………………………….. 109

1.7 Conclusions ………………………………………………………………………………………. 110

2. Paper II: Empirical Study ……………………………………………………………………… 111

2.1 Study Aims and Rationale …………………………………………………………………… 111

2.2 Development Stage …………………………………………………………………………….. 111

2.3 Recruitment Considerations ………………………………………………………………… 112

2.4 Conducting Research in Prison ……………………………………………………………. 114

2.5 The Role of Clinical Psychology in Prison ……………………………………………. 117

2.6 Delivering Psychological Intervention in Prison …………………………………….. 118

2.7 System-level Considerations ……………………………………………………………….. 120

2.8 Final Considerations …………………………………………………………………………… 121

3. References ………………………………………………………………………………………….. 123

Appendices ……………………………………………………………………………………………. 128

1. Paper I: Systematic Review …………………………………………………………………… 128

2. Paper II: Empirical Study ……………………………………………………………………… 144

3. Paper III: Critical Review Paper…………………………………………………………….. 229


Figures and Tables

Paper I: Systematic Review

Figure 1: A PRISMA Chart to Outline Screening and Eligibilty Procedures …….. 24

Table 1: Characteristics of Studies …………………………………………………………. 29-33

Table 2: Component and Global Quality Ratings using the EPHPP …………………. 35

Table 3: Changes to Mean Scores and Calculated Effect Sizes for Psychological

Distress Associated with Mental Health ……………………………………………………… 39

Table 4: Changes to Mean Scores and Calculated Effect Sizes for Pain ………….. 41

Table 5: Changes to Mean Scores and Calculated Effect Sizes for Distress

following Trauma ……………………………………………………………………………………… 42

Paper II: Empirical Paper

Figure 1: Consort Diagram of Recruitment and Study Retention …………………….. 71

Figure 2: A Box Plot to Demonstrate Therapists Rating of Adherance to Therapy

……………………………………………………………………………………………………………….. 83

Figure 3: Suicide Ideation as Rated by Participants and Therapists, across all Five

Sessions …………………………………………………………………………………………………… 86

Table 1: An Overview of the Therapeutic Modules Delivered During the

Programme ……………………………………………………………………………………………… 82

Table 2: CSQ Mean Scores and Overall Satisfaction Score ……………………………. 84

Table 3. Mean Scores and Effect Sizes at Baseline and Follow Up………………….. 84


Table of Appendices

Paper I: Systematic Review

Appendix 1: Clinical Psychology Review Guidance for Authors ……………….. 129

Appendix 2: EPHPP Quality Tool ………………………………………………………….. 140

Paper II: Empirical Paper

Appendix 3: Archives of Suicide Research Guidance for Authors ………………… 145

Appendix 4: University of Manchester Ethical Approval ……………………………… 147

Appendix 5: Health Research Authority Ethical Approval ……………………………. 149

Appendix 6: Favourable Research and Ethics Committee Letter …………………… 152

Appendix 7: HMPSS Ethical Approval ………………………………………………………. 157

Appendix 8: Clinical Trial Registration ……………………………………………………… 159

Appendix 9: Participant Information Sheet …………………………………………………. 161

Appendix 10: Summary Participant Information Sheet ………………………………… 166

Appendix 11: Informed Consent Form ………………………………………………………. 168

Appendix 12: Prison GP Letter …………………………………………………………………. 171

Appendix 13: The InSPire Programme: What to Expect ………………………………. 173

Appendix 14: Participant Debriefing Sheet …………………………………………………. 176

Appendix 15: Certificate of Completion …………………………………………………….. 178

Appendix 16: Demographics Questionnaire ……………………………………………….. 180

Appendix 17: Additional Study Metrics …………………………………………………….. 185

Appendix 18: Therapist Session Summary Sheet ………………………………………… 187

Appendix 19: Therapist Rating Scale …………………………………………………………. 190

Appendix 20: Client Satisfaction Questionnaire ………………………………………….. 192

Appendix 21: Discharge Summary Sheet …………………………………………………… 196

Appendix 22: Beck Suicide Scale ……………………………………………………………… 198

Appendix 23: The Difficulties in Regulating Emotions Scale ……………………….. 201

Appendix 24: Social Problem Solving Inventory …………………………………………. 207

Appendix 25: Multi-dimensional Scale of Percieved Social Support ……………… 209

Appendix 26: Participant Sessional Measure ………………………………………………. 211

Appendix 27: Therapist Sessional Measure ………………………………………………… 213

Appendix 28: Qualitative Interview Topic Guide ………………………………………… 215

Appendix 29: CBSP Therapy Modules ………………………………………………………. 219


Appendix 30: Distress Protocol …………………………………………………………………. 221

Appendix 31: Safe Working Practices and Risk Management Protocol ………….. 223

Paper III: Critical Review

Appendix 32: EPHPP Dictionary ………………………………………………………………. 230

Appendix 33: InSPire Appointment Slips …………………………………………………… 235


Word Counts

(excluding abstracts, references, tables, figures and appendices)


Paper I: Systematic Review

Paper II: Empirical Paper

Paper III: Critical Reflection

Total word count

Word Counts




22, 697


Overall Abstract

Paper I: Intensive Cognitive Behavioural Therapy (CBT) is an emerging intervention
for psychological distress and mental health. There is no known review in this area
in an adult population. Paper II: The InSPire programme was developed to deliver
intensive cognitive behavioural suicide prevention (CBSP) therapy within a prison,
to address barriers to long term engagement in previous psychological intervention
studies (i.e. attrition).

Paper I systematically reviewed studies which have delivered intensive CBT within
an adult population experiencing psychological distress. Paper II aimed to
determine the feasibility of intensive CBSP in a prison, with individuals experiencing
suicidal thoughts and behaviours.

Paper I was a systematic review of 17 studies delivering intensive CBT across
populations experiencing psychological distress associated with mental health,
addiction, chronic pain and following a traumatic incident. Paper II was a feasibility
case series with single baseline and single follow up. Thirteen individuals consented
to the InSPire programme, delivering an intensive CBSP intervention within a three
week period (five two-hourly sessions were offered). Outcome measures assessed
suicidality (including thoughts of self-harm) and client satisfaction. Psychological
mechanisms associated with suicide were measured, including perceived social
support, emotional regulation and problem solving.

Paper I found promising results in the efficacy and feasibility of intensive CBT,
particularly in the population experiencing distress associated with mental health
difficulties. The review unearthed a number of recommendations for further
research in this field. Paper II found the InSPire programme to be feasible, as
determined by successful recruitment and retention across the study, including
high participant satisfaction. The programme appeared to have an efficacious
benefit for those who took part across all outcomes measured.

Paper I highlights the promising feasibility and efficacy of intensive CBT, yet more
rigorously designed studies (i.e. RCTs) must be conducted before firm conclusions
can be drawn and prior to a future repeat review. Paper II highlighted the potential
benefit of conducting intensive CBSP in prison. Given the limited generalisability of
this study, a larger scale feasibility trial would now be warranted to determine more
conclusive evidence.
Paper III was a critical review paper appraising papers I and II. This included
consideration of the methodological process, strengths and limitations, and
considerations alongside further literature.



No portion of the work referred to in the thesis has been submitted in support of an
application for another degree or qualification of this or any other university or
other institute of learning.

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I would like to thank the participants for taking part in the InSPire programme.

Involvement has allowed us to further our understanding of psychological therapy

in prison for those experiencing suicidal thoughts and behaviours. Thank you to all

prison and NHS staff who worked alongside us to make this programme possible.

Thank you to Dr Daniel Pratt, for this incredible opportunity, and for the ongoing

inspiration, patience and guidance throughout. Thank you to Dr Charlotte Lennox

for research support and guidance throughout.

Thank you to Minjae Kim for data entry. Thank you to Claire Steele and Megan

McKenna for support with inter-rater reliability. Thank you to Jemma Gaskell,

Martin Parrington and Claire Oakes for support with proof reading.

Thank you to Jessica Killilea, for being my ‘wingman’ on this project, for always

having a listening ear and encouraging voice.

Thank you to the incredible cohort that I have been so lucky to have been a part of

during the three years.

Finally, thank you to Gareth Moore, without whom none of this would be possible.

Thank you for being you.



To those who have lost their lives to suicide.

To families and friends who have been affected by suicide.

To the individuals who continue to fight every day.


Introduction to Paper I

Paper I is a systematic review written in accordance with the author guidance for

submission to the journal Clinical Psychology Review (Appendix 1). The authorship

for this paper will be as follows: Hampson, L., Killilea, J., Lennox, C., & Pratt, D.


Previous years have seen the emergence of innovative and adapted formats in the

delivery of Cognitive Behavioural Therapy (CBT), across all clinical populations. The

NHS adapts and shapes services based upon clinical need and cost-effectiveness.

Intensive CBT is one method of therapeutic delivery which has attracted research

interest over the past decade. Although there is one published review in this field

that investigates intensive CBT with children with anxiety disorders, there are no

known equivalent reviews which investigate intensive CBT in an adult population.

This review takes a broader approach into investigating the use of intensive CBT

across clinical populations experiencing psychological distress. This review seeks to

understand more about how intensive CBT has been delivered so far, and the

efficacy of its delivery. This review will be relevant for clinicians delivering CBT, in

highlighting the importance of patient choice in the delivery of services, as well as

providing recommendations in terms of overall service delivery. First and foremost,

this review will provide a foundation for future, larger scale, reviews of this type.

Paper I explores the components of an intensive delivery of CBT, as was delivered in

the research study of Paper II. This gave the author a broader understanding of

what intensive CBT is and the areas in which it has been delivered to date.


Paper I Systematic Review

Intensive Cognitive Behavioural Therapy for Psychological

Distress: A Systematic Review

Written in preparation for submission to

Clinical Psychology Review

Word count: 8456 (excluding abstract, tables, figures and references)


1. Abstract

Delivery of Cognitive Behavioural Therapy (CBT) has adapted over time in response

to the need for more streamlined services. This systematic review aims to examine

existing literature to understand the primary characteristics and efficacy of

‘intensive’ CBT across clinical populations experiencing psychological distress.

Intensive CBT offers a quicker intervention which is completed in a much shorter

time than the traditional weekly delivery.

Seventeen papers were included in this review. Four categories of clinical

population were defined, including psychological distress associated with mental

health, chronic pain, addiction and following a traumatic incident. Delivery of

intensive CBT differed across the studies. An average of 17 hours of therapy was

received per participant. Studies delivered a variety of different components of

CBT, most often being cognitive restructuring. Effect sizes were promising at post-

intervention and longer term follow-up, particularly within studies investigating

mental health difficulties.

This review has collated information on the delivery of intensive CBT and highlights

the promising results in the efficacy of intensive CBT. However, most studies were

exploratory in design, with small sample sizes and weak methodological quality.

Recommendations are given for larger scale trials of intensive CBT to be conducted

in order to establish a more reliable evidence base.

Key words: Systematic, Review, Intensive, Cognitive Behavioural Therapy.


2. Introduction

2.1 Mental Health and Psychological Distress

It is widely reported that one in four people in the UK will experience a mental

health difficulty during their lifespan (Ginn & Horder, 2012), with one in six

reporting symptoms of anxiety or depression within the past week (McManus,

Bebbington, Jenkins, & Brugha, 2016). Mental health retains a significant focus in

the government’s political agenda, as it holds considerable bearing upon rates of

employment, housing, debt and poverty (Mental Health Foundation, 2016). There

are financial consequences both on an individual and societal level. Costs to the UK

economy are substantial and taking into account the associated reduced quality of

life, the cost in England alone in 2010 reached £105.2 billion (Centre for Mental

Health, 2010). Both nationally and globally the investment into resources for

prevention and treatment is outweighed by the cost. Despite this, mental health

remains a political focus, as outlined in many Government initiatives, emphasising

the importance of effective service provision and investment into both physical and

mental health (Department of Health [DH], 2011; Mental Health Taskforce, 2016).

Whilst mental health difficulties are generally captured within a diagnostic

framework, (American Psychiatric Association [APA], 2013), ‘psychological distress’

is a broader term used throughout the literature. Mirowsky (2007) offers an

understanding of ‘distress’ as being beyond concepts or diagnoses, which

essentially captures the emotional suffering experienced by the individual. Ridner

(2004) suggested that psychological distress is most often, although not exclusively,

pre-empted by a stressor for which coping is ineffective. Ridner (2004) defines

psychological distress as the “unique discomforting, emotional state experienced by

an individual in response to a specific stressor or demand that results in harm, either

temporary or permanent, to the person” (p. 539). The description by Ridner (2004)

was the working definition of psychological distress for the current review.

Psychological distress is commonly measured using the General Health

Questionnaire [GHQ] (Goldberg, 1972) or Kessler Psychological Distress Scale [K10]

(Kessler et al., 2002). According to these measures, prevalence of psychological

distress has been shown to vary greatly from 7% to 33% in general populations


across the world (Australia: Chittleborough, Winefield, Gill, Koster, & Taylor, 2011;

Phongsavan, Chey, Bauman, Brooks, & Silove, 2006; Spain: Gispert, Rajmil,

Schiaffino, & Herdman, 2003; Japan: Kuriyama et al., 2009). There are further

variations within particular population groups. Using the GHQ, Gispert et al. (2003)

found psychological distress was reported by 15.4% of females, compared to 9.2%

of males within a Catalan community. Using the K10, Phongsavan et al. (2006)

reported even higher rates of distress within the Australian population, with up to

35.5% in females compared to 29.9% in males. Furthermore, chronic physical health

conditions or severe ill health were found to greatly increase prevalence of

psychological distress (Arvidsdotter, Marklund, Kylén, Taft, & Ekman, 2016;

Drapeau, Marchand, & Beaulieu-Prévost, 2012). Chittleborough et al. (2011)

reported a prevalence of 15.8% in a population with chronic health conditions.

Further social factors were found to increase psychological distress: being young or

old age; being a smoker or drinker; having a low or high BMI; having lower social

capital or education levels; unemployment; restricted or reduced daily physical

activity; and a lack of social support or integration within a community

(Arvidsdotter et al., 2016; Drapeau et al., 2012; Kuriyama et al., 2009; Gispert et al.,

2003; Phongsavan et al., 2006).

2.2 Cognitive Behavioural Therapy

Cognitive Behavioural Therapy (CBT) has been identified as the primary

psychological intervention in many disorders of psychological distress, with

particular effectiveness noted in disorders of anxiety (Stewart & Chambless, 2009;

Hofmann & Smits, 2008) and depression (Butler, Chapman, Forman, & Beck, 2006).

CBT is recommended as first-line treatment before pharmacological intervention

for anxiety disorders (National Institute for Health and Care Excellence [NICE],

2014). Specific anxiety disorders and other disorders (i.e. depression; NICE, 2011)

have individual quality standards recommending the appropriate level of

psychological input.

Beyond anxiety and depression, a number of meta-analyses highlight the efficacy of

CBT across populations with psychological distress: behavioural parent training

(BPT) for antisocial behaviour in young people (post-treatment ES = 0.35; follow up


ES = 0.31) (McCart, Priester, Davies, & Azen, 2006); male offenders experiencing

anger management issues, with treatment aimed to reduce recidivism (ES = 0.77)

(Henwood, Chou, & Browne, 2015); difficulties with insomnia (medium to large

effects; Okajima, Komada, & Inoue, 2011); chronic pain, improvements noted in

mood (standardised mean difference [SMD] = -0.24; p = 0.004) and pain coping

(SMD = 0.85; p = 0.006; Bernardy, Füber, Köllner, & Häuser, 2010); and problem

gambling (large effect sizes at post treatment and follow up; Gooding & Tarrier,

2009). Finally, a Cochrane Review demonstrated the effectiveness of a CBT-based

intervention (i.e. cognitive reframing) in supporting carers of people with dementia,

with associated anxiety (SMD = -0.21), depression (SMD = -0.66) and subjective

stress (SMD = -0.23; Vernooij‐Dassen, Draskovic, McCleery, & Downs, 2011).

The studies above are important for highlighting the broad scope of CBT and its

efficacy beyond psychiatric disorders and into issues of psychological distress. CBT

has an established evidence base across a number of psychological disorders (Epp &

Dobson, 2010). More specifically, The Department of Health published a document

for the Improving Access to Psychological Therapies (IAPT) Programme (2007)

outlining the most evidence based CBT models for a number of psychological

disorders, including social phobia (Heimberg, 1995; Clark & Wells, 1995); panic

disorder (Clark, 1994; Barlow, Craske, Cerny & Klosko, 1989); obsessive compulsive

disorder (OCD) (Steketee, 1993; Kozak & Foa, 1997); generalised anxiety disorder

(GAD) (Borkovec & Ruscio, 2001; Dugas, Gagnon, Ladouceur & Freeston, 1998;

Zinbarg, Barlow, Brown & Hertz, 1992; Craske, 1999); post-traumatic stress disorder

(PTSD) (Foa & Rothbaum, 1998; Ehlers & Clark, 2000; Resick, 2000) and depression

(Beck, 1979; Jacobson, Martell & Dimidijan, 2001). CBT is therefore recommended

by the National Institute for Health and Care Excellence (NICE) for a number of

psychological disorders.

2.3 Components of Cognitive Behavioural Therapy

CBT is essentially focussed upon our thoughts, feelings and behaviours and the

interactions between them (Beck, 1979). It highlights unhelpful thinking and

behavioural patterns that emerge and maintain distress (British Association for

Behavioural and Cognitive Psychotherapies, [BABCP], 2019). The Department of


Health (DoH) published a document for the Improving Access to Psychological

Therapies (IAPT) Programme (2007), which provides detail of therapeutic standards

and competencies which are important for practitioners to deliver CBT to an

appropriate level according to good practice. In addition, there are variations across

the literature as to which therapeutic components make up a CBT intervention. The

Association for Behavioural and Cognitive Therapies (ABCT) condenses CBT to three

main components, each with specific therapeutic techniques. These components

are case conceptualisation, behavioural components (self-monitoring, behavioural

activation, exposure) and cognitive components (eliciting and modifying thinking)

(ABCT, 2019). Tolin (2010) determined six categories which were used as a checklist

within a meta-analysis investigating the effectiveness of CBT.

In line with Tolin’s (2010) approach, the components below were used as a

framework for this current review:

i. Psychoeducation

ii. Relaxation Training (including progressive muscle relaxation, meditation, or

breathing retraining)

iii. Exposure Therapy (imaginal or in vivo exposure, including flooding)

iv. Behaviour Rehearsal (behavioural training in social skills, habit reversal, or

problem solving)

v. Cognitive Restructuring (including direct strategies to identify and alter

maladaptive thought processes)

vi. Operant Procedures (systematic manipulation of reinforcers or punishers for


2.4 Clinical Guidelines for Delivery of CBT

There have been many variations across the decades in CBT delivery. Traditionally,

CBT was delivered solely by a qualified professional with specialised graduate

training (i.e. psychiatrists, psychologists, master’s-level social workers)

(Montgomery, Kunik, Wilson, Stanley, & Weiss, 2010). In recent years, CBT has been

effectively administered by ‘paraprofessionals’ (i.e. individuals without

postgraduate training) under appropriate clinical supervision (Montgomery et al.,

2010). Sessions can take place in a number of settings (i.e. hospital clinics,


community bases, home) and in a number of formats (i.e. 1:1, group, family).

Guidelines for standard delivery of CBT vary depending upon presenting difficulty.

For example, standard delivery of CBT for social anxiety is 14 sessions lasting 90

minutes per session, delivered 1:1 and on a weekly basis (NICE, 2013). There is a

broad literature of the many forms in which CBT delivery has been transformed

over recent years.

There is evidence for the benefit of long-term outcomes of weekly therapy

compared to an intensive delivery, although much of the evidence is focussed upon

adolescent populations, including CBT for smoking cessation (Cavallo et al., 2007)

and panic disorder (Chase, Whitton, & Pincus, 2012). However, a number of studies

found intensive CBT to be more suited to an adolescent population with Obsessive

Compulsive Disorder (OCD; Storch et al., 2008; Whiteside, Brown, & Abramowitz,

2008; Lewin et al., 2005). Each of these studies cited the challenges of weekly CBT

for some families (i.e. geographical barriers, access to appropriate specialist

services and suitability to the individual [i.e. severity of symptoms and

functioning]). Arguably, intensive delivery could be better suited to particular

populations, or individuals, and perhaps patient choice in their treatment is

important to consider.

From a health economics perspective, recent years has seen a shift in the format of

CBT delivery towards more effective streamlined services. Perhaps a considerable

amount of difference in response to treatment relates to the individual and the

difficulties they present with. Stiles, Barkham, Connell and Mellor-Clark (2008)

report that for some individuals, one or two sessions of therapy resulted in the

same positive outcome as 15 or 16 sessions. Stiles et al. (2008) introduced the

response regulation model, which recommended therapy dose determined by

recovery, as decided between the patient and therapist, rather than a standardised

dose of therapy for a fixed duration. Additionally, in line with streamlining NHS

services, the stepped care model of healthcare delivery recommends individualised

therapy durations, with patients being offered add-on sessions or more intensive

input should they not respond to briefer interventions first (Bower & Gilbody,

2005). Taking the above into account, appropriate clinical decisions must be made

concerning delivery of services in the NHS. This must consider patient choice and be


in keeping with national guidelines (i.e. NICE). Recent years has seen the emergence

of ‘brief’ or ‘intensive’ CBT interventions; although, there are variations in the

definition of such interventions.

2.5 Intensive CBT

Öst and Ollendick (2017) define ‘brief’ CBT as a 50% reduction of sessions compared

to standard treatment (as outlined in NICE guidelines); ‘concentrated’ CBT as being

the same number of sessions as standard treatment but delivered over a shorter

time period (i.e. daily sessions over a few weeks); and ‘intensive’ CBT as a reduction

in both the number of sessions and duration of treatment delivery compared to

standard treatment. Research so far offers promise in the feasibility and efficacy of

intensive CBT: although, the definition and delivery has somewhat varied. For

example, Storch et al. (2007) delivered ‘intensive’ CBT for 90 minute sessions, five

days per week for three weeks, in a family based intervention for childhood OCD. In

an adult OCD population, Oldfield, Salkovskis and Taylor (2011) found delivery of up

to 18 hours of CBT equally effective when delivering over five days, compared to 18

weeks. Ehlers et al. (2010) delivered novel intensive therapy to individuals with

post-traumatic stress disorder (PTSD) for up to 18 hours over five to seven working

days. Other research has involved longer session duration (i.e. up to five hours per

session) across two days, for individuals with panic disorder (Deacon & Abramowitz,


There are no known reviews published to date which explore the delivery of

intensive CBT within an adult population. One published review investigates the

delivery of ‘brief’, ‘intensive’ and ‘concentrated’ CBT in childhood anxiety disorder

(Öst & Ollendick, 2017). This review found 14 randomised control trials (RCT)

investigating the delivery of intensive CBT, with large treatment effects (g = 0.84)

overall. Two further published prospero protocols are currently exploring intensive

CBT for adults with OCD (Millar, Bauer, Salkovskis, Gregory, & Halligan, 2018) and

intensive CBT for OCD, anxiety and PTSD in children and adolescents (Clarkson,

Allcott-Watson, Shafran, & Bennett, 2018). Both reviews define intensive CBT as

being no more than four weeks in length, with at least five hours per week and a

minimum of 10 hours in total.


Whilst the four week completion period seems to capture the definitions used

above, a broader range of therapy dose has been delivered, with as few as two

sessions making up an intensive treatment package (i.e. Deacon & Abramowitz,

2006). This shows the varied definitions and approaches to ‘intensive’ delivery that

are currently used across the literature. Whilst this current review used the four

week delivery period, a broader definition of therapeutic dose was applied (i.e. two

or more sessions of CBT per week), to allow inclusivity and a broader understanding

of how the term ‘intensive’ is used. No minimum requirements of the hours of

therapy delivered were applied, which was appropriate for the exploratory nature

of this current review.

2.6 Review Aims

To our knowledge, this was the first systematic review to explore literature

evaluating intensive CBT with adults experiencing psychological distress. The review

aimed to synthesise what was already known about ‘intensive’ CBT, focusing upon

therapy components (i.e. number of sessions, duration and content) and efficacy

across a range of clinical populations experiencing psychological distress. Following

the exploration and synthesis of review literature, recommendations and guidance

were provided for future use of intensive CBT.


3. Method

3.1 Review Protocol

The review protocol was published on PROSPERO (ID: CRD42018086546) and the

review follows the ‘Preferred Reporting Items for Systematic review and Meta-

Analysis Protocols’ (PRISMA; Moher et al., 2015).

3.2 Search strategy

Online medical and psychological databases were reviewed, including EMBASE,

PsychINFO, MEDLINE and CINAHL PLUS, from point of database inception to August

2018. Search terms were first tested to ensure a specific search across a broad

enough scope of the literature. Keyword search terms were used to capture CBT

alongside the ‘intensive’ nature of delivery ([intense OR intensive] AND [cog* beh*

OR cog* treat* OR cog* ther* OR cog* int*]).

In order to maximise the ability to capture all papers in this area, no restrictions

were applied to initial searches (i.e. publication year, English language or full text

article). However, review papers, grey literature, conference abstracts and non-

English articles were not included. Rationale for the omission of such papers was

based upon the lack of guidance in systematically searching for grey literature and

the potential for a large search yield, beyond the practical scope of this review

(Mahood, Van Eerd, & Irvin, 2014).

Citations were exported to a reference management software system and all

duplicates were removed from initial search results. The first author (LH) reviewed

all titles and abstracts according to PICO (i.e. Problem or Patient or

Population; Intervention or Indicator; Comparison; Outcome of interest) inclusion

criteria (Miller & Forrest, 2001), with full-text papers then reviewed if uncertain

about eligibility from title and abstract alone. Inter-rater reliability of title and

abstract screens was conducted with a co-author (JK). Ten percent of all abstracts

and titles were co-reviewed (n = 360) and inter-rater reliability was strong (Kappa =

.88). Following title and abstract screens, full-texts were reviewed. Figure 1

presents a PRISMA diagram of the screening and eligibility procedures.


Figure 1. A PRISMA Chart to Outline Screening and Eligibility Procedures

















Records identified through
database searches

(n = 4332)

Records after
duplicates removed

(n = 3619)

Titles and abstracts
screened for eligibility


Full-text articles
screened for eligibility


Studies included in
the review


Records excluded
(n = 3488)

Full-text articles excluded (n= 105)

Unable to access (n = 10)
Citation/conference paper only (n = 12)

Not English (n = 4)
Group therapy (n = 32)

Insufficient CBT components (n = 12)
Therapy surpasses four weeks (n = 17)

Non-clinical population (n = 6)
Child population (n = 1)

Duplicate analyses papers (n = 6)
Not ‘intensive’ (n = 2)

Wrong study design (n = 3)


3.3 Inclusion Criteria

General Inclusion Criteria

i. Papers published in peer reviewed journal.

ii. Papers written in English.

iii. Quantitative methodology that included pre- and post-therapy outcome


iv. Papers included more than one participant

Population Inclusion Criteria

v. Participant sample of adults (16 years and above).

vi. A clinical population with a mental health difficulty or ‘psychological


‘Intensive’ Cognitive (Behavioural) Therapy Inclusion Criteria

vii. Face-to-face and 1:1 therapy sessions (i.e. group, computerised, or manual-

directed interventions were excluded in an attempt to mediate consistency

in the intervention delivery and limit heterogeneity of the sample).

viii. As guided by previous literature in this area, interventions were completed

within a four week period and included at least two therapy sessions per

week. To allow a more inclusive exploration of the literature, no minimum

dose (i.e. total number of hours) of therapy was applied.

ix. Eligible studies included one or more of the widely recognised variants of

CBT as defined by Tolin (2010). These included psychoeducation; relaxation

training; exposure therapy; behaviour rehearsal; cognitive restructuring; and

operant procedures (NB. not psychoeducation alone).

3.4 Quality Assessment

The Effective Public Health Practice Project (EPHPP; 1998; Appendix 2) was used to

quality assess included papers. The EPHPP includes six items which assess the

following: selection bias; study design; confounders; blinding; data collection

method and withdrawals and drop outs. The EPHPP has excellent inter-rater

reliability for final ratings of papers (i.e. weak, moderate or strong; Armijo‐Olivo,

Stiles, Hagen, Biondo, & Cummings, 2012). The EPHPP was chosen as it considers all


methodological designs and is reasonably straightforward to apply and to

determine and justify appropriate ratings (Voss & Rehfuess, 2013; Bennett et al.,

2018). A peer group was established with two independent researchers (clinical

psychology doctoral students). The peer group discussed the EPHPP tool in detail to

ensure consistent interpretation of questions and a robust process of decision

making. The group was then used for specific queries related to study design, and

they were used to determine inter-rater reliability. Twenty nine percent of papers

were secondary reviewed between the peer group and there was an almost perfect

agreement (Kappa = .99). Additionally, individual queries related to quality ratings

were discussed and agreed alongside co-authors (DP and CL). Outcome of the

quality assessment was used during analysis, by reviewing papers of weaker quality

with more caution upon interpretation. No studies were excluded based upon


3.5 Analysis of Studies

Descriptive analyses were explored using Microsoft Excel. Frequencies, means and

standard deviations were calculated to determine study characteristics (i.e. session

duration, length of therapy and components of CBT most frequently delivered).

Effect sizes were computed to provide an indication of changes associated with

treatment delivery. Where authors reported effect sizes, the published figures were

repeated in the analysis tables. In all other cases, effect sizes were calculated where

the studies clearly detailed pre and post means and number of participants in their

analysis. Primary outcome measures specified by the review papers were used to

generate effect sizes. Where studies identified a number of outcomes or did not

specify the primary outcome measure, the first author (LH) used the measure with

the most complete dataset or otherwise the one most relevant to psychological

distress specific to the clinical population. For studies with a comparison group,

effect sizes were calculated comparing the pre- and post- data of both intervention

and comparison group using Morris’ (2008) effect size calculation for repeated

measures designs. For all other studies without a comparison group, effect sizes

were calculated using a repeated measures method using a correlation coefficient

of 0.5. Effect sizes were interpreted using Cohen’s d (Cohen, 1977). Lastly, effect


sizes were calculated for those studies which included longer term follow up, to

provide an indication as to whether the effect had been sustained over time. Across

all effect size calculations, where pre and post group sizes differed, effect size was

calculated using both participant number totals. In the case of a difference, lower

effect sizes were reported to avoid over inflation.


4. Results

4.1 Description of Papers

Seventeen papers were identified using the outlined search strategy and inclusion

criteria, as presented in Table 1. Study designs included cohort (k = 13) [4–10, 12–

17], cohort analytic (i.e. with a matched group, k = 2) [1, 2] and randomised control

trials (k = 2) [3, 11]. It must be noted that four studies defined themselves as case

histories or series. All four studies had multiple participants and allowed for group

comparisons of the data. Therefore, for the purposes of this review, they were

classified as ‘cohort’ or ‘cohort analytic’.

A number of clinical populations were included in the review, most commonly

anxiety (including PTSD) (k = 8), OCD (k = 3) and Body Dysmorphic Disorder (BDD) (k

= 2) and pain (k = 3). Papers scope from 1993 to 2018, with much of the research in

this area taking place within the last decade and the majority of studies being

conducted in the US. A total of 647 participants were included across the papers.

An average number of 10 sessions were offered per participant, lasting just over 1.5

hours, across a period of 20 days. This equates to approximately 17 hours of

therapy per individual. Mostly commonly, CBT components of psychoeducation,

exposure and cognitive restructuring were delivered. This will be outlined in more

detail in section 4.4.


Table 1. Characteristics of Studies

Authors Design Clinical

N Intervention

No. of




Brief Summary of

1 Abramowitz,

Kozak, & Foa




87 Exposure Therapy
Behaviour Rehearsal
Cognitive Restructuring

15 2 hours 4 weeks BDI

All groups showed
treatment effects.
treatment gains
were attained for
the highest severity
of depression.

2 Abramowitz,
Foa, &




OCD 40 :

20 Intensive
20 Twice weekly

Exposure Therapy
Behaviour Rehearsal
Cognitive Restructuring

15 2 hours 3 weeks BDI

Both programs were
effective. Greater
improvement for
intensive group.

3 Bernard et al.



trauma &

56 :

31 Intervention
25 Control

Relaxation Training
Cognitive Restructuring

3 45 – 55

2 weeks BDI

Mothers in the
intervention group
reported lower
levels of depression,
but trauma
symptoms remained
in both groups.

4 Bitran,
Spiegel, &




Panic and

40 Exposure Therapy
Cognitive Restructuring

6 Not

8 days ADIS

Solution focussed
intensive therapy
reduced panic
symptoms, with
gains maintained at


5 Deacon &



Panic 10 Exposure Therapy
Behaviour Rehearsal
Cognitive Restructuring

2 9 hours:
(day 1 =
6 hours
day 2 =
3 hours)

2 days ASI-R

60% were panic-
free after

6 Hickling,
Blanchard, &
Kuhn (2005)


Cohort PTSD 3 Relaxation Training
Exposure Therapy
Cognitive Restructuring

2 60 – 90



Found to be an
treatment option,
with improvements
in symptoms of
PTSD and low

7 Johren,

Heinen, &



Cohort Dental

160 Relaxation Training
Exposure Therapy
Cognitive Restructuring

3 1 hour Not

HAQ Anxiety was higher
for therapy
completers, but
their subsequent
adherence to dental
treatment was high

8 McCracken,
Gross, &


Cohort Pain 59 Behaviour Rehearsal

15 Not

3 weeks BDI

improvement in
pain severity, pain
distress, activity and


9 McManus,
Treacy, &

Cohort Pain 5 Relaxation Training
Behaviour Rehearsal
Cognitive Restructuring

8 40

4 weeks PSEQ-C (mod’)
Developed for
this study:
– The Pain
Knowledge Scale
– Coping

Pain management
knowledge and
coping increased
after the
intervention (not
maintained at
follow up).

10 Morefield et
al. (2014)


Cohort Addiction 53 Exposure Therapy
Behaviour Rehearsal
Cognitive Restructuring

6 – 12 Not

2 weeks GHQ-28

Scores on all
measures improved.

11 Motivala et
al. (2018)


RCT OCD 44 :

23 Treatment
21 Waitlist then

Exposure Therapy

20 90

4 weeks GAS

Symptoms of OCD,
depression and
functioning all

12 Neziroglu &

Tobias (1993)

Cohort Body

5 :

3 Intensive
2 Standard

Exposure Therapy
Cognitive Restructuring

20 90

4 weeks Y-BOCS

80% of patients
improved on
measures of

13 Neziroglu,

Todaro, &

(1996) (US)

Cohort Body

17 Exposure Therapy
Cognitive Restructuring

20 90

4 weeks GAF

Significant decrease
in preoccupation
and time engaging
in problem


14 Stoddard,
Rosellini, &


Cohort Social

5 Exposure Therapy
Behaviour Rehearsal
Cognitive Restructuring

6 2 – 4

8 days BDI

80% improved on
measures of
outcome (SPAI, ISPI,

15 Suman et al.

Cohort Pain 25 Exposure Therapy
Cognitive Restructuring

10 90

3 week BPCI

Pain intensity
significant reduced,
CES-D scores

16 Wootton et


Cohort Social

17 Exposure Therapy
Cognitive Restructuring

12 50

4 weeks DASS-21
Developed for
this study:
– Acceptability

Moderate to large
effect sizes.
59% no longer met
criteria for SAD
(71% at follow up).

17 Worden,

Genova &


Cohort Anxiety &

21 Exposure Therapy
Cognitive Restructuring

6 1.5

3 – 5

Developed for
this study:
– Post-treatment

Significant reduction
in anxiety and
abstinence from

Table Abbreviations: Acute stress disorder scale (ASDS); Agoraphobic Cognitions Questionnaire (ACQ); Albany Panic and Phobia Questionnaire (APPQ); Anxiety Disorders
Interview Schedule (ADIS-IV); Anxiety Sensitivity Index (ASI); Beck Anxiety Inventory (BAI); Beck Depression Inventory (BDI); Body Vigilance Scale (BVS); Brief Pain Coping


Inventory (BPCI); Center for Epidemiologic Studies Depression Scale (CES-D); Choice of Outcome in CBT for psychosis (CHOICE); Clinical Global Impressions Scale (CGI);
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5); Cognitive-Behavioural Therapy Adherence Measure (CAM); Coping Strategies Questionnaire (CSQ); Davidson
Trauma Scale (DTS); Depression Anxiety Stress Scale-21 (DASS-21); Emotion Regulation Questionnaire (ERQ); Global Assessment of Functioning (GAF); Global Assessment
Scale (GAS); Goldney Scale of Suicidal Ideation (GHQ-28); Hamilton Anxiety Scale (HAM-A); Hierarchical Anxiety Questionnaire (HAQ); Hospital Anxiety and Depression Scale
(HADS); Index of Social Phobia Improvement (ISPI); Kessler Psychological Distress Scale (K10); Montgomery-Ashberg Depression Rating Scale (MADRS); Multidisciplinary
Pain Inventory (MPI); Overvalued Ideas Scale (OVI); Pain Anxiety Symptoms Scale (PASS); Pain Self-efficacy Scale for Children (PSEQ-C); Panic and Agoraphobia Scale (PAS);
Panic Disorder Severity Scale (PDSS); Penn State Worry Questionnaire (PSWQ); Psychotic Symptom Rating Scales (PSYRATS); PTSD Checklist for DSM-5 (PCL-5); Ruminative
Responses Scale (RRS); Self-efficacy Questionnaire (SEQ); Social Phobia and Anxiety Inventory (SPAI); Social Phobia Inventory (SPIN); Social Interaction Anxiety Scale (SIAS);
Social Phobia Endstate Functioning Index (SPEFI); Social Phobia Scale (SPS); Stanford Acute Stress Reaction Questionnaire (SASRQ); Time Line Follow Back (TLFB); Treatment
Services Review (TSR); Victorian Gambling Screen (VGS); Wechsler Abbreviated Scale of Intelligence (WASI); Work and Social Adjustment Scale (WSAS); Yale-Brown
Obsessive Compulsive Scale (Y-BOCS); Yale-Brown OCD Scale for Body Dysmorphic Disorder (BDD-YBOCS).


4.2 Quality of Studies

The EPHPP rating tool grades papers as weak, moderate or strong in their

methodological quality. Quality varied across the 17 papers, with strong (k = 1; 6%),

moderate (k = 5; 29%) and weak (k = 11; 65%). Details of quality ratings are

presented in Table 2.

The EPHPP is influenced by methodological design and presence of a control group.

For many studies in this review this was a contribution to the weaker overall rating.

When considering studies with medium to high quality, all six studies gave evidence

to support the effectiveness of intensive CBT, with small [12], medium [1, 2] and

large [11, 13, 14] treatment effects. Three of these studies included comparison to

a control group and all were within the same participant cohort (i.e. distress

associated with mental health), as will be discussed in more detail in sections



Table 2. Component and Global Quality Ratings (strong, moderate or weak) using


Study Selection


Confounds Blinding Data




Abramowitz et al.

M M n/a M S M

Abramowitz et al.


Bernard et al.


Bitran et al. (2008) M M n/a W S W

Deacon &
Abramowitz (2006)

W M n/a W S S

Hickling et al.

W M n/a W S S

Johren et al.

M M n/a W S W

McCracken et al.

M M n/a W S W

McManus et al.

M M n/a M W S

Morefield et al.

S M n/a W S S

Motivala et al.


Neziroglu &


M M n/a W S S

Neziroglu et al.

M M n/a W S S

Stoddard et al.

M M n/a M S S

Suman et al.

M M n/a W S W

Wootton et al.

M M n/a W S M

Worden et al.

M M n/a W S W

S = Strong
M = Moderate
W = Weak
n/a = Not Applicable


4.3 Participants

A total of 647 participants were included across the 17 papers, ranging from n = 3

to n = 160 (M = 38; SD 39.48). Highest numbers of participants were from clinical

populations of anxiety and PTSD (n = 326) and OCD (n = 171). Mean age of

participants was 37.3 years (SD = 7.07), and 59.4% of participants were female

(female = 384; male = 263). Studies were conducted across a number of countries,

including Australia [16]; Germany [7]; Italy [15]; UK [8, 9]; and America [1–6, 10–14,


Diagnostic criteria varied greatly across studies. Four studies used the Anxiety

Disorder Interview Schedule (ADIS) [4, 7, 11, 14], four used criteria from

The Diagnostic and Statistical Manual of Mental Disorders (DSM) [1, 2, 12, 13] and

one used the Mini International Neuropsychiatric Interview (MINI) [5]. Two studies

used disorder specific diagnostic tools (i.e. The Diagnostic Interview for Anxiety,

Mood and OCD and Related Neuropsychiatric Disorders [DIAMOND] [16]; and the

American College Rheumatology [ACR] criteria for Fibromyalgia [15]). One paper

used outcome measures as diagnostic cut offs (i.e. Addiction Severity Index [ASI]

[17]) and two others quantified the presence of chronic pain (i.e. three months or

more) [8] which was then confirmed by a medical professional [9]. Two studies did

not specify their diagnostic criteria [3, 10] and one was self-referral [6].

4.4 Characteristics of Intensive CBT

Intensive CBT was offered across all studies, yet delivery specifics varied greatly.

Number of intensive sessions offered per participant ranged from two to 20

sessions (M = 10.19; SD = 6.62). Duration of individual sessions ranged from 40 to

270 minutes, with an average of just over 1.5 hours (M = 101.07 [minutes]; SD =

60.39; Mdn = 90), with sessions accessed across an average of 20.33 (SD = 9.00)

days. This equates to an average of 16.85 hours of therapy per individual. Number

of hours of therapy offered per participant varied across studies, with more hours

allocated within studies of OCD and BDD (n = 30) and less within pain (n = 12) and

anxiety (n = 9). Hours per person could not be calculated for one addiction paper

(Morefield et al., 2014).


Using Tolin’s (2010) criteria, the following components of CBT were identified as

having been offered across the 17 studies; psychoeducation (k = 14); relaxation (k =

4); exposure (k = 14); behavioural rehearsal (k = 7); and cognitive restructuring (k =

15). Use of operant procedures was not specifically cited within any paper. Studies

delivered either two (k = 5), three (n = 4) or four (k = 8) components of CBT, with an

average of three offered per study (M = 3.18; SD = 0.88; Mdn = 3).

4.5 Effects of Intensive CBT

There were considerable variations in study methodologies (i.e. control groups,

number of follow ups, number of outcome measures). This review structured

results by clinical populations experiencing distress, as this was the most efficient

and coherent way of synthesising results. The following group categorisations of

distress were developed: distress following trauma, chronic pain, addiction and

psychological distress associated with mental health.

i) Psychological Distress Associated with Mental Health

Ten studies investigated delivery of intensive CBT within populations experiencing

psychological distress associated with mental health difficulties [1, 2, 4, 5, 7, 11 –

14, 16]. Several studies in this group were by the same two leading authors [1 and

2; 12 and 13], albeit different time frames and a different participant pool.

Although this review aimed to deviate from psychiatric diagnoses and capture a

broader understanding of psychological distress, studies in this section correlate

with NICE guideline definitions of common mental health conditions. NICE capture

all anxiety difficulties as one mental health and behavioural condition, inclusive of

symptoms of panic, phobia, anxiety in social situations and general anxiety (NICE,

2014). Secondly, NICE capture distress associated with obsessions and compulsions

(i.e. OCD) and distress associated with preoccupations in appearance (i.e. BDD) as

one condition (NICE, 2005). The following clinical populations made up the studies

for psychological distress associated with mental health; anxiety in social situations

(k = 2) [14, 16]; dental phobia (k = 1) [7]; panic (k = 2) [4, 5]; distress associated with

obsessions and compulsions (i.e. OCD) (k = 3) [1, 2, 11]; and distress associated with

preoccupations in personal appearance (i.e. BDD) (k = 2) [12, 13].


As presented in Table 3, studies with a comparison group are presented first [1, 2,

12] and found small to medium treatment effect sizes. It must be noted that one

study had a particularly small sample size (n = 5) [12]. Remaining studies with pre

and post comparisons all had very large effect sizes, with one paper in particular

having a much smaller sample size (n = 5) [14].

Whilst studies offered a variety of CBT components, all offered exposure in their

delivery of CBT. Four studies specifically focussed upon exposure and response

prevention (ERP) (Skeketee & Nishith, 1993) [2, 11 – 13], each identifying ERP as an

effective treatment for their particular cohort (i.e. experiencing symptoms of

obsession, compulsion, preoccupation and low mood). For the four ERP-focussed

studies, those with comparison groups had small to medium treatment effects [2,

12] and those without found very large treatment effects [11, 13].

A number of studies (k = 4) used the Yale-Brown Obsessive Compulsive Scale (Y-

BOCS) (Goodman et al., 1989) to measure outcome, which is considered gold

standard in measuring symptoms of OCD (Deacon & Abramowitz, 2005). Scores on

the Y-BOCS were similar for all studies pre and post intervention. However, effect

sizes were greater for non-controlled studies. Although Neziroglu and Yaryura-

Tobias (1993) also aimed to measure obsessive symptoms, their Y-BOCS data was

incomplete, rendering the Overvalued Ideation Scale (OVI; for symptoms of BDD) a

more interpretable measure.

There appeared to be quite clear differences in therapeutic dose offered depending

upon symptomatology of the cohorts. For studies focussed upon symptoms of OCD

and BDD, 15 – 20 sessions were offered, with each session lasting between 90 and

120 minutes, with all sessions delivered within a 3-4 week window. For Neziroglu

and Yaryura-Tobias (1993), those participants in the intensive CBT arm opted for

that format of therapy, as opposed to weekly delivery. For studies focussed upon

anxiety, therapy delivery was more varied, with between two and 12 sessions

offered ranging from 50 minutes to nine hours per session across a span of

between two days and four weeks.


Table 3. Changes to Mean Scores and Calculated Effect Sizes for Psychological

Distress Associated with Mental Health

Intensive Intervention Comparison group

Study Primary

No of
participants a






No of






et al. (2000)

Y-BOCS 28 26.5




59 26.5



et al. (2003)

Y-BOCS 20 25.8


CBT twice
weekly for 8


20 25.55



Neziroglu &

Tobias (1993)

OVI 2 5


CBT for
8 – 12

3 9



a The same number of participants remained at both time points for both groups (for all three studies)

Study Primary

No of


M (SD)

No of


M (SD)

Effect Size
(Cohen’s d)

Bitran et al.

PDSS 32 17.8 (5.7) 24 7.1 (5.2) -1.89

Deacon &


PDSS 10 1.8 (0.9) 10 0.2 (0.3) -1.73b

Motivala et
al. (2018)

Y-BOCS 44 24.9 (4.5) 44 14.7 (5.2) -2.27

Neziroglu et
al. (1996)

YBOCS-BDD 17 26.5 (4.4) 17 12.7 (8.2) -3.13

Stoddard et
al. (2008)

SPAI 5 147.9 (15.9) 5 113.6 (36.5) -2.17

Wootton et
al. (2018)

SPIN 11 48.1 (11.7) 11 32.9 (13.6) -1.29

b Effect size was calculated using the reported means by Deacon and Abramowitz (2006), which is the
mean of the mean totals.
Table Abbreviations: Overvalued Ideas Scale (OVI); Panic Disorder Severity Scale (PDSS); Social
Phobia and Anxiety Inventory (SPAI); Social Phobia Inventory (SPIN); WASI); Yale-Brown Obsessive
Compulsive Scale (Y-BOCS); Yale-Brown OCD Scale for Body Dysmorphic Disorder (BDD-YBOCS).

An effect size for Johren et al. (2007) was not calculated. Johren et al. (2007) used

data of therapy completers (n = 104; M = 47.22; SD = 5.50) versus non-completers

(n = 52; M = 43.67; SD = 6.42) to measure attendance at dental appointments for

specific dental phobia, and concluded that non-completers had lower anxiety


scores on the Hierarchical Anxiety Questionnaire (HAQ) (p < .01), but attended

fewer subsequent dental sessions (p < .01).

Across the 10 studies in this section, four were rated as having weak

methodological quality, five rated moderate and one strong. The paper by

Abramowitz et al. (2003), which was an RCT design with a moderate treatment

effect, was the only paper rated to have a strong methodological quality. Of the

studies rated moderate in quality, two used control group comparisons (with small

to medium effect) and the other three were repeated measures designs with the

highest effect sizes. This gives more assurance in the accuracy of effect sizes


ii) Chronic Pain

Three studies explored intensive CBT for chronic pain [8, 9, 17], including chronic

low back pain (with pain-related anxiety), chronic pain in people with an intellectual

disability, and fibromyalgia. Studies recorded various outcomes, including pain

related anxiety, severity of pain symptoms and coping strategies. Studies used

different outcome measures, including the Multidisciplinary Pain Inventory (MPI)

(subscale – affective distress), the Pain Self-Efficacy Questionnaire (PSEQ) (the only

standardised measure) and the Centre for Epidemiologic Studies Depression Scale


Effect sizes for interventions were small to medium (see Table 4). Studies offered

between eight and 15 sessions within three to four weeks. McManus et al. (2014)

delivered 40 minute sessions, Suman et al. (2009) 90 minutes, and McCracken et al.

(2002) did not state session duration. Treatment effect was highest for McCracken

et al. (2002), which was the study with the largest sample size (n = 59) and highest

number of sessions offered (n = 15), delivered every day for three weeks. Similarly,

Suman et al. (2009) ran a daily multidisciplinary programme of treatment for a

three week period, whilst McManus et al. (2014) delivered two sessions per week

for four weeks. In terms of therapy content, McCracken et al. (2002) included

behavioural therapies alongside physical exercise, McManus et al. (2014) offered

CBT techniques for effective pain management alongside staff support, and Suman

et al. (2009) delivered a scheduled multidisciplinary programme, with physical


exercise intervention (i.e. stretching, aerobics) alongside CBT. Studies offered a mix

of CBT components, with McManus et al. (2014) delivering more than the other

two studies. Methodological quality for the three studies was rated as weak and

therefore effect sizes could be overinflated.

Table 4. Changes to Mean Scores and Calculated Effect Sizes for Pain

Study Primary

No of


M (SD)

No of


M (SD)

Effect Size


et al. (2002)


59 48.8 (9.9) 59 43 (10) -0.59

et al. ,

PSEQ-C b 5 4 (1.9) 5 4.6 (1.1) 0.32

Suman et
al. (2009)

CES-D c 25 24.8 (9.9) 25 21.5 (9.7) -0.33

a Multidisciplinary Pain Inventory, Subscale – Affective Distress; b Pain Self-efficacy Scale for Children;

c Center for Epidemiologic Studies Depression Scale

iii) Distress following Trauma

Two studies explored intensive CBT within a population experiencing distress

following a traumatic incident, including a motor vehicle accident [6] and for new

mothers whose infants were admitted to a neonatal intensive care unit (NICU) [3].

Table 5 presents data from these two studies. The RCT by Bernard et al. (2011),

presented first, reported a small effect when comparing an intensive intervention

to a control group, although this was not statistically significant (p = .23) and the

study was underpowered to detect an effect. The effect size for Hickling et al.

(2005) was large (d = -1.88), when comparing pre and post data, although this study

was not a controlled design and had a sample size of three participants. Both

studies offered a similar duration of therapy, with Hickling et al. (2005) offering two

60-90 minute sessions and Bernard et al. (2011) offering three 45-55 minute

sessions. Both studies delivered components of psychoeducation, relaxation and

cognitive restructuring, but Hickling et al. (2005) additionally delivered exposure

techniques which could arguably be more suited to that particular trauma

population. The considerable difference in treatment effect could relate to small

sample sizes and varied study designs. Hickling et al. (2005) had a particularly small


sample size and the RCT by Bernard et al. (2011) had superior methodological

rigour. Additionally, there is a noteworthy difference in the longer term outcomes

and expectations between the cohorts. For example, complications following an

NICU admission could be long-term, whereas Hickling et al. (2005) anticipated a

significant improvement for participants over time, even without treatment. It must

be noted that methodological quality of both studies were rated weak and

therefore results must be interpreted cautiously.

Table 5. Changes to Mean Scores and Calculated Effect Sizes for Distress following


Intervention Control group
(no intervention)

Study Primary

No of









Effect Size
(Morris’ d)

Bernard et
al. (2011)

DTS a 25
(for all groups)






Pre- Intervention Post- Intervention

Study Primary

No of

M (SD) No of

M (SD) Effect Size
(Cohen’s d)

Hickling et
al. (2005)

PCL-5 b 3 60.3 (8.6) 2 45.5 (4.5) -1.88

a Davidson Trauma Scale; b PTSD Checklist for DSM-5

iv) Addiction

Two studies explored intensive CBT for addiction problems, including gambling [10]

and substance use [17]. Worden et al. (2015) investigated intensive CBT for

individuals with substance use or dependence, alongside symptoms of anxiety.

Scores on the Anxiety Sensitivity Index (ASI) generated a large treatment effect (d =

-1.23) comparing pre (M = 41.6; SD = 9.7) to post (M = 29.7, SD = 13.3) intervention

scores. Morefield et al. (2014) studied an inpatient treatment program for

gambling. They used the K10 scale for psychological distress. Post-intervention

scores were not published and therefore an effect size could not be calculated,

although significant improvements in reduction of gambling behaviours (p < 0.001),


reduced psychological distress (p < 0.001) and improvement on the Work and Social

Adjustment Scale (p < 0.001) were reported.

Both studies included psychoeducation, exposure and cognitive restructuring, with

the intervention by Morefield et al. (2014) also featuring behavioural rehearsal.

Morefield et al. (2014) offered 6-12 sessions within two weeks, but did not specify

session length. Worden et al. (2015) offered six sessions of up to 1.5 hours, across

four weeks. Worden et al. (2015) initially intended for a group delivery of the

intensive intervention. The methodology was changed to individual therapy due to

scheduling difficulties of all participants not being able to attend simultaneously.

Both studies offered the intervention alongside intensive day programmes (Worden

et al., 2015) or within inpatient programmes (Morefield et al., 2014). This

inpatient/intensive programme delivery appears suited to the needs of the

population, which counteracts barriers people with addictions face when accessing

more general community assertive outreach programmes (i.e. client resistance,

non-participation and a more complex social population [i.e. homelessness, criminal

history]; Amodeo et al., 2011). Both studies were rated weak in quality on the

EPHPP and thus strength to detect accurate results may be insufficient.

4.6 Long Term Follow Up

Eight studies reported results of longer term follow up [2, 4, 6, 9, 12, 14, 16, 17],

ranging from one month to one year. Six studies reported a large effect size when

comparing pre intervention scores to longer term follow up [4, 6, 12, 14, 16, 17].

McManus et al. (2014) maintained the same effect at long-term follow up, which

remained small to medium. Abramowitz et al. (2003) reported a reduction in effect

at longer term follow up, from medium to small.

4.7 Acceptability

Of the studies that reported therapy completion (k = 13), an average of 88% (SD =

16.61) of participants completed the intervention. Reasons for drop out included:

time constraints, family commitments, illness or stress, transportation difficulties,

unable to be contacted, transferred services, or at a decision point during therapy

(i.e. before exposure, or at a point perceived that the therapist could provide no


further support). Given the high completion rate, it appears that intensive CBT was

acceptable for most individuals, although some reasons for drop out appeared to

be circumstantial (i.e. illness), whereas others (i.e. time constraints, commitments,

transportation difficulties) could relate to the demand on the participants due to

the nature of intensive delivery. This again highlights the importance of patient

choice in the delivery of clinical interventions. It must be noted, that high

completion of therapy does not fulfil the assumption of acceptability. This has been

further explored in a separate qualitative review paper of intensive versus weekly

delivery of CBT (Bevan, Oldfield & Salkovskis, 2010), which will be considered

further in section 5.3.


5. Discussion

5.1 Summary of Evidence

The aim of this review was to examine existing literature evaluating delivery of

intensive CBT with clinical populations. The review identified 17 studies that

evaluated this intervention. Review papers were categorised into four cohorts of

psychological distress. Most studies found promising results at post intervention,

long-term follow up and when evaluated against comparison groups. However,

most studies were exploratory in design (i.e. feasibility), without a control group,

with small sample sizes and rated weak in terms of methodological quality.

All studies evaluated intensive CBT with some variations in delivery. Therapeutic

dose ranged across studies, with an average 17 hours of therapy per person which

was implemented in different ways (i.e. daily sessions, two sessions per week,

longer session duration). Therapy dose delivered within this review was in line with

national guidance but was completed more intensively (i.e. within four weeks as

opposed to weekly). For example, for particular mental health diagnoses (i.e.

anxiety disorder, OCD, BDD), NICE (2005; 2014) recommends 7-21 hours of

therapeutic input depending upon subgroup. This demonstrates that carrying out

recommended therapeutic dose can occur within a more condensed therapy

delivery window. Similarly, all included studies delivered at least two components

of CBT during this period. Attrition was low for studies that reported it, which

appears to support to the feasibility and acceptability of an intensive delivery of


Effect sizes for treatment for distress associated with chronic pain conditions was

small to medium. Effect size calculated for one addiction paper was large, with the

second study in this area offering promise. Effect sizes for studies exploring distress

following trauma were small and large, with the smaller effect size reported by an

RCT. Studies exploring intensive CBT for distress associated with mental health

difficulties offered most promise, with small to medium effect sizes in the three

trials, and very large effect sizes for the other six studies. Across all subgroups,

effect sizes were smaller for comparison designs (i.e. RCT’s, cohort analytic designs)

compared to non-control group comparisons. Arguably, whilst trials may not have


been powered enough to detect an effect, which Bernard et al. (2011) noted to be

the case in their RCT, non-control group studies may have overinflated effect sizes

based upon lack of control in their methodologies. Rigorous design and reporting of

data in RCTs limit the potential over inflation of effect sizes, therefore rendering it

more difficult to generate inaccurate results and making well-designed RCT’s more

valid and generalisable (Kraemer & Kupfer, 2006). The small sample sizes in review

papers could increase the likelihood of overinflated effect sizes. Further studies

with a more rigorous methodological design and larger sample sizes are required to

strengthen these findings.

Effect sizes of intensive CBT across review papers were promising, particularly in

areas of mental health. Whilst we address the practical factors and the importance

of patient choice in the delivery of intensive CBT in Section 5.3, it is important to

consider potential theoretical implications behind the utility of intensive CBT. There

are a number of active ingredients which have been theorised as improving

engagement and outcomes of CBT interventions, some which may be particularly

significant to the intensive delivery. Non-specific therapy factors, alongside

therapeutic alliance, are longstanding components understood to be a large

contributor to successful outcome, irrespective of the treatment modality

(Goldfried, 2013; Carter et al., 2015; Bevan, Oldfield & Salkovskis, 2010). Four non-

specific factors are identified as influencing treatment outcome during

psychotherapy, including; treatment expectancy (such as the placebo effect), extra-

therapeutic factors (i.e. factors that occur outside of the therapy space, such as

social support), common therapy factors (i.e. alliance) and therapy specific

techniques (i.e. specific components of CBT; Lambert & Barley, 2001). One non-

specific factor specific to intensive CBT is patient treatment expectancy, in how

logical the patients perceive the intervention to be beforehand being a key

predictor of outcome (Carter et al., 2011). If patients anticipate the intervention to

be effective this is more likely to improve engagement and in the long-term

contribute to symptom reduction (Meyer et al., 2002). A positive outcome is also

further intensified when therapists’ have expectancies for positive treatment

outcome. Perhaps for intensive delivery of CBT, patients will have been briefed

upon the rationale of intensive compared to traditional delivery, have an outline of


the treatment plan and in some cases will have opted for intensive CBT over

traditional delivery. In terms of particular mental health difficulties, Oldfield,

Salkovskis and Taylor (2011) give rationale for the delivery of intensive CBT, over

traditional delivery, due to the longstanding nature of OCD and the tendency for it

to be ‘treatment refractory’. The intensive delivery compliments the delivery of

exposure and response prevention interventions and is driven by early theories on

the success of ‘massed’ trials compared to ‘spaced’ trials of exposure (Mackintosh,

1974) and furthermore on the likelihood of avoidance behaviours and limited

exposure opportunities hampering the effects of treatment (Rachman, 1979). From

a neuropsychological perspective, it could be argued that certain cognitive factors

play an important role in engaging in intensive CBT (i.e. memory, retention of

therapy content, concentration), and furthermore, Saxena et al. 2009 found distinct

changes in regional brain functions following an intensive CBT intervention for OCD.

Beyond active therapy components Tang, DeRubeis, Beberman, and Pham (2005)

discussed the mechanisms behind ‘inter-session’ or ‘sudden gains’ (i.e. significant

symptom improvements between individuals CBT sessions). Tang et al. (2005)

reported sudden gains to occur when cognitive changes happened during

intervention sessions. This finding highlights the importance of particular therapy

sessions which target change and therefore influence treatment outcome. It could

be argued that the momentum of intensive CBT sessions could facilitate increased

motivation, with motivation being a recognised factor influencing therapy outcome.

Bevan, Oldfield and Salkovskis (2012) note the importance of momentum and

motivation specifically during the delivery of intensive CBT.

To our knowledge, no other published reviews have investigated intensive CBT in an

adult clinical population. One published review (Öst and Ollendick, 2017) focused

upon intensive CBT for anxiety disorders in children and adolescents. It would

appear that there is an interest in reviewing disorders of anxiety, perhaps due to

increased literature in this area and the effectiveness of intensive CBT in this area

to date (i.e. Deacon & Abramowitz, 2006).


5.2 Strengths and Limitations

This section outlines a number of limitations alongside justifications for decisions

made and descriptions of how limitations were minimised. Strengths of this review

are presented first.

Firstly, two steps were taken to minimise bias and limit subjectivity during the

abstract screening and quality appraisal stages. Interrater reliability is an important

measure in determining the accuracy of evaluations made during research (i.e.

quality) and kappa is a longstanding tool in determining this (Banerjee, Capozzoli,

McSweeney, & Sinha, 1999). Interrater reliability was ‘strong’ for abstract screening

and ‘almost perfect’ for quality appraising, which is important in highlighting the

precision and accuracy of those aspects of the review that were dual-rated. A

further strength of this review was the systematic nature in how it was conducted.

The review adhered to a number of strict processes important in developing a

robust systematic review. This included adherence to the PRISMA systematic

review protocol (Moher et al., 2015), an evidence-based approach to searching (i.e.

PICO; Miller & Forrest, 2001) and a practice guide (Boland, Cherry, & Dickson,


One limitation was operationalising the term ‘intensive CBT’, as this appeared to be

inconsistently defined within existing literature. Included papers varied in their

delivery of CBT, particularly therapeutic dose, which may undermine the reliability

of conclusions drawn in this review. The definition for intensive CBT was shaped by

previous literature (Storch et al., 2007; Oldfield et al., 2011; Ehlers et al., 2010;

Deacon & Abramowitz, 2006) and both published and ongoing reviews investigating

intensive CBT (Öst & Ollendick, 2017; Millar et al., 2018; Clarkson et al., 2018).

Whilst scoping exercises were conducted to test search terms, the final PICO

criteria resulted in the exclusion of some studies defining themselves as ‘intensive

CBT’. For example, a number of studies completed the main intervention within

four weeks, but offered ‘booster’ sessions for several weeks afterwards (Ehlers et

al., 2010; Oldfield et al., 2011; Challacombe & Salkovskis, 2011; Ehlers et al., 2014).

This meant that some potentially relevant studies were excluded. Whilst these

papers could have added to our understanding of intensive CBT delivery, the


decision was to remain consistent with the established PICO criteria, as published

on prospero (ID: CRD42018086546). Boland et al. (2017) highlight potential for bias

during the screening phase, particularly where supplement papers are included by

the author. Therefore, adhering to PICO criteria avoided such bias and maintained

elements of reliability and consistency with the eligibility criteria. A larger review in

the future could consider broadening the PICO criteria to allow inclusion of studies

with booster sessions.

The review included a number of clinical populations experiencing psychological

distress (i.e. pain, mental health, addiction, and trauma). The review sample was

somewhat heterogeneous which did not allow for more in depth exploration and

data synthesis (e.g. meta-analysis). Whilst this current review provided a narrative

overview of the literature, broadening inclusion criteria in the future (i.e. group or

computer delivered CBT) could allow a larger-scale review to explore more variants

of intensive delivery. This could allow a more rigorous analysis (i.e. meta-analysis) in

more specific groups (i.e. diagnostic patient groups, methods of delivery, therapy

dose). Many studies had sample sizes smaller than would be desired for

generalisable results and reliable effect sizes. As mentioned, grey literature and

non-English papers were discounted, which could have unintentionally excluded

relevant literature.

Many papers in this review (k = 11, 65%) were rated as having weak methodological

quality, as determined using the EPHPP quality tool. This was important to consider

when interpreting data, as many of the reported results may be inaccurate and

difficult to generalise beyond each individual study. EPHPP rates as Gold Standard

both RCT’s and controlled clinical trials, but only two studies used an RCT design,

which lowered the rating for remaining studies. Similarly, many studies did not

control for confounding variables as most studies did not have multiple groups and

therefore did not report any group differences. This rendered overall outcome of

confounding variables as weak for many studies. Other methodological weaknesses

included limited reporting of attrition rates (or reasons for drop out), limited

blinding of outcome assessors and participants (or otherwise not reported), and

variable clarity on the methods of sample selection. Literature exploring intensive

CBT is emerging and many studies are in an exploratory phase. Future emphasis


must be placed upon the design and implementation of higher quality studies (i.e.

RCT’s) before a repeat review can take place.

Whilst the EPHPP rates a number of factors relating to bias (i.e. selection bias,

confounders, blinding) it does not evaluate the reporting of treatment outcome, as

is scrutinised in other tools, such as the Cochrane Collaboration Risk of Bias Tool

(CCRBT) (Armijo et al., 2012). The way in which studies analyse and report their

data (i.e. selective reporting, intent to treat analyses) does not affect global rating

of the EPHPP and thus could lead to bias in the reporting of outcome.

5.3 Clinical Implications and Future Directions

Although further investigation is required, this current review highlighted a number

of papers evaluating intensive CBT in clinical populations experiencing psychological

distress, with some promising results in terms of feasibility, acceptability and

efficacy. There is a growing recognition within the literature of the suitability of ERP

to an intensive delivery format (Oldfield et al., 2011). In this review, many studies

delivered components of exposure therapy, particularly within the cohort

experiencing distress associated with mental health difficulties. Treatment effects

within this group were promising, which raises the question of whether some

components of CBT, such as ERP, are particularly suited to an intensive delivery

format and whether intensive CBT itself is suited to certain clinical populations.

Whilst intensive delivery appeared suited to individuals experiencing mental health

difficulties, perhaps a longer term intervention would suit those experiencing

distress associated with chronic pain. This can be hypothesised given the small

effect of treatment in this area, but also the requirement for a more multimodal

treatment programme, which arguably could be suited to a longer term delivery.

Treatment effectiveness for pain and addiction were mixed and further exploration

would be warranted before drawing any conclusions about these populations.

Participant preference seems to be a factor in the delivery of intensive or standard

CBT. For example, there were a number of drop outs related specifically to

intensive delivery (i.e. time constraints or competing commitments). There

appeared to be no clear pattern of drop-out affected by the intensity of therapy,

the cohort in which it applied to or the therapy components delivered for those


studies that cited such difficulties [3, 16, 17]. Neziroglu and Yaryura-Tobias (1993)

offered participants the option of an intensive delivery or weekly sessions, with half

the sample opting for each. Furthermore, Worden et al. (2015) began with the

intention of a group format, which was changed to individual therapy following

barriers to participants accessing the group sessions simultaneously. These factors

highlight the differences in treatment preference and the level of commitment

people are able to invest.

Use of intensive CBT also has implications for services whereby intensive

interventions might be favoured over weekly delivery. In some studies within this

review, intensive delivery was favoured over long-term intervention commitments

(Neziroglu & Yaryura-Tobias, 1993). Bevan, Oldfield and Salkovskis (2010)

interviewed participants following an intensive or weekly delivery of CBT for OCD,

with interviews eliciting both benefits and drawbacks. Time between therapy

sessions naturally reduced in the intensive format. Those who had weekly delivery

stated they had longer to learn and consolidate therapy material, whereas those

who had the intensive format stated a preference of having less time to ruminate

between sessions and an increased focus on the issues. The intensive group stated

that delivery was more time effective, with weekly sessions requiring a longer-term

commitment. The weekly group perceived intensive delivery to be too stressful,

although the intensive group experienced it as being more motivating with better

momentum. Overall, this challenges the view that CBT can only be delivered on a

weekly basis and highlights the importance of considering non-traditional methods

of delivery, based upon patient preference. Understanding patient preference

raises important considerations for the development, acceptability and

effectiveness of services (Bevan et al., 2010). These perspectives provide support

for the response regulation model and the stepped care model of healthcare

delivery, as discussed earlier (Stiles et al., 2008; Bower & Gilbody, 2005). Intensive

CBT could be a starting point, with further booster sessions or weekly sessions

being available as determined by need.


5.4 Conclusions

By conducting this review we are able to better understand the varied

characteristics of intensive CBT and its delivery across a number of clinical

populations. We were able to highlight the efficacy of intensive CBT although this is

tentative given the emerging nature of this literature. Whilst previous reviews have

focussed upon specific diagnoses or populations, this current attempt provides a

useful contribution in the broader opportunities for use of intensive CBT. Large

scale rigorously designed studies (i.e. RCTs) are now needed to establish the

efficacy of intensive CBT for clinical populations.


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Introduction to Paper II

Paper II is a research study written in preparation for submission to the Archives of

Suicide Research (Appendix 3). The authorship for this paper will be as follows:

Hampson, L., Killilea, J., Lennox, C., & Pratt, D. (2019).

Paper II investigates the feasibility of investigating an intensive cognitive

behavioural suicide prevention (CBSP) programme conducted in a male prison. The

presence of mental illness in prison is far greater than that in the community, with

an increased risk of self-harm and suicidality. Prisoners present with a much higher

risk of suicide and a number of complex factors which mediate this risk. It is

important to focus preventative interventions into this population. The outcome of

this study will highlight the feasibility of an intensive intervention in this population

and thus provide recommendations for future research studies in this area. There

are no known studies to date that have delivered intensive Cognitive Behavioural

Therapy (CBT) in this format within a prison.

The Intensive CBT for Suicide Prevention in Prison (InSPire) Programme was co-

developed and co-delivered alongside a fellow trainee (JK) on the University of

Manchester Clinical Psychology Doctoral Programme. The completion of all

research activities was equally distributed between the author and the second

trainee. A number of North West prisons were contacted in order to establish a

host prison for the InSPire programme. The required ethical applications were

submitted, with approval granted from the University of Manchester (Appendix 4),

the National Research Ethics Committee for Wales (IRAS ID: 238927) (Appendix 5

and 6), Her Majesty’s Prison and Probation Service National Research Committee

(ID: 2018-154) (Appendix 7) and from the Governor of the host prison. The study

was registered as a Clinical Trial (ID: NCT03499548) (Appendix 8). The author and

the second trainee both collected the study data and delivered the therapeutic

components of the InSPire programme, carrying an equal caseload of participants.

The author then collated all of the quantitative data for this thesis which led onto

the development of this paper.


Paper II Research Study

Intensive CBT for Suicide Prevention in Prison:

The InSPire Programme

Written in preparation for submission to

Archives of Suicide Research

(NB. The word count has been extended for

this version to provide additional context)

Word count: 8275 (excluding abstract, tables, figures and references)


1. Abstract

Objectives: This study aimed to evaluate the feasibility of an intensive programme

of cognitive behavioural suicide prevention therapy within a male prison.

Methods: Thirteen participants consented to take part. Up to ten hours of therapy

were offered, across five sessions, within a three week delivery window. Outcome

measures were completed at baseline and follow up.

Results: Programme completion and client satisfaction with the intensive

programme were high. Outcomes related to suicidal distress were assessed, with

small to large effect sizes found.

Conclusions: The study holds promise for the feasibility and efficacy of delivering

intensive cognitive behaviours therapy (CBT) for suicidal prisoners. Further

exploration on a larger scale is warranted.

Key words: Prison, Suicide, Cognitive Behavioural Therapy, Intensive.


2. Introduction

Suicide involves “the act or an instance of taking one’s own life voluntarily and

intentionally” (Merriam-Webster, 2019). Suicide is recognised as the second leading

cause of death in 15-29 year olds, with previous suicide attempts being the highest

reported risk factor for death from suicide (World Health Organisation [WHO],

2017). Nearly 800,000 people lose their lives to suicide each year worldwide (WHO,

2017). There were 5,821 suicides in the UK in 2017, with males accounting for three

quarters of this number (Office for National Statistics [ONS], 2018). In 2017, the

highest risk of suicide in the UK was males aged between 45-49 years (ONS, 2018).

In a UK survey, one fifth of adults reported experiencing thoughts of suicide at

some point during their life, with one in fifteen having made an attempt (McManus

et al., 2014). These figures stress the importance of preventative and responsive


The National Institute for Health and Care Excellence (NICE, 2018) published a

report on preventing suicide in community and custodial settings, highlighting

groups at higher risk of suicide as being young and middle aged males, those

already affected by suicide, individuals who self-harm, are under mental health

services, use substances, have a physical illness, have a diagnosis of autism, are

from a marginalised societal group (i.e. Lesbian, Gay, Bisexual, Transgender [LGBT])

or who work within a particular occupational group (see ONS, 2017). NICE (2018)

report a heightened suicide risk for individuals in contact with the criminal justice

system, especially those in prison or a detention centre.

Individuals in prison have an increased vulnerability to self-injurious behaviour and

thoughts and acts of suicide (Palmer & Connelly, 2005). Risk of suicide in prison is

reportedly five and 20 times that expected for male and females respectively (Fazel,

Benning, & Danesh, 2005; Fazel & Benning; 2009). Recent years have seen

increasing rates of suicide and self-harm in UK prisons (Georgiou et al., 2017).

Fazel and Baillargeon (2011) note the higher prevalence of mental health disorders

in prison, compared to the general population. This disparity is related to many

factors, including increased use of substances (and associated higher risks of

physical health conditions) (Fazel & Baillargeon, 2011). A number of short comings


in health treatment are reported in recognition of, immediate response to and long

term follow up of mental and physical health conditions (Fazel & Baillargeon, 2011).

Shaw, Baker, Hunt, Moloney and Appleby (2004) reported that one third of suicides

in prison take place within seven days of reception, affirming concerns of a lack of

recognition and response to mental health.

In 2005, the National Offender Management Service (NOMS), in partnership with

the Department of Health (DoH), introduced the Assessment, Care in Custody and

Teamwork (ACCT) system. The Ministry of Justice (MoJ) (2013) states that “any

prisoner identified as being at risk of suicide or self-harm must be managed using

the Assessment, Care in Custody and Teamwork (ACCT) procedures”. The system

was developed to allow at risk individuals to be identified and appropriately

supported by prison staff. Usual care should involve active supervision and

monitoring of risk; consideration of triggers (i.e. demographics, history,

psychological and psychosocial factors); facilitation of peer support and listener

schemes; regular multidisciplinary ACCT reviews and completion of individualised

care plans (MoJ, 2013). The ACCT system is overseen by each prison’s Safer Custody

Team (MoJ, 2013).

Fraser, Gatherer and Hayton (2009) reported on the increased risk of poor mental

health within prison, with mediating factors including overcrowding; exposure to

violence; long periods of enforced solitude; lack of privacy; lack of access to

meaningful activities; insecurity about the future and a shortfall in the delivery of

health services, particularly mental health. Liebling (2011) reported about the moral

climate of prisons and how environmental influences (i.e. staff-prisoner

relationships, issues of fairness and humanity) contribute to poor mental well-

being. Experiences of perceived powerlessness and isolation feature in

psychological models that seek to explain why a person may choose to end their life

through suicide.

A number of established theoretical models seek to explain suicidal behaviour. One

pertinent to this current research is the Cry of Pain (CoP) Model (Williams, 1997),

which captures experiences of suicidal thoughts and behaviour from a cognitive

behavioural perspective. The model identifies suicidal behaviour as a reaction to

stressful situations. Six key components correlate with increased risk of suicide:


access to means; presence of a major stressor; perception of stressors (i.e. negative

appraisal, defeat); cognitive biases and lack of problem solving skills); hopelessness

and no means of rescue (including lack of social support). The Schematic Appraisal

Model of Suicide (SAMS) (Johnson, Gooding, & Tarrier, 2008) builds upon CoP by

developing a formulaic representation of the driving mechanisms behind suicide.

This includes the CoP understanding of cognitive biases, but extends it to

encompass suicide schema and a system of appraisal (including appraisals of the

self, past, future, and current situations).

Cognitive Behavioural Therapy (CBT) is a recommended intervention for suicidal

behaviour and self-harm (NICE, 2011) with an evidence base in both community

(Stanley et al., 2009; Tarrier, Taylor, & Gooding, 2008) and prison settings (Pratt,

Gooding, Awenat, Eccles, & Tarrier, 2016; Pratt et al., 2015). A manualised Cognitive

Behavioural Suicidal Prevention (CBSP) intervention (Tarrier et al., 2013) was

developed to address underlying mechanisms of suicidal behaviour informed by the

SAMS model. The CBSP intervention is underpinned by principles of CBT with an

emphasis on building a collaborative empathic relationship, developing recovery

goals, formulating resilience, whilst continually assessing and responding to clinical

risk (Tarrier et al., 2013). CBSP has typically been delivered across 20-24 individual

sessions, for up to one hour, 1-2 times per week (e.g. Pratt et al., 2015; Haddock et

al., 2016). Delivery of the CBSP intervention is focused upon establishing safety (i.e.

risk management), assessment and engagement, socialisation to the SAMS model

and formulation development, intervention and change techniques and developing

a maintenance plan (Tarrier et al., 2013). The Prevention of Suicide in Prisons

(PROSPeR) study offered the first randomised control trial of CBSP in prison (Pratt

et al., 2015). The PROSPeR trial was successful in delivery and outcome, with

clinically significant recovery achieved by over half the sample of suicidal prisoners.

This demonstrates the feasibility of CBSP in a male prison population.

Previous research has captured challenges of attrition rates in CBT trials for suicide

prevention. Stanley et al. (2009) reported a 28% dropout rate for 12 sessions of CBT

in an adolescent population. In a randomised control trial (RCT), only 50% of the

adult sample (n = 30/60) received the intended 10 (or more) sessions of CBT (Brown

et al., 2005). These challenges are further emphasised within prisons. During the


PROSPeR trial (Pratt et al., 2015), 35% of the prison sample were unexpectedly

released or transferred, which contributed to an overall attrition of 44%. This

impedes the long-term support available for prisoners and advocates a potential

benefit of moving away from traditional weekly delivery of CBT. Pratt et al. (2015)

recommended that future studies pilot the delivery of CBT for suicide prevention in

an intensive format.

Outside of suicide prevention, previous studies have modelled the delivery of

intensive CBT. Challacombe and Salkovskis (2011) found six sessions of CBT

delivered within a two week period to be acceptable and effective in reducing

symptoms in six women with postnatal Obsessive Compulsive Disorder (OCD).

Oldfield, Salkovskis and Taylor (2011) conducted a similar study and found that

intensive CBT was as effective as a non-intensive delivery for 22 individuals with

OCD. A further study explored feasibility for 14 people with post-traumatic stress

disorder (PTSD) (Ehlers et al., 2010). Intensive delivery was well tolerated and 86%

no longer met PTSD criteria post intervention. Compared to a weekly format,

intensive delivery was associated with a quicker and more substantial reduction in

symptoms of OCD and co-morbid depression. These studies highlight the emerging

potential of intensive CBT, which should be examined further within a prisoner

sample experiencing suicidal thoughts and behaviours. As such, the ‘Intensive

Suicide Prevention in Prison’ (InSPire) Programme was developed to explore this for

the first time.

The primary aim was to evaluate the feasibility of an intensive CBSP intervention for

individuals experiencing suicidal thoughts and behaviours in prison. Secondly,

changes on measures of three key psychological mechanisms associated with

suicidality were explored, which link to modules within the CBSP intervention

manual (Tarrier et al., 2013). These were problem solving (Biggam & Power, 1999),

emotional regulation (Pratt et al., 2015) and perceived social support (Rivlin,

Hawton, Marzano, & Fazel, 2013). Primary hypotheses related to the feasibility of

the InSPire programme delivery. Secondary hypotheses related to clinical outcome,

with participants attending the programme expected to experience reduced

suicidal ideation and beneficial changes in the three psychological mechanisms.


3. Method

3.1 Study Design

The InSPire Programme used a feasibility case series design, with a single baseline

and single follow up.

3.2 Participant Sample

The sample was recruited from an adult male prison in the North of England, with a

capacity of approximately 1000 male prisoners. Recruitment occurred between 1st

October and 21st November 2018 and follow up between 17th October and 5th

December 2018. Participants were identified to be on an ACCT in the host prison.

The recruitment target was for 10 participants to complete the programme, in line

with previous intensive CBT feasibility studies (i.e. Challacombe & Salkovskis, 2011;

Ehlers et al., 2010). Led by previous literature (Pratt et al., 2015), it was anticipated

that a recruitment total of 16 participants would be required in order for 10

participants to complete therapy.

3.3 Inclusion Criteria

Inclusion criteria were male prisoners over 21 years, who had been identified to be

at risk of suicide, according to the host prison’s ACCT system, currently or within

the past month. Individuals were excluded from the study if they had insufficient

understanding of English language (i.e. unable to understand the participant

information sheet [PIS] and deemed unable [by programme staff] to engage in

intervention content); were unable to provide informed consent; were due to be

released from the host prison within six weeks of InSPire Programme

commencement; were considered to be under the influence of substances (based

upon prison staff report); had any underlying organic disorder (as per prison and

healthcare records); or were deemed by prison staff to pose a risk of harm to

InSPire staff. Both therapists were female, which posed a barrier to inmates whose

risk specifically applied to working with women, as it automatically denied their

access to the programme.


All potential participants were identified and screened by the Safer Custody team

who held administrative responsibility for the ACCT system. Following agreement to

be contacted, eligible individuals were approached by a researcher and the PIS was

read and a copy provided (Appendix 9 and 10). No less than 24 hours later,

individuals were re-approached by a researcher. Participants were given the

opportunity to ask questions and discuss the study to ensure they understood what

participation would entail. Written informed consent was taken from those wanting

to take part (Appendix 11). The prison GP was notified of all participants’ entry to

the programme (Appendix 12). Administration of outcome measures was

conducted by a researcher a baseline and follow up.

3.4 Recruitment

The Safer Custody team identified a total of 83 prisoners on an ACCT during the

recruitment window. All 83 were screened for eligibility and 52 (63%) were deemed

unsuitable, as outlined in Figure 1. The remaining 31 (37%) individuals were

approached and provided with a PIS, of which 17 (55%) expressed interest in taking

part. Two interested individuals were unable to take part as the study came to its

planned end prior to their recruitment and two individuals were deemed ineligible

at point of consent, leaving 13 prisoners to be consented into the InSPire



Figure 1. Consort Diagram of Recruitment and Study Retention

Participant pool
(n = 83)

(provided with PIS)

(n = 31)

(n = 13)

Follow up
(n = 13)

Unable to participate/Declined
(n = 18)

No current thoughts of suicide (n = 9)
Refused/Reluctant to engage (n = 5)
Not eligible at consent (n = 2)
Interested, study ended (n = 2)

Not eligible following initial screen
(n =52)

Risk of harm to researcher (n = 17)
Intoxicated (n = 9)
Release or imminent release (n = 13)
Located on Segregation Unit (n = 12)
Judged to be self-isolative (n = 1)

Attended all five
therapy sessions

(n = 10)

Did not complete therapy
(n = 3)

Did not commence programme (n = 1)
Discharged from the programme
following two DNAs (n = 2)
(Both attended three sessions before


3.5 Procedure

Two trainee clinical psychologists held roles of ‘researcher’ (i.e. completing study

measures) and ‘therapist’ (i.e. conducting 1:1 therapy). Participants were randomly

assigned to one of the two study therapists. Roles were coordinated between the

two trainees, so that the trainee completing study measures with a participant did

not deliver therapy to the same participant.

During baseline assessment, the researcher administered a demographic

questionnaire and psychometric battery to each participant. Participants were

informed when the InSPire programme would commence and were briefed about

what to expect (Appendix 13). Following this, participants commenced the

intervention with the therapist. Sessions took place on the wing, in education or in

chaplaincy during morning or afternoon slots, organised in conjunction with prison

movement. Within two weeks of programme completion, the researcher met again

with the participant to complete follow up measures. Participants were debriefed

on their involvement (Appendix 14) and provided with a certificate of completion,

which had been designed in one of the prison workshops (Appendix 15).

Participants were discharged from the programme if there were two ‘did not

attend’ (DNA) appointments (non-attendance without prior cancellation) or if they

opted for voluntary withdrawal. Participants were made aware upon consent that

two DNAs would result in discharge from the programme. Participants were

reminded of the rule following the first DNA. Predictable absences or ‘cannot

attend’ (CNA) appointments were considered on a case by case basis.

3.6 Measures

i) Demographic and Clinical Risk Information

Demographic information was collected using a proforma adapted from a previous

prison research study (Tucker et al., 2017). The questionnaire captured

criminological information (i.e. sentence type/length, ACCT details) and socio-

economic information (i.e. employment, marital status) (Appendix 16). Clinical risk

information was obtained from the prison’s information management system (i.e.

specific risk factors including risk to females, risk of weapons, risk of hostage).


ii) Feasibility Outcome Measures

Feasibility measures were completed by participants and therapists;

a) Feasibility metrics were captured, including recruitment data (eligibility,

population pool, rate of recruitment) and retention (number of sessions

attended, total number of DNAs and CNAs [including reasons]; Appendix 17).

b) Therapists completed a Session Summary Sheet following each session, to

capture participants’ level of engagement and adherence to the InSPire

programme (Appendix 18). This scale has been used in previous trials delivering

CBSP therapy, in prison (Pratt et al., 2015) and in the community (Gooding et

al., 2017). Therapists reported attendance, session duration, level of

formulation and CBSP phases of therapy delivered in that session. An agenda

and ‘additional notes’ captured qualitative information about session content.

c) Upon programme completion, therapists completed a Therapist Rating Scale to

measure therapy adherence (Appendix 19), as used in previous CBSP trials

(Pratt et al., 2015; Gooding et al., 2017). The form recorded session attendance

(i.e. DNA/CNA reasons, session duration, location) and content (i.e. CBSP

intervention components delivered). Therapists rated seven questions using a

Likert format (i.e. poor [1], moderate [3], excellent [5]). Questions assessed

level of attendance, promptness, level of participation, mastery of content,

disruptive behaviour, completion of homework and overall evaluation of

programme success. Scores of five indicated optimum engagement (NB: Scores

of disruptive behaviour were reversed, therefore higher scores denote less


d) Participant satisfaction was measured using the Client Satisfaction

Questionnaire Revised (CSQ-8-R; Larsen, Attkisson, Hargreaves, & Nguyen,

1979) (Appendix 20), upon completion of the InSPire programme. The CSQ-8-R

is a widely used tool with high internal consistency (coefficient α = .91) when

used to assess psychotherapy outcome (Attkisson & Zwick, 1982). This scale has

been used in prison to assess outcome of an alcohol recovery programme

(Johnson, Schonbrun, & Stein, 2014). Qualitative feedback was optional at the

end of the measure.


e) Therapists completed a Discharge Summary form for participants who

terminated the programme detailing the number of sessions attended and

reasons for termination of therapy (Appendix 21).

iii) Clinical Outcome Measures

Outcome measures were completed at baseline and follow up;

a) The Beck Scale for Suicide Ideation (BSS; Beck & Steer, 1991) (Appendix 22) is a

21-item questionnaire measuring suicidal ideation over the past week. An

adapted version of this measure was also completed for ideation occurring over

the past one month to ensure eligibility and allow a broader picture of suicidal

ideation. The BSS has been widely used within prison populations (Mandracchia

& Smith, 2015; Way, Kaufman, Knoll, & Chlebowski, 2013; Pratt et al., 2016).

Excellent internal consistency of this measure has been reported (coefficient α =

.94; Mandracchia & Smith, 2015).

b) The Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)

(Appendix 23) is a 36-item questionnaire in a 5-point Likert Scale format,

measuring components of emotional regulation. The scale has excellent internal

consistency (coefficient α = .93; Gratz & Roemer, 2004) and has been used in a

prison population (Walsh, DiLillo, & Scalora, 2011).

c) The Social Problem Solving Inventory-Revised (SPSI-R; D’Zurilla, Nezu, &

Maydeu-Olivares, 2002) (Appendix 24) is a 25-item scale assessing an

individual’s ability to generate solutions to problems. This scale has been

validated to use within a prison population and has good internal consistency

(coefficient α = .86) and excellent test-retest reliability (coefficient r = .94)

(Wakeling, 2007).

d) The Multidimensional Scale of Perceived Social Support (MSPSS; Zimet, Dahlem,

Zimet, & Farley, 1988) (Appendix 25) is a 12-item scale in a 7-point Likert Scale

format, measuring perceived support from friends, family or significant others.

This measure has been widely used within a prison population (Staton-Tindall,

Royse, & Leukfeld, 2007; Brown & Day, 2008; Johnson & Zlotnick, 2008) with

excellent internal consistency (coefficient α = .92; Brown & Day, 2008).


iv) Sessional Measures

The authors adapted brief sessional measures to capture a basic overview of the

main focus of each session, as used during a previous CBSP trial (Gooding et al.,

2017). Five questions were asked at each session which mapped onto standardised

outcome measures. Using a four point Likert format (i.e. not at all [0], a little [1],

mostly [2], completely [3]), participants were asked to rate, since the previous

session, how much they felt they had someone supportive to turn to (perceived

social support); had been struggling to manage emotions (emotional regulation);

had been able to deal with problems (problem solving); had felt like harming

themselves and had felt suicidal (Appendix 26). Therapists rated the same

questions, based upon how much of the session had been spent upon each of the

five issues (Appendix 27). Both forms had an ‘additional comments’ section to

capture additional contextual information.

v) Qualitative Interviews

Upon completion of the InSPire programme, all participants were offered the

opportunity to engage in a qualitative interview to investigate treatment

acceptability (Appendix 28). Analysis of these data are not the focus of the current

study and will be reported elsewhere (Killilea, 2019).

3.7 Intervention

All consenting participants were offered the InSPire programme alongside input

they received as part of their ACCT plan (i.e. regular observations, risk reviews).

Intervention for the current study was based upon the manualised therapy by

Tarrier et al. (2013) as amended by Pratt (2016). The CBSP intervention was a

cognitive behavioural therapy informed by the SAMS model (Johnson et al., 2008).

Intervention was tailored to each individual as guided by psychological assessment

and completion of a formulaic framework.

The manualised CBSP intervention was delivered in a tailored format to fit the

intensive nature required for this study. The original delivery of this intervention is

over 20 therapy sessions. For the current study, CBSP was condensed into a format

which allowed it to be delivered across five two-hour sessions. The original outline

of sessions, as specified by the developers of this intervention (Tarrier et al., 2014;


Pratt, 2016), was amended to adjust for more intensive delivery. The outline

compromised of the following;

Sessions 1 – 2: Engagement and building the therapeutic relationship

Sessions 1 – 2: Risk assessment and increasing understanding of the function

of suicidal behaviours

Sessions 1 – 2: Socialisation to the CBSP model and development of the

SAMS formulation

Sessions 3 – 4: Intervention modules

Session 5: Developing the maintenance and well-being plan

Intervention consisted of three phases, including an initial engagement, assessment

and formulation phase, intervention (with a choice of up to five modules) and

maintenance and handover (Tarrier et al., 2013);

i. Engagement, Assessment and Formulation: Therapists focused upon

building engagement; engaging the client to talk about their concerns;

identifying how suicidal thoughts fit into concerns; establishing a shared

understanding/formulation and strengthening a commitment for change

(i.e. developing goals, using the SAMS model).

ii. Intervention

a) Attention broadening: Aiming to broaden participants’ control of their

attentional focus and overcome patterns of negative bias and becoming

stuck in a suicide schema cycle.

b) Cognitive restructuring: Supporting participants to identify unhelpful

thinking styles and develop helpful alternatives.

c) Mood management and behavioural activation: Supporting participants to

increase activities associated with pleasure and achievement and build them

into daily routines.

d) Problem-solving training: Supporting individuals to strengthen problem

solving skills and implement new problem solving techniques when

approaching interpersonal difficulties.

e) Improving self-esteem and positive schema: Aiming to reduce the cycle of

suicide schema by accessing positive self-schemas, positive ways of coping

and alternate approaches to problems.


iii. Maintenance and Handover: This phase had two components: maintaining

well-being and working towards staying well and developing a handover

plan (involving prison staff).

Delivery of the InSPire programme consisted of up to five sessions, delivered within

a three week period. Each session lasted up to two hours. All participants began

with the initial engagement phase and received the maintenance phase upon

completion of the programme. It was not expected for all five intervention modules

to be delivered during the programme. Participants were made aware of the

modules available and collaboratively agreed with therapists as to which ones they

accessed during the programme (Appendix 29). This was informed by participant’s

formulation and therapy goals.

Treatment was provided by two therapists, with at least three years’ experience of

CBT training. Therapists received a two day training workshop with the Clinical

Supervisor (DP), to familiarise with CBSP intervention delivery. During this

workshop, existing CBSP manuals (Tarrier et al., 2013; Pratt, 2016) were adapted

into an intensive delivery format. Further training and practice experiences were

conducted with individuals from a Forensic Patient and Public Involvement (PPI)

Group at the University of Manchester. The group consisted of a number of ex-

prisoners who provided constructive opinion to the research team during the

treatment development phase to gauge any potential difficulties of implementing

the study within a prison. Two further sessions were conducted with one group

member, to rehearse therapeutic skills in the delivery of CBSP.

Clinical supervision was provided up to four times per week for 1-2 hours, by an

experienced qualified Clinical Psychologist (DP), to explore each therapy case and

address clinical issues arising. A Distress Protocol (Appendix 30) and Safe Working

Practices and Risk Management Protocol (Appendix 31) were adhered to when

responding to clinical risk and issues of safety.

3.8 Data Analysis

All data was entered into Microsoft Excel spreadsheets by an independent data

entry clerk, to limit bias. Data was checked by first author (LH) and minimal errors


had been made (error rate 0.44%). Data was exported to SPSS. To be included in

data analysis, participants were required to have attended at least one therapeutic


i. Feasibility and Acceptability

Descriptive analyses were performed using Microsoft Excel to examine feasibility

data. Using the metric data, percentages were calculated to demonstrate

recruitment rates (i.e. proportion of participants eligible and interested in taking

part) and retention (i.e. level of attendance, rate of DNA/CNAs).

ii. Clinical Outcome Measures

Descriptive statistics and QQ plots were generated using SPSS and data were

checked for normality. Values of skewness and kurtosis were converted into z

scores and indicated normality for all variables at all time points (NB. values were

within the 1.96 criterion; Field, 2009).

Means, standards deviations and effect sizes were calculated. Baseline and follow

up assessment scores were taken into account when calculating effect sizes by

calculating Pearson’s correlations, as suggested by Morris and DeShon (2002).

Effect sizes assessed changes between baseline and follow up and were interpreted

using the pooled standard deviation Cohen’s d (Cohen, 1977). The method by

Cohen (1977) has been used in a number of other small scale case series (Searson,

Mansell, Lowens, & Tai, 2012; Watkins et al., 2007; Wells & Sembi, 2004). Cohen

(1977) interpreted effect sizes as small (d = 0.2), medium (d = 0.5) and large (d =


Participant and therapist sessional data were examined using descriptive statistics

to review individual changes on a sessional basis.

3.9 Ethical Approval

The InSPire programme was registered as a Clinical Trial (ID: NCT03499548) and

received approval from the National Research Ethics Committee for Wales (IRAS ID:

238927); Her Majesty’s Prison and Probation Service National Research Committee

(ID: 2018-154) and the Governor of the host prison. Paper and electronic data were

held securely on the prison site, with access only available to the research team.


Upon completion, all data were safely transported to the University of Manchester,

were securely stored and again made accessible only to the research team.


4. Results

4.1 Demographic and Clinical Characteristics

Participants’ ages ranged from 21 to 52 years with a mean of 31.6 (SD = 9.3) years.

In terms of ethnicity, all 13 participants identified themselves as White

British/Other. Participants were serving a prison sentence of 38.5 (SD = 32) months,

on average. Sentences were categorised using the Home Office (2017) Offence

Classification Index. Participants reported index offences of violence against the

person (including sexual offences) (n = 8, 62%) and theft (including robbery,

burglary, fraud and forgery) (n = 5, 38%). Of the sample, three (23%) participants

had not previously served a sentence.

Two (15%) participants were on an ACCT at point of entry to the programme and a

further three had ACCT’s reopened during the programme. All participants had

made a suicide attempt at some point in their life, with seven (54%) participants

doing so within the previous year and five (38%) during the last month.

4.2 Feasibility Outcome Measures (Hypothesis One)

i) Recruitment and Retention

Thirteen participants were recruited to the study. The target was 16, with the view

that approximately 10 would go on to complete the InSPire programme.

Recruitment ceased when it became apparent that programme completion rates

were high (i.e. 12/13 participants completed the programme). Study retention was

high, with 100% of participants who completed baseline assessment also available

for follow up.

ii) Engagement and Programme Adherence

Of the 13 participants, 10 (77%) attended all five sessions of the programme. Two

(15%) participants were discharged from the programme, both after three sessions

due to non-attendance; although, one individual voluntarily opted for discharge.

One (8%) further participant was unable to engage in therapy as the programme

was not approved for delivery on the Care and Segregation Unit (CSU). The

individual was moved to this unit immediately after completing baseline


assessment and was held on a wait list until return to the wing. This did not occur

during the programme and thus he never commenced therapy.

For the 12 individuals who did commence the programme, a total of 65 sessions

were offered and 56 (86%) sessions were attended. Therapy sessions lasted

between 15 to 135 minutes (M = 102.68 minutes; SD = 26.56), with an average of 8

hours of therapy delivered to each participant (M = 7.99 hours; SD = 2.52; range 2-

10 hours).

Across the programme, nine sessions were not attended. Four DNAs resulted in the

discharge of two participants from the programme and the remaining five were

CNAs which were rearranged. Reasons included: hospital appointment, forgot the

appointment, therapist unable to locate a suitable room, physically unwell, not

feeling up to talking and prison regime preventing attendance. Completion of

outcome measures were high at both baseline and follow up (99%) and sessional

measures (98%).

iii) Therapist Session Summary

Table 1 shows the proportion of therapy modules delivered across the programme

and the percentage of participants that accessed these modules. Therapists

reported all participants to use the engagement phase and for some (n = 3; 30%),

elements of this continued throughout the five therapy sessions. Across all sessions

delivered, a strong emphasis was placed upon initial engagement, assessment and

formulation activities with 57% of all sessions reported to include this phase.

Engagement was broken down further to capture five main areas (i.e. building

engagement; engaging client to talk about concerns; identifying where suicidal

thoughts/behaviours fit into concerns; establishing a formulation, strengthening a

commitment for change and eliciting goals). Each of the five components of

engagement were used. All individuals except one moved beyond the engagement

phase into intervention. The one individual who did not access the intervention

stage took voluntary withdrawal during the engagement phase, prior to developing

a SAMS formulation.

Eleven participants moved onto intervention work, which accounted for 39% of all

therapy sessions delivered. The most commonly delivered intervention module was


cognitive restructuring, which was accessed by 10 (83%) participants. The two

individuals who did not access this module were the two discharged from the

programme. All other modules accounted for between 5-7% of sessions. Mood

management (n = 4) and attention broadening (n = 5) were accessed by more

participants than problem solving (n = 2) or schema work (n = 3). Finally, most

individuals (n = 10, 83%) completed the maintenance phase in the final two

sessions, the two who did not had previously disengaged. The maintenance phase

involved two components (i.e. developing a staying well plan; handover to staff).

Staff handover was only facilitated in cases of risk, which applied to one participant.

Table 1. An Overview of the Therapeutic Modules Delivered During the


Intervention Modules No. of participants who
received the module

Total (%)

Engagement, Assessment and Formulation Phase:

12 (100%)

Intervention Modules:

11 (92%)

Attention broadening 5 (42%)

Cognitive restructuring 10 (83%)

Mood management and behavioural activation 4 (31%)

Problem-solving training 2 (17%)

Improving self-esteem and positive schema 3 (25%)

Maintenance Phase

10 (83%)

iv) Therapist Rating Scale

This measure was not completed for the individual who could not attend any

therapy sessions. Attendance (M = 4.50; SD = 0.80) and promptness (M = 4.67; SD =

0.65) were rated highly. Level of participation (M = 4.00; SD = 0.74) and completion

of homework (M = 4.00; SD = 1.21) were both reported to be reasonable. Mastery

of content (M = 3.42; SD = 0.90) and overall evaluation of therapy success (M =

3.42; SD = 1.24) were both rated to be reasonable. Level of disruptive behaviour

was a reverse item (higher scores denote less disruptive behaviour); therefore, this

reasonable score suggests limited disruptive behaviour during sessions (M = 3.42;


SD = 0.67). Figure 2 presents a graphic demonstration of the therapist measure of


Figure 2. A Box Plot to Demonstrate Therapists Rating of Adherence to Therapy

v) Client Satisfaction Questionnaire

Scores on the CSQ-8-R are presented in Table 2. All items scored above the mid-

point of the 1-4 point Likert rating scale (with a score of four denoting complete

satisfaction). Amongst higher scoring items, ‘recommending the service to a friend’

was rated 3.83 (SD = 0.39) and overall satisfaction of the service was rated 3.67 (SD

= 0.49). Amongst lower scoring items, the extent to which the InSPire programme

met participant’s needs was rated 2.67 (SD = 0.65) and the service helping

participants to deal more effectively with their problems was rated 3.25 (SD = 0.87).

Attendance Promptness Participation Mastery Disruptive

Homework Overall

Components of Therapy









Box Plot of the Therapist Rating Scale


The mean score for overall satisfaction (from a range of 8 – 32) was 29.67 (SD =


Table 2. CSQ Mean Scores and Overall Satisfaction Score

CSQ Questionnaire Items Mean (SD)

1. How would you rate the quality of the service you have received? 3.67 (0.49)

2. Did you get the kind of service you wanted? 3.42 (0.51)

3. To what extent has our program met your needs? 2.67 (0.65)

4. If a friend were in need of similar help, would you recommend our program to him or her? 3.83 (0.39)

5. How satisfied were you with the amount of help you received? 3.50 (0.67)

6. Have the service you received helped you to deal more effectively with your problems? 3.25 (0.87)

7. In an overall, general sense, how satisfied about you with the service you have received? 3.67 (0.49)

8. If you were to seek help again, would you come back to our program? 3.75 (0.45)

Total Scale Score

29.67 (3.28)

M = mean; SD = standard deviation

4.3 Clinical Outcome Measures (Hypothesis Two)

i) Baseline and Follow up

All participants completed four outcome measures at baseline and follow up (n =

13). One participant was unable to access the InSPire intervention and therefore

has been removed from this analysis for consistency. Repeated measures effect

sizes were calculated using the total mean change of all participants and the pooled

standard deviation of scores at baseline and follow up (see Table 3).

Table 3. Mean Scores and Effect Sizes at Baseline and Follow Up.

Measure Baseline
(n = 12)
M (SD)

Follow up
(n = 12)
M (SD)

Effect Size

BSS (weekly rating) 10.00 (8.83) 8.42 (8.11) -0.29

BSS (monthly rating) 18.67 (7.51) 10.67 (7.07) -0.86 a

DERS 119.17 (30.14) 106.83 (23.81) -0.94

MSPSS 45.92 (24.62) 44.08 (24.84) -0.20

SPSI 47.08 (16.00) 49.50 (14.27) 0.18

BSS = Beck Suicide Scale; DERS = The Difficulties in Emotional Regulation Scale; MSPSS =
Multidimensional Scale of Perceived Social Support; SPSI = Social Problem Solving Inventory.

a Data missing for one participant at follow up

A large effect size was found when measuring suicidal ideation across the previous

month; however, this effect was small when measuring suicidal ideation on a


weekly basis. There was a large effect when comparing intervention scores for

emotional regulation. A small effect was found for perceived ability to solve

problems and for perceived social support when comparing baseline and follow up


ii) Sessional Measures

At the start of each therapy session, participant’s completed sessional measures

which captured change during therapy (i.e. problem solving, social support,

emotional regulation and thoughts of self-harm or suicide). Therapists captured the

proportion of time during each session that was spent discussing the mechanisms

(which mapped directly onto the sessional measure).

On the Therapist Rating Scale, emotional regulation appeared to be a leading focus

during sessions. Self-harm ideation was the lowest focus, perhaps mirrored by the

population and the lack of reported self-harm ideation during sessions. Suicidal

ideation was a common focus, which reduced during session three, but increased

again as sessions were coming to an end (see Figure 3). This could reflect the need

for increased risk management during the maintenance phase, but might reflect the

increase of some symptoms for some participants as sessions were ending (as

captured on sessional measures). On Figure 3, participant data suggests a relatively

stable suicidal ideation across sessions, with a slight increase in the final session.

Therapist data mirrors participant data, in that higher reporting of suicidal ideation

increased focus on that issue during sessions. This focus increased considerably in

final sessions.


Figure 3. Suicidal Ideation as Rated by Participant and Therapist, across all Five



5. Discussion

5.1 Acceptability and Feasibility

The InSPire programme was a feasibility pilot of an intensive CBSP intervention for

prisoners experiencing suicidal thoughts or behaviours in the past one month, with

some individuals continuing to actively engage in suicidal behaviours during the

delivery of the programme. Results suggest that delivering intensive CBSP within a

prison environment is feasible, with a large majority of participants completing the

CBSP intervention and all participants completing follow up assessments. For the

two individuals discharged from the programme, one was discharged solely based

upon the DNA rule (i.e. two DNAs before discharge). This participant was made

aware of the rule at each DNA, although did express an interest in continuing with

the programme upon point of discharge. The second participant opted to terminate

therapy after two DNAs and expressed that it was difficult for him to engage at this

current time. Prisoner samples have previously been shown to be less likely to

access help for suicidal thoughts, compared to other emotional difficulties (Deane,

Skogstad, & Williams, 1999). Therefore, perhaps traditional models of engagement

are a challenge in this population. Engagement difficulties are a reality in prison, as

there are increased barriers to accessing mental health services (Reingle-Gonzalez

& Connell, 2014), repeated discharges from services and a ‘revolving door’ pattern

of prison recall and reoffending (Padfield & Maruna, 2006; Nagin, Cullen, & Jonson,

2009). Perhaps a more flexible DNA rule could be considered for future studies of

this type, to facilitate engagement amongst those who find it more difficult to

access therapy, akin to an assertive outreach model of care (McIvor, Ek, & Carson,

2004). This could be suggestive of the need for pre-therapy work with individuals

with suicidal ideation, to strengthen motivation to change and to better facilitate

engagement into programmes such as InSPire (Britton, Patrick, Wenzel, & Williams,

2011). Research suggests there is an increased risk of suicide following discharge,

with a recommendation for increased follow up during this time (Shaw et al., 2004).

Overall participant satisfaction with the InSPire programme was high. The CSQ-8

has been used in a prison setting previously, to evaluate an alcohol recovery

programme, with a reported total scale score of 26.5 (SD = 3.4) (Johnson et al.,


2014). Comparably, the total scale score measuring overall satisfaction was

marginally higher following the InSPire programme (M = 29.67; SD = 3.28). In a

further intervention of CBT to prevent suicide in the community, Britton et al.

(2011) reported individual mean scores of 3.45 (SD = 0.46), which was the same for

this current study (M = 3.4; SD = 0.4). In the InSPire programme, areas to improve

on included supporting individuals to better attend to their problems and

addressing a larger proportion of their needs. The nature of this feedback raises the

question of whether offering a longer duration of therapy might be helpful for

some individuals. Qualitative feedback on the CSQ-8 suggested that the InSPire

programme was too short, with participants stating that therapy ‘went too quickly’

and ‘did not last long enough’. Giving participants the option of a longer duration or

tailoring a package of treatment based upon individual need could be beneficial.

One option, in line with previous studies of intensive CBT, is to offer ‘booster’

sessions to maintain and increase the likelihood of change over time (Challacombe

& Salkovskis, 2011; Ehlers et al., 2010; Ehlers et al., 2014; Oldfield et al., 2011).

Alternatively, Bower and Gilbody (2005) propose a stepped care model of

intervention delivery, which offers some individuals additional sessions or longer-

term input based upon individual need.

Many studies have conducted intensive CBT in other settings, with hours of

treatment ranging from four hours (Paulik, Jones, & Hayward, 2018; distressing

voices); 7.5 hours (Bryant, Harvey, Dang, Sackville, & Basten, 1998; acute stress

disorder); 10 hours (Whiteside, Brown, & Abramowitz, 2008; OCD); and up to 18

hours (Ehlers et al., 2010; PTSD). Whilst there is no specific guidance for

psychological intervention in relation to suicide prevention, NICE guidelines

currently suggest between 3-12 sessions of psychological therapy with individuals

who self-harm (NICE, 2013). The InSPire programme delivered a compromise of 10

hours within a three week intensive window. Whilst for some this may have been

sufficient, many participants stated that they wanted therapy to be longer. Some

resolutions to this issue have been addressed above. It has been reported that

provision of mental health services in prison is not equivalent to that in the

community (Patel, Harvey, & Forrester, 2018). This was echoed by InSPire

therapists, who were regularly approached by inmates interested in the


programme, but whom were not eligible. The widespread interest in the study,

alongside recruitment success and high level of programme completion, attaches

importance to the high level of unmet need for psychological support amongst

prisoners. Reingle-Gonzalez and Connell (2014) emphasised ongoing barriers to

mental health treatment in prison and the lack of continuity of treatment from the

community to prison. Psychological interventions to alleviate distress are essential

to mental health and well-being of the prison community. The participants within

this programme present at a much higher risk of suicide than the general

population (NICE, 2018).

Social complexity and increased risk of the population must be taken into

consideration when determining the most appropriate number of hours of

therapeutic input. The complex needs of this population ought to contribute to the

way services are shaped and delivered within prison. Andrews, Bonta and Wormith

(2006) presented an outline of major needs or risk factors that might present within

a prison context (i.e. antisocial factors [behaviour, associates, cognitions, and

personality], family or marital issues, unemployment, limited leisure activities and

use of substances). Interventions should be focussed upon dynamic need with

specific responsivity to individual factors (i.e. personality, motivation and individual

demographics) (Andrews et al., 2006).

Whilst therapists rating of programme participation was reasonable, considerations

could be given to improving homework completion, level of participation and

therapy mastery. For example, whilst specific figures on homework completion

were not obtained in this study, it could be hypothesised that completion of

homework between sessions could increase overall mastery of the intervention.

However, due to the intensive nature of the programme, sessions often fell on

consecutive days, leaving limited time or opportunity for homework completion.

Additionally, access to homework resources (i.e. writing tools) and privacy (i.e.

shared cell) in completing homework could have been a barrier.

The three phases of CBSP intervention included an engagement phase at the

beginning and a maintenance phase at the end. In between this, an intervention

phase with up to five therapeutic CBT skills based modules could be delivered, as

guided by the formulation. All of the five intervention modules were delivered to


some extent across the 12 therapy completers, although this varied on an individual

level. Some participants remained longer in the engagement phase than others,

some accessed a number of different therapeutic modules during intervention,

whereas others accessed one module. There was a high proportion of investment in

the engagement phase and in the cognitive restructuring module. All other modules

were accessed although to a lesser extent. It raises the question of therapeutic

readiness to change. Individuals who remain in therapy tend to be at contemplation

stage or higher, whereas those who disengage are perhaps in a pre-contemplation

stage (Brogan, Prochaska, & Prochaska, 1999). This could have been a factor for the

individuals who remained mostly within the engagement phase and for those who

were discharged. Readiness to change was not assessed in this study, but may be

useful to consider in future studies of this type. Given what we know about the lack

of provision in prison, alongside the high proportion of engagement-focused

sessions, perhaps offering someone a confidential space to talk about and make

sense of suicide presents as much of a therapeutic benefit as a structured, skills-

based intervention. The Collaborative Assessment and Management of Suicidality

(CAMS) is an evidence based clinical intervention with a specific focus upon

assessment and treatment planning processes (Jobes, 2012). The CAMS does not fit

within a therapeutic modality and involves collaborative analysis of patients’

suicidal experiences through in depth assessment. Risk is continually considered

(i.e. access to means, suicide plans) and treatment and crisis plans are devised at

the end of each session. Whilst in this study there was a stronger emphasis on

cognitive restructuring interventions, the use of other modules was variable and a

leading focus appeared to be the engagement, assessment and formulation phase.

It could be efficacious to consider trialling other interventions, such as CAMS, using

an intensive delivery within the prison setting.

5.2 Clinical Outcome

A large treatment effect was found for suicidal ideation when assessed across one

month, compared to only a small effect when assessed for the past week. This

difference could be understood by considering the ACCT system. Participants were

recruited if they had experienced thoughts of suicide within the past one month,


which meant for some that scores for the past week at baseline, were low

compared to scores across the month. This could have meant less of a change on a

week by week measure, but perhaps a more noticeable change when assessed


There appeared to be less of an effect on problem solving and perceived social

support. Perhaps perceived social support was more challenging to address within

prison, due to practical difficulties and barriers in accessing social support. There

was a large effect on emotional regulation which is perhaps indicative of the time

spent on emotional regulation as captured on therapist sessional measures.

Effect sizes must be cautiously interpreted due to the small sample size and due to

Pearson’s correlation not taking into account the dependent groups. Effect sizes

could be overinflated due to these issues. What we can deduce, is that attendance

appears to be associated with beneficial change and is therefore worthy of further

investigation. In line with the Medical Research Council (MRC) Guidance (Craig et

al., 2013), effectively developing and evaluating complex interventions requires a

number of stages, the InSPire programme being an example of a preliminary pilot

feasibility stage. Feasibility results should be reviewed with caution and more work

is required on a larger scale in order to make more accurate assumptions about

intervention effects (Craig et al., 2013).

Another clinical issue, as captured on sessional measures, was the increase in

reported distress for some participants towards the end of therapy. Clinicians have

an ethical responsibility to manage therapeutic endings (Vasquez, Bingham, &

Barnett, 2008). Within this study, programme duration was made transparent from

the beginning, endings were discussed at every session, and were addressed within

the maintenance phase of the intervention, which was accessed by all those who

completed the CBSP intervention. Therapists noted that the programme delivery

and duration felt fast paced. Following feedback from participants, there was the

sense that ending therapy felt premature and difficult. In a previous study by

Bevan, Oldfield, and Salkovskis (2010), individuals completing weekly treatment

were disinclined to access intensive treatment because of anticipated

overwhelming pace and perceptions of having a more limited time to change.

However, those who attended intensive treatment described the pace as highly


motivating. Perhaps this echoes the lack of provision of psychological interventions

for mental health difficulties in prison and that InSPire participants were motivated

to engage given the lack of provision otherwise. This could be suggestive of the type

of person that intensive interventions are more suited to, again tapping into issues

of readiness to change and motivation. Given the fast pace of intensive

interventions, Bevan et al. (2010) highlight the importance of follow up and longer-

term crisis intervention, particularly in intensive delivery. In the current study, the

therapist and researcher ensured effective risk assessment and management during

the ending transition, including handover to staff, attendance at ACCT reviews and

documentation of risk on healthcare systems.

5.3 Strengths and Limitations

There are a number of limitations to this study. This being a small-scale feasibility

study meant there was no control group to provide a comparator and no control of

variables. Having another person to talk to was often iterated by participants, which

could arguably account for some of the notable improvements. Effect sizes must be

interpreted with caution due to the small sample size. The sample from one prison

in the North of England was largely homogeneous, particularly with regards to

ethnicity and gender. A larger, more diverse, sample from a range of prisons with

varied levels of risk and security would give a broader understanding of the effects

of the intervention. Similarly, 20% of the pool were screened out due to risk.

Perhaps with more time, having both male and female therapists and increased

security support from the prison, this figure could have been lower. Kupers (2005)

explores the resistance to psychological therapy in prisons, which undoubtedly

contributed to some individuals declining participation. Future studies should

consider making the programme more accessible for all individuals. One further

limitation was the omission of both the formal recording and reporting of adverse

events during this study. In line with Trust Guidance on the recording and reporting

of non-clinical trials (Haddock, 2016), all adverse events should be formally

documented and reported in the study findings. This is recommended for future

studies of this nature.


Working within a prison environment requires a considerable amount of flexibility.

Difficulties arose with limited access to an appropriate and safe therapeutic space

and in maintaining a reasonable level of privacy and confidentiality. Sessions were

occasionally disturbed by others and the level of noise was at times disruptive.

Occasionally sessions were cancelled (i.e. no room availability), began late, or were

terminated early (i.e. lock-down). Participants were generally resilient to many of

these issues, as it was considered the ‘norm’. However, a private home-like therapy

space correlates with increased social interaction and improvements in well-being

(Papoulias, Csipke, Rose, McKellar, & Wykes, 2014). Arguably, the prison

environment could serve as a barrier to engagement, as the absence of a

comfortable and safe environment could hinder participants’ ability to concentrate

entirely upon therapy material.

The 1:1 delivery of the programme was advantageous. Many individuals expressed

that they would have been reluctant to engage or would have declined a group-

based programme. As was the rationale for intensive delivery, no participants were

released or unexpectedly transferred during the programme. Some were due to be

released or transferred imminently and the programme felt timely in preparing for

transition to the community or to a new placement. Participants generally tolerated

longer sessions of up to two hours. This coupled with an intensive delivery meant

that ‘catch up’ time, as would happen with weekly/more intermittent sessions, was

not required as much, thus allowing for increased session time focusing upon

content. Many of these factors were addressed with participants directly, in the

follow up qualitative interviews exploring treatment acceptability of the InSPire

programme (Killilea, 2019).

5.4 Further Clinical and Research Considerations

Traditional psychological input in prison is most often focused upon risk

management and reoffending behaviour (Towl, 2002; Harvey & Smedley, 2012).

Harvey and Smedley (2012) highlight the importance of considering a combined

way of working, using a problem focussed approach and individualised

psychological formulations, alongside offending work. Arguably, supportive

interventions focusing upon psychological need in the short-term, may increase the


likelihood of individuals being better able to engage in offending behaviour

programmes, perhaps facilitating better long-term outcomes in terms of recovery

and criminality. To our knowledge, this is the first study to offer a non-offending

focussed intensive CBT intervention programme for suicide prevention within a

prison environment.

This was a single baseline and single follow up design. Having multiple baselines and

long-term follow ups would be useful to accurately attribute change to intervention

delivery and capture whether change effects have been maintained over time.

Whilst follow up data captured aspects of satisfaction and symptomology, further

consideration could be given to other outcome measures. As mentioned, readiness

to change could provide a useful insight into readiness for therapy, additionally

other contextual change information could be captured (i.e. changes in level of

ACCT observations, and increased participation in prison social roles [i.e. work,


Further adaptations to the InSPire programme could be considered on a systemic

level. Considerations could include staff liaison sessions; working alongside prison

staff to share psychological formulations and considering consultation or training

programmes to increase staff awareness and knowledge of how to respond to

individuals experiencing suicidal thoughts and behaviours. Increasing prison staffs

understanding and awareness of mental health is an important issue within a prison

environment (Leibling & Karup, 1993; Hansson & Markstron, 2014).

This feasibility study has demonstrated the potential for CBSP in an intensive

format within a prison setting. Whilst effect sizes were indicative of beneficial

change, this needs examining on a larger scale. As per MRC guidelines, this area

would now warrant further investigation with the design and implementation of a

feasibility trial (Craig et al., 2013).


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Introduction to Paper III

Paper III is a critical review which reflects upon the development and delivery of

Paper I and Paper II. This paper appraises the research processes and the

developmental decisions that were made as guided by theoretical, empirical and

professional contexts. Paper III considers decisions in more detail and offers

alternate options that were considered along the way. Strengths and limitations of

both will be considered. Recommendations for future research will be detailed.

Paper III begins with an introduction to both papers and leads on to discuss the

issues as mentioned above. In addition to this, the author’s reflective experiences

are integrated throughout, in reflecting upon the challenges of developing and

conducting both pieces of research and in the delivery of psychological therapy

within a prison. This links into a body of literature highlighting the challenges and

barriers clinicians face when integrating psychological services into such a

challenging environment.


Paper 3: Critical Reflection Paper

Word count: 5966



Paper III presents a critical reflection of the research conducted for this thesis. The

systematic review (Paper I) explored intensive Cognitive Behavioural Therapy (CBT)

conducted with clinical populations experiencing psychological distress. Findings

highlighted variations in the definition and the delivery of intensive CBT, with some

promise in the feasibility and efficacy of intensive CBT. Due to the heterogeneity of

the sample, small sample sizes and limited methodological quality of papers, it was

difficult to draw firm conclusions. It is recommended for future large scale studies

to use a more rigorous methodological design (i.e. randomised control trials [RCT]),

before future reviews take place. Future reviews could broaden inclusion criteria to

capture more studies, to facilitate more rigorous analysis (i.e. meta-analysis).

Paper II investigated the feasibility of intensive CBT in prison. The InSPire

programme used a case series design with single baseline and follow up. Intensive

CBT consisted of five sessions (up to two hours) of Cognitive Behavioural Suicide

Prevention (CBSP) (Tarrier et al., 2013) completed within a three week period.

Follow up measures assessed client satisfaction, suicidal ideation and three

psychological mechanisms associated with suicide (i.e. emotional regulation,

problem solving and perceived social support). Thirteen male prisoners were

recruited and retention was high. Effect sizes indicated a potential benefit of the

intervention for all outcomes measured. The intensive delivery of the programme

appeared feasible given the high attendance and programme completion and high

levels of client satisfaction, which holds promise in continuing larger-scale research

in this field. Throughout, the author reflects upon the experience of delivering

psychological therapy within a prison, and the professional and personal challenges

that occurred alongside.


1. Paper I: Systematic Review

1.1 Rationale for the Review

Review topics were considered in areas of suicide prevention and work within

forensic settings, with a final decision to focus upon psychological intervention as

delivered in Paper II. Recent years have seen the emergence of alternate formats of

CBT delivery in line with streamlining NHS services and facilitating patient choice.

Compared to traditional weekly delivery, intensive CBT involves a reduction in the

duration of therapy (i.e. number of sessions) (Öst & Ollendick, 2017). Whilst there is

a comprehensive body of evidence for use of CBT across many clinical populations,

there appeared to be a gap in the literature for reviews of intensive CBT. Initial

scoping of key databases (i.e. PsychINFO) generated enough literature to justify

further exploration. A number of studies have investigated intensive CBT, including

family based intensive CBT with children with Obsessive Compulsive Disorder

(OCD), for 90 minute sessions, five days per week, for three weeks (Storch et al.,

2007). In an adult OCD population, 18 hours of CBT were equally as effective when

delivered over five days, compared with 18 weeks (Oldfield, Salkovskis, & Taylor,

2011). In an adult post-traumatic stress disorder (PTSD) population, intensive CBT

consisted of 18 therapy hours over five to seven working days (Ehlers et al., 2010).

Lastly, individuals with panic disorder were offered two longer sessions (i.e. up to

five hours per session) across two days (Deacon & Abramowitz, 2006). One review

investigated intensive CBT in a child population with anxiety (Öst & Ollendick,

2017), yet intensive delivery had not been reviewed with adults. Two unpublished

reviews were ongoing, in a child population (Clarkson, Allcott-Watson, Shafran, &

Bennett, 2018) and investigating adults with OCD (Millar, Bauer, Salkovskis,

Gregory, & Halligan, 2018). Reviews to date have focussed upon specific

populations defined by diagnostic criteria. For this current review, investigating a

population experiencing ‘psychological distress’ allowed a broader scope, as

opposed to investigating diagnoses. The review aimed to increase understanding on

the delivery of intensive CBT and its efficacy across clinical populations. The review

felt relevant alongside Paper II, which delivered intensive CBT within a prison, for

what was understood to be the first time.


1.2 Scoping and Database Searching

Following preliminary scoping on the PsychINFO database, the terms ‘cognitive

behavioural therapy’ AND ‘intensive’ retrieved 70 articles. The search reduced to 60

when limited to English only. Twenty-one papers remained following a more in-

depth review and the author was aware of other relevant papers, which suggested

that enough literature existed to develop a systematic search. Development of the

review was guided by the ‘Preferred Reporting Items for Systematic review and

Meta-Analysis Protocols’ (PRISMA) systematic review protocol (Moher et al., 2015)

and a student practice guide (Boland, Cherry, & Dickson, 2017).

Given the varied definitions used to operationalise ‘intensive CBT’ there was

deliberation about defining search terms. There was debate about crossover

terminologies, such as ‘brief’ CBT (50% reduction of sessions compared to standard

delivery) and ‘concentrated’ CBT (the same number of sessions as standard delivery

but in less time) (Öst & Ollendick, 2017). One published review in this area

determined search terms using psychiatric diagnostic criteria, without reference to

intensive, brief or concentrated CBT delivery (Öst & Ollendick, 2017). Whilst the

current review focussed upon psychological distress, use of the term ‘psychological

distress’ alone generated many papers lacking a particular focus (n = >120, 000).

Broad search terms were trialled which included other terminologies for intensive

CBT (i.e. brief, concentrated) however this too yielded a large number of papers (n

= >19, 500) and was too broad for this scale of review given the time and resources

available. Development of search strategies is recognised as an iterative process

(Boland et al., 2017) and research supervision was used to consider the benefits

and drawbacks of including (or not including) particular terms. Supervision helped

to shape the ‘PICO’ inclusion criteria (i.e. Problem or Patient or

Population; Intervention or Indicator; Comparison; Outcome of interest) (Miller &

Forrest, 2001). It was a challenge to determine a comprehensive enough search

strategy which was inclusive enough to capture relevant studies but feasible for a

review of this scale. This is anticipated with a systematic review and there requires

a degree of intuition, practice and trial and error in determining search terms (Ecker

& Skelly, 2010). The author experienced a lack of confidence during this phase, yet


the process fostered valuable learning in the development of systematic reviews.

Final search terms were justified using definitions from published studies

investigating intensive CBT (Storch et al., 2007; Oldfield et al., 2011; Ehlers et al.,

2010; Deacon & Abramowitz, 2006) and as guided by published and unpublished

reviews in this area (Öst & Ollendick, 2017; Millar et al., 2018; Clarkson et al., 2018).

Once databases searches were completed, title and abstract screening began.

Interrater reliability was conducted to ensure consistency with the PICO criteria.

1.3 Quality Appraisal

A number of quality tools were considered. The Critical Appraisal Skills Programme

(CASP) tool is known for its applicability across different methodological designs

(Voss & Rehfuess, 2013), which felt relevant for this review. After trialling the CASP

on a few papers the author wondered about the degree of subjectivity in questions

which asked for judgment upon the acceptability or appropriateness of certain

methodological components (i.e. appropriate method, acceptable recruitment).

Voss and Rehfuess (2013) note the importance of developing review tool questions

in a specific way, to avoid the likelihood of variability in responses. This is a criticism

of the CASP. The author reflected that a tool with more focused and specific

questions would be preferred. The Effective Public Health Practice Project (EPHPP;

1998) tool asks specific questions which require quantitative answers (i.e. attrition),

which increase the precision of the tool (Voss & Rehfuess, 2013). Whilst there were

limitations to EPHPP (i.e. heavy weighting of RCT’s renders other methodologies as

weak quality), it was considered the best option without designing a new tool.

Quality checking was a long process and the author lacked some confidence in the

possibility of increased subjectivity and unreliability of final ratings. In order to

combat this, a peer group was formed with two other doctoral trainees

(independent of this project). This group reviewed the EPHPP tool to determine

consistency in the interpretation of questions. Consistent approaches to each

question were justified during group discussion guided by the EPHPP quality

assessment dictionary (EPHPP, 2017) (Appendix 32). Additional input related to

uncertainties on specific queries (i.e. methodological design, calculating attrition) as


well as quality rating a reasonable percentage of papers (29%). Interrater reliability

was almost perfect, which reassured the issues around subjectivity.

1.4 Synthesising Results

The sample was largely heterogeneous, restricting the author from conducting a

more rigorous synthesis of the results (i.e. meta-analysis). A meta-analysis offers

the advantage of statistically combining results which improves the reliability of

effect sizes, therefore being a more rigorous analysis than a systematic review

(Fagard, Staessen, & Thijs, 1996). This would have allowed increased confidence in

the assumptions and conclusions drawn from the effect sizes generated. The

variability of papers (i.e. design, sample size, target problems) required

consideration of how best to synthesise them within the analysis. Various methods

were considered in order to present sensible and succinct results (i.e. psychiatric

diagnostic criteria, intervention characteristics). As this review focussed upon

psychological distress, psychiatric diagnostic criteria was not used to categorise

results. This decision was driven by an intention to broaden the scope of clinical

populations reviewed and to avoid falling into the reliability and validity pitfalls of

psychiatric diagnoses (Timimi, 2014). This was a challenge given that a large

proportion of the papers determined their population using diagnostic criteria. For

the purposes of this review these papers were captured as ‘distress associated with

mental health’. Other categories included distress associated with chronic pain,

addiction and following a traumatic incident.

1.5 Limitations

The inclusion criterion required intervention completion within four weeks, yet four

papers offered booster sessions which surpassed this timeframe (Ehlers et al., 2010;

2014; Oldfield et al., 2011; Challacombe & Salkovskis, 2011). These papers

appeared important and pioneering and the authors appeared to have an interest

in the development of intensive CBT. Despite the potential added value of these

four papers, it felt important to adhere to the established PICO criteria in line with

the information published on prospero (ID: CRD42018086546) and to note this as a

recommendation for future larger scale reviews. Boland et al. (2017) note the


potential for bias during the screening and inclusion phase. This decision

maintained reliability and consistency with the eligibility criteria and limited bias

generated by the author including supplement papers.

The review excluded grey literature, non-English papers, conference titles and

abstracts. Whilst this may have increased publication bias, the omission of grey

literature was deemed appropriate given the challenges in its inclusion and given

the relatively small scope of the review (Boland et al., 2017). Additionally some

papers (n = 10) were not accessible through the University of Manchester library

without incurring a fee. Whilst the final decision was to exclude these papers, there

was debate during supervision as the omission was likely to introduce further

publication bias. There is recognition that studies with non-significant results often

remain unpublished and difficult to access, thus leaving published literature to be

an inaccurate representation (Balshem et al., 2013). For this review the search

results were deemed to be sufficiently inclusive to proceed.

1.6 Clinical Implications and Future Directions

This review felt clinically important during an era of increased emphasis on

streamlining NHS services. The review found promise in the feasibility and efficacy

of intensive CBT in clinical populations experiencing psychological distress.

Development of this intervention could have an important role in service

development. The Care Quality Commission’s (CQC; 2015) objective to facilitate the

delivery of efficient NHS services is continually hampered by increasing pressures,

lack of resources and significant funding gaps. Government initiatives (i.e. ‘No

health without mental health’) (Department of Health [DoH], 2011), emphasise the

importance of improving mental health well-being, given the significant impact

mental health has upon physical health. Poor mental health has a number of

societal and socio-economic costs, therefore earlier investment into treatment

could have profound impacts upon individuals, reducing their reliance upon

services and increasing their ability to engage in society (DoH, 2011). Access to

psychological interventions is important in supporting government initiatives.

Effectiveness of services is influenced by severity of need, presenting difficulties,

patient preference and their ability to engage in interventions. The National


Institute for Health and Care Excellence (NICE) offers specific guidelines for

psychiatric conditions which outline recommendations for therapy delivery (i.e.

number of sessions). However, Stiles, Barkham, Connell, and Mellor-Clark (2008)

place less emphasis upon the number of sessions, reporting that some individuals

experience as much of a benefit after one to two sessions compared to the

recommended 16. This steered the development of the response regulation model,

which determines therapy dose based upon need (Stiles et al., 2008). This model

fosters efficient services which respond to patient need. Patient choice is another

key mediator in the acceptability and efficacy of services. Bevan, Oldfield, &

Salkovskis (2010) interviewed patients following intensive or weekly CBT for OCD.

Both groups determined benefits and drawbacks to each delivery. Benefits of

weekly included the advantage of having increased time to consolidate therapy

material and this group held the assumption that intensive delivery would be too

stressful. Whereas, the intensive group reported an increased motivation and

momentum and preferred the shorter-term commitment. Further studies

investigated intensive CBT for childhood OCD, highlighting a number of barriers in

committing to weekly therapy (i.e. geography, access to appropriate specialist

services, severity of difficulties) (Storch et al., 2008; Whiteside, Brown, &

Abramowitz, 2008; Lewin et al., 2005). All of the above, including the current

systematic review, challenge the assumption that therapy can only be delivered in a

traditional weekly format, and propose that intensive deliveries are as effective.

1.7 Conclusions

The review provided an overview into populations that intensive CBT has been

explored with, as well as understanding more about feasibility and effectiveness.

Although this review had limitations, much was done to combat criticism and to

shape the review into a manageable size. This was a learning curve for the author,

having never conducted a systematic review before. Whilst the author questioned

their competence at times, this led to more investment in quality appraisal,

interrater reliability and adhering to systematic practice and guidelines, thus, one

hopes, creating a more ‘systematic’ review.


2. Paper II: Empirical Study

2.1 Study Aims and Rationale

The InSPire programme was developed following previous research delivering CBT

in a prison (The PROSPeR Study; Pratt et al., 2015). The aim was to address attrition

rates during psychological therapy in prison with barriers preventing long-term

engagement and therapy completion (i.e. sudden transfer or release). In response,

the InSPire programme delivered an intensive programme of cognitive behavioural

suicide prevention (CBSP) (Tarrier et al., 2013), across five two-hourly sessions

within three weeks. Baseline and follow up measures investigated effects on

suicidality, emotional regulation, problem solving and perceived social support.

The issue of suicide poses a worldwide concern, requiring investment of time,

resources and research. In the UK, suicide rates are high, which is further

heightened within forensic settings (Georgiou et al., 2017). Prison outcomes are

more concerning than ever, with the highest ever prisoner population experiencing

increasing rates of suicidality and reconviction (Leibling, 2006). Given the high

suicide risk in prison, there is an ever increasing importance in providing

psychological therapy with the aim of reducing self-inflicted deaths (Pratt, Gooding,

Awenat, Eccles, & Tarrier, 2016). This was evident within the host prison, whereby

two suicide incidents had taken place, days before commencement of the InSPire

programme and during it. The recent deaths in custody unsettled staff and

prisoners, and led to a spike in Assessment, Care in Custody and Teamwork (ACCT)

documents being opened upon commencement of the InSPire programme.

2.2 Development Stage

Trainees approached all the North West prisons to establish a site for the InSPire

programme. The Governor of the hosting prison expressed initial interest and was

welcoming of hosting the research. The Governor linked the research team with

healthcare and the safer custody team and various communications and meetings

were coordinated. There was some negotiation regarding who would oversee (and

ultimately hold responsibility) for the programme, which took time due to some

hesitancy. Although study participants were identified through safer custody,


healthcare oversaw the programme, which required written consent from head of

healthcare. Whilst healthcare oversaw the programme, there was not the capacity

(i.e. rooms) to deliver the programme from this department. Finding a research

base and therapy space became a logistical challenge. Other requirements included

locked facilities for data, access to ACCT data and risk information, access to

healthcare computers (for clinical notes) and generally ensuring the InSPire

programme could run safely. Delays to research commencement felt like a likely

reality and continual liaison and problem solving ensured that this was avoided.

Safer custody staff supported the research team to embed within the prison and

distribute study information to prison staff on every wing. Prison staff became

increasingly more aware of the InSPire programme and were active in receiving risk

feedback and supporting therapists to find safe and appropriate therapeutic spaces

on the wings. Whilst the programme was completed with few setbacks, this was

likely due to the effective planning and coordination between the research team

and prison staff. This highlights aspects of research development which were a

challenge specifically related to conducting research within the criminal justice

system, which may not require the same degree of consideration in the community.

2.3 Recruitment Considerations

The research period was pre-defined by the doctoral programme and a lot of

consideration went into tailoring the project to fit within the allotted timeframe.

Whilst previous case studies helped to shape the recruitment target (Challacombe

& Salkovskis, 2011; Ehlers et al., 2010), the target was also shaped by what was

feasible during the research period. Öst and Ollendick (2017) define ‘intensive’ CBT

as being a reduction in both the number and duration of sessions compared to

standard treatment. ‘Standard delivery’ in this instance was that delivered as part

of The PROSPeR Trial (i.e. 20-24 one hour sessions; Pratt et al., 2015). The 10 hours

of therapy in this trial fits with the definition of intensive CBT alongside the

standard delivery to date.

A common recruitment challenge is engaging enough participants to successfully

recruit to time and target, particularly in prison research (Apa et al., 2012). This

study raised other recruitment challenges. A high interest meant that some eligible,


although mostly ineligible, individuals were unable to take part. Therapists accessed

the wings daily to deliver InSPire programme sessions. During this time therapists

were regularly approached from other prisoners requesting to take part. This raised

issues of maintaining the confidentiality of those involved in the programme and

was an ongoing reminder of the level of need. Managing confidentiality was

discussed in supervision in the interests of adhering to the Code of Ethics and

Conduct (BPS, 2018). Therapists did not disclose details of the programme when

approached by others. Many individuals who approached therapists were not on an

ACCT list and therefore ineligible for the programme. This felt like a rejection given

the high level of need, motivation and willingness to engage expressed by these

individuals. Conversations regarding non-eligibility were managed sensitively and

individuals were encouraged to liaise with staff regarding a healthcare referral. This

highlights a difficulty in limiting eligibility only to those on an ACCT document, as

there could be individuals outside of this system who experience suicidal thoughts

and behaviours. This maps onto many service-related issues in the NHS currently, in

only having resources to respond to risk when it reaches a level of severity deemed

to be ‘priority’ (St John-Smith et al., 2009), determined by lack of resources rather

than level of need. It raises the question of whether earlier investment into mental

health treatment would be an effective preventative strategy in reducing suicidality

(Aleman & Denys, 2014). Other barriers which determined ineligibility included use

of substances and specific risk presentations (i.e. risk of hostage, risk to females –

both researchers were female). For reasons of safety, sessions could not be

facilitated in prison cells, therefore ‘self-isolative’ individuals (i.e. who declined

leaving their cell) were unable to take part. One self-isolative individual expressed

an interest and agreed to leave his cell only to access InSPire sessions in facilities

which he felt safe (i.e. staff office, education). This challenged staff assumptions

that he truly met the perceived criteria as self-isolative, which resulted in some

judgement to both the prisoner and therapist. Jolliffe and Haque (2017) note how

many individuals experiencing mental health difficulties in prison are considered

‘manipulative’ or ‘challenging’. This opinion is heightened towards those

experiencing suicidal ideation and raises the likelihood of their difficulties, risks and


vulnerabilities being overlooked by staff and evoking less care than needed (Joliffe

& Haque, 2017).

The care and segregation unit (CSU) was deemed by staff to be an inappropriate

place to deliver therapy. Firstly because of practical issues (i.e. rooms, staffing) but

additionally because individuals may be of increased risk of harm to themselves,

others, or from others. This raised several ethical questions about obstructing

access to support during increased times of need. Contrary to its purpose, the CSU

can increase a person’s isolation and negatively impact mental well-being (Browne,

Cambier, & Agha, 2011). Proactive engagement, access to meaningful activities,

support during transitions (i.e. transfer, relationships, sentencing) were all

identified as important factors in minimising ‘near miss’ incidents within a female

prison (Borrill, Snow, Medlicott, Teers, & Paton, 2005). During the InSPire

programme, one participant was moved to the CSU immediately following baseline

assessment. This individual was motivated to engage and the level of need

appeared to be high, yet he was prevented from taking part. The individual was

held on a waitlist in case he was reintegrated onto the wings, but this did not

happen. He was approached to complete follow up measures and reflected that the

programme could have been the help he required. This individual’s personal

circumstances and mental health, as captured on outcome measures, deteriorated

at follow up. Given that completion of the InSPire programme was indicative of

beneficial change for all completing participants across all measures, this

participant could have similarly benefitted from the intervention. Involvement

could have reduced isolation and supported him to cope with ongoing prison

stressors maintaining his suicide schema.

2.4 Conducting Research in Prison

i) Logistical Considerations

Lack of availability of psychological interventions in prison, beyond offending-

focused work, has been a growing concern (Towl, 2002; Harvey & Smedley, 2012).

This current study highlighted complexities in the suitability of the prison

environment when delivering psychological interventions. The level of noise and


disruption is unlikely to be encountered to the same degree in the community and

finding a therapeutic space for sessions was challenging. Recruitment sessions were

conducted in various spaces, including a chemicals room, bike locker and corridor

amidst broken furniture. It felt important to facilitate a more therapeutic space for

intervention sessions, although this was not always feasible. At times, lack of

appropriate rooms and low staffing levels raised lone working concerns. Therapists

managed their personal safety and adhered to the InSPire Safe Working Practices

Protocol whilst making appropriate use of clinical supervision.

Timing of sessions was a logistical issue complicated by the prison regime. Sessions

were facilitated in between morning and afternoon movement schedules (i.e.

between 9am – 11.30am and 2pm – 4.30pm). Therapists adhered to movement

times due to being unable to independently escort prisoners if sessions overran.

Early/late movement times and lock-downs (i.e. where prisoners are confined to

their cell for an undetermined period of time) further complicated this picture and

occasionally sessions began late or were terminated prematurely. Therapists were

required to attend to frustrations expressed by prisoners when sessions abruptly

ended. The prison environment could be unpredictable, which challenges the

foundation of stability, predictability and consistency required during therapy.

‘Stability’ has been captured as an integral human need (Flanagan, 2010). During

the programme, issues of stability, predictability and consistency were managed by

booking appointments directly with participants (including provision of reminder

slips), or otherwise posting appointments in the prison mail (appendix 33).

Therapists always attended at the agreed time. In the event that the therapist could

not attend, a contingency was in place for the researcher to inform the participant.

Participants were aware of the location, timing and anticipated content of therapy

sessions. The therapist and participant collaboratively agreed an agenda at the start

of sessions and bridging between sessions was used to reflect upon the previous

session and plan for the next (The Association for Behavioural and Cognitive

Therapies [ABCT], 2019). A metaphorical ‘stop button’ was introduced to offer an

opportunity to pause at any point and to foster a sense of control.


ii) Personal Safety

Issues of personal safety, of therapists and participants, were a daily consideration

in peer supervision, clinical supervision and prison staff conversations. The author

experienced situations which challenged their sense of safety, including witnessing

physical altercations, low staffing levels and experiencing unsuitable therapy

facilities (i.e. rooms without functional panic alarms). Feeling overwhelmed and a

lack of safety is a difficult reality amongst prison staff (Liebling, 2011). This reality

often evoked emotional reactions which mirrored that of the participant (i.e.

frustration, overwhelmed, ‘stuckness’). Self-care and use of supervision were


iii) Role Dilemmas

Alternate roles were required from the research team interchangeably for a

number of months. The author alternated between ‘researcher’ and ‘therapist’,

whilst all the while being a doctoral student with a vested interest in the success of

the project. The principle investigator alternated between roles of research

supervisor, clinical supervisor and teacher/lecturer. Participants were receivers of

therapy and research participants. Each competing role had different expectations,

requiring a level of continual flexibility.

Being a research participant required involvement in research processes (i.e.

informed consent, outcome measures, therapy engagement). If participants did not

attend (DNA) two sessions they were discharged from the programme. Given the

level of complexity and barriers to trust and engagement, the presence of the DNA

‘rule’ felt difficult. Future studies could consider increased DNAs prior to automatic

discharge (i.e. more than two) or consider discharge on a case by case basis.

Involving the participant in conversation about discharge could be useful, given that

one discharged individual had wanted to continue.

Response to risk was regularly required from the therapist and researcher as they

were often the primary clinician assessing or working with the individual at the

time. During times of increased risk, the therapist/researcher attended emergency

ACCT reviews and supported the participant in an advocacy type capacity (i.e.

advocate for a wing move in the interests of personal safety). Most attendance at


ACCT reviews were valued by prison staff, in the interests of sharing risk. However,

it was sometimes perceived that opening an ACCT or calling for an emergency ACCT

review was problematic. Staff work tirelessly under constant pressures of

understaffing and compromised personal safety (Steiner & Wooldredge, 2017). The

ACCT system generates a number of ‘tasks’ and requirements, and arguably

another level of pressure. Jolliffe and Haque (2017) reflect upon the ACCT system

being a litigation process, as opposed to eliciting individualised care. An ACCT

requires a judgement on risk severity, which triages the individual according to the

level of risk they are perceived to require.

2.5 The Role of Clinical Psychology in Prison

Aside to direct involvement in clinical risk, the therapist and researcher adhered

strictly to the research protocol. Whilst important for research consistency, rigour

and replicability, it is important to consider the therapist’s role beyond the therapy

manual. The role of a clinical psychologist involves advocating for individuals and

supporting with difficult transitions (i.e. wing moves, transfer, release), including

working alongside staff teams (The British Psychological Society [BPS], 2008). In a

community setting, a clinical psychologist might work with the staff team and

individual to prepare for and facilitate transitions (BPS, 2008). In prison, transitions

were unpredictable and without knowledge or preparation of the individual, often

leading to escalations in behaviours that challenged staff (i.e. threats and actual

harm to self and others). There is a high level of uncertainty involved in a prison

sentence, which leads to a high level of psychological distress (Harvey, 2011).

‘Control’ was a central issue in therapy, as prisoners expressed that they had little

or no control. It seemed that escalating behaviours (i.e. self-harm, assault, suicide

attempts, self-isolating) were an attempt at maintaining control. Whilst there is the

perception that some behaviours (i.e. self-harm) are ‘manipulative’ (Dear,

Thomson, & Hills, 2000) it feels important to reflect that these behaviours can be

interpreted as a call for help, an expression of distress, or limited skills in effective

communication and problem solving. Working psychologically within an

environment geared towards punishment can ultimately feel challenging (Harvey,

2011), and being a psychologist bound by the same prison regime creates barriers


in developing a trusting therapeutic relationship. The regime itself strengthened

schemas of distrust, unsafety and lack of control and power, with many of these

factors central to individuals’ suicide formulation (Tarrier et al., 2013). Limiting

psychological distress during such transitions was not a primary focus. Being

unaware of transitions discounted the therapist’s ability to prepare for them during

sessions and instead required a responsive approach to escalating behaviour and

risk disclosures (i.e. imminent intentions to harm self or others). Realistically it begs

the question of how 1:1 psychological interventions can work in a prison without

making changes on a systemic level.

2.6 Delivering Psychological Intervention in Prison

i) Engagement and the ‘Prison Mask’

Encouraging control and autonomy was part of the InSPire intervention, yet issues

of control and power were a dynamic within therapy itself. The prison creates a

dynamic of compliance and therapy requires a shift towards collaboration, which

was difficult for some. Harvey (2011) reflects upon how prisoners struggle to

determine therapeutic goals as their level of autonomy is challenged and a lack of

trust and power can make it difficult to deliver effective therapy. Haney (2012)

highlights the perception of vulnerability or weakness as intolerable for prisoners,

often generating interpersonal distance. Adoption of the ‘prison mask’ prevents

anyone from getting close, both emotionally and behaviourally (Haney, 2012).

Whilst hypervigilance is an important survival strategy in prison (Haney. 2012), the

adaptive quality appears useful only to particular situations. The mask has negative

consequences in being able to engage socially and develop healthy and useful

relationships, as well as being a barrier to therapy. There is a widely recognised

reluctance to accept help within prison for the fear of being perceived as weak and

the repercussions this could trigger (i.e. bullying) (Cobb & Farrants, 2014). Therapy

raised questions about individuals’ readiness to change and motivational

interviewing techniques, such as ‘rolling with resistance’, were commonly used

(Rollnick & Miller, 1995). Outside the parameters of a research protocol, it is

unlikely that therapy would end with such instability and risk ongoing and perhaps


more would be done to facilitate transitions and stabilise issues. This felt like a

drawback to the intensive delivery and questions whether more sessions would be

beneficial. NICE (2013) quality standard for self-harm recommend up to 12 one

hour sessions, which could be trialled in future studies (i.e. 12 hours compared to

10). Alternatively, studies of intensive CBT have offered booster sessions to

increase long-term effects (Ehlers et al., 2010; 2014; Oldfield et al., 2011;

Challacombe & Salkovskis, 2011). Further models of intervention delivery have

considered offering additional sessions based upon need (Stiles et al., 2008; Bower

& Gilbody, 2005).

ii) CBSP Intervention

The intensive intervention was developed from the CBSP manual (Tarrier et al.,

2013). Research steering meetings adapted the CBSP manual into an intensive

format and ensured it was compatible with the prison regime. Delivering sessions

on consecutive days became routine and appeared to facilitate an element of

momentum (Bevan et al., 2010). Longer durations between sessions (i.e. across a

weekend) began to feel infrequent and as with the nature of the environment,

could mean that a lot had changed between sessions. The intensive delivery meant

that less time was spent ‘catching up’ and participants were able to develop case

conceptualisations more readily. This momentary focus allowed cognitive (i.e.

thought challenging) and behavioural (i.e. exposure) components of CBT to be

trialled day by day.

iii) Endings

The intensive intervention started and finished within a matter of weeks. Endings

were managed throughout sessions and were not unexpected, yet for some

prisoners there was a shift in interpersonal dynamics in final sessions (i.e.

resistance, dis-engagement). Arguably, therapy endings within prison could be

more difficult given the nature of the environment and the population (i.e.

increased prevalence of historical abuse, rejection, abandonment and unstable

attachments) (Rogers & Law, 2010). Disengagement could be interpreted as a

protective factor, as it is safer to put the ‘prison mask’ back on before facing prison

life independently again (Harvey, 2011).


iv) Clinical Supervision

There is an emphasis on the importance of good clinical supervision when working

with complex risk presentations, particularly within a prison (NICE, 2013; Marzano,

Ciclitira, & Adler, 2012). Clinical supervision was joint between the author and

fellow doctoral trainee. Supervision took place early morning prior to prison

movement and occurred most days as sessions were delivered on consecutive days.

In weekly delivery of therapy, participants reflected upon the benefit of time

between sessions to consolidate the material (Bevan et al., 2010). This too felt

relevant for the therapist as intensive delivery allowed limited reflection time

between sessions and supervisions. Supervision mirrored the quick pace and

intense nature of therapy. This intensity was likely heightened by the trainee’s lack

of experience in delivering this model. During the early stages of the InSPire

programme, supervision required a directive approach, as opposed to way-finding

and experiential learning. Over time, supervision began to feel akin to what

qualified supervision might look like, yet this conflicted with the current role as a

trainee psychologist and the challenge of holding more clinical risk than ever

before. The process generated a lot of learning and development, particularly in

autonomy and initiative in managing clinical risk. Some of these issues could be

lessened by having more practice sessions to improve competence (i.e. role play

and feedback) and by increasing the gap between intensive CBT sessions (i.e. every

other day compared to everyday).

2.7 System-level Considerations

A prisoner’s experience of psychological distress and suicidality is mediated by

relationships with others (Liebling, Durie, Stiles, & Tait, 2005). Leibling (2006)

emphasises how prisoners seek ‘fairness’, ‘respect’, ‘trust’, ‘humanity’ and ‘safety’,

which when undermined leads to anger, tension, depression and rage. Issues of

authority and injustice lead to isolation, increased distress and lack of self-worth

(Leibling, 2006). Prisoners struggle to find meaning, particularly when serving an

indeterminate sentence (Liebling, 2011). The above issues were commonly

considered during therapy and issues (i.e. powerlessness) were central to some


individuals’ suicide schema. The author sought support during supervision for these

therapy dilemmas and was directed to literary works which emphasised a human’s

ability to survive in the most extreme situations: by finding a reason to live,

choosing the way to ‘be’ in each moment and by holding on to moments already

lived (Frankl, 1985). One strategy delivered during the CBSP intervention was the

broad minded affective coping procedure (BMAC), a CBT strategy for eliciting

positive emotions (Tarrier, 2010). Furthermore, problem solving techniques

supported individuals to effectively communicate needs and address current


A focus on increasing staffs understanding and awareness of mental health is

important (Leibling & Karup, 1993; Hansson & Markstron, 2014). Future research

considerations could include increased staff liaison, consultation and teaching.

Wider presentation of the InSPire programme could have increased understanding

and recognition of suicidality in prison, alongside modelling helpful responses to


2.8 Final Considerations

The InSPire programme offered the author an opportunity to deliver a clinical

intervention in a prison, with previous prison experience being solely research

based. This opportunity led to considerable professional development and learning

experiences in the delivery of the research and in managing clinical risk whilst

delivering therapy with such a complex population. This study was the first to

deliver intensive CBT in prison and future research considerations and

recommendations have evolved following the InSPire programme. Feasibility

studies offer an advantage by highlighting successes and pitfalls in the feasibility

stage which is an important mediator in increasing the likelihood of success in

larger trials (Van Teijlingen & Hundley, 2002). The InSPire programme was

successful in recruitment and retention and given the promising results in this

study, intensive CBSP holds some promise in supporting prisoners with issues of


Whilst the results were promising, the sample size was small and therefore not

generalisable. Further analysis was considered in terms of efficacy (i.e. Reliable


Change Index; Jacobson & Truax, 1991), however, the same sample size issue would

apply. Whilst a limited sample size might be expected within a feasibility study

(Arain, Campbell, Cooper, & Lancaster, 2010), other factors affected

generalisability. The sample was largely homogenous (i.e. ethnicity, gender, same

host prison) and prisoners were motivated to engage, as reflected in the high

retention rate. As both therapists were female, some individuals were excluded due

to specific risk towards females. Future studies could include male and female

therapists and increase collaboration with the host prison to facilitate wider

engagement (i.e. self-isolative individuals). Reaching harder to engage individuals

could improve generalisability and strengthen the conclusions made regarding


Dissemination will include submission to a peer reviewed journal, alongside

presentation of the findings at the University of Manchester and the host prison.

Where opted for, prisoners will receive a short summary of the findings. Personally,

application of the CBSP model will influence future ways of working, by applying the

clinical formulation within community settings when working with individuals

experiencing suicidality.


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1. Paper I: Systematic Review


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Gordon J. G. Asmundson, University of Regina, Regina, Saskatchewan, Canada
Associate Editors
Ernst H. W. Koster, Universiteit Gent, Gent, Belgium
Christine Purdon, University of Waterloo, Waterloo, Ontario, Canada
Annemieke van Straten, Vrije Universiteit Amsterdam, Amsterdam, Netherlands
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Jeremy Pettit, Florida International University, Miami, Florida, USA
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Example: Authors A and B designed the study and wrote the protocol. Author C conducted literature searches

and provided summaries of previous research studies. Author D conducted the statistical analysis. Author B

wrote the first draft of the manuscript and all authors contributed to and have approved the final manuscript.

Statement 3: Conflict of Interest

All authors must disclose any actual or potential conflict of interest. Conflict of interest is defined as any

financial or personal relationships with individuals or organizations, occurring within three (3) years of beginning

the submitted work, which could inappropriately influence, or be perceived to have influenced the submitted

research manuscript. Potential conflict of interest would include employment, consultancies, stock ownership

(except personal investments equal to the lesser of one percent (1%) of total personal investments or USD$5000),

honoraria, paid expert testimony, patent applications, registrations, and grants. If there are no conflicts of interest

by any author, it should state that there are none.

Example: Author B is a paid consultant for XYZ pharmaceutical company. All other authors declare that they

have no conflicts of interest.

Statement 4: Acknowledgements (optional)

Authors may provide Acknowledgments which will be published in a separate section along with the manuscript.

If there are no Acknowledgements, there should be no heading or acknowledgement statement.

Example: The authors wish to thank Ms. A who assisted in the proof-reading of the manuscript.


Upon acceptance of an article, authors will be asked to complete a ‘Journal Publishing Agreement’ (see more

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Subscribers may reproduce tables of contents or prepare lists of articles including abstracts for internal

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For gold open access articles: Upon acceptance of an article, authors will be asked to complete an ‘Exclusive

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Author rights

As an author you (or your employer or institution) have certain rights to reuse your work. More information.

Elsevier supports responsible sharing

Find out how you can share your research published in Elsevier journals.

Role of the funding source

You are requested to identify who provided financial support for the conduct of the research and/or preparation

of the article and to briefly describe the role of the sponsor(s), if any, in study design; in the collection, analysis

and interpretation of data; in the writing of the report; and in the decision to submit the article for publication. If

the funding source(s) had no such involvement then this should be stated.

Funding body agreements and policies

Elsevier has established a number of agreements with funding bodies which allow authors to comply with their

funder’s open access policies. Some funding bodies will reimburse the author for the gold open access publication

fee. Details of existing agreements are available online.

Open access

This journal offers authors a choice in publishing their research:


Articles are made available to subscribers as well as developing countries and patient groups throughour

universal access programs.

No open access publication fee payable by authors.

The Author is entitled to post the accepted manuscript in their institution’s repository and make this public after

an embargo period (known as green Open Access). The published journal article cannot be shared publicly, for

example on ResearchGate or Academia.edu, to ensure the sustainability of peerreviewed research in journal

publications. The embargo period for this journal can be found below.

Gold open access

Articles are freely available to both subscribers and the wider public with permitted reuse.


A gold open access publication fee is payable by authors or on their behalf, e.g. by their researchfunder or


Regardless of how you choose to publish your article, the journal will apply the same peer review criteria and

acceptance standards.

For gold open access articles, permitted third party (re)use is defined by the following Creative Commons user


Creative Commons Attribution (CC BY)

Lets others distribute and copy the article, create extracts, abstracts, and other revised versions, adaptations or

derivative works of or from an article (such as a translation), include in a collective work (such as an anthology),

text or data mine the article, even for commercial purposes, as long as they credit the author(s), do not represent

the author as endorsing their adaptation of the article, and do not modify the article in such a way as to damage

the author’s honor or reputation.

Creative Commons Attribution-NonCommercial-NoDerivs (CC BY-NC-ND)

For non-commercial purposes, lets others distribute and copy the article, and to include in a collective work (such

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The gold open access publication fee for this journal is USD 1950, excluding taxes. Learn more about Elsevier’s

pricing policy: https://www.elsevier.com/openaccesspricing.

Green open access

Authors can share their research in a variety of different ways and Elsevier has a number of green open access

options available. We recommend authors see our green open access page for further information. Authors can

also self-archive their manuscripts immediately and enable public access from their institution’s repository after

an embargo period. This is the version that has been accepted for publication and which typically includes

author-incorporated changes suggested during submission, peer review and in editor-author communications.

Embargo period: For subscription articles, an appropriate amount of time is needed for journals to deliver value

to subscribing customers before an article becomes freely available to the public. This is the embargo period and

it begins from the date the article is formally published online in its final and fully citable form. Find out more.

This journal has an embargo period of 24 months.

Elsevier Researcher Academy

Researcher Academy is a free e-learning platform designed to support early and mid-career researchers

throughout their research journey. The “Learn” environment at Researcher Academy offers several interactive

modules, webinars, downloadable guides and resources to guide you through the process of writing for research

and going through peer review. Feel free to use these free resources to improve your submission and navigate the

publication process with ease.

Language (usage and editing services)

Please write your text in good English (American or British usage is accepted, but not a mixture of these).

Authors who feel their English language manuscript may require editing to eliminate possible grammatical or

spelling errors and to conform to correct scientific English may wish to use the English Language Editing service

available from Elsevier’s WebShop.


Our online submission system guides you stepwise through the process of entering your article details and

uploading your files. The system converts your article files to a single PDF file used in the peer-review process.

Editable files (e.g., Word, LaTeX) are required to typeset your article for final publication. All correspondence,

including notification of the Editor’s decision and requests for revision, is sent by e-mail.


Peer review

This journal operates a single blind review process. All contributions will be initially assessed by the editor for

suitability for the journal. Papers deemed suitable are then typically sent to a minimum of two independent expert

reviewers to assess the scientific quality of the paper. The Editor is responsible for the final decision regarding

acceptance or rejection of articles. The Editor’s decision is final. More information on types of peer review.

Use of word processing software

It is important that the file be saved in the native format of the word processor used. The text should be in single-

column format. Keep the layout of the text as simple as possible. Most formatting codes will be removed and

replaced on processing the article. In particular, do not use the word processor’s options to justify text or to

hyphenate words. However, do use bold face, italics, subscripts, superscripts etc. When preparing tables, if you

are using a table grid, use only one grid for each individual table and not a grid for each row. If no grid is used,

use tabs, not spaces, to align columns. The electronic text should be prepared in a way very similar to that of

conventional manuscripts (see also the Guide to Publishing with Elsevier). Note that source files of figures,


tables and text graphics will be required whether or not you embed your figures in the text. See also the section

on Electronic artwork.

To avoid unnecessary errors you are strongly advised to use the ‘spell-check’ and ‘grammar-check’ functions of

your word processor.

Article structure

Manuscripts should be prepared according to the guidelines set forth in the Publication Manual of the American

Psychological Association (6th ed., 2009). Of note, section headings should not be numbered.

Manuscripts should ordinarily not exceed 50 pages, including references and tabular material. Exceptions may be

made with prior approval of the Editor in Chief. Manuscript length can often be managed through the judicious

use of appendices. In general the References section should be limited to citations actually discussed in the text.

References to articles solely included in meta-analyses should be included in an appendix, which will appear in

the on line version of the paper but not in the print copy. Similarly, extensive Tables describing study

characteristics, containing material published elsewhere, or presenting formulas and other technical material

should also be included in an appendix. Authors can direct readers to the appendices in appropriate places in the


It is authors’ responsibility to ensure their reviews are comprehensive and as up to date as possible (at least

through the prior calendar year) so the data are still current at the time of publication. Authors are referred to the

PRISMA Guidelines (http://www.prisma-statement.org/statement.htm) for guidance in conducting reviews and

preparing manuscripts. Adherence to the Guidelines is not required, but is recommended to enhance quality of

submissions and impact of published papers on the field.


If there is more than one appendix, they should be identified as A, B, etc. Formulae and equations in appendices

should be given separate numbering: Eq. (A.1), Eq. (A.2), etc.; in a subsequent appendix, Eq. (B.1) and so on.

Similarly for tables and figures: Table A.1; Fig. A.1, etc.

Essential title page information

Title. Concise and informative. Titles are often used in information-retrieval systems. Avoid abbreviations and

formulae where possible. Note: The title page should be the first page of the manuscript document indicating the

author’s names and affiliations and the corresponding author’s complete contact information.

Author names and affiliations. Where the family name may be ambiguous (e.g., a double name), please indicate

this clearly. Present the authors’ affiliation addresses (where the actual work was done) below the names. Indicate

all affiliations with a lower-case superscript letter immediately after the author’s name and in front of the

appropriate address. Provide the full postal address of each affiliation, including the country name, and, if

available, the e-mail address of each author within the cover letter.

Corresponding author. Clearly indicate who is willing to handle correspondence at all stages of refereeing and

publication, also post-publication. Ensure that telephone and fax numbers (with country and area code) are

provided in addition to the e-mail address and the complete postal address.

Present/permanent address. If an author has moved since the work described in the article was done, or was

visiting at the time, a “Present address”‘ (or “Permanent address”) may be indicated as a footnote to that author’s

name. The address at which the author actually did the work must be retained as the main, affiliation address.

Superscript Arabic numerals are used for such footnotes.


A concise and factual abstract is required (not exceeding 200 words). This should be typed on a separate page

following the title page. The abstract should state briefly the purpose of the research, the principal results and

major conclusions. An abstract is often presented separate from the article, so it must be able to stand alone.

References should therefore be avoided, but if essential, they must be cited in full, without reference to the

reference list.

Graphical abstract

Although a graphical abstract is optional, its use is encouraged as it draws more attention to the online article.

The graphical abstract should summarize the contents of the article in a concise, pictorial form designed to

capture the attention of a wide readership. Graphical abstracts should be submitted as a separate file in the online

submission system. Image size: Please provide an image with a minimum of 531 × 1328 pixels (h × w) or

proportionally more. The image should be readable at a size of 5 × 13 cm using a regular screen resolution of 96

dpi. Preferred file types: TIFF, EPS, PDF or MS Office files. You can view Example Graphical Abstracts on our

information site.

Authors can make use of Elsevier’s Illustration Services to ensure the best presentation of their images and in

accordance with all technical requirements.



Highlights are mandatory for this journal. They consist of a short collection of bullet points that convey the core

findings of the article and should be submitted in a separate editable file in the online submission system. Please

use ‘Highlights’ in the file name and include 3 to 5 bullet points (maximum 85 characters, including spaces, per

bullet point). You can view example Highlights on our information site.


Immediately after the abstract, provide a maximum of 6 keywords, using American spelling and avoiding general

and plural terms and multiple concepts (avoid, for example, ‘and’, ‘of’). Be sparing with abbreviations: only

abbreviations firmly established in the field may be eligible. These keywords will be used for indexing purposes.


Define abbreviations that are not standard in this field in a footnote to be placed on the first page of the article.

Such abbreviations that are unavoidable in the abstract must be defined at their first mention there, as well as in

the footnote. Ensure consistency of abbreviations throughout the article.


Collate acknowledgements in a separate section at the end of the article before the references and do not,

therefore, include them on the title page, as a footnote to the title or otherwise. List here those individuals who

provided help during the research (e.g., providing language help, writing assistance or proof reading the article,


Formatting of funding sources

List funding sources in this standard way to facilitate compliance to funder’s requirements:

Funding: This work was supported by the National Institutes of Health [grant numbers xxxx, yyyy]; the Bill &

Melinda Gates Foundation, Seattle, WA [grant number zzzz]; and the United States Institutes of Peace [grant

number aaaa].

It is not necessary to include detailed descriptions on the program or type of grants and awards. When funding is

from a block grant or other resources available to a university, college, or other research institution, submit the

name of the institute or organization that provided the funding.

If no funding has been provided for the research, please include the following sentence:

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit



Footnotes should be used sparingly. Number them consecutively throughout the article. Many word processors

can build footnotes into the text, and this feature may be used. Otherwise, please indicate the position of

footnotes in the text and list the footnotes themselves separately at the end of the article. Do not include footnotes

in the Reference list.

Electronic artwork General points

Make sure you use uniform lettering and sizing of your original artwork.

Embed the used fonts if the application provides that option.

Aim to use the following fonts in your illustrations: Arial, Courier, Times New Roman, Symbol, oruse fonts that

look similar.

Number the illustrations according to their sequence in the text.

Use a logical naming convention for your artwork files.

Provide captions to illustrations separately.

Size the illustrations close to the desired dimensions of the published version.

Submit each illustration as a separate file.

A detailed guide on electronic artwork is available.

You are urged to visit this site; some excerpts from the detailed information are given here. Formats

If your electronic artwork is created in a Microsoft Office application (Word, PowerPoint, Excel) then please

supply ‘as is’ in the native document format.

Regardless of the application used other than Microsoft Office, when your electronic artwork is finalized, please

‘Save as’ or convert the images to one of the following formats (note the resolution requirements for line

drawings, halftones, and line/halftone combinations given below):

EPS (or PDF): Vector drawings, embed all used fonts.

TIFF (or JPEG): Color or grayscale photographs (halftones), keep to a minimum of 300 dpi.

TIFF (or JPEG): Bitmapped (pure black & white pixels) line drawings, keep to a minimum of 1000 dpi. TIFF (or

JPEG): Combinations bitmapped line/half-tone (color or grayscale), keep to a minimum of 500 dpi.

Please do not:

Supply files that are optimized for screen use (e.g., GIF, BMP, PICT, WPG); these typically have alow number

of pixels and limited set of colors;

Supply files that are too low in resolution;


Submit graphics that are disproportionately large for the content.

Color artwork

Please make sure that artwork files are in an acceptable format (TIFF (or JPEG), EPS (or PDF), or MS Office

files) and with the correct resolution. If, together with your accepted article, you submit usable color figures then

Elsevier will ensure, at no additional charge, that these figures will appear in color online (e.g., ScienceDirect and

other sites) regardless of whether or not these illustrations are reproduced in color in the printed version. For

color reproduction in print, you will receive information regarding the costs from Elsevier after receipt of your

accepted article. Please indicate your preference for color: in print or online only. Further information on the

preparation of electronic artwork.

Figure captions

Ensure that each illustration has a caption. Supply captions separately, not attached to the figure. A caption

should comprise a brief title (not on the figure itself) and a description of the illustration. Keep text in the

illustrations themselves to a minimum but explain all symbols and abbreviations used.


Please submit tables as editable text and not as images. Tables can be placed either next to the relevant text in the

article, or on separate page(s) at the end. Number tables consecutively in accordance with their appearance in the

text and place any table notes below the table body. Be sparing in the use of tables and ensure that the data

presented in them do not duplicate results described elsewhere in the article. Please avoid using vertical rules and

shading in table cells.


Citations in the text should follow the referencing style used by the American Psychological Association. You

are referred to the Publication Manual of the American Psychological Association, Sixth Edition, ISBN 1-4338-

0559-6, copies of which may be ordered from http://books.apa.org/ books.cfm?id=4200067 or APA Order Dept.,

P.O.B. 2710, Hyattsville, MD 20784, USA or APA, 3 Henrietta Street, London, WC3E 8LU, UK. Details

concerning this referencing style can also be found at


Citation in text

Please ensure that every reference cited in the text is also present in the reference list (and vice versa). Any

references cited in the abstract must be given in full. Unpublished results and personal communications are not

recommended in the reference list, but may be mentioned in the text. If these references are included in the

reference list they should follow the standard reference style of the journal and should include a substitution of

the publication date with either ‘Unpublished results’ or ‘Personal communication’. Citation of a reference as ‘in

press’ implies that the item has been accepted for publication.

Web references

As a minimum, the full URL should be given and the date when the reference was last accessed. Any further

information, if known (DOI, author names, dates, reference to a source publication, etc.), should also be given.

Web references can be listed separately (e.g., after the reference list) under a different heading if desired, or can

be included in the reference list.

Data references

This journal encourages you to cite underlying or relevant datasets in your manuscript by citing them in your text

and including a data reference in your Reference List. Data references should include the following elements:

author name(s), dataset title, data repository, version (where available), year, and global persistent identifier. Add

[dataset] immediately before the reference so we can properly identify it as a data reference. The [dataset]

identifier will not appear in your published article.

References in a special issue

Please ensure that the words ‘this issue’ are added to any references in the list (and any citations in the text) to

other articles in the same Special Issue.

Reference management software

Most Elsevier journals have their reference template available in many of the most popular reference

management software products. These include all products that support Citation Style Language styles, such as

Mendeley and Zotero, as well as EndNote. Using the word processor plug-ins from these products, authors only

need to select the appropriate journal template when preparing their article, after which citations and

bibliographies will be automatically formatted in the journal’s style. If no template is yet available for this

journal, please follow the format of the sample references and citations as shown in this Guide. If you use

reference management software, please ensure that you remove all field codes before submitting the electronic

manuscript. More information on how to remove field codes.

Users of Mendeley Desktop can easily install the reference style for this journal by clicking the following link:



When preparing your manuscript, you will then be able to select this style using the Mendeley plugins for

Microsoft Word or LibreOffice. Reference style

References should be arranged first alphabetically and then further sorted chronologically if necessary. More than

one reference from the same author(s) in the same year must be identified by the letters “a”, “b”, “c”, etc., placed

after the year of publication. References should be formatted with a hanging indent (i.e., the first line of each

reference is flush left while the subsequent lines are indented).

Examples: Reference to a journal publication: Van der Geer, J., Hanraads, J. A. J., & Lupton R. A. (2000). The

art of writing a scientific article. Journal of Scientific Communications, 163, 51-59.

Reference to a book: Strunk, W., Jr., &White, E. B. (1979). The elements of style. (3rd ed.). New York:

Macmillan, (Chapter 4).

Reference to a chapter in an edited book: Mettam, G. R., & Adams, L. B. (1994). How to prepare an electronic

version of your article. In B.S. Jones, & R. Z. Smith (Eds.), Introduction to the electronic age (pp. 281-304).

New York: E-Publishing Inc.

[dataset] Oguro, M., Imahiro, S., Saito, S., Nakashizuka, T. (2015). Mortality data for Japanese oak wilt disease

and surrounding forest compositions. Mendeley Data, v1. http://dx.doi.org/10.17632/ xwj98nb39r.1


Elsevier accepts video material and animation sequences to support and enhance your scientific research. Authors

who have video or animation files that they wish to submit with their article are strongly encouraged to include

links to these within the body of the article. This can be done in the same way as a figure or table by referring to

the video or animation content and noting in the body text where it should be placed. All submitted files should

be properly labeled so that they directly relate to the video file’s content. . In order to ensure that your video or

animation material is directly usable, please provide the file in one of our recommended file formats with a

preferred maximum size of 150 MB per file, 1 GB in total. Video and animation files supplied will be published

online in the electronic version of your article in Elsevier Web products, including ScienceDirect. Please supply

‘stills’ with your files: you can choose any frame from the video or animation or make a separate image. These

will be used instead of standard icons and will personalize the link to your video data. For more detailed

instructions please visit our video instruction pages. Note: since video and animation cannot be embedded in the

print version of the journal, please provide text for both the electronic and the print version for the portions of the

article that refer to this content.

Supplementary material

Supplementary material such as applications, images and sound clips, can be published with your article to

enhance it. Submitted supplementary items are published exactly as they are received (Excel or PowerPoint files

will appear as such online). Please submit your material together with the article and supply a concise,

descriptive caption for each supplementary file. If you wish to make changes to supplementary material during

any stage of the process, please make sure to provide an updated file. Do not annotate any corrections on a

previous version. Please switch off the ‘Track Changes’ option in Microsoft Office files as these will appear in the

published version.

Research data

This journal encourages and enables you to share data that supports your research publication where appropriate,

and enables you to interlink the data with your published articles. Research data refers to the results of

observations or experimentation that validate research findings. To facilitate reproducibility and data reuse, this

journal also encourages you to share your software, code, models, algorithms, protocols, methods and other

useful materials related to the project.

Below are a number of ways in which you can associate data with your article or make a statement about the

availability of your data when submitting your manuscript. If you are sharing data in one of these ways, you are

encouraged to cite the data in your manuscript and reference list. Please refer to the “References” section for

more information about data citation. For more information on depositing, sharing and using research data and

other relevant research materials, visit the research data page.

Data linking

If you have made your research data available in a data repository, you can link your article directly to the

dataset. Elsevier collaborates with a number of repositories to link articles on ScienceDirect with relevant

repositories, giving readers access to underlying data that gives them a better understanding of the research


There are different ways to link your datasets to your article. When available, you can directly link your dataset

to your article by providing the relevant information in the submission system. For more information, visit the

database linking page.


For supported data repositories a repository banner will automatically appear next to your published article on


In addition, you can link to relevant data or entities through identifiers within the text of your manuscript, using

the following format: Database: xxxx (e.g., TAIR: AT1G01020; CCDC: 734053; PDB: 1XFN).

Mendeley Data

This journal supports Mendeley Data, enabling you to deposit any research data (including raw and processed

data, video, code, software, algorithms, protocols, and methods) associated with your manuscript in a free-to-use,

open access repository. During the submission process, after uploading your manuscript, you will have the

opportunity to upload your relevant datasets directly to Mendeley Data. The datasets will be listed and directly

accessible to readers next to your published article online.

For more information, visit the Mendeley Data for journals page.

Data statement

To foster transparency, we encourage you to state the availability of your data in your submission. This may be a

requirement of your funding body or institution. If your data is unavailable to access or unsuitable to post, you

will have the opportunity to indicate why during the submission process, for example by stating that the research

data is confidential. The statement will appear with your published article on ScienceDirect. For more

information, visit the Data Statement page.


Online proof correction

Corresponding authors will receive an e-mail with a link to our online proofing system, allowing annotation and

correction of proofs online. The environment is similar to MS Word: in addition to editing text, you can also

comment on figures/tables and answer questions from the Copy Editor. Web-based proofing provides a faster and

less error-prone process by allowing you to directly type your corrections, eliminating the potential introduction

of errors.

If preferred, you can still choose to annotate and upload your edits on the PDF version. All instructions for

proofing will be given in the e-mail we send to authors, including alternative methods to the online version and


We will do everything possible to get your article published quickly and accurately. Please use this proof only for

checking the typesetting, editing, completeness and correctness of the text, tables and figures. Significant changes

to the article as accepted for publication will only be considered at this stage with permission from the Editor. It

is important to ensure that all corrections are sent back to us in one communication. Please check carefully before

replying, as inclusion of any subsequent corrections cannot be guaranteed. Proofreading is solely your



The corresponding author will, at no cost, receive a customized Share Link providing 50 days free access to the

final published version of the article on ScienceDirect. The Share Link can be used for sharing the article via any

communication channel, including email and social media. For an extra charge, paper offprints can be ordered

via the offprint order form which is sent once the article is accepted for publication. Both corresponding and co-

authors may order offprints at any time via Elsevier’s Webshop. Corresponding authors who have published their

article gold open access do not receive a Share Link as their final published version of the article is available

open access on ScienceDirect and can be shared through the article DOI link.


Visit the Elsevier Support Center to find the answers you need. Here you will find everything from Frequently

Asked Questions to ways to get in touch.

You can also check the status of your submitted article or find out when your accepted article will be published.
© Copyright 2018 Elsevier | https://www.elsevier.com


Appendix 2

The Effect Public Health Practice

Project (EPHPP) Quality Tool


Appendix A: Effective Public Health Practice

Project (EPHPP) Quality Assessment Tool for

Quantitative Studies

© The Author(s) 2015 45
N. Evans et al., A Systematic Review of Rural Development Research,
SpringerBriefs in Public Health, DOI 10.1007/978-3-319-17284-2

46Appendix A: Effective Public Health Practice Project (EPHPP) Quality Assessment






2. Paper II: Empirical Study


Appendix 3

Archives of Suicide Research

Guidance for Authors


Instructions to Authors
Archives of Suicide Research, the official journal of the International Academy for Suicide Research, is an

international journal in the field devoted to suicide research. The contributions in Archives represent the breadth

of suicide erudition in the scientific community featuring original research from diverse disciplines including

biology, psychiatry, psychology and sociology. The journal has become renowned for reporting on the most

current and relevant aspects of suicide research, as well as defining the foundations of the field.

Submission of Manuscripts: Please send questions and/or electronic manuscripts in English to the Editor-in-

Chief: Barbara Stanley, Ph.D. E-mail: [email protected] Manuscripts, including tables,

figures, and references, should be prepared in accordance with the American Psychological Association 5th

Edition. All manuscripts must be typed, double-spaced, on 8.5 x 11 inch paper with a 1-inch margin all around.

Articles should be limited to 6000 words. For any other inquiries please contact Abbie Kwitel, Editorial

Assistant at (country code: 001) 212-543-2913.

Review Process. The Journal Editor and Editorial Staff determine whether the subject matter and content of the

manuscripts submitted are pertinent to ASR. The manuscript will be sent out for peer review if it is found to be

relevant and important. The author may expect to receive the reviewers’ responses within 4 to 6 weeks from the

date the manuscript was originally sent to ASR. All reviewers remain anonymous. Authors will be informed of

the Editor’s decision regarding their manuscript’s status of publication when the review process ends.

Manuscript Organization. Cover Letter: A cover letter must be included indicating that the material is intended

for publication and that all the authors have agreed to the content and submission of the manuscript.

Title page: The title page should include the following:

·Title of the manuscript: Authors should also supply a shortened version of the title suitable for the running head,

not exceeding 50 characters and spaces.

·Total word count

·Up to 6 keywords

·Complete contact information: this includes the corresponding author’s full name, title, telephone number, fax

number, and e-mail address.

Disclosures and Acknowledgments: authors are required to disclose of all forms of support, including financial

support or involvement in their cover letter. Pharmaceutical company and grant support, as well as any other

supportive agency, grant number or contract, and acknowledgments of individuals should all be included here.

Abstract: Each article should be summarized in an abstract of no more that 120 words. Abstract should be

separated into Objectives, Methods, Results, Conclusion. Avoid abbreviations, diagrams, and reference to the


Text: The contents of the text should adhere to the general structure of scientific papers: introduction, method,

results, and discussion. If applicable, it should be made clear in the methods section that informed consent was

obtained from subjects who participated in the study.

Illustrations: Illustrations submitted (line drawings, halftones, photos, photomicrographs, etc.) should be clean

originals or digital files. Digital files are recommended for highest quality reproduction and should follow

these guidelines: 300 dpi or higher; sized to fit on journal page; EPS, TIFF, or PSD format only; submitted as

separate files, not embedded in text files.

Color illustrations will be considered for publication; however, the author will be required to bear the full cost

involved in their printing and publication. The charge for the first page with color is $900.00. The next three

pages with color are $450.00 each. A custom quote will be provided for color art totaling more than 4 journal

pages. Good-quality color prints or files should be provided in their final size. The publisher has the right to

refuse publication of color prints deemed unacceptable.

Tables and Figures. Tables and figures should be numbered and included as separate sheets or files. Tables and

figures should not be embedded in the text. A short descriptive title should appear above each table with a clear

legend and any footnotes suitably identified below. All units must be included. Figures should be completely

labeled, taking into account necessary size reduction. Captions should be typed, double-spaced, on a separate


References. References should be listed on separate pages following the text. They should be listed

alphabetically by first author and should not be numbered. Be sure all references have been cited in the text.

Provide the last names and first initials of maximum three authors; “et al.” should be used for articles containing

more than three authors. Journal names should not be abbreviated. Italicize journal names and book titles. Article

references should include the author names, year of publication, title of the article, complete name of the journal,

the volume and the page numbers in which the article appears.

Proofs. One set of page proofs is sent to the designated author. Proofs should be checked and returned within 48


Off prints and Complimentary Copies. The corresponding author of each article will receive up to 3

complimentary issues. Off prints of the article and additional issues may be ordered from Taylor & Francis by

using the link to the order form included with the page proofs.

Permissions. Authors are responsible for obtaining permission to reproduce copyrighted material from other



Appendix 4

University of Manchester Ethical Approval


Faculty of Biology, Medicine & Health
The University of Manchester

Oxford Road
Manchester M13 9PT


5 April 2018

To whom it may concern

Sponsor Reference: NHS001347

Role of the Research Sponsor under the UK Policy Framework for Health and Social Care
(2017) and the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI2004/1031)

I hereby confirm that the University of Manchester would be prepared to accept the role of
research sponsor as currently defined in the UK Policy Framework for Health and Social Care
(2017) and the Medicines for Human Use (Clinical Trials) Regulations 2004 (SI2004/1031), in
relation to the study:

The INSPiRe Programme: Developing an Intensive Suicide Prevention Therapy for suicidal

I have been informed that this study will be led by Dr Daniel Pratt of The University of

Sponsorship is subject to the following conditions:
The lead investigator for the study must be an employee of the University of Manchester. For
student research the academic supervisor is considered to be the lead investigator.
An appropriate contract must be agreed between the University and the funding body.
The research must be reviewed and approved by appropriate ethics, NHS and regulatory bodies
and registered in accordance with University insurance requirements.

To enable the sponsor to meet their responsibilities as listed in section 9.10 of the UK Policy
Framework for Health and Social Care (2017), Chief Investigators are asked to adhere to the
responsibilities as outlined in section 9.2 of the UK Policy Framework for Health and Social Care
(2017) (available at: https://www.hra.nhs.uk/documents/1068/uk-policy-framework-health-
social-care-research.pdf). In line with this requirement Dr Daniel Pratt must ensure that all
involved in the research project understand and discharge their responsibilities in accordance
with the agreed protocol and any relevant management, ethical and regulatory approvals.

If you have any queries about sponsorship of this project then please address them to Ms
Lynne MacRae, Faculty Research Practice Coordinator, University of Manchester, Simon
Building, Brunswick Street, Manchester M13 9PL, or email [email protected]

Yours Faithfully,

Lynne MacRae Dated: 5

April 2018

Research Practice Governance Coordinator
Faculty of Biology, Medicine and Health
The University of Manchester, Oxford Road, Manchester M13 9PL Royal Charter Number:


Appendix 5

Health Research Authority Ethical Approval


Dr Daniel Pratt
Clinical Psychologist Email: [email protected]
University of Manchester [email protected]
2nd Floor Zochonis Building
Brunswick Street
University of Manchester
M13 9PL

04 June 2018

Dear Dr Pratt

HRA and Health and Care

Research Wale(HCRW) Approval Letter

Study title: The INSPiRe Programme: Developing an Intensive Suicide

Prevention Therapy for suicidal prisoners.

IRAS project ID: 238927

Protocol number: 7923

REC reference: 18/NE/0158

Sponsor University of Manchester

I am pleased to confirm that HRA and Health and Care Research Wales (HCRW) Approval
has been given for the above referenced study, on the basis described in the application form,

protocol, supporting documentation and any clarifications received. You should not expect to receive

anything further relating to this application.

How should I continue to work with participating NHS organisations in England and
Wales? You should now provide a copy of this letter to all participating NHS organisations in
England and Wales*, as well as any documentation that has been updated as a result of the

*‘In flight studies’ which have already started an SSI (Site Specific Information) application for NHS

organisations in Wales will continue to use this route. Until 10 June 2018, applications on either

documentation will be accepted in Wales, but after this date all local information packs should be

shared with NHS organisations in Wales using the Statement of Activities/Schedule of Events for

non-commercial studies and template agreement/ Industry costing template for commercial studies.

Following the arranging of capacity and capability, participating NHS organisations should formally
confirm their capacity and capability to undertake the study. How this will be confirmed is detailed
in the “summary of assessment” section towards the end of this letter.
Page 1 of 8

You should provide, if you have not already done so, detailed instructions to each organisation as to

how you will notify them that research activities may commence at site following their confirmation

of capacity and capability (e.g. provision by you of a ‘green light’ email, formal notification


following a site initiation visit, activities may commence immediately following confirmation by

participating organisation, etc.).

It is important that you involve both the research management function (e.g. R&D office) supporting

each organisation and the local research team (where there is one) in setting up your study. Contact

details of the research management function for each organisation can be accessed here.

How should I work with participating NHS/HSC organisations in Northern Ireland and


HRA and HCRW Approval does not apply to NHS/HSC organisations within the devolved

administrations of Northern Ireland and Scotland.

If you indicated in your IRAS form that you do have participating organisations in either of these

devolved administrations, the final document set and the study wide governance report (including this

letter) has been sent to the coordinating centre of each participating nation. You should work with the

relevant national coordinating functions to ensure any nation specific checks are complete, and with

each site so that they are able to give management permission for the study to begin.

Please see IRAS Help for information on working with NHS/HSC organisations in Northern Ireland

and Scotland.

How should I work with participating non-NHS organisations?

HRA and HCRW Approval does not apply to non-NHS organisations. You should work with your

nonNHS organisations to obtain local agreement in accordance with their procedures.

What are my notification responsibilities during the study?

The document “After Ethical Review – guidance for sponsors and investigators”, issued with
your REC favourable opinion, gives detailed guidance on reporting expectations for studies,

including: Registration of research

• Notifying amendments

• Notifying the end of the study

The HRA website also provides guidance on these topics, and is updated in the light of changes in

reporting expectations or procedures.

I am a participating NHS organisation in England or Wales. What should I do once I

receive this letter?

You should work with the applicant and sponsor to complete any outstanding arrangements so you

are able to confirm capacity and capability in line with the information provided in this letter.

The sponsor contact for this application is as follows:
Name: Lynne Macrae (University of Manchester)
Tel: 0161 275 5436
Email: [email protected]

Who should I contact for further information?

Please do not hesitate to contact me for assistance with this application. My contact details are below.

Your IRAS project ID is 238927. Please quote this on all correspondence.

Yours sincerely

Andrea Bell


Email: [email protected]

Copy to: Ms Lynne Macrae – Sponsor contact

Ms Rachel Rosenhead, Greater Manchester Mental Health NHS

Foundation Trust – Lead NHS R&D contact


Appendix 6

Favourable Research and Ethics Committee Letter


North East – York Research Ethics Committee

NHSBT Newcastle Blood Donor Centre
Holland Drive

Newcastle upon Tyne

Telephone: 0207 1048091
Please note: This is
the favourable
opinion of the REC
only and does not
allow you to start
your study at NHS
sites in England until
you receive HRA

29 May 2018

Dr Daniel Pratt
Clinical Psychologist
University of Manchester
2nd Floor Zochonis Building
Brunswick Street
University of Manchester
M13 9PL

Dear Dr Pratt

Study title: The INSPiRe Programme: Developing an Intensive

Suicide Prevention Therapy for suicidal prisoners.

REC reference: 18/NE/0158

Protocol number: 7923

IRAS project ID: 238927

Thank you for your letter of 23 May 2018, responding to the Committee’s request for further

information on the above research [and submitting revised documentation].

The further information has been considered on behalf of the Committee by the Chair.

We plan to publish your research summary wording for the above study on the HRA website,

together with your contact details. Publication will be no earlier than three months from the

date of this opinion letter. Should you wish to provide a substitute contact point, require

further information, or wish to make a request to postpone publication, please contact

[email protected] outlining the reasons for your request.

Confirmation of ethical opinion

On behalf of the Committee, I am pleased to confirm a favourable ethical opinion for the above
research on the basis described in the application form, protocol and supporting documentation [as

revised], subject to the conditions specified below.

Conditions of the favourable opinion

The REC favourable opinion is subject to the following conditions being met prior to the start of the



Management permission must be obtained from each host organisation prior to the start of the

study at the site concerned.

Management permission should be sought from all NHS organisations involved in
the study in accordance with NHS research governance arrangements. Each NHS
organisation must confirm through the signing of agreements and/or other
documents that it has given permission for the research to proceed (except where
explicitly specified otherwise).

Guidance on applying for HRA and HCRW Approval (England and Wales)/ NHS
permission for research is available in the Integrated Research Application System,
at www.hra.nhs.uk or at http://www.rdforum.nhs.uk.

Where a NHS organisation’s role in the study is limited to identifying and referring
potential participants to research sites (“participant identification centre”), guidance
should be sought from the R&D office on the information it requires to give
permission for this activity.

For non-NHS sites, site management permission should be obtained in accordance
with the procedures of the relevant host organisation.

Sponsors are not required to notify the Committee of management permissions from
host organisations

Registration of Clinical Trials

All clinical trials (defined as the first four categories on the IRAS filter page) must be

registered on a publically accessible database within 6 weeks of recruitment of the first

participant (for medical device studies, within the timeline determined by the current

registration and publication trees).

There is no requirement to separately notify the REC but you should do so at the earliest

opportunity e.g. when submitting an amendment. We will audit the registration details as part

of the annual progress reporting process.

To ensure transparency in research, we strongly recommend that all research is registered but

for non-clinical trials this is not currently mandatory.

If a sponsor wishes to request a deferral for study registration within the required timeframe,

they should contact [email protected] The expectation is that all clinical trials

will be registered, however, in exceptional circumstances non registration may be permissible

with prior agreement from the HRA. Guidance on where to register is provided on the HRA

It is the responsibility of the sponsor to ensure that all the conditions are complied

with before the start of the study or its initiation at a particular site (as applicable).

Ethical review of research sites

NHS sites

The favourable opinion applies to all NHS sites taking part in the study, subject to management

permission being obtained from the NHS/HSC R&D office prior to the start of the study (see

“Conditions of the favourable opinion” below).

Non-NHS sites

The Committee has not yet completed any site-specific assessment (SSA) for the non-NHS research

site(s) taking part in this study. The favourable opinion does not therefore apply to any non-NHS site

at present. We will write to you again as soon as an SSA application(s) has been reviewed. In the

meantime no study procedures should be initiated at non-NHS sites.

Approved documents


The final list of documents reviewed and approved by the Committee is as follows:

Document Version Date

Covering letter on headed paper [Response Letter to Prov Opin] 23 May 2018

Evidence of Sponsor insurance or indemnity (non NHS Sponsors only) [Insurance] 05 April 2018

GP/consultant information sheets or letters [GP Letter] 1 04 January 2018

Interview schedules or topic guides for participants [Topic Guide] 2 17 April 2018

IRAS Application Form [IRAS_Form_23052018] 23 May 2018

IRAS Checklist XML [Checklist_23052018] 23 May 2018

Letter from sponsor [Letter from Sponsor] 05 April 2018

Other [Student CV – Lauren Hampson] 1 18 December 2017

Other [MDSPS] 1 06 April 2018

Other [DERS] 1 06 April 2018

Other [Liability Confirmation Letter] 25 May 2017

Other [Distress Protocol] 2 13 March 2018

Other [Employers Liability] 31 May 2017

Other [Insurance Confirmation] 01 June 2017

Other [Participant Debriefing Sheet] 2 13 March 2018

Other [Public Liability]

Other [UoM Risk Assessment] 01 April 2018

Other [Safe Working Practices and Risk Management Protocol] 2 13 March 2018

Other [Social Problem Solving Inventory – Revised]

Other [Beck Suicide Scale]

Other [Participant Sessional Measure] 2 21 May 2018

Other [Demographics Form] 2 21 May 2018

Other [Additional Metrics] 19 April 2018

Other [CV Yvonne Awenat] 19 April 2018

Other [Demographics Form] 19 April 2018

Other [Discharge Summary] 19 April 2018

Other [Session Summary Sheet] 19 April 2018

Other [The Client Satisfaction Questionnaire] 19 April 2018

Other [The Multidimensionla Scale of Percieved Social Support ] 19 April 2018

Other [Therapist Sessional measure] 19 April 2018

Other [Therapy Rating Form] 19 April 2018

Other [Summary Participant Information Sheet] 2 21 May 2018

Participant consent form [Consent Form] 3 21 May 2018

Participant information sheet (PIS) [Participant Information Sheet] 4 21 May 2018

Research protocol or project proposal [The INPRiRe Programme Protocol] 2 13 March 2018

Summary CV for Chief Investigator (CI) [CI Summary CV] 01 December 2017

Summary CV for student [Student CV – Jessica Killilea] 18 December 2017

Summary CV for supervisor (student research) [Supervisor CV] 01 December 2017


Statement of compliance

The Committee is constituted in accordance with the Governance Arrangements for Research Ethics

Committees and complies fully with the Standard Operating Procedures for Research Ethics

Committees in the UK.

After ethical review

Reporting requirements

The attached document “After ethical review – guidance for researchers” gives detailed
guidance on reporting requirements for studies with a favourable opinion, including:

• Notifying substantial amendments

• Adding new sites and investigators

• Notification of serious breaches of the protocol

• Progress and safety reports

• Notifying the end of the study

The HRA website also provides guidance on these topics, which is updated in the light of

changes in reporting requirements or procedures.

User Feedback

The Health Research Authority is continually striving to provide a high quality service to all

applicants and sponsors. You are invited to give your view of the service you have received and the

application procedure. If you wish to make your views known please use the feedback form available

on the HRA website:


HRA Training

We are pleased to welcome researchers and R&D staff at our training days – see details at


18/NE/0158 Please quote this number on all correspondence

With the Committee’s best wishes for the success of this project.

Yours sincerely


Mr Chris Turnock Chair

Email: [email protected]

Enclosures: “After ethical review – guidance for researchers”
Copy to: Ms Lynne Macrae

Ms Rachel Rosenhead, Greater Manchester Mental Health NHS

Foundation Trust


Appendix 7

HMPSS Ethical Approval Letter


19 July, 2018

Lauren Hampson
Trainee Clinical Psychologist
Division of Psychology and Mental Health
Faculty of Biology, Medicine and Health
2.01, 2

Floor Zochonis Building 1

Brunswick Street
Manchester M13 9PL

Dear Lauren

Re: NRC Research Application 2018-154: The INSPiRe Programme : Developing an

Intensive Suicide Prevention Therapy for Suicidal Prisoners

Your research application above has been approved by NW Psychological Services and the

Governor of HMP Risley.

Please note should you wish to publish or present any of the findings from your research you

will need to obtain permission. The procedure is:

An email should be sent to:

Lynne Carter (email [email protected]) with:

 A brief synopsis of the purpose and conclusions of the research

 A copy of the research paper/presentation

 An indication of anything contentious within the paper/presentation

Yours sincerely

Sue Thomas

Dr. Sue Thomas, AFBPsS
Chartered and Registered Forensic Psychologist
Cluster Manager: Training, Research & Consultancy Service (TRaC)
North West Psychological Services
0177244 (VPN7236) 2472


Appendix 8

Clinical Trial Registration


ClinicalTrials.gov Protocol Registration and Results System (PRS) Receipt

Release Date: April 4, 2018

ClinicalTrials.gov ID: [Not yet assigned]

Study Identification
Unique Protocol ID: 238927 Brief Title: The INSPiRe Programme Official Title: The INSPiRe Programme: Intensive Suicide

Prevention Therapy in Prison Secondary IDs:

Study Status
Record Verification: April 2018 Overall Status: Not yet recruiting Study Start: June 1, 2018 [Anticipated] Primary Completion:
July 31, 2019 [Anticipated] Study Completion: September 30, 2019 [Anticipated]

Sponsor: University of Manchester Responsible Party: Principal Investigator Investigator: Jessica Killilea [jkillilea] Official

Title: University of Manchester Affiliation: University of Manchester Collaborators:

U.S. FDA-regulated Drug: No U.S. FDA-regulated Device: No U.S. FDA IND/IDE: No Human Subjects Review: Board

Status: Exempt Data Monitoring: Yes FDA Regulated Intervention: No

Study Description
Brief Summary: This study aims to assess the acceptability and feasibility of a short-term, intensive Cognitive Behavioural

Therapy (CBT) delivered to male prisoners who have thoughts of ending their lives. Detailed Description: 10 hours of an

adapted CBT therapy for suicide will be delivered across 2 weeks in 5 2 hour sessions to male prisoners. They will initially be
assessed on several measures of mood, social support and suicidality. They will then undergo therapy. Following this they will

be asked to re-completed the initial measures and a post-therapy interview to ascertain their thoughts on their experience of the


Conditions: Suicide Keywords: Intensive Cognitive Behavioral Therapy Male prisoners

Study Design
Study Type: Interventional Primary Purpose: Treatment Study Phase: N/A Interventional Study Model: Single Group
Assignment Number of Arms: 1 Masking: None (Open Label) Allocation: N/A Enrollment: 16 [Anticipated]

Arms and Interventions
Arms: Experimental: Intervention 10 hours of intensive CBT for suicide will be delivered to male prisoners who are havin g

thoughts of ending their lives. This will be delivered in 2 hours sessions, 5 times across 2 weeks.
Assigned Interventions: INSPiRe Programme Intensive CBT for suicide

Outcome Measures
Primary Outcome Measure:

1. The Client Satisfaction Questionnaire (CSQ-8) A measure of participant satisfaction with therapy [Time Frame: 20 minutes]

2. Therapist Session Summary Measuring levels of adherence and engagement [Time Frame: 5 minutes]
3. Discharge summary sheet Capturing individuals’ adherence to the programme or discharge from it [Time Frame: 15

minutes] 4. Therapist Rating Form Giving an overall picture of each individual’s engagement and progress during the study.

[Time Frame: 20 minutes] 5. Post-intervention interview Qualitative interview to explore the participant’s experience of
therapy [Time Frame: 1 hour]

Minimum Age: 21 Years Maximum Age: Sex: Male Gender Based: Yes All participants will be recruited from a prison site that

houses males. Accepts Healthy Volunteers: No Criteria: Inclusion Criteria: Aged over 21 years old. Has been managed under

the Assessment, Care in Custody, and Teamwork (ACCT) system within the last 1 month (including current ACCT review).
Sufficient English language proficiency, as judged by the researcher, in order to complete psychometric questionnaires (i.e.

adequate reading comprehension) and engage in intensive CBT programme (i.e. adequate verbal communication). Adult is able

to provide informed consent as established during baseline clinical interview (BPS, 2006; MCA, 2005). Currently residing in
HM Prison (and expected to remain there for at least six weeks; determined through staff and prisoner report). Exclusion

Criteria: A primary organic disorder (indicated by prison medical staff report or records). Any current risk behaviour which

would compromise the safety of others, as identified by prison staff.

Central Contact Person: Jessica Killilea Telephone: 0161 306 0401 Email: [email protected]

Central Contact Backup: Lauren Hampson Telephone: 0161 306 0401 Email: [email protected]

Study Officials: Daniel Pratt Study Principal Investigator University of Manchester; Yvonne Awenat Study Chair University of
Manchester; Charlotte Lennox Study Chair University of Manchester


Plan to Share IPD: No

Citations: Links: Available IPD/Information:

U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services


Appendix 9

Participant Information Sheet


Participant Information Sheet

The INSPiRe Programme
Intensive Suicide Prevention

Therapy in Prison

Study Invitation

You are being invited to take part in The INSPiRE Programme. Before you decide

whether or not you wish to take part, it is important for you to understand why the

research is being done and what it will involve. Please take time to read the

following information sheet carefully and discuss it with others if you wish. Please

ask us if there is anything that is not clear or if you would like more information.

Thank you for taking the time to read this.

What is the purpose of the study?

The INSPiRe Programme is a new programme of Cognitive Behavioural Therapy

(CBT) for suicide within a prison population. The INSPiRe Programme will be

delivered ‘intensively’, meaning that individuals will receive up to 10 hours of

therapy across a two week period. The study aims to find out how practical and

suitable it is to deliver therapy in a quicker format.

Why have I been asked to take part?

We are interested in talking to prisoners who in the past one month may have had

suicidal thoughts and/or behaviours.

Do I have to take part?

No, you do not have to take part. If you would prefer not to take part then you do not

have to give a reason and you will not be pressured to change your mind. This will

not affect the normal support you receive.

If you decide to take part you will be asked to sign a consent form. You are able to

leave the study at any time, without giving a reason. If you do decide to leave we

may ask you to discuss your reasons for leaving. However you will not have to do

this if you do not wish. Information you have already given will remain part of the


research. Should you lose capacity to consent (for example, because of drug use) your role

in the study may stop, but any data collected up to that point will still be used.

What does taking part involve?

First Meeting:

We shall contact you to talk to you about the programme and to see whether you

might be interested in taking part. We will give you some time to consider this (no

less than 24 hours). If you would like to take part we shall support you to complete a

consent form and then we would like to ask you further questions about how you

have been feeling recently. This should take about 30 minutes and can be arranged at

a time suitable for you. It may be the case that during this meeting that the INSPiRE

Programme is not suitable for you. If the Programme is not suitable for you then we

will not need to see you again and that will be the end of your part in the study. This

does not mean that your problems are more or less important than anyone else’s

problems; it just means that our Programme is not suitable for you.

INSPiRE Programme:

The INSPiRE Programme will last for two weeks. This will involve the Intensive

CBT Programme. Each of the ten sessions will last for up to two hours and will take

place on weekdays from Monday to Friday. Sessions will be on a one to one basis

with a member of the research team. Participant’s involvement in the programme

may be stopped should they miss two sessions without giving a reason (NB:

However, incidents outside of the participants’ control i.e. lock-down, would not be

grounds to end participation).

Final Meetings:

Once the programme has been completed, we would like to hear about how you

found the INSPiRe programme. We would like to complete the questionnaires with

you once more, which again should take about 20 minutes. We would also like to

hear your thoughts within an ‘interview’ format. We would like to hear about how

you found the Intensive CBT and how you think this could be improved in the

future. This interview will be audio tape recorded so that we can explore your

experiences at a later stage. If you wish to do the interview without recording it then

this will be possible however there will be another member of the research team

present to take notes during the interview.


What are the possible benefits of taking part?

We hope that the Intensive CBT Programme will be helpful for you in managing

your difficult experiences. However, this may not be the case. Findings from the

research may be helpful in making CBT in prisons better in the future.

What are the possible risks or cons of taking part?

We do not see any serious risks in taking part in the study. You will be asked to give

up some of your time to take part. It would not be unusual for people to feel some

emotional distress when they are asked to think about difficult events from their past.

If you are upset you will be able to talk to the researcher about it. If you feel you

require further support they will be able to tell you about other sources of help or


What if there is a problem?

If you have concerns about how you have been treated during this study, you can ask

to speak to a member of the research team, who will do their best to answer your

questions. You can also direct any complaints, concerns, requests for information

and queries through the prison. In the event that something goes wrong and you are

harmed during the research, and whereby someone is at fault, then you may have

grounds for a legal action for compensation but you may have to pay your own legal


Will my taking part in the study be kept confidential?

Yes. Information collected about you will be kept strictly confidential and will not

be shared with anyone outside the research team without your consent. Any personal

information that we collect about you, and any consent forms will be stored securely

and will only be used for research purposes. If you take part, prison staff or those

responsible for your care will be informed of your involvement in the study, but they

will not have access to information collected during the study.

Audio tape recordings will only be transcribed by members of the research team.

Any quotes from research participants used in the project report will be anonymised

and no real names will be used.

You have the right to check the data held about you and to correct any errors.

Procedures for the handling, processing, storage and destruction of your data will be

in line with the Data Protection Act 1998. Some parts of the data collected for the

study may be looked at by individuals working with the research team at the

University of Manchester or within the Sponsoring NHS Trust. Records also may be


reviewed by persons authorised to do so within regulatory authorities to check that

the study is being correctly carried out, but this information will remain anonymous.

All such individuals have a duty of confidentiality to you as a research participant.

The data will be securely disposed of by 5 years. During the study, data will be held

securely at the University of Manchester.

Are there any circumstances in which confidentiality would be broken?

Yes. You should be aware that the researcher has a duty to inform an appropriate

person should you disclose any of the following:

a) Behaviour that is against prison rules and can be prosecuted for

b) Information that suggests a risk of harm to yourself or another person, or refers

to a new crime or plans to commit a new crime

c) Undisclosed illegal acts

d) Information that raises concerns about terrorism, radicalisations, or security


What will happen to the results of the study?

The results of this study may be available in a report or criminal justice or medical

journal. If you would like a copy of any report or a summary of the results, please let

the researcher know. You will not be identified in any report following this study.

This study is being completed as part of a Clinical Psychology Doctoral Thesis by

Trainee Clinical Psychologists within the University of Manchester.

Who has reviewed this study?

The research has been reviewed by an independent group of people, called a

Research Ethics Committee (REC) to protect your safety, rights, wellbeing and

dignity. This study has been reviewed and given a favourable opinion by North East

– York REC (Ref: 18/NE/0158). The research has been reviewed and approved by

the Health Research Authority (ID: 238927) and HMPPS (Ref: 2018-154).

Thank you for reading this.

If you need further information, please speak with a member of the research team:

Lauren Hampson and Jessica Killilea (Trainee Clinical Psychologists).

We will give you this information sheet to keep as well as a signed consent form if

you agree to take part.
Should you require support during your participation in The INSPiRE Programme, you are

able to access the following services: Samaritans Helpline; Prisoner Listener/Buddy/Peer

Service; Personal Officer; Prison GP

Mental Health Team; Chaplaincy.


Appendix 10

Summary Participant Information Sheet


The INSPiRe Programme:
Intensive Suicide Prevention Therapy in Prison

Do you experience difficult thoughts about

ending your life?
Do you find yourself feeling hopeless, or feel

that there is no point going on?

If you feel this way, you may be interested in
taking part in the INSPiRe Programme. This is

a new programme for people experiencing

thoughts about ending their life.

We want to learn more about how best to offer help and
treatments to suicidal prisoners.

We are looking for English speaking adults who have

experienced suicidal thoughts in the past month.

The study will require you to attend the INSPiRe
Programme for up to 10 hours over a course of 2 weeks
with a psychologist. You will be asked to fill in some
questionnaires and attend a researcher meeting to find

out about your experiences of the therapy.

If you would like some more information or are interested in
taking part please contact your Personal Officer or Member

of the Prison Staff Team.


Appendix 11

Informed Consent Form


The INSPiRe Programme: Intensive Suicide Prevention
Therapy in Prison


1. I confirm that I have read and understood the Participant Information Sheet,

version 4 (16/05/2018), and have been given the opportunity to ask



I understand that my participation is voluntary and that I am free to

withdraw at any time, without giving any reason and without my legal rights

being affected.

3. I understand that if I withdraw from the study I will stop receiving the

intervention, but this will not affect any other aspects of my medical care.

4. I understand that if I withdraw from the study data collected up to this point

will still be used and I will still be contacted to discuss my reasons for

withdrawing, but that this is also voluntary and that I can refuse without


5. I understand that if I lose capacity to consent (e.g. because of drug use) I

will stop receiving the intervention but any data collected up to that point

will still be used.

6. I understand that whilst I participate in the study, the researcher has a duty to

inform prison staff should I disclose:

e) Behaviour that is against prison rules and can be adjudicated against

f) Information that either indicates a risk or harm to yourself or others or

refers to a new crime committed or plans to commit a new crime

g) Undisclosed illegal acts

h) Information that raises concerns about terrorist, radicalisations, or

security issues.

7. I give permission for the research team to look at my criminal justice and

health records for the purpose of informing the research.

8. I give permission for the research team to inform the prison GP and

healthcare team about my participation in this research study.

9. I agree to the interview part of the study to be audio-recorded. I understand

that the audio-recording will be written out in full (transcribed) by the

research team.

10. OPTIONAL: I agree for quotes to be used when writing up and publishing

the study. I understand that any identifiable data will be removed so that no-


one will be able to identify me from the quotes.

11. I understand that data collected during the study may be looked at by

individuals from the University of Manchester, from regulatory authorities

or from the NHS Trust, where it is relevant to my taking part in this

research. I give permission for these individuals to access my data.

12. I agree to take part in the above study.

13. OPTIONAL: I would like to receive a summary of the findings of this study

once it has been completed.

Sign below for participant completed consent form

Name of participant Date Signature

Name of researcher Date Signature

Sign below for researcher completed consent form

“I [researcher name] have read this form of consent to [participant name]

because [participant name] is not able to read this informed consent document.

I have asked [participant name] to make his mark to confirm that he has
understood the informed consent document”

Name of participant Date Signature

Name of researcher Date Signature

*1 copy for participant: 1 copy for researcher
Principal Investigator: Dr Dan Pratt, University of Manchester


Appendix 12

Prison GP Letter


Division of Psychology and Mental Health
School of Health Sciences

Faculty of Biology, Medicine and Health
University of Manchester

2nd Floor Zochonis Building
Brunswick Street

M13 9PL

Private and Confidential
<GP Name>
Healthcare Centre
HMP Risley
Warrington Rd


Dear Doctor ………
Re: <Participant’s name> Prison Identification Number: <number> DoB:
<date of birth>
I am writing to you because the above patient has consented to take part in the
INSPiRe: Intensive Suicide Prevention Therapy in Prison study at HMP Risley. The study
aims to explore participants’ experiences of a short-term, intensive CBT intervention for
people experiencing suicidal thoughts. The research involves taking part in 10 hours of CBT
delivered across 2 weeks (5 x 2 hour sessions), then completing a series of questionnaire
measures and discussing their experience of the intervention within a post-therapy
Attached is the information sheet your patient received about the study before they
consented to take part.
If you have any questions, please do not hesitate in contacting us.
Yours sincerely

Jessica Killilea
Email: [email protected]
Lauren Hampson
Email: [email protected]
Under the Supervision of Dr. Daniel Pratt, Clinical Psychologist


Appendix 13

The InSPire Programme: What to Expect


Thank you for agreeing to take part in the Intensive CBT for Suicide in Prison (INSPiRE)

Programme. You have been allocated to the treatment list, which means you have the

chance to meet with one of the INSPiRE team (Lauren or Jess) over the next few months.

This leaflet will tell you a little more about what kind of work you might want to do with

Lauren or Jess.

What is the INSPiRE Programme?

CBT, or Cognitive Behavioural Therapy, is a psychological treatment that was developed

through scientific research. All of the parts of CBT have been tested by researchers to

determine whether they help and that they do what they are intended to do. The INSPiRE

programme is a new type of CBT designed to be helpful to prisoners who are currently, or

have previously, been suicidal.

What does the INSPiRE Programme involve?

The sessions:

 You will meet with Lauren or Jess, the INSPiRE therapists, for up to 5 sessions.

These will run across a two week period, and will last up to 2 hours each.

 In the first session(s), the therapist will check that you can use this sort of

treatment and you will check that you feel comfortable with it.

 The therapist will also ask you questions about your past life and background.

Although the INSPiRE Programme concentrates more on the ‘here and now’, at

times you may need to talk about the past to understand how it is affecting you


 With your therapist, you will learn to understand more about problems you may

have struggled with and why you may have thoughts about suicide or feeling


 You decide which of these problems you want to deal with in the sessions.

 You and the therapist will usually start by agreeing on what to talk about that day.

The work:

 With the therapist, you break each problem down into its separate parts. To help

with this, your therapist may ask you to keep a diary. This will help you to identify

your individual patterns of thoughts, emotions, bodily feelings and actions.

 Together you will look at your thoughts, feelings and behaviours to work out:

o If they are unhelpful

o How they affect each other, and you

 The therapist will then help you to work out how to change unhelpful thoughts and



 It’s easy to talk about something, but much harder to actually do it. So, after you

have worked out what you can change, your therapist will suggest “homework” –

you practice these changes in your everyday life. Depending on the situation, you

might start to:

o Question a self-critical or upsetting thought and replace it with a more

helpful (and more realistic) one that you have developed in session with

your therapist

o Recognise that you are about to do something that will make you feel

worse and, instead, do something more helpful.

 At each session, you will talk about how you’ve got on since the last session. Your

therapist can help with suggestions if any of the tasks seem too hard or don’t seem

to be helping.

 They will NOT ask you to do things you don’t want to do – you decide the pace of

the programme and what you will and won’t try. The strength of CBT is that you

can continue to practise and develop your skills even after the sessions have

finished. This makes it less likely that your problems will return.

What are the problems with the INSPiRE Programme?

 The programme is not a quick fix. A therapist is like a personal trainer at the gym –

they can advise and encourage you, but they cannot ‘do’ it for you.

 If you are feeling low, it can be difficult to concentrate and get motivated.

 To overcome problems with feeling nervous or worried, you need to face it head

on. This may lead you to feel more anxious for a short time.

 A good therapist will pace your sessions. You decide what you do together, so you

stay in control.

How long does the INSPiRE Programme last?

The INSPiRE Programme can last up 2 weeks. How long you spend working with your

therapist will depend on the type of problem and how the programme is working for you.

Once we have completed the five sessions, we would like to talk to you once more to find

out how you found being involved in the INSPiRE Programme.

What if my problems come back?

There is always a risk that the problems related to feeling suicidal might return. If they do,

your new skills developed in the INSPiRE Programme should make it easier for you to

manage these problems. So, it is important to keep practising your new skills, even after

you are feeling better.

So what impact would the INSPiRE Programme have on my life?

Problems related to feeling suicidal can be very unpleasant. The INSPiRE Programme may

help you to manage these problems better. It is unlikely to have a negative effect on your

life, apart from the time and effort you need to put into the sessions with your therapist.


Appendix 14

Participant Debriefing Sheet


The InSPire Programme
Intensive Suicide Prevention Therapy in Prison


Thank you for taking the time to participate in this research. We hope that you

have found it interesting and have not been upset by any of the topics in the

questionnaires or interview

However, if you have found any part of this experience to be distressing there

are a number of people and organisations that you can contact for support:
 If you feel as though you are struggling to cope or feeling low in mood it is

important that you tell a member of the prison staff.

 If you have been upset by anything discussed as part of this research you should

tell a member of the research team.

 You can also talk to the Samaritans Listener on your wing.

Giving Feedback

People react differently after being in studies like this one. Please let us know

any thoughts or feelings you have about the study. Honest feedback from you

will help us learn. It also gives us a chance to explain parts of the study that

may still be confusing.

Purpose of the Study

This study involved investigating the experiences of people who had a short

course of intensive therapy for suicidal thoughts. The study focused on 2 key

1. Whether people liked the therapy.

2. Whether it was possible to deliver such an intensive therapy in a prison


You will have been asked to fill out several questionnaires before starting

therapy and after finishing therapy. You will also have been asked to discuss

your experiences of therapy in an interview. The data collected during the

interview and with the questionnaires will be analysed to answer these two


Once all the data is collected and analysed, a summary of the findings will be

made available to you on request. If you wish to receive a summary of results

please indicate this below and provide contact details. Please note the summary

may take up to 18 months to complete.

I wish to receive a summary of the results of this study:

Contact address: _____________________________________________


If you have any further questions feel free to ask now.

Thank you for taking part in this study.


Appendix 15

Certificate of Completion



Appendix 16

Demographics Questionnaire


Participant ID: __ __ __ Researcher Initials: __ __ Assessment date: _ _/ _ _ /_ _ _ _

The INSPiRE Programme


1. Establishment:

Prison Name: ____________________

2. Age and DOB: …………………………….…

3. Ethnicity:

 White British (1)

 White Irish (2)

 Other, White (3)

 White & Black Caribbean (4)

 White & Black African (5)

 White & Asian (6)

 Other, Mixed (7)

 Black Caribbean (8)

 Black African (9)

 Other, Black (10)

 Indian (11)

 Pakistani (12)

 Bangladeshi (13)

 Other, Asian (14)

 Chinese (15)

 Other, specify (16) ………….…………

 Prefer not to answer (17)

 Unknown (18)

4. Marital status: (immediately prior to prison entry)

 Single (1)

 Married/Civil Partner/Co-habiting with Partner (2)

 Divorced (3)

 Widowed (4)

 Separated (5)

 Other, specify (6) …………………..……

 Prefer not to answer (7)

 Unknown (8)

5. Employment status: (immediately prior to prison entry)

 Employed full time (1)


 Employed part time (2)

 Unemployed (but casual work) (3)

 Unemployed (4)

 Long term sick (on benefits) (5)

 Long term sick (employed) (6)

 Not seeking work & not receiving benefits (7)

 Retired (8)

 Other, specify (9) .……………………….

 Prefer not to answer (10)

 Unknown (11)

6. Religious Status:

 Christian (Catholic) (1)

 Christian (Protestant) (2)

 Christian (other) (3)

 Muslim (4)

 Hindu (5)

 Buddhist (6)

 Agnostic (7)

 Other (8)

7. Living circumstances: (immediately prior to prison entry)

 Alone (1)

 With spouse/partner (with children) (2)

 With spouse/partner (without children) (3)

 With children only (4)

 With parents (5)

 Other, specify (6) ………………………….

 Prefer not to answer (7)

 Unknown (8)

8. Accommodation type: (immediately prior to prison entry)

 Homeless / No fixed abode (sleeping rough) (1)

 Temporary accommodation (sleeping on friends/family sofa) (2)

 Supervised hostel (3)

 Unsupervised hostel (4)

 House or flat (renting) (5)

 House or flat (own) (6)

 Other, specify (7)…………………………

 Prefer not to answer (8)

 Unknown (9)

9. Date arrived in this prison: __/____ (MM/YY)


10. Main (index) offence you are charged with/convicted of:

 Violence against another person (1)

 Robbery / burglary (2)

 Theft & handling (3)

 Motoring (4)

 Arson (5)

 Criminal damage (6)

 Fraud & forgery (7)

 Drugs (8)

 Sexual (9)

 Other, specify (10)…………….…………

 Unknown (11)

 Prefer not to answer (12)

11. Prisoner status:

 Remand (1)

 Convicted – un-sentenced (2)

 Convicted – sentenced, if so please specify:

o sentence length (mths) ………… or NK

o date of sentence ___/_____ (MM/YY) or NK (3)

12. Have you been to prison before this sentence/charge?

 Yes, if so how many times ……. (not including this occasion, but including remands) or NK (1)

 No (2)

 Unknown (3)

13. What type of wing are you currently located in?

 Remand/induction (1)

 Convicted (2)

 Vulnerable Prisoner Unit (3)

 Healthcare (4)

 Cat A /Closed Secure Unit (5)

 Segregation Unit (6)

 Detox (7)

 Drug free (8)

 Older person (9)

 Other, please specify (10) …….…………………

14. What regime are you currently on?

 Basic (1)

 Standard (2)

 Enhanced (3)

 Other, please specify (4) ………………….


15. Cell type

 Single occupancy (1)

 Shared cell (2)

16. Previous Talking Therapy for Suicide prevention/ideation?

 Yes (1)

 No (2)

17. Currently on an ACCT?

 Yes (1), if so since what date ……..…..

 No (2) When did ACCT end ………..…

18. Previously been on an ACCT?

 Yes (1) How many times …………..…..

When was the last time? ……..…

 No (2)

19. Previous suicide attempts?

 In Prison: ………………………………..

 In community: …………………………..

Date of more recent attempt: …………….……



Appendix 17

Additional Study Metrics


Additional Study Metrics

To be recorded during Recruitment, Intervention and Follow Up

Number of referrals to the study

Proportion of referrals attending the first appointment

Number of pre- and post- outcome measures

completed (as a measure of acceptability)

Total number of DNAs

Total number of sessions attended

Number of participants completing the treatment


Appendix 18

Therapist Session Summary Sheet


Session summary sheet
Therapist to complete at the end of every session

Participant ID: Session no: Date & Time of session:

Duration of session: Location: S/U DNA/CNA:


1. Building Engagement
2. Engaging client to talk about concerns, values and life satisfaction
3. Identifying how suicidal thoughts / suicide attempts fit into concerns
4. Establishing a shared understanding / formulation
5. Strengthening a commitment for change & eliciting goals for therapy


6. Intervention: Information biases and attention (e.g. Attention Training, BMAC)
7. Intervention: Cognitive (e.g. appraisal restructuring, thought challenging)
8. Intervention: Behaviour (e.g. activity scheduling & behavioural activation)
9. Intervention: Affective (e.g. emotional regulation training, distress tolerance)
10. Intervention: Schema change


11. Plan for maintaining wellbeing / staying well
12. Develop a ‘handover plan’ (inc. involving care team in handover session)

Stage of Therapy: _____________________ (indicate all stages above that apply to current


Level of Formulation: 1 2 3 4 5 (rate conservatively if falls between two



Planned agenda:

Actual agenda:

Notes (continue overleaf):

Therapist Name: _________________________________________________

Therapist Signature: _______________________________________________

Date: ___________________________________________________________

2. Shared agreement between client and therapist about key problems but no summary or formulation

around how these relate to each other and to how they relate to other salient issues for the client.

3. Therapist attempted to negotiate a collaborative formulation or proposed a formulation around

main problem areas, however, client not fully engaged in this and formulation not collaboratively


4. Shared and agreed formulation of key problem/s that highlight maintaining factors in

terms of thoughts, feelings, and behaviours. Suicidal ideation and/or behaviour is

incorporated into the formulation appropriately. Development of problems not included

and the formulation may not be fully comprehensive and cover all issues.

5. Comprehensive, shared and agreed formulation of key problem/s highlighting

development factors (including onset, schema etc) and maintenance factors in

terms of thoughts, feelings, and behaviour. Suicide ideation and behaviour and

other salient issues are incorporated appropriately.

1. The therapist has endeavoured to explore client concerns, however, there has been little shared enlightenment

about key concerns, an absence of key concerns, or it has been impossible to facilitate the client to discuss any

concerns with the therapist.


Appendix 19

Therapist Rating Scale


Therapist Rating Form

Participant ID Number: ………………………… Therapist Name: …………………………

Date of Commencement: …………………………

Date of Completion /

Termination: …………………………

1. Did the offender complete the program? Yes  No 

2. Did the offender drop-out of the program? Yes  No 

If YES, number of sessions attended prior to


Please rate the following items on the scale provided to the right of the question, regardless of

whether or not the offender completed the program. Circle the number on each scale that best

suits the offender behaviour in each question.

3. Attendance.






4. Promptness.











Offender’s level of participation during













6. Mastery of programme content.







7. Disruptive behaviour.











8. Completion of homework or assignments.





half of the







Overall evaluation of offender programme








Additional comments or Notes:




Appendix 20

Client Satisfaction Questionnaire


The Client Satisfaction Questionnaire (CSQ-8)


Purpose: To assess client satisfaction with treatment.

Scoring: The CSQ-8 is easily scored by summing the individual item scores to
produce a range of 8 to 32, with high scores indicating greater satisfaction.

Description: The CSQ-8 is an 8-item, easily scored and administered measurement
that is designed to measure client satisfaction with services. The items for the CSQ-
8 were selected on the basis of ratings by mental health professionals of a number
of items that could be related to client satisfaction and by subsequent factor
analysis. The CSQ-8 is unidimensional, yielding a homogeneous estimate of general
satisfaction with services.
The CSQ-8 has been extensively studied, and while it is not necessarily a measure of
a client’s perceptions of gain from treatment, or outcome, it does elicit the client’s
perspective on the value of services received. The CSQ-8 seems to operate about
the same across all ethnic groups. This also is true for a version of the CSQ-8 that
was translated into Spanish.

Primary Reference: Larsen, D.L., Attkisson, C.C., Hargreaves, W.A., and Nguyen, T.D.
(1979). Assessment of client/patient satisfaction: Development of a general scale,
Evaluation and Program Planning, 2, 197-207. Instrument reproduced with
permission of C. Clifford Attkisson.
Availability: Dr. C. Clifford Attkisson, Professor of Medical Psychology, Department
of Psychiatry, Box 33-c, University of California, San Francisco, CA 94143.


Please help us improve our program by answering some questions about the services you
have received. We are interested in your honest opinions, whether they are positive or
negative. Please answer all of the questions. We also welcome your comments and
suggestions. Thank you very much; we really appreciate your help.

Circle your answer:



Appendix 21

Discharge Summary Sheet


Discharge Summary Sheet

Participant No:

Prisoner Number:

Sentence Status (Remand / Sentenced):

Therapist Initials:

Date of Baseline Assessment:

Date of Discharge / Termination:

Number of sessions attended:

Reason for discharge:

Successful completion of therapy:

If yes, please complete aspects of therapy completed:

Yes / No

Unexpected termination of therapy:

If yes, please tick all reasons for termination:

Yes / No

Transfer / release from prison

Lost motivation to continue with therapy

Unwillingness to engage in therapy

Participant reports therapy not to be beneficial

Participant reports therapy not to be relevant

Lack of available time to dedicate to sessions

Lack of available room / space for sessions
Withdrawn from study due to risk concerns of staff
Did not attend sessions (how many DNAs:________)
Other, please state: __________________________

Comments on discharge:

Date form completed: _______________


Appendix 22

Beck Suicide Scale



ID number Assessor Date

Please carefully read each group of statements below. Circle the one statement in each group that best describes

how you have been feeling for the past week, including today. Be sure to read all of the statements in each

group before making a choice.

1. Do you have strong, moderate or weak wish to live?

0. I have a moderate to strong will to live
1. I have a weak wish to live
2. I have no wish to live

2. Do you have strong, moderate or weak wish to die?

0. I have no wish to die
1. I have a weak wish to die.
2. I have a moderate to strong wish to die.

3. Do your reasons for living outweigh your reasons for dying?

0. My reasons for living outweigh my reasons for dying.
1. My reasons for living and dying are about equal
2. My reasons for dying outweigh my reasons for living.

4. Do you ever have the desire to kill yourself?

0. I have no desire to kill myself
1. I have a weak desire to kill myself.
2. I have a moderate to strong desire to kill myself.

5. Would you try to save yourself if you found yourself in a life threatening situation?

0. I would try to save my life if I found myself in a non-threatening situation.

1. I would take a chance on life or death if I found myself in a life threatening situation.

2. I would not take the steps necessary to avoid death if I found myself in a life-threatening


If you have ticked 0 statements for questions 4 and 5 above the skip to question 20.

If you have ticked 1 or 2 on either question 4 or 5 then go to question 6.

6. If you do think about killing yourself, how long do you think about it for?

0. I have brief periods of thinking about killing myself which pass quickly

1. I have periods of thinking about killing myself which last for moderate amounts of time.

2. I have long periods of thinking about killing myself

7. If you do think about killing yourself, how often do you think about it?

0. I rarely or only occasionally think about killing myself.

1. I have frequent thoughts about killing myself.

2. I continuously think about killing myself.

8. Do you accept this idea of killing yourself?

0. I do not accept the idea of killing myself

1. I neither accept nor reject the idea of killing myself.

2. I accept the idea of killing myself

9. Can you keep yourself from committing suicide?

0. I can keep myself from committing suicide.

1. I am unsure that I can keep myself from committing


2. I cannot keep myself from committing suicide.

10. Do concerns about friends and family, religion or possible injury from an unsuccessful attempt

stop you?

0. I would not kill myself because of my family, friends, religion, possible injury from

unsuccessful attempts etc.

1. I am somewhat concerned about killing myself because of my family, friends, religion,

possible injury from unsuccessful attempt etc.

2. I am not or only a little concerned about killing myself because of my family, friends,

religion, possible injury from unsuccessful attempts etc.

11. Are your reasons for wanting to commit suicide aimed at influencing other people i.e. getting

even with someone or to make people happy?

0. My reasons for wanting to commit suicide are primarily aimed at influencing other people

such as getting even with people, making people happier, making people pay attention to me,



1. My reasons for wanting to commit suicide are not only aimed at influencing other people, but

also represent a way of solving my problem.

2. My reasons for wanting to commit suicide are primarily based upon escaping from my


12. Do you have a plan?

0. I have no specific plan about how to kill myself.

1. I have considered ways of killing myself but have not worked out the details.

2. I have a specific plan for killing myself.

13. Do you have access to a method or an opportunity?

0. I do not have access to a method or an opportunity to kill myself.

1. The method I would use for committing suicide takes time, and I really do not have an

opportunity to use this method.

2. I have access or anticipate having access to the method that I would choose for killing myself

and also have or shall have the opportunity to use it.

14. Do you have the courage or ability?

0. I do not have the courage or ability to commit suicide.

1. I am unsure that I have the courage or ability to commit suicide.

2. I have the courage and the ability to commit suicide.

15. Do you expect to make an attempt?

0. I do not expect to make a suicide attempt.

1. I am unsure that I shall make a suicide attempt.

2. I am sure that I shall make a suicide attempt.

16. Have you made preparations?

0. I have made no preparations for committing suicide.

1. I have made some preparations for committing suicide.

2. I have almost finished or completed my preparations for committing suicide.

17. Have you written a suicide note?

0. I have not written a suicide note.

1. I thought about writing a suicide note or have started to write one, but not completed it.

2. I have completed a suicide note

18. Have you made arrangements for what will happen after?

0. I have made no arrangements for what will happen after I have committed suicide.

1. I have thought about making arrangements for what will happen after I have committed

2. I have definite arrangements for what will happen after I have committed suicide.

19. Do you try and hide these thoughts etc from others?

0. I have not hidden my desire to kill myself from people.

1. I have held back telling people about wanting to kill myself.

2. I have attempted to hide, conceal, or lie about wanting to commit suicide.

20. Have you attempted suicide before?

0. I have never attempted suicide.

1. I have attempted suicide once.

2. I have attempted suicide two or more times.

If you have previously attempted suicide please continue with the next question.

21. Was your wish to die strong, moderate or weak before?

0. My wish to die during the last suicide attempt was low.

1. My wish to die during the last suicide attempt was moderate.

2. My wish to die during the last suicide attempt was high.


Appendix 23

The Difficulties in Regulating Emotions Scale


The Difficulties in Emotion Regulation Scale (DERS)






Appendix 24

Social Problem Solving Inventory



Appendix 25

Multi-dimensional Scale of Perceived Social Support


The Multidimensional Scale of Perceived Social
Support (MSPSS)

Canty-Mitchell, J. & Zimet, G.D. (2000). Psychometric properties of the Multidimensional Scale of

Perceived Social Support in urban adolescents. American Journal of Community Psychology,
28, 391-400.

Zimet, G.D., Dahlem, N.W., Zimet, S.G. & Farley, G.K. (1988). The Multidimensional Scale of Perceived
Social Support. Journal of Personality Assessment, 52, 30-41.

Zimet, G.D., Powell, S.S., Farley, G.K., Werkman, S. & Berkoff, K.A. (1990). Psychometric
characteristics of the Multidimensional Scale of Perceived Social Support. Journal of
Personality Assessment, 55, 610-17.


Appendix 26

Participant Sessional Measure


Participant Sessional Measure

(to be completed at the start of each therapy session)

Session Number: ______________________

Please rate how much you agree with each of the following


Since the previous session

Please circle one option…

Not at all

A little



I felt that I had someone

supportive to turn to

0 1 2 3

I have been struggling to manage

my emotions

0 1 2 3

I have been able to deal with my


0 1 2 3

I have felt like harming myself

0 1 2 3

I have felt suicidal

0 1 2 3

Additional Comments (feel free to write any notes below):






Appendix 27

Therapist Sessional Measure


Therapist Sessional Measure

(to be completed after every therapy session)

Session Number: ______________

Please rate how much of this session was focussed upon the following mechanisms:


at all





Social Support

(appraisals of having someone supportive to turn


0 1 2 3

Emotional Regulation

(ability to manage emotions / emotional reactions)

0 1 2 3

Interpersonal problem solving

(ability to deal with relationship problems)

0 1 2 3

Self-harm Ideation (thoughts, feelings, urges,

behaviours relating to self-harm)

0 1 2 3

Suicide Ideation (thoughts, feelings, urges,

behaviours relating to suicide)

0 1 2 3

Additional Comments (feel free to write any notes below):






Appendix 28

Qualitative Interview Topic Guide


INSPiRe Programme Post-Intervention Feedback Interview Topic Guide

This is a guide for the areas and topics to be explored during the interview however specific

questions will be determined by the context of the participant’s individual experience of

the programme:

We are really interested in hearing about your personal experiences of engaging in the

INSPiRe psychological programme.

I would like to ask you to think back to when you were going through the programme and

tell me about your feelings and views of your psychological treatment. Anything and

everything that you want to tell me will be helpful so that we can get a better

understanding of how it was for you.

Sometimes this involves people talking about positive things about the programme,

sometimes negative things about the programme and sometimes a mixture of the two.

Through this feedback and that of other people we will hopefully be able to adapt what we

do and improve it. It is important that we learn about your experience and other individual’s

experiences who also participated in the INSPiRe programme.

Before we start can I check that you would still like to participate and that it is okay for me

to record this conversation? We do this because we don’t want to miss anything that you

say which could happen if we had to just rely on writing notes.

If you want a break at any point just let me know.

Start recording

The areas to be explored are in bold font:

Topic: Participants’ past experience of suicidality & psychological therapy programmes

Q. Can you tell me how things were for you before you started the INSPiRe programme?

Prompts: How were you feeling at that time?

Can you tell me about the difficulties were you experiencing?

How bad were things for you at that time?

Topic: What interested the participant in taking part in the study

Q. What made you want to take part in this research?

Prompts: What were your expectations of the INSPiRe programme?

Topic: The participant’s experience of the INSPiRe programme

Q. How would you describe your experience of the programme?

Prompts: In what way did it make a difference to you?

What do you think was helpful about the programme?

What do you think was beneficial about doing the programme?

Have you learned any skills or coping strategies that you think you would keep

using in the future?

Topic: Differences in how the participant manages thoughts of suicide and self-harm prior

to the programme compared to after the programme


Q. Can you tell me about your experience of thoughts of self-harm or suicide in the past?

Q. Can you tell me about your experience of thoughts of self-harm or suicide currently?

Prompts: Has going through the INSPiRe programme influenced these experiences?

If so, how?

If not, why do you think it did not influence you?

Topic: Areas that could be improved on when delivering the INSPiRe programme

Q.Could you tell me about your experience of the INSPiRe programme??

Q.What did you think the positives and negatives of the INSPiRe programme were??

Prompts: What did you think was the most beneficial about it?

What do you think was the least helpful thing about it?

How could this/What do you think could be improved on?

What do you think did not make a difference for you?

Topic: How the participant find the therapeutic experience

Q. How did you find talking to [name of therapist] about your experiences?

Prompts: Did they do anything that was helpful? What was that?

Could you tell me how you found talking to them?

Q. How did you find the timing of the sessions?

Prompts: how did you find the time of day when the session were delivered?

How did you find the length of sessions?

How did you find the length time between sessions?

Topic: What are the reasons for a participant disengaging from the INSPiRe


Q. (If DNA) Could you tell me the reason why you didn’t attend the sessions?

Q. (If DNA) Could you tell me what prevented you from attending the sessions?


What do you think could have been done to support you to attend the session?

What additional supports could have been put in place to help you attend?

Do you think changing the way the programme was carried out would reduce these


Q. (If dropped out) Could you tell me the reasons why you did not attend your sessions?

Q. (If dropped out) What do you think could have been done to prevent this?

Prompts: what made it hard to attend the sessions?

What additional supports could have been put in place?

Do you think changing the delivery format would reduce these difficulties?



What are the reasons for a participant disengaging from the INSPiRe programme

Q. (If DNA) Could you tell me the reason why you didn’t attend the session?

Q. (If DNA) What do you think could have been done to support you to attend the session?

Prompts: What made it hard to attend the sessions?

What additional supports could have been put in place?

Do you think changing the way the programme was carried out would reduce these


Q. (If dropped out) Could you tell me the reasons why you did not attend your sessions?

Q. (If dropped out) What do you think could have been done to prevent this?

Prompts: what made it hard to attend the sessions?

What additional supports could have been put in place?

Do you think changing the delivery format would reduce these difficulties?

Topic: Did the prison environment influence the participants’ experiences of the


Q. Could you tell me about your experience of engaging in a therapy programme in


Q. Was there anything about the prison environment that made it difficult to go to the


Prompt: How did the sessions fit with other prison services and systems/by the ACCT


Topic: Further feedback on the INSPiRe programme

Q. Do you have any other comments or suggestions about how we deliver this programme

to other prisoners?

Topic: General feedback on interview

Q. Finally may I ask how you have found being involved in this interview today?

Prompts: How might we improve the experience for other participants?

I would really like to thank you for spending your time talking to me today. The things we

have discussed will be very helpful in improving treatments in the future.

Explain what will happen to the information discussed and offer to provide summary of

study findings when available.

End interview

Implement Debrief protocol


Topic guide structure:

1. Background of their experiences prior to inspire programme; 2. Expectations of inspire;

3. Actual experience of inspire; 4. What could be improved upon?; 4. Thoughts

surrounding self-harm and suicide; 5. Therapeutic relationship; 10. Why disengagement if

they did?; 11. Influence of prison environment on experiencing the programme.


Appendix 29

Cognitive Behavioural Suicide Prevention (CBSP) Therapy Modules


Part 1. Are you in control of your thoughts or are your thoughts in control of you?

Do you ever get stuck thinking about your problems? Do you struggle to think about other

things when this happens? Depressing thoughts can often be hard to ignore. This module

helps you learn how to become more in control of what you focus your mind on. You will

learn how to pay attention to more positive thoughts and find out if helps you cope better

when negative thoughts happen

Part 2. Changing our thoughts by challenging our thoughts

Do your think about your current situation and what it’s like to be in prison? Do these

thoughts stress you out? Do they make you feel bad about yourself and put you “on a

downer”? Do you spend a lot of time thinking about your past and the mistakes you’ve

made? Do you think about your future and worry about what this may hold for you? This

module will help you to look at your thoughts and understand more about where they have

come from and why you think in the way that you do. You will learn about unhelpful ways

of thinking and try to learn new ways of thinking that may be more helpful to you.

Part 3. Managing your mood

How’s your mood right now? Do you ever get depressed or stuck in a low mood? This

module will teach you how to manage your mood by doing things that lift your spirits.

When people are depressed they tend to be less active than normal and stop doing things

they used to enjoy doing. This can be a vicious circle and make you feel even worse. It can

help hugely to do things which you get pleasure from, or things which give you a sense of


Part 4. Improve how to solve problems

Do you have problems in your life? Can these problems sometimes be difficult to solve? Do

you ever feel stuck with a problem and can’t seem to find a way round it? You might find it

more difficult to cope if you have lots of problems that you can’t seem to get on top of. This

can have a clear impact on our mood and stress levels. Struggling with unresolved problems

can often make us feel worse. We can end up worrying about our problems without finding

a way to resolve them. This module will help you to develop a structured way of working

through a problem. Beginning to overcome some of your problems might help you to feel

better. You can improve your problem solving skills by learning to apply the steps outlined in

this module.

Part 5. Improving your self-esteem

From time to time, we can all feel bad about ourselves. How we were treated when we

were younger can affect how we feel about ourselves now. If we have been criticised by

other people or if bad stuff has happened to us in the past, we are more likely to have low

self-esteem. This module will help you to see when you are being too critical of yourself.

You can then try to develop more helpful ways of thinking about yourself and what you can



Appendix 30

Distress Protocol


The INSPiRe Programme
Intensive Suicide Prevention Therapy in



1. If a participant is identified as being distressed during therapy or
data collection, the researcher will invite them to take time out
and have a break. Participants will be allowed to take as many

breaks as they wish without any detriment to their participation.
The researcher will offer to accompany them.

2. If the researcher judges that participation is causing undue

distress to the participant, they will sensitively terminate the

session/interview prematurely. Depending on the instance, the
researcher will either assure the participant that therapy will

continue as planned. Otherwise, their participation in the study
may cease, in the interest of safety. Participants will be assured
that their contribution is valuable and unless they ask to withdraw

their data, this will be retained for analysis. Each individual case
such as this, will be discussed within Clinical Supervision prior to

any decision making.

3. Following the completion of the battery of questionnaires, all

participants will be debriefed by the researcher to ensure that no-
one leaves the room in a distressed state.

4. The debrief sheet given to participants will detail avenues of
support that participants can access should they feel the need.

5. The Researchers will also inform a member of Prison staff should

any participant display distress either during a therapy session or
during data collection so that any increase in risk will be managed

6. The Researchers will make every effort to support the participant
should they become distressed however if the participant becomes

so distressed that their safety is at risk the ‘Safe Working Practices
and Risk Assessment’ Protocol will supersede the Distress Protocol.


Appendix 31

Safe Working Practices and Risk Management Protocol


The INSPiRe Programme

Intensive Suicide Prevention

Therapy in Prison

Safe Working Practices and Risk

Management Protocol



1. Introduction 3
1.1 Foreword 3
1.2 Study Roles 3
2. Study Procedures and Safety Considerations 4
2.1 Screening and Baseline Period 4
2.2 Intervention Period 4
3. Staff Safety Procedures 4-5
3.1 Participant Factors 4
3.2 Environmental Factors 5
3.3 Specific Safety Procedures 5
4. Indications of Intent to Harm Self or Others 6-7
4.1 Disclosures of Harm to Self or Others 6-7



1. List Of Useful Study Contacts 9
2. Risk Assessment: History Checklist And Prompts 10-12
3. Child Protection Service Contact Details 13
4. Flowchart Of Actions For Participants With Identified Imminent

Suicidal Intent

5. Procedures for Serious Adverse Events



6. Supportive Resources For Participants 16
7. Disclosure Of Risk During A Session 17-18
8. Safe Working Practices – Declaration 19



1.1) Foreword

This document outlines the Safe Working Practices for The INSPiRE Programme:

Intensive Suicide Prevention Therapy in Prison

It describes the general procedures and specific safe working practices.

Throughout The INSPiRE Programme, the Safe Working guidelines will be reviewed regularly

and will also incorporate any necessary changes to procedure, which may become apparent

during the general running of the study

All Safe Working guidelines will work alongside HMP Risley Prison Safe working protocols and

safe practice guidelines. Prison mandatory training must be completed by all study staff and must

be adhered to at all times.

The procedures outlined here have been modified from previous trials, as prior referenced. Such

guidelines were developed from existing Safe Working guidelines from the Department of

Clinical Psychology, University of Manchester and from the Mental Health Trusts of

Manchester; Bolton, Salford and Trafford; Pennine Care and Lancashire Care NHS Foundation

Trust Lone Working Policy and the Lone Worker Procedure for the Lancashire Early

Intervention Service.

1.2) Study Roles

Dr Dan Pratt Clinical Supervisor

Chief Investigator

Dr Charlotte Lennox Supervisor

Ms Yvonne Awenat Supervisor

Lauren Hampson Researcher

Jessica Killilea Researcher

Prison Staff

Wing Staff


Safer Custody Manager

Healthcare Staff

For appropriate contact details, see Appendix 1.


2.1) Screening and Baseline Assessment
1. The Researcher contacts the Safer Custody Manager prior to recruitment.
2. A Risk Assessment Checklist (See Appendix 2) is completed prior to initial contact with

each participant.

3. All risk information must be recorded and placed into the participant file.
4. The Researcher should contact prison staff prior to each contact with the individual

participant, for an update on any current risk concerns.

5. Safety procedures are followed for each contact with the participant.
6. All Lone Worker Practices and Prison Protocols are adhered to.

2.2) Intervention Period
1. All risk information from baseline assessment is passed on to the Researcher delivering the


2. The Researcher should contact prison staff prior to each contact with the individual
participant, for an update on any current risk concerns.

3. All Lone Working Practices and Prison Protocols are adhered to.
4. Any new risk information should be discussed within Clinical Supervision and responded to

accordingly, in the interests of safety.


5. At the earliest opportunity, all new risk pertinent information should be communicated to
prison staff, in the interests of risk and protecting a person’s safety.


Prior to recruitment, Researchers should complete a Risk Assessment Checklist to identify any

current concerns (Appendix 2). Researchers must do this by liaison with the Prison Staff. Risk must

be considered thereon prior to every session, by liaison with Prison Staff. If there are any doubts

about personal safety then the session must be rearranged and the case discussed in supervision.

3.1) Participant Factors

 Information concerning historical/current violent or aggressive behaviour must be recorded.

 Prison Staff should be asked about the participant’s current mental state, their current level of
distress and any known risk factors or potential problems. They should also be asked whether it is

safe for the participant to be visited by a lone female.

 If there are any concerns about visiting the participant, their participation in the The INSPiRE
Programme must be considered by the study team and within supervision.

 All parties in contact with the participant must be informed of any identified risk factors that

might place someone visiting the participant in danger.

 If the Researcher feels uncomfortable or unsafe for any reason, they should make their apologies

and leave. They should not be under pressure to carry on.

3.2) Environmental Factors

 Sessions will take place within the prison, either in Healthcare or on the Prison Wings. The
Prison Staff in that area should be informed of who the Researchers are seeing and the expected

duration of the session, so that they can be mindful of their safety.

 Other factors of risk within the environment, such as other prisoners, prison movement hours,
periods of lockdown should be considered.

 Each Researcher should be aware of what security systems are in place for the area that they are
in and how to use them.

 The Researchers should be aware of how to summon help as quickly as possible i.e. use of a
panic alarm, if there is anyone in a room nearby who can be called upon for assistance.

 Researchers should avoid carrying out sessions on Friday afternoons, to allow for adequate time
to respond to risk, if required.

3.3) Specific Safety Procedures
The following Safety Procedures must be adhered to for all lone visits.

(1) Name of the person being seen and their prison location (i.e. wing).
(2) Names of researchers who will be making the visit.
(3) Time and location of appointment.

On the day of sessions, both Researchers should meet prior to participant contact. Both Researchers

should know the three details as above, and the expected time to reconvene in a staff area of the

prison. Whilst sessions are in place, staff in the close vicinity should be made aware of the

researcher’s presence and the intended duration of the session. Researchers must be away of the local

safety protocols and the best way to signal for help if required. Researchers can terminate a session at

any time if required, in the interests of safety, for both themselves and the participant.


During a session a participant may indicate intent to harm themselves or others. Alternatively they

may provide information to the effect that a child or other vulnerable person may be in danger. Any

information of this nature must be acted upon.

At the beginning of each session the participant should be informed that what is discussed

during the session is confidential. However, the participant should also be made aware that


confidentiality cannot be guaranteed if they indicate any current intention to harm themselves

or others, or if they provide information to the effect that a child or other vulnerable person

may be in danger. In such situations the staff member has a legal duty to break confidentiality.

Other incidents in which confidentiality can be broken include:

i) Behaviour that is against prison rules and can be adjudicated against
j) Undisclosed illegal acts
k) Information that raises concerns about terrorism, radicalisations, or security issues.

The Researchers will discuss any risk issues they have encountered during supervision. There will be

a set agenda item for this at each supervision session. If the Researchers are in any doubt as to

whether to raise a risk issue they will follow best practice guidelines and raise it.

If the Researchers have any concerns regarding a child’s welfare they will contact the child

protection team (Appendix 3) and inform the Chief Investigator.

4.1) Disclosure of Harm to Self or Others

In the case that the individual indicates current intention to harm themselves or others the action taken

is to remind the participant of the staff member’s Duty of Care to break confidentiality where risk is

identified (as previously outlined at the commencement of the session) and contact the appropriate

member of staff within the prison to verbally report the situation. This must be documented in both

the Study Participant File and within the Prison’s Clinical Records System (SystemOne) as soon as

possible but always before the staff member leaves for the day.

The following is an agreed standard format:

“During the course of a study session on (date & time) (specify as appropriate) XX (participant’s full

name) disclosed information indicating risk of harm to him/herself / and / or others (specify as

appropriate). This has been verbally reported to XX (Prison staff full name)”

In situations where the researcher is uncertain of whether information disclosed by a participant

constitutes a risk, contact should be made with Dr Daniel Pratt (Clinical Supervisor) by phone or

during supervision the same day, for advice on the appropriate action. If it is not possible to make

contact with Dr Daniel Pratt, the situation should be reported to the appropriate member of prison

staff (as above) and recorded similarly.

It is advisable for Researchers to record details of the situation within study specific records for

evaluation, training and supervision purposes. Identifying and managing disclosure of risk should

always feature within supervision sessions.

Research staff should not carry out full Risk Assessments and must ensure prison staff understand that

a formal Risk Assessment has not been done as this is their responsibility. The specific details of any

risk disclosed will determine decisions of whether to stop the session at that point or continue to the

natural conclusion of the session. Generally this will be influenced by the participant’s demeanour

and level of distress and / or the researcher’s level of perceived threat in situations where there is a

risk of harm to others.

In a situation where a participant expresses intent to harm the researcher, or if the researcher feels that

their personal safety is threatened, they must signal for support from prison staff and remove

themselves to a place of safety. Incidents such as this must be discussed with the Chief Investigator,

and during Clinical Supervision. The individual’s participation must be reviewed and may be

terminated, if it considered that the researcher’s safety will continue to be compromised.

In a situation where a participant begins to engage in self-harm behaviour, or express immediate

suicidal intent, during a session (e.g. ligaturing, cutting, taking medications etc.) the researcher should

immediately signal for support from Prison Staff, commence first-aid or resuscitative interventions if

necessary and not leave the participant until prison staff have taken over (Appendix 4). Such

situations should be reported to Dr Daniel Pratt (Clinical Supervisor) at the earliest opportunity.

Document recordings should be made in line with HMPPS and NHS Trust policies, (i.e. DATIX,

Serious Adverse Events) (Appendix 5). Additional reports may need to be completed if it is

determined to be a Serious Incident Requiring Investigation (SIRI). For such incidents research staff

should participate in Trust procedures including Debriefing sessions and other staff support


mechanisms. Relevant supportive contact details can be provided to individuals during the study

(Appendix 6).

The Researchers should ensure they record all information and actions taken, including telephone

calls and discussions with the project lead/clinical supervisor, in the participant’s study file.

Researchers must follow this Protocol at all times (see Appendix 8).

NB. Appendices for the Safe Working Practices and Risk Management Protocol have not been

included in this thesis due to the large scale of the document.

Please see APPENDIX 7 for further guidelines and examples of managing

disclosure of risk during an interview with a patient in a prison setting.



3. Paper III: Critical Review Paper


Appendix 32

EPHPP Dictionary


Quality Assessment Tool


Quantitative Studies


The purpose of this dictionary is to describe items in the tool thereby

assisting raters to score study quality. Due to under-reporting or lack

of clarity in the primary study, raters will need to make judgements

about the extent that bias may be present. When making judgements about each component, raters should form

their opinion based upon information contained in the study rather than making inferences about what the

authors intended. Mixed methods studies can be quality assessed using this tool with the quantitative
component of the study.


(Q1) Participants are more likely to be representative of the target population if they are randomly
selected from a comprehensive list of individuals in the target population (score very likely). They may

not be representative if they are referred from a source (e.g. clinic) in a systematic manner (score

somewhat likely) or self-referred (score not likely).

(Q2) Refers to the % of subjects in the control and intervention groups that agreed to participate in the
study before they were assigned to intervention or control groups.

In this section, raters assess the likelihood of bias due to the allocation process in an experimental

study. For observational studies, raters assess the extent that assessments of exposure and outcome are

likely to be independent. Generally, the type of design is a good indicator of the extent of bias. In
stronger designs, an equivalent control group is present and the allocation process is such that the

investigators are unable to predict the sequence.

Randomized Controlled Trial (RCT)

An experimental design where investigators randomly allocate eligible people to an intervention or

control group. A rater should describe a study as an RCT if the randomization sequence allows each

study participant to have the same chance of receiving each intervention and the investigators could

not predict which intervention was next. If the investigators do not describe the allocation process and

only use the words ‘random’ or ‘randomly’, the study is described as a controlled clinical trial.

See below for more details.

Was the study described as randomized?

Score YES, if the authors used words such as random allocation, randomly assigned, and random


Score NO, if no mention of randomization is made.

Was the method of randomization described?

Score YES, if the authors describe any method used to generate a random allocation sequence.

Score NO, if the authors do not describe the allocation method or describe methods of allocation

such as alternation, case record numbers, dates of birth, day of the week, and any allocation

procedure that is entirely transparent before assignment, such as an open list of random numbers of


If NO is scored, then the study is a controlled clinical trial.

Was the method appropriate?

Score YES, if the randomization sequence allowed each study participant to have the same chance of

receiving each intervention and the investigators could not predict which intervention was next.

Examples of appropriate approaches include assignment of subjects by a central office unaware of

subject characteristics, or sequentially numbered, sealed, opaque envelopes.

Score NO, if the randomization sequence is open to the individuals responsible for recruiting and

allocating participants or providing the intervention, since those individuals can influence the

allocation process, either knowingly or unknowingly.


If NO is scored, then the study is a controlled clinical trial.

Controlled Clinical Trial (CCT)

An experimental study design where the method of allocating study subjects to intervention or control

groups is open to individuals responsible for recruiting subjects or providing the intervention. The

method of allocation is transparent before assignment, e.g. an open list of random numbers or

allocation by date of birth, etc.

Cohort analytic (two group pre and post)

An observational study design where groups are assembled according to whether or not exposure to the

intervention has occurred. Exposure to the intervention is not under the control of the investigators.

Study groups might be nonequivalent or not comparable on some feature that affects outcome.

Case control study

A retrospective study design where the investigators gather ‘cases’ of people who already have the

outcome of interest and ‘controls’ who do not. Both groups are then questioned or their records

examined about whether they received the intervention exposure of interest.

Cohort (one group pre + post (before and after)

The same group is pretested, given an intervention, and tested immediately after the intervention. The

intervention group, by means of the pretest, act as their own control group.

Interrupted time series

A study that uses observations at multiple time points before and after an intervention (the

‘interruption’). The design attempts to detect whether the intervention has had an effect significantly

greater than any underlying trend over time. Exclusion: Studies that do not have a clearly defined

point in time when the intervention occurred and at least three data points before and three after the


One time surveys or interviews


By definition, a confounder is a variable that is associated with the intervention or exposure and

causally related to the outcome of interest. Even in a robust study design, groups may not be balanced
with respect to important variables prior to the intervention. The authors should indicate if

confounders were controlled in the design (by stratification or matching) or in the analysis. If the

allocation to intervention and control groups is randomized, the authors must report that the groups

were balanced at baseline with respect to confounders (either in the text or a table).


(Q1) Assessors should be described as blinded to which participants were in the control and

intervention groups. The purpose of blinding the outcome assessors (who might also be the care

providers) is to protect against detection bias.

(Q2) Study participants should not be aware of (i.e. blinded to) the research question. The purpose of

blinding the participants is to protect against reporting bias.


Tools for primary outcome measures must be described as reliable and valid. If ‘face’ validity or

‘content’ validity has been demonstrated, this is acceptable. Some sources from which data may be

collected are described below:

Self reported data includes data that is collected from participants in the study (e.g. completing a

questionnaire, survey, answering questions during an interview, etc.).

Assessment/Screening includes objective data that is retrieved by the researchers. (e.g. observations by

Medical Records/Vital Statistics refers to the types of formal records used for the extraction of the



Reliability and validity can be reported in the study or in a separate study. For example, some

standard assessment tools have known reliability and validity.


Score YES if the authors describe BOTH the numbers and reasons for withdrawals and drop-outs.
Score NO if either the numbers or reasons for withdrawals and drop-outs are not reported.
Score NOT APPLICABLE if the study was a one-time interview or survey where there was not
follow-up data reported.
The percentage of participants completing the study refers to the % of subjects remaining in the study

at the final data collection period in all groups (i.e. control and intervention groups).


The number of participants receiving the intended intervention should be noted (consider both

frequency and intensity). For example, the authors may have reported that at least 80 percent of the

participants received the complete intervention. The authors should describe a method of measuring if

the intervention was provided to all participants the same way. As well, the authors should indicate if

subjects received an unintended intervention that may have influenced the outcomes. For example, co-

intervention occurs when the study group receives an additional intervention (other than that intended).

In this case, it is possible that the effect of the intervention may be overestimated. Contamination

refers to situations where the control group accidentally receives the study intervention. This could

result in an under-estimation of the impact of the intervention.


Was the quantitative analysis appropriate to the research question being asked?

An intention-to-treat analysis is one in which all the participants in a trial are analyzed according to the

intervention to which they were allocated, whether they received it or not. Intention-to-treat analyses

are favoured in assessments of effectiveness as they mirror the noncompliance and treatment changes

that are likely to occur when the intervention is used in practice, and because of the risk of attrition

bias when participants are excluded from the analysis.

Component Ratings of Study:

For each of the six components A – F, use the following descriptions as a roadmap.


Good: The selected individuals are very likely to be representative of the target population (Q1 is 1)
and there is greater than 80% participation (Q2 is 1).
Fair: The selected individuals are at least somewhat likely to be representative of the target
population (Q1 is 1 or 2); and there is 60 – 79% participation (Q2 is 2). ‘Moderate’ may also be
assigned if Q1 is 1 or 2 and Q2 is 5 (can’t tell).

Poor: The selected individuals are not likely to be representative of the target population (Q1 is 3);
or there is less than

60% participation (Q2 is 3) or selection is not described (Q1 is 4); and the level of participation is not
described (Q2 is 5).

Good: will be assigned to those articles that described RCTs and CCTs.
Fair: will be assigned to those that described a cohort analytic study, a case control study, a cohort
design, or an interrupted time series.

Weak: will be assigned to those that used any other method or did not state the method used.


Good: will be assigned to those articles that controlled for at least 80% of relevant confounders (Q1
is 2); or (Q2 is 1).


Fair: will be given to those studies that controlled for 60 – 79% of relevant confounders (Q1 is 1)
and (Q2 is 2).
Poor: will be assigned when less than 60% of relevant confounders were controlled (Q1 is 1) and
(Q2 is 3) or control of confounders was not described (Q1 is 3) and (Q2 is 4).


Good: The outcome assessor is not aware of the intervention status of participants (Q1 is 2); and the
study participants are not aware of the research question (Q2 is 2).

Fair: The outcome assessor is not aware of the intervention status of participants (Q1 is 2); or the
study participants are not aware of the research question (Q2 is 2).
Poor: The outcome assessor is aware of the intervention status of participants (Q1 is 1); and the
study participants are aware of the research question (Q2 is 1); or blinding is not described (Q1 is 3
and Q2 is 3).


Good: The data collection tools have been shown to be valid (Q1 is 1); and the data collection tools
have been shown to be reliable (Q2 is 1).

Fair: The data collection tools have been shown to be valid (Q1 is 1); and the data collection tools
have not been shown to be reliable (Q2 is 2) or reliability is not described (Q2 is 3).
Poor: The data collection tools have not been shown to be valid (Q1 is 2) or both reliability and
validity are not described (Q1 is 3 and Q2 is 3).


Good: will be assigned when the follow-up rate is 80% or greater (Q1 is 1 and Q2 is 1).
Fair: will be assigned when the follow-up rate is 60 – 79% (Q2 is 2) OR Q1 is 4 or Q2 is 5.
Poor: will be assigned when a follow-up rate is less than 60% (Q2 is 3) or if the withdrawals and
drop-outs were not described (Q1 is No or Q2 is 4).

Not Applicable: if Q1 is 4 or Q2 is 5.


Appendix 33

InSPire Appointment Slips


HMP Risley

The InSPire Programme

Prison Number …………………. Name ……………………………………

Location …………………….

On (Day) ……………………………. Date ………………………………. Time


Please speak to wing staff if you are unable to attend.

Reasons as to why you cannot attend your appointment


HMP Risley

The InSPire Programme

Prison Number …………………. Name ……………………………………

Location …………………….

On (Day) ……………………………. Date ………………………………. Time


Please speak to wing staff if you are unable to attend.

Reasons as to why you cannot attend your appointment


HMP Risley

The InSPire Programme

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Reasons as to why you cannot attend your appointment


An Engagement Intervention for Young
Adults with Serious Mental Health Conditions

Michelle R. Munson, PhD
Andrea Cole, MSW
James Jaccard, PhD
Derrick Kranke, PhD
Kathleen Farkas, PhD
Fred J. Frese III PhD


Young adults with serious mental health conditions (SMHCs) often do not engage continuously
with mental health services, and there are few engagement interventions designed for them. This
qualitative study presents a blueprint for conceptualizing and developing an engagement
intervention designed for young adults with SMHCs. The blueprint includes the following
activities: (1) establishing a strong theoretical basis, (2) designing an initial manual based on
previous research and practice, (3) systematically examining feedback on the manual from
stakeholders, and (4) examining the feasibility, acceptability, and implementation demands of the
intervention. Interviews, group discussions, and journaling were utilized to collect information
from young adult participant-researchers, intervention facilitators (i.e., recovery role models and
clinicians), and additional stakeholders (e.g., clinic staff and administrators) (N=43). Analyses
were performed with multiple coders using constant comparative methods. Results revealed critical
information to improve the intervention, while also suggesting that the engagement intervention for
young adults with SMHCs has promise.

Address correspondence to Michelle R. Munson, PhD, New York University Silver School of Social Work, 1 Washington
Square North, New York, NY 10003, USA. Email: [email protected]
Andrea Cole, MSW, New York University Silver School of Social Work, New York, NY, USA.
James Jaccard, PhD, New York University Silver School of Social Work, New York, NY, USA.
Derrick Kranke, PhD, Veterans Administration, Veterans Emergency Management Evaluation Center (VEMEC), North

Hills, CA, USA.
Kathleen Farkas, PhD, Mandel School of Applied Social Sciences, Case Western Reserve University, Cleveland, OH,

Fred J. Frese III PhD, Department of Psychiatry, Northeast Ohio Universities College of Medicine, Rootstown, OH, USA.

Journal of Behavioral Health Services & Research, 2014. 542–563. c) 2014 National Council for Behavioral Health. DOI

542 The Journal of Behavioral Health Services & Research 43:4 October 2016


Unmet mental health needs among children and young adults (YAs) with serious mental health
conditions (SMHCs), defined as either serious emotional disturbances or serious mental illness, is
an urgent matter; one that experts have deemed a crisis.1 Many young adults, those ages 18 to 30,
with SMHCs drop-out, or at best experience fragmentation, of mental health care during the
transition to adulthood.2 Rates of some mental disorders among young adults are almost two
times that of older age cohorts.3,4 Beyond prevalence, research has documented the
difficulties young adults with SMHC face as they transition to adulthood, such as poor
education outcomes, early parenting, and increased risk of suicidality.5 The majority of the
young adults included in the present study had been, and/or were currently involved with,
public systems of care (i.e., child welfare, juvenile justice, and mental health). These youth
are arguably at heightened risk, as research shows their transition is often complicated by
poverty, trauma, and loss of support.5,6 One reason these young adults have difficulties
transitioning to adulthood is lack of continued engagement in services.7,8 Mental health
treatment is unlikely to be effective if young adults do not receive a full dose or near-full
dose of treatment. In sum, research reveals young adults have elevated rates of SMHCs and
they do not consistently engage in treatment.

To address this situation, the current project conceptualized, developed, refined, and tested the
feasibility and acceptability of a new and innovative engagement intervention designed with and
for young adults with SMHCs. The intervention, Just Do You, is designed to improve engagement
in mental health services among young adults through explicit acknowledgement that they are now
the “drivers”8,9 of their mental health decisions. The intervention aims to orient young adults with
SMHCs to the mental health clinics where they are initiating care, while educating and supporting
them in addressing empirically based barriers to help-seeking.8 Unlike most engagement strategies,
which focus on extending child-systems’ provision of services, Just Do You utilizes the adult
mental health system as a leverage point for engagement of young adults. This study articulates a
blueprint for the early stages of intervention development, when theory is first being translated into
substantive application in real-world settings.

The project used elements of a “participatory action” framework10, learning side-by-side with
young adult participant-researchers to understand intervention materials. Specifically, the project
team examined what works and what does not work, while building a clearer understanding of the
protocols and assessments needed to refine and solidify the intervention. The first step was to
outline relatively novel theoretical frameworks used to formulate an initial draft of the intervention,
including communication theory, relational-cultural theory, and narrative theory, among others.
Then steps were taken to affirm, refine, and modify the intervention to reflect the perspectives of
young adults with SMHC and key stakeholders from the types of organizations where the
intervention ultimately will be implemented.

Theoretical underpinnings of the intervention

Systematic design of interventions to change behavior: What needs to change?

In the field of mental health services, there has been a dearth of theoretical scholarship on the
phenomenon of disengagement of youth transitioning to adulthood with SMHCs. This is
unfortunate as the problem of disengagement in services during the transition is common due to
the coming together of systemic, relational, and developmental transitions.8 It is also an important
phenomenon to understand as decisions during this time can impact the mental health of young
adults for years. Just Do You is distinct because the development of the curriculum has been
theoretically and empirically based. Furthermore, it was constructed with feedback at every step

Intervention for Young Adults with Mental Health Conditions MUNSON et al. 543

from young adults, professionals, advocates, and policy makers, all bringing their insights to bear
on strategies they believe are best to impact behavior change and positive outcomes.

A theoretical framework of determinants of mental health decision making

Prior to the development of Just Do You, a study was conducted on mental health service
experiences during the transition to adulthood among young adults (N=60), ages 18 to 25, all of
whom were struggling with mood and emotional difficulties and had a history of both mental
health and social service use during childhood.8 A major outcome of this effort was a mid-level
theoretical framework for mental health decision-making among youth (see Fig. 1).11 This
framework provides a starting point for identifying the determinants of mental health service use
among youth with SMHCs, while providing a framework for conceptualizing and testing

The model draws upon theories of decision making, operant learning, and prior theories of
mental health service use. It is described in detail elsewhere.11 As Figure 1 indicates, context
matters (see boxes A and B), especially those surrounding critical social relationships and
community resources and influencers. These contexts shape the ways in which young adults think
and feel about engaging with the mental health system (boxes C–G). The study identified five
classes of cognitions/affective reactions that are particularly relevant: (1) behavioral beliefs about
engaging the system (i.e., perceived advantages and disadvantages of service use), (2) social norms
associated with engaging the system (e.g., perceptions of important others approval/disapproval of
using mental health services), (3) image management considerations (e.g., the image one thinks
one will convey to others if they use services; stigma), (4) emotions one feels when thinking about
engaging the system, and (5) efficacy, or one’s perceived ability to use services. Not all of these
factors will be relevant for all populations; rather, the relative importance of these factors in
shaping decisions to engage the system will differ depending on the population, behavior, or
context. This, in turn, impacts the factors one addresses in one’s intervention.

These five classes of variables combine in complex ways to determine an individual’s decision
or intention to engage the mental health system (box H). However, making the decision to engage
the system is not enough. Individuals must translate those decisions into behavior. Figure 1 also
identifies factors that facilitate or create barriers to an intention becoming a behavior (boxes I to L).

Figure 1
Determinants of mental health decision making

Determinants of Mental Health Decision-Making

A. Community

B. Social

C. Behavioral Beliefs

D. Social/Normative

E. Image/Impression

F. Emotion

G. Self-Efficacy

Intention to



Service Use

Contextual Factors
A. – B.

Individual Factors
MediatingC. – H.


K. Behavioral Cues
L. Habitual

J. EnvironmentalI. Knowledge

I. – L.

544 The Journal of Behavioral Health Services & Research 43:4 October 2016

Specifically, the individual must have the knowledge and skills necessary to perform the behavior,
there must be no or minimal environmental constraints that prevent the individual from performing
the behavior, the behavior must be salient to the individual, and habitual and automatic
processes cannot interfere with behavioral performance. Also, an intention to act may not
translate into behavior because youth change their mind (e.g., based on new information) and
decide not to get care after all. Decision analysis for this segment underscores the importance
of recognizing that the focus of an intervention often needs to be helping youth carry out
their (positive) intentions rather than convincing them to perform a behavior. Facets of this
model informed Just Do You sessions, focusing on empirically based factors that emerged as
relevant to mental health service use.

Theories to impact determinants of decisions/behavior: how to make change happen

It is not enough to suggest what variables to address to increase service engagement; research
also needs to provide guidance on how to change such factors. The Just Do You intervention relied
on two classes of theories for such purposes, communication and clinical theories.

Communication theory and service engagement program design

Most mental health service engagement programs for youth involve communication of some
form in which the program educates youth about services and how to effectively interact with the
system. Despite this, few intervention efforts have drawn upon formal communication theory when
designing their programs.12 Classic theories of top-down communication distinguish five key facets
of communication that may impact the effectiveness of an engagement intervention: (1) the source
of the communication, (2) the content and structure of the communication (the message), (3) the
medium or channel through which the message is transmitted (e.g., face-to-face, over the web), (4)
unique characteristics of the recipients, and (5) the context in which the communication occurs.13

Each of these facets has subcomponents. For example, sources may differ in their age, gender, and
perceived trustworthiness. Recipients of communications differ in their age, gender, motivation,
and expectations. The surrounding environment varies in terms of its temporal, social, and cultural
features. Variations in these factors represent key independent variables that can affect
communication effectiveness. While there is not yet a compelling body of literature in the domain
of young adult mental health that will help inform program decisions about these communication
factors, Just Do You addresses each of them.

Clinical theories undergirding the young adult engagement intervention

Just Do You draws upon social-cognitive, relational cultural, empowerment, and narrative
theories. Of note, many of these theories are in line with “The Pathways to Positive Futures

Social Cognitive Theory Social cognitive theory14,15 assumes that “most human behavior is learned
observationally through modeling (p. 22).14 Observational learning happens through a four-step
process: (1) individuals must attend to, and perceive accurately, the modeled behavior; (2)
individuals must retain, or remember modeled behavior; (3) the symbolic representations are
engaged, reproduced, and used to influence behavior; and (4) individuals must be motivated to
reproduce the behavior.14,15 Social cognitive theory lays a foundation for understanding how role
models influence health behaviors through vicarious learning16,17 A novel component of Just Do
You is that it builds on social cognitive theory14,15 and youth mentoring18 through the inclusion of
role models, as sources of communication, in two distinct ways as follows: (1) inclusion of a

Intervention for Young Adults with Mental Health Conditions MUNSON et al. 545

recovery role model as a co-facilitator and (2) introducing young adults to role models through the
use of narrative mental health communication (see below).

Recovery role models (RRM) who co-facilitate Just Do You are typically a decade or more older than
participants, have been in recovery for at least 3 years, and have achieved success in at least one “mental
health in action outcome” (e.g., school and work). Also, they must be actively engaged in mental health
services, as needed, and be willing and able to speak about key mediating determinants of service use,
such as stigma, and developing trust in providers. Aworking premise of Just Do You is that role models’
voices (as a source) will be attended to closely and heard as particularly credible and trustworthy. In a
previous study, young adults reported that they would like to hear from others who have been through
similar experiences as the ones that they have been through.19 Recovery role models are conceptualized
as a type of peer in that they also live with a SMHC. However, there is an important distinction between
recovery role models and peers, namely they focus on modeling aspects of living independently as an
adult with a SMHC and educating by sharing lessons on structured topics (i.e., moving toward
acceptance) important to their recovery. The intervention also builds on the field of mentoring in that
recovery role models are screened for a set of knowledge, skills, and experiences, including the ability to
model healthy relationships and factors needed to achieve independence in adulthood. Recovery role
models are trained to provide guidance on managing recovery while modeling life with a SMHC. Some
peer support specialists meet the criteria to become a recovery role model; others do not.

Just Do You also exposes young adults to individuals whose courageous narratives can be heard
through web videos (e.g., Mary J. Blige20), books (e.g., An Unquiet Mind21) and articles that
discuss recovery narratives or provide examples of professionals who have been diagnosed with a
SMHC.22 This is further elaborated upon in the below on narrative theory. Both types of modeling
have promise as a complementary strategy to traditional peer support. Recovery role models deal,
in part, with challenges that can surface in peer support, particularly with youth and young adults
(e.g., high turnover, boundary issues, less rigorous screening and training). The use of recovery
role models fits with a transforming mental health system, which has increased its focus on the use
of a nonclinical workforce and outcome-based reimbursement. Recovery role models can be cost-
effective colleagues in the mental health system.

Relational Cultural Theory Relational cultural theory (R-CT) suggests that the development of a
mature self requires connection to others, as opposed to autonomy and differentiation. In R-CT, the
central focus is growth through and toward relationships.23 R-CT suggests that mutual attachments
are essential to psychological well-being throughout the life cycle, suggesting that “adolescents do
not need to detach from parents or supports, rather they need to change the dynamics of support
relationships to promote healthy development” (p. 53).24 Recently, R-CT has been applied with
young girls living in institutions where Sparks (2004) found that provider authenticity was essential
to gain the girls’ trust, as “they viewed all relationships (except those with a few close friends) as
emotionally and/or physically dangerous” (p. 241).25 Taking into account the recipients (or
audience) of Just Do You, in this case youth who may be lacking in trust of providers, the model
draws upon the principles of R-CT, including the need for clinicians to be authentic and respectful
to young adults in order to create an environment where the relationship between the
interventionists and the clients is viewed as central to psychotherapeutic effects. Facilitators are
trained on the importance of relational qualities in facilitating group. Co-facilitators stay closely
attuned to relational dynamics, as one of the main goals is to improve the “connection” that young
adults have to the clinic and their providers. Thus, the more youth trust and “connect” with the
engagement facilitators, the more that may occur more broadly with clinic providers.

Empowerment Empowerment, conceptualized as “a process of increasing personal, interpersonal,
or political power so that individuals can take action to improve their life,” (p. 149)26 focuses on

546 The Journal of Behavioral Health Services & Research 43:4 October 2016

increasing self-efficacy, reducing self-blame, and helping people assume personal responsibility for
creating change in their lives.26 Just Do You draws on empowerment theory to encourage youth to
feel confident in becoming the “drivers” in their mental health decisions.9 In developing Just Do
You, researchers took into account that the recipients of Just Do You may feel like “the other” for
having been diagnosed with a SMHC, and thus, may be especially lacking in power and confidence
to change their situation.26 For this reason, Just Do You acknowledges racism, classism,
homophobia, and the injustices that often accompany living with a SMHC. Through the
inclusion of the role model, a focus on hope and providing clients with advocacy knowledge
and skills, Just Do You seeks to empower young adults.

Narrative Narrative therapy proposes that through the telling of stories, one ascribes meaning to
their experiences, and through interaction with others in sharing the stories, those others become
participants in the shaping of meaning.27 Just Do You utilizes these strategies as a channel through
which to communicate, both through the use of creative arts to share individual narratives of those
in the group, coupled with the use of narratives brought into the group of others’ stories of living
well with SMHC. Research has found that being exposed to individuals’ narratives can both
decrease resistance and increase hope.28,29,30 As young adults tell their own stories and hear stories
from recovery role models, there may be a normalizing effect as they realize their stories are similar
to others who are doing well in their recovery.

The use of narratives is designed to help young adults reframe the meanings they ascribe to the
challenges of living with a SMHC. In the modules, young adults listen to the narratives of the
recovery role model who is there in person, (the channel is face-to-face) and public figures who
have spoken/written publicly (the channel is video, book, or article) about their mental health
challenges.20,22 In order to make Just Do You as relevant and compelling as possible to this age
group, it includes art-related activities, providing youth with art kits and allowing time during the
sessions for them to express their stories creatively through drawing and writing. There is also time
to share narratives. Such tailored approaches, which were suggested in previous research, may help
to capture and maintain young adult’s attention, potentially more than the standard manualized
versions of psychoeducation content lessons.19 In addition to normalizing, these techniques hold
youth’s attention so as to make an impact on cognitive, social, and affective processes that
influence intentions and behaviors.

ADAPT Finally, the Just Do You program uses the ADAPT model to address the need for flexibility
in group sessions while also assuring fidelity to the model. ADAPT is based on Yalom’s core
principles of group work,31 but also trains facilitators to use the acronym ADAPT as a reminder of
the five components of each module: (1) An introduction of purpose and content, (2) Discussion,
(3) Activity, (4) Process of activity, and (5) Take-home points.

The feasibility research described here had eight key components: (1) exploring the viability
and utility of the intervention in a participatory action framework with young adults who ultimately
will use the program as well as key stakeholders who administer the program in clinic contexts; (2)
using the theoretical frameworks described above to guide exploration of participant reactions to
the initial manual in the context of face-to-face interviews; (3) based on interviews, revising the
manual to better reflect the perspectives of participants; (4) recruiting participants to formally
participate in the intervention and provide feedback on sessions; (5) conducting post-session
meetings with participants for feedback on each session; (6) asking facilitators to write in a journal
their feedback on each intervention session; (7) conducting postintervention interviews on the
acceptability and implementation of the intervention program within the practice setting; and (8)
making revisions in the manual as well as intervention to reflect the prior steps. The remainder of
this article elaborates and illustrates features of this blueprint.

Intervention for Young Adults with Mental Health Conditions MUNSON et al. 547

The present study

Intervention Just Do You is a theory-driven, empirically based intervention, directly informed by
young adults and the professionals who have worked with them in mental health settings. The
intervention is innovative in that it was designed to improve young adult mental health treatment
engagement through the enhancement of acceptance, hope, literacy, and efficacy, as well as the
decrease of negative attitudes, mistrust, and negative emotion towards mental health care. It
provides young adults with an opportunity to learn about mental health and ways that services can
help combat symptoms and enhance functioning. The intervention is based on positive identity
development and formation through the modeling of a positive orientation toward mental health
care as part of recovery.

Setting and purpose Just Do You was piloted in three urban mental health settings in the United
States. The purpose was (1) to describe the conceptualization and refinements to the intervention
using data obtained from stakeholder interviews as well as feedback obtained from young adult
participants, and (2) examine the feasibility, acceptability, and implementation outcomes of a small-
scale, preliminary evaluation of the intervention.


Recruitment and participants

Participants in the pilot study were recruited from three agencies serving young adults with
SMHCs. They included young adults (N=27), recovery role models (N=2), and key stakeholders
(e.g., clinic staff, administrators, and experts in the field) (N=14), totaling 43 participants for the
study. Many participants were interviewed on more than one occasion. Young adults who met the
following inclusion criteria met with the research staff to learn about the study: (1) between the
ages of 18 and 30, (2) diagnosed with a SMHC, and (3) living in the community. Recovery role
models were invited to participate if they met the following inclusion criteria: (1) living with a
mental illness, (2) approximately 10 years older than the participants, (3) in recovery for at least
3 years, and (4) managing their illness with services as needed. Key stakeholders, including clinic
staff, were recruited to participate if they had worked at the agencies for at least 3 months, or were
experts in young adult mental health. Young adults were excluded if they were currently psychotic,
and/or they did not speak English well enough to participate. Sample statistics for the young adult
study participants are in Table 1. An IRB approved all protocols.

Data collection

Data collection strategies included (1) individual interviews with key stakeholders who critiqued
the program manual, (2) post-session feedback meetings, and (3) postintervention face-to-face
individual interviews on acceptability and implementation. The majority of the qualitative
interviews were audio-recorded and transcribed (on some occasions investigators took hand-
written notes). Interviews lasted between 10 min and 1 h. Research staff developed interview
protocols for the following: (1) preintervention interviews about the manual, (2) post session
feedback meetings, and (3) postintervention acceptability study (which included separate questions
for young adults and agency staff; see Table 2 for example questions).

548 The Journal of Behavioral Health Services & Research 43:4 October 2016

Data analysis

For all qualitative analyses, the team utilized a constant comparative approach.32 Two analysts read,
in depth, all transcripts, comparing and contrasting data elements within and between interviews.
Analysts wrote notes and memos on emerging codes, and emerging questions that responses
engendered. Then, analysts met numerous times to discuss memos, ideas, and make a list of meaningful
topics that were important to understanding the intervention program. One analyst took notes and then
merged the perspectives of both analysts, building a set of codes and larger themes that incorporated
both analysts’ points of view. Then, one analyst again read through the transcripts, this time coding
them for empirical data elements that fit a given code or theme. When questions emerged, the analysts
met to discuss them and the coding scheme. This process continued until the analysts agreed they had a
completed codebook that was inclusive of the grouped codes and themes from the interview data.
Themes and illustrative quotes from the interviews constitute the research results.


Preintervention feedback on the manual from stakeholders

Preintervention feedback interviews (N=13) were conducted to learn about perspectives on the
intervention manual. Ten participants were clinicians or administrators, one was a recovery role

Table 1
Sample characteristics (N=24*)

Variables Mean (SD) or Mean (%)

Age 21.5 (2.9)
Sex Female 12 (50%)
Race White/Caucasian


5 (21%)
11 (46%)
2 (8%)
5 (21%)
1 (4%)

Note 1: These are young adults
that reported specific diagnoses.
Note 2: Participants
reported comorbidities

Mood disorder
Schizophrenia spectrum
Psychotic disorder
Disruptive behavioral disorder
Personality disorder
Adjustment Disorder
Cannabis abuse
Don’t know/not sure

5 (21%)
7 (29%)
1 (4%)
1 (4%)
7 (29%)
2 (8%)
1 (4%)
3 (13%)
1 (4%)
1 (1%)
1 (1%)
2 (8%)
3 (13%)

Medication use Psychotropic medication use ever 22 (92%)

*Did not capture baseline data from all young adults who participated, as some became part of the project after
the first session and therefore never completed a baseline interview

Intervention for Young Adults with Mental Health Conditions MUNSON et al. 549

model, one was a young adult, and one was an expert in mental health among youth. The
themes that emerged were (1) manual language, (2) narrative mental health communication,
(3) recovery role model as co-facilitator, (4) focus on young adults, and (5) global
suggested changes. In addition to the quotes in the text, see Table 3 for additional

Table 2
Qualitative interview protocol item examples

Project section Participant/focus Example items

Manual feedback

Young adult
Recovery role
Clinic administrators

1. What are your overall general impressions
of the manual?

2. Do you have any reactions to the idea
of a recovery role model working
alongside a social worker?

3. How do you think the young adults would
react to the narrative mental health
communication (i.e., testimonials)?

process group

Young adult

Developed for each session
1. After the introductory session, what

do you know about this program, Just Do You?
2. What questions do you have—or what

remains unclear—about Just Do You?
3. When a new group begins, it is important

to feel safe. Also, having a chance to
express yourself in a way that you would
like to—and learning a little about other
members and the facilitators can make
it more likely for participants to return.
Did this happen for you?

4. Was anything said—or not
said—during this session that makes
you feel unsure about coming again?

5. What was the main point you’ll
take away from this session?

for “acceptability

Young adults
Recovery role models
Clinic administrators

1. Did attending the “Just Do You” group
impact your overall experience at the
agency would you say? And if so, how?

2. How did your experiences in the “Just
Do You” group impact how you
experienced your other services,
like medication or counseling?

3. And of all the topics, do any of the
topics from the group or the discussions
topics stand out to you or things you did?

550 The Journal of Behavioral Health Services & Research 43:4 October 2016

Table 3
Pre-intervention feedback themes and exemplars

Themes Exemplar quotations

Manual language
Term “mental health struggles”

is nonalienating
“I prefer to use the word ‘struggles’ myself. I even try to avoid

Language is simple,

“And it seems like it is simple enough for counselors and peer
supports that are so busy.”

Language is respectful “I mean the impression I got when I was skimming it you know
was it is respectful. It breaks it down in a respectful way.”

Language is normalizing “You know sort of normalize the idea that life presents everyone
with lots of struggles and challenges, whether it be you know
depression, whether it be financial issues, whether it be
physical, right, but you know overcoming these are certainly

Language is hopeful “I see thus far all of it having potentials for hope and healing.”
The name Just Do You will

resonate with YAs
“They’re gonna resonate with that title…And so I thought that

that was kind of catchy, and some of them are gonna run with
it and others will hopefully be able to internalize it and then
figure out what the definition of it means for them.”

Language is extensive enough
to allow for fidelity

“I think it will make it easier in terms of fidelity, and that’s one
of the things that I know our group facilitators had varying
degrees of experience, and so when using a new model, if it
does need to be…you know if we’re worried about fidelity,
actually giving them scripts is actually a great idea.”

Narrative mental health communication
Videos are relatable (abuse

experiences in particular)
“The only thing about her is that she’s very good. She’s very

grand, but yet her words are really relatable and humbling
and the themes she talks about, abuse, about family neglect,
they’re universal.”

“There’s somebody that actually I can identify with and that
goes through the same sort of issue.”

Videos help combat stigma
(particularly among African-

“I think oftentimes, like in our department, we’re pretty much
all White females, so I think you know seeing an African-
American male who’s talking about mental health and
showing like a vulnerability I think that would really you
know get them interested.”

“I also like that he’s African American, because I think there’s a
significant stigma in the African American community.”

Create motivation and hope “I think you know he embodies the idea of the role model and
someone that these guys can look up to and see that you
know there’s clearly hope.”

Demonstrate goal-setting and

“So I think that setting goals, that he wanted to make sure he
was successful, and he definitely talked about that and I think
that would be good for the kids to hear that.”

“I think even if a person can’t identify, I mean it’s just enough
to give them insight and some more education.”

Intervention for Young Adults with Mental Health Conditions MUNSON et al. 551

Table 3

Themes Exemplar quotations

Illustrate importance of seeking

“He talked about it [help-seeking], and then he even said, ‘you
could go to your dad’, or so who to actually go to. So I did
like that part of it.”

Show value of supportive

“I think that was great. He talks about support systems, ‘cause
we believe it’s one of the biggest issues for our kids…Who
are they? Are they trying to connect with some family while
they’re here so that they can build that once they go out into
the community? And I like the fact he kind of talks about
other adults that you can go to…”

Recovery role model (RRM) as co-facilitator
Provides perspective YAs can

connect with
“I think they would be more receptive to hearing something

from them [RRM] than me and another co-facilitator that’s
just a social worker also.”

Concerns about RRM age “Well my first reaction was a bit too old, but I mean because it’s
just a communications struggle.”

Concern about possible
“personality issues”

“I would wonder what headbutting would go on, especially with
personality types.”

Important to make clear the
role of RRM in session

“And then some also clear boundaries that were drawn from the
beginning in terms of the kids understanding that ‘this
facilitator [RRM] might be personal, but this facilitator
can’t’. So I think it’s gonna have to be very clearly
explained to the clients.”

Appreciation for age of RRM “I think it’d be really beneficial, since you know being only a
decade older, they’re still, like they could probably still feel
they could relate to them, and especially if I’m sure they
would probably have similar experiences, or like at least be
able to relate to them.”

Provides hope “I think some kids say ‘Wow. She did it, so I could do it,’ which
is of course what we would like for them to get from it, and
others say ‘That’s her problem. Not ours.’”

Allows RRM to gain skills “I think it’s a great thing because it will allow [RRMs] to be
more sharp in the work they do. It’ll allow [RRMs] to
facilitate groups in a more structured way, to be more
sufficient in what they do.”

Focus on young adults
Encourages YAs to “buy in” to

“I personally think they would really relate to it [NMHC] and

buy into it more than if it was just me in here, like I said,
doing worksheets or talking with them on the symptoms and
stuff. I think that they would really buy into it.”

Reduces stigma for YAs “I think it’s a good concept [Just Do You] and I think it would
be beneficial for those, especially obviously those who are
very reluctant or maybe haven’t had therapy before and just
have this like stigma about it, it would definitely I think help
them to get them to a point that they either will be
agreeable…to going to a therapist…”

Table 3

552 The Journal of Behavioral Health Services & Research 43:4 October 2016

Table 3

Themes Exemplar quotations

Encourages YAs to advocate
for themselves

“So to introduce, to in a way reintroduce them to an idea that
will address their new status might be more meaningful to
them and help them to see themselves in a different light, that
they are not just passive recipients by virtue of the fact that
they’re a child and we can tell them what to do, but that now
they’re an adult who had choices.”

Focus on hope will resonate
with YAs

“I definitely think the Instilling Hope and Empowerment piece
is what I think that they will react to the strongest because
they have so many strong feelings about being controlled by
the system and not feeling like they having any choices.”

Art therapy will help YAs
express themselves

“I mean I think all the creative arts are ways to help kids to
bring out whatever it is inside them that they want to show,
explain, and so I think that yeah, that would be…It’s one of
the tools.”

Focus intervention more on
practical issues relevant to

“So in terms of I think that the overall goal is absolutely needed
by our kids. My experience with the transition youth is the
mental illness or identity of having a mental illness or mental
health struggles is extremely separate in their mind to being a
transitioning youth. I don’t think they blend the two things
together. I don’t think they think about ‘how is my mental
health gonna impact my ability to transition successfully into

Suggested changes
Add psychoeducation around

mental illness
“I think probably the psychoeducation, just to help them maybe

get more of an understanding or like an insight on their
symptoms and what that really means, ‘cause a lot of time I
think you know they don’t see it as like depression or as that
serious as we probably feel it is. They say ‘Well I’m just lazy
or I’m unmotivated.’”

Steps of CBT are broken down “I do like the idea that you all are introducing basic concepts of
CBT, not as a therapeutic intervention, but breaking down
concepts like in a teacher kind of way.”

Add SAMHSA recovery

“Personally, I love using the SAMHSA’s principles of recovery”
“What I really love, in fact it would be number one on my
principle, is that recovery is a very individualized path. There is
no one route to recovery.”

Add positive scenario to CBT

“So my immediate reaction is I would like to create situations
that put a more positive spin. ‘So you are going out’, instead
of ‘You find out you did not get a job,’…I’d like a scenario,
‘You have an interview today for a job at Target.’”

Add young adult workbook “One of the things, though, that I’m wondering if we could sort
of integrate into the manual is how to make this more
personalized for them in terms of this being a workbook that
is useable.”

Focus more on strengths and “For me personally, I would probably switch the first two

Table 3

Intervention for Young Adults with Mental Health Conditions MUNSON et al. 553

Manual language

Some participants reported liking the use of the term “mental health struggles,” as this language
is not alienating and is easier for youth to connect with, as opposed to mental disorder/mental
illness. Some participants reported that the language was simple and understandable, which is
important since youth will enroll who may have cognitive, reading, and processing challenges.
Other feedback included reports that the language was respectful, normalizing, and hopeful. One
participant reported that the name, Just Do You, should resonate with young adults (it was chosen
because it was a phrase used by young adults in previous research by our team). Participants
reported the language was simple enough for clinicians and recovery role models to learn, and the
script was extensive enough to allow for fidelity.

Narrative mental health communication

Participants provided a number of comments related to the narrative mental health
communication (NMHC) videos featuring Ron Artest, a professional basketball player with a
mood disorder, and Mary J. Blige, a famous singer/hip hop artist with an abuse history and past
battles with mood challenges and suicidality. A number of participants reported that they
believed young adults were able to relate to the narrative content in the videos. In particular,
participants felt that the description of abuse experiences would resonate with many young
adults. They also felt that it was helpful that both Mary and Ron are African-American, as
they modeled mental health treatment use. Such modeling helps combat stigma among
African-American participants. Some participants reported that the NMHC helps with the
following outcomes: (1) creating motivation and hope, (2) demonstrating the importance of
goal-setting and having insight, (3) the importance of seeking help, and (4) showing the
value of supportive family members and others in the recovery process. One participant
stated, “…For him [Ron Artest] to acknowledge his own vulnerabilities and to break down
what he had to do, I think somebody, I think a person can identify and may probably be
motivated probably after watching it.”

Recovery role model as co-facilitator

Participants provided feedback on the inclusion of a recovery role model as a co-facilitator who
provides modeling. Several participants reported that the role model provides an important
perspective that is easier for youth to connect with than the clinician. Two participants reported
concerns about the age of the role model, reporting that s/he may be too old for the clients to relate
to, and one participant reported the concern that the role model’s lack of training may lead to
“personality issues” that could get in the way of the treatment process. Participants also provided

Table 3

Themes Exemplar quotations

recovery sentences by starting with a more positive statement by
saying ‘We want to first acknowledge your strengths’ and
starting out with a more positive comment.”

Table 3

554 The Journal of Behavioral Health Services & Research 43:4 October 2016

feedback that it is important for the co-facilitators to make clear the role of the role model, since
this is a new treatment model.

In contrast to reservations about age, others liked the idea of the role model being a
decade older. One participant pointed out that the recovery role model, not being a peer of
the same age, may bring less “drama” and more clear boundaries between participant and the
role model. One participant also reported that a recovery role model may be a better
exemplar than a peer support specialist because s/he has already met developmental
milestones, such as obtaining and maintaining employment. One staff member said, “so the
idea of having someone who is a generation older, who’s not only figured things out, but
who’s been able to have a job and learn how to navigate, I like that concept.” Participants
reported other positive aspects of the recovery role model, including that s/he may provide
hope to the youth. Perspectives also were shared that the recovery role model position allows
for them to gain skills through working with the clinician. One participant stated with regards
to the role model sharing his/her narrative:

I think that’s definitely a good thing. It’s an absolute good thing…I think it gives the participant a little bit more hope
or much more hope knowing that you know you have people that overcame the struggles that you know a participant
is going through at that time.

Narrative mental health communication in the form of both individuals who have spoken
publicly about their stories and a role model who co-facilitates the group sharing narrative
segments of their recovery story in a structured way is a promising dimension of Just Do You.

Focus on young adults

Participants commented on aspects related to the focus on young adults. Several reported on the
importance of an intervention like Just Do You because there is a need for programming that
encourages youth to “buy in” to mental health treatment, to reduce stigma, and to encourage youth
to advocate for themselves in the treatment process. Others felt that the intervention’s focus on
hope and empowerment would resonate with young adults. A few participants reported that they
felt the inclusion of art therapy will help youth express themselves. In terms of improvements,
some participants suggested that the intervention should focus more clearly on practical issues,
such as housing and obtaining a job.

Suggested changes

There were also suggestions for additions and changes to Just Do You. Several participants felt
that Just Do You should include a psychoeducation component that helps young adults understand
what a mental illness is, what diagnosis they have, and what that diagnosis means. These
participants cited the importance of this beginning step in the treatment process. In contrast,
two participants highlighted that Just Do You clarifies the treatment process and helps young
adults to understand what therapy is. Another participant noted that s/he liked that the
intervention breaks down the steps of CBT and other concepts such as stigma, emotions,
beliefs, knowledge, and efficacy. One participant suggested integrating the SAMHSA
Principles of Recovery and also including additional hopeful messages throughout the
intervention. Other suggestions included adding a more positive scenario to the section on
understanding cognitive behavioral therapy, as opposed to only negative scenarios, including
a workbook the young adults can reference during the sessions and afterwards, increasing the
emphasis on the individual nature of recovery, and focusing more on strengths.

Intervention for Young Adults with Mental Health Conditions MUNSON et al. 555

Conclusion of the stakeholder feedback

The research team responded to this feedback by integrating a number of the suggestions into the
Just Do You manual before piloting the intervention. For example, SAMHSA’s Principles of
Recovery were added and sections related to understanding mental illness and diagnoses were
enhanced. Positive scenarios were added to the description of CBT and a “young adult workbook”
was developed.

Post-session feedback

Post-session feedback was gathered through meetings held immediately after each session with
young adults (N=27a). In addition, facilitators kept journal notes of the group process that they
provided the investigators at the end of the pilot project.

In general, feedback regarding the intervention sessions was positive. Youth reported that they
liked attending a group that was tailored to their age cohort, and facilitators observed that
participants were able to provide support to one another around developmentally relevant issues
such as finding jobs, relationships, and treatment. Young adults reported that the inclusion of a role
model and the narrative mental health communication were relatable and that hearing stories
through narratives helped them to feel less alone and more hopeful. Facilitators suggested that there
be more inclusion of community resources. Facilitators also reported that the ADAPT model
allowed for flexibility, so the group was both guided but could unfold naturally.

There were suggestions for changes as well. Some youth enjoyed the art kits and felt it gave
them an opportunity to express themselves. Facilitators found it effective to allow participants to
write feelings or experiences in narrative form (i.e., poetry and lyrics) if they did not feel
comfortable engaging in art. The reactions to the young adult workbook were mixed; some
participants thought it helped to solidify the points of the group, while other participants interpreted
the workbook to be “paperwork.” With regards to the CBT principles, both young adults and
facilitators commented that participants seemed to understand the concepts well after the two
sessions, but that having back-to-back sessions on CBT was redundant.

Preliminary evaluation of just do you: feasibility, acceptability, and implementation

The team conducted postintervention face-to-face interviews with 14 young adults, 2 role
models, and 8 clinic staff to examine feasibility, acceptability, and implementation. The themes that
emerged were as follows: (1) acceptance of the recovery role model, (2) shifting motivation, (3)
improved attitudes, (4) improved attendance and medication adherence, (5) emotional effects, (6)
social relationships, (7) goal setting, and (8) other outcomes.

Acceptance of the recovery role model

The young adults reported general acceptance of the recovery role model and had a number of
positive responses to his or her inclusion. Some young adults reported feeling that the recovery role
model was relatable and that they believed that the role model had been through many of the same
types of hardships that they had been through. One young adult reported feeling appreciative that
the recovery role model could open up and trust the group members in the way that s/he did.
Another young adult described it as a “relief” to realize that s/he and the recovery role model had
experienced the same “kinds of problems.” A number of youth reported feeling that the recovery
role model was inspiring, was someone to look up to, and was like a mentor. One participant stated
the recovery role model inspired him/her to make something out of his/her hardship and another

556 The Journal of Behavioral Health Services & Research 43:4 October 2016

said, “The recovery role model does not put you down. They put you up.” Some young adult
participants were impacted by the resilience of the recovery role model, explaining:

Look what [RRM] went through and look what ___ is. ____ fought through all that stuff, all that shit that happened
to ___ and ___ made something of it to help other people. …And I look up to [RRM] that way because ___ made
something out of it, and I want to be just like that, and I just can’t get over how amazing [RRM] is. Sometimes I think
they’re not doing this for the money. I think they’re doing it just to help us, and that’s the feeling they give me.

Finally, one young adult talked about how the most “useful” part of the recovery role model was
when the model spoke about outcomes young adults wanted for themselves, such as housing, “The
most useful part was when the recovery role model talked about being in a residence and what that
process was like.”

Clinicians also generally reported high levels of acceptance of the recovery role model and noted
a number of positive aspects of this innovation. One clinician reported that s/he felt that co-
facilitating the group gave the role model an opportunity to be active, to take ownership, and be an
equal participant in leading the group. Another clinician reported that s/he developed a strong
relationship with the recovery role model through the process of co-facilitating the intervention.
Other clinicians felt that the role model was able to learn new skills through mentorship by the
clinician, such as how to maintain appropriate boundaries with clients.

Finally, role models reported on their experiences. They found that by sharing their story, the
young adults felt more comfortable sharing their own stories as well. Recovery role models
believed that they provided hope to the young adults and helped them to feel less alone. One role
model reported hearing young adults state that now they know they have potential, that they are
important. A role model stated that through their experience co-facilitating the group, the recovery
role models also feel less alone, and it helped them form a closer relationship with other staff at the
agency. One recovery role model felt that their role in the group had helped to facilitate some of the
individual work they were engaged in with the young adult participants.

Shifting young adult motivation

Generally, young adults had positive reactions to the group, stating it helped, they were glad they
decided to attend, and the group made them feel like they were “a part of something.” A number of
young adults reported that given the opportunity, they would attend the group again. One young
adult stated the group gave him/her something to look forward to: “Yeah, like ‘cause every single
time I went I wasn’t dragging my feet to get there. I was just, I went with a smile on my face. I was
happy to go…you know I enjoyed it. I like being able to share my poems with other people that
understand it.” This is a valuable outcome, as shifting motivation to attend clinic appointments and
increasing actual attendance at clinic appointments, through the use of creative, young adult-
centered activities, are the main goals of the intervention program.

Improved young adult attitudes

A goal of Just Do You is to improve engagement and attendance in mental health services. In
part, the theory proposes this change occurs through a change in participant cognitions and
attitudes. Participants felt that engaging in Just Do You helped them to get more out of mental
health treatment, “This group helped with the other PTSD group I’m in and dealing with the past.”
Participants also reported increased trust in mental health service providers. For example, a participant
reported that his/her attitude towards services had changed, included feeling more comfortable opening
up to staff and understanding that staff are there to help rather than control or judge. Another participant
shared that while she had had negative experiences with providers in the past, she is learning to “put
those feelings aside and learn to trust a new provider.” When reflecting on the role model, one person

Intervention for Young Adults with Mental Health Conditions MUNSON et al. 557

stated, “S/he made me realize that s/he’s there to actually hear us out, you know. S/he’s not there to
judge us. So that was really, I mean I like feel really comfortable with him/her now.”

Improved attendance and medication adherence

There were also reports by participants of increased attendance at mental health services as well
as increased medication compliance. One participant reported that the group influenced him/her to
be more connected to the mental health agency, “I told my ICM [Intensive Case Manager] here at
[agency] that since I wasn’t working this summer, I would spend more time at [agency].” Some
participants also reported that because of Just Do You, they understood the need for medication
better and would be more likely to see a psychiatrist or counselor for mental health challenges.

It helps me want to take my medication more, because like regardless, I always felt I had to do it for somebody else
and the Just Do You group made me feel like my medicine, I should do it for me, do it for myself. That’s what I got
from it. So it helped me with that.

Another participant stated:

It made me want to take my medication, ‘cause I’m starting to realized the older I get, the more I need it … Like I
would take them, but then I would go days without taking them, and then I would take them, but now I take them
every day. Like I do it every day now at the same time every day.

Emotional effects

Young adults also reported positive emotional effects. Some stated that through the group, they
learned new ways of dealing with emotions, learned to control their anger and stress, and learned to
make better decisions when upset. One participant stated that participation in the Just Do You
intervention helped to decrease anxiety and PTSD symptoms.

Social relationships

Many young adults reported that participation in the group increased their peer social support, stating
that they developed new friendships, provided advice to each other, and were able to understand each
other’s problems. Two participants reported appreciating that everyone in the group was a young adult
because it made it easier for them to relate to each other and express themselves. One participant
reported that the group helped him/her to understand that s/he was not the only one with difficult
experiences. Some young adults also reported that participation in the group helped them to develop
new and stronger connections to agency staff. One young adult stated that s/he got to see a side of the
recovery role model s/he had never seen before, and this was “inspiring.”

Other outcomes

With regards to other aspects of the intervention, young adults believed that both the inclusion of
art as well as the CBT concepts were helpful. A few reported that the inclusion of art, music, and
writing helped them process difficult feelings and express themselves in a different way. One
participant stated that s/he used the art supplies at home on a daily basis, and another participant
reported that engaging in art helped bring a sense of calm and focus. The sharing of poems and
songs also helped bring about understanding between the participants, according to one young
adult. Some participants reported using CBT outside of the group to reduce impulsivity and
implement positive conflict resolution skills.

558 The Journal of Behavioral Health Services & Research 43:4 October 2016

Goal setting

Participants also stated that the Just Do You group improved their level of motivation and goal-
setting. For example, one participant stated that the group made him/her feel like s/he had a
purpose. Another reported that taking part motivated him/her to take the GED exam and another
was able to find stable housing after 6 months of homelessness.


Promising intervention, protocols, manuals, and processes

A major goal of the pilot study, beyond a feasibility test of the intervention, was the development
and testing of all protocols, manuals, and processes to execute a larger efficacy trial of the
intervention. Results suggest that young adults find the overall program to be engaging, helpful,
and for some, the program changed attendance, adherence, attitudes, and motivation. Results also
suggested that the co-facilitation model of a clinician and a recovery role model is promising, with
young adults reporting acceptance of the role model and the program components delivered by the
recovery role model. Interestingly, data also suggested mixed perspectives on the use of a recovery
role model who is approximately a decade older than the participants, with some respondents
stating it is a good idea, while one respondent raised concern about whether young adults can relate
to someone older. The data suggest that the recovery role models were indeed relatable. Also, clinic
staff and administrators perceived a need to develop developmentally specific engagement
interventions for young adults. Staff and administrators also supported the necessary processes to
develop and pilot test the feasibility of the program within their mental health setting.

Furthermore, results suggested reducing the number of sessions from eight sessions over
4 weeks to four sessions over 2 weeks. Participants reported that there was redundancy in working
on understanding principles of evidence-based treatments (i.e., cognitive behavioral therapy and
psychoeducation) on more than one occasion. Also, the feasibility study illuminated clinic
challenges of delivering an eight-session engagement intervention. Therefore, the manual (see
Tables 4 and 5 for an outline of the eight and the four session format) was modified so as to not
lose important content, while also decreasing the program to a more feasible number of sessions. In
addition, the team is continuing to develop training protocols for the recovery role model, as it is a
new role in the mental health system. As the position develops, the team will be involved in
developing protocols for recruitment, screening, training, monitoring, and supervision.

Finally, similar to research in other related health fields (i.e., cancer), the present study found that
narrative mental health communication increases hope and addresses barriers to help-seek-
ing.28,29,30 These results suggest the use of narratives as a promising channel of communication for
positive messages about mental health services. More research is needed to examine the efficacy of
narratives as a channel for young adults.

Implications for behavioral health

Currently, there are no evidence-based engagement interventions for young adults with SMHCs.
The field needs to invest in moving forward programs that are designed explicitly to improve the
engagement of young adults in mental health services, as they have been found to be less likely to
seek mental health services33 and more likely to drop out of treatment.2 The present article has
outlined theoretical frameworks that can be used to develop service engagement interventions for
young adults with SMHCs. The frameworks can be applied to develop and test programs designed
to improve mental health service use, mental health outcomes, and functioning among young
adults. It is critical for behavioral health programs to base the development of programs and
empirical tests of those programs on established behavior change and communication theories.

Intervention for Young Adults with Mental Health Conditions MUNSON et al. 559

Table 4
Description of eight sessions of Just Do You

Session 1 • Introduce SAMHSA Recovery Principles
• Video of Ron Artest speaking about living with mental illness
• Recovery role model shares his/her own journey
• YAs complete a personal life goals worksheet

Session 2
(Psychoeducation I)

• Discussion of various causes of mental illness
• Discussion of ways to cope with MI
• RRM presents his/her experience with receiving a diagnosis,
process of acceptance, coping, and the usefulness of knowledge
and skills

Session 3
(Instilling hope and healing I)

• Discussion on oppression and disempowerment, how this
interacts with mental illness

• YAs create a piece of art depicting their past
• RRM shares his/her piece of art describing aspects of the past
that have been difficult

Session 4

• Introduction to cognitive-behavioral therapy
• Exercise for understanding the connections between situations,
thoughts, feelings, and behaviors

• Video of Mary J. Blige discussing her journey with mental
illness and addiction

• Discussion of how Mary J. Blige connects situations, thoughts,
feelings, and behaviors

• Homework: participants encouraged to bring to next session
song lyrics, poetry, readings, that reflect emotions re: living
with SMI

Session 5

• Continued review of CBT
• Use adaptation of exercises for understanding connections
between situations, thoughts, feelings, and behaviors, encouraging
YAs to apply situations from their own lives

• Homework: participants are encouraged to bring to next session
song lyrics, poetry, and readings that reflect emotions around
living with SMI

Session 6 • Discussion on how to access mental health services
• Handout on local mental health service agencies
• RRM shares his/her own experiences of trust/mist-trust when accessing
mental health services and YAs discuss their own experiences

Session 7
(Instilling hope and healing II)

• Arts exercise—YAs create art piece depicting what they hope
to achieve in the future

• RRM models by sharing his/her own art piece and discussing
what s/he hopes to achieve in the future

• Participants share their pieces with one another, if comfortable
Session 8 • Review of content from previous seven sessions

• Discussion regarding what YAs have learned in group
• RRM sharing what they have taken from group
• Discussion of the importance of supportive others in recovery
• Graduation ceremony—each YA given a certificate of completion

560 The Journal of Behavioral Health Services & Research 43:4 October 2016

Just Do You includes a promising position for the workforce, a recovery role model. The
position has considerable potential and may be a cost-effective way for providers to employ
others who have experienced recovery to share their narratives in a structured way, to model
their strategies for coping, and to teach ways of managing to live with a SMHC. Future
research in behavioral health is needed to test the recruitment, screening, training, and
employment of recovery role models in mental health settings. In addition, future research
studies can examine Just Do You to further understand the underlying mechanisms of change,
and also which elements of the intervention make the greatest impact. An example of the
latter could be comparing outcomes of Just Do You if delivered with and without a recovery
role model.

Table 5
Description of four sessions of Just Do You

Session 1: recovery and “doing you”
(Debunking stigma, increasing hope)

• Group ground rules and introduction
• Presentation of concepts: recovery, stigma, and hope
• SAMHSA Recovery Principles
• Discussion of recovery, stigma, and hope
• Narrative mental health communication (NMHC, Ron

• Recovery role model shares his/her journey
• Certification for YAs who have completed all four

Session 2: need for trust, learning about
access and understanding

(Processing mistrust and services
at clinic)

• Group ground rules and introduction
• Presentation of concepts: need for trust (processing
mistrust), access, and understanding

• Discussion: trust, access, and understating
• CBT exercise (with NMHC, Mary J Blige)
• Worksheet and discussion on services
• Recovery role model journey II
• Certificates for YAs who have completed all four

Session 3: processing past
(Hope and recovery)

• Group ground rules and introduction
• Presentation of concepts: processing the past, hope,
and recovery

• Creative arts to depict the past
• Discussion of past and art pieces, with RRM leading
• Certificates for YAs who have completed all four

Session 4: processing future
and “doing you”

(Hope and recovery)

• Group ground rules and introduction
• Presentation of concepts: processing the future, hope,
and recovery

• Creative arts to depict the future/hope
• Discussion of the future with RRM leading
• Certificates for YAs who have completed all four

Intervention for Young Adults with Mental Health Conditions MUNSON et al. 561

Finally, Just Do You holds promise for changing important behavioral health outcomes, such as
motivation, attitudes, emotions, and behavior, as is evidenced by the empirical data in the present
study. Improving young adult motivation, attitudes, and behavior around treatment through
engagement interventions may decrease missed appointments and ultimately increase clinic
efficiency. The next step in this research is to test change in outcomes in a randomized clinical trial

The program uses innovative engagement strategies (i.e., art), while also utilizing strategies
found to be effective in increasing hope and decreasing resistance in other related health behavior
fields, such as narrative health communication.28,29,30 In the young adult mental health field, the
online website “half of us” is a great resource for access to compelling narrative mental health
communication for research teams to utilize.31 Further research is needed to examine the
effectiveness of this channel of communication as well, compared to standard psychoeducation
curriculums and motivational interviewing interventions.


The authors would like to especially thank the Ohio Department of Mental Health and the Fahs
Beck Fund/New York Community Trust for financial support and all of the participants who helped
us develop and refine the young adult engagement intervention reported on in this article.

Conflict of Interest None for any authors.

Notes There were 27 young adults that were part of post-session process discussions, which is
more than the 24 young adults described in Table 1, because 3 young adult participants consented
and became involved after the baseline data was collected.


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Advancement of Mental Health 2005; 4(3): 1–34.

Intervention for Young Adults with Mental Health Conditions MUNSON et al. 563

Reproduced with permission of the copyright owner. Further reproduction prohibited without

  • An Engagement Intervention for Young Adults with Serious Mental Health Conditions
    • Abstract
    • Introduction
      • Theoretical underpinnings of the intervention
        • Systematic design of interventions to change behavior: What needs to change?
        • A theoretical framework of determinants of mental health decision making
        • Theories to impact determinants of decisions/behavior: how to make change happen
        • Communication theory and service engagement program design
        • Clinical theories undergirding the young adult engagement intervention
      • The present study
    • Methods
      • Recruitment and participants
      • Data collection
      • Data analysis
    • Results
      • Preintervention feedback on the manual from stakeholders
      • Manual language
      • Narrative mental health communication
      • Recovery role model as co-facilitator
      • Focus on young adults
      • Suggested changes
      • Conclusion of the stakeholder feedback
      • Post-session feedback
      • Preliminary evaluation of just do you: feasibility, acceptability, and implementation
      • Acceptance of the recovery role model
      • Shifting young adult motivation
      • Improved young adult attitudes
      • Improved attendance and medication adherence
      • Emotional effects
      • Social relationships
      • Other outcomes
      • Goal setting
    • Discussion
      • Promising intervention, protocols, manuals, and processes
    • Implications for behavioral health
    • Acknowledgments
    • References

Mechanisms of functional improvement in a 2-year
trial of cognitive enhancement therapy for early

S. M. Eack1,2*, M. F. Pogue-Geile3, D. P. Greenwald2, S. S. Hogarty2 and M. S. Keshavan2,4

1 School of Social Work, University of Pittsburgh, Pittsburgh, PA, USA
2 Western Psychiatric Institute and Clinic, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA
3 Department of Psychology, University of Pittsburgh, Pittsburgh, PA, USA
4 Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, MA, USA

Background. Cognitive rehabilitation has emerged as an effective treatment for addressing cognitive impairments

and functional disability in schizophrenia; however, the degree to which changes in various social and non-social

cognitive processes translate into improved functioning during treatment remains unclear. This research sought to

identify the neurocognitive and social-cognitive mechanisms of functional improvement during a 2-year trial of

cognitive enhancement therapy (CET) for early-course schizophrenia.

Method. Patients in the early course of schizophrenia were randomly assigned to CET (n=31) or an enriched
supportive therapy control (n=27) and treated for up to 2 years. A comprehensive neurocognitive assessment battery
and the Mayer–Salovey–Caruso Emotional Intelligence Test (MSCEIT) were completed annually, along with measures

of functioning. Mediator analyses using mixed-effects growth models were conducted to examine the effects of

neurocognitive and social-cognitive improvement on functional change.

Results. Improvements over 2 years in neurocognition and the emotion management branch of the MSCEIT were

found to be significantly related to improved functional outcome in early-course schizophrenia patients. Neuro-

cognitive improvement, primarily in executive functioning, and social-cognitive change in emotion management also

mediated the robust effects of CET on functioning.

Conclusions. Improvements in neurocognition and social cognition that result from cognitive rehabilitation are both

significant mediators of functional improvement in early-course schizophrenia. Cognitive rehabilitation programs for

schizophrenia may need to target deficits in both social and non-social cognition to achieve an optimal functional


Received 1 April 2010; Revised 29 June 2010; Accepted 29 July 2010; First published online 22 September 2010

Key words : Cognitive rehabilitation, cognitive remediation, psychosocial treatment, social cognition.


Schizophrenia is a chronic mental disorder that is

characterized by significant impairments in cognition

and functioning. Marked deficits have been observed

in social and non-social cognitive domains (Penn

et al. 1997; Heinrichs & Zakzanis, 1998), which cross-

sectional and longitudinal studies have found to be

significant and consistent predictors of functional

outcome (Green et al. 2000; Couture et al. 2006). Such

findings have fueled arguments for the treatment

of cognitive impairments in schizophrenia as a key

mechanism for improving functioning in the disorder

(Hogarty & Flesher, 1992; Green & Nuechterlein,


While the pharmacological treatment of cognitive

impairments in schizophrenia has produced limited

improvements (Keefe et al. 2007; Sergi et al. 2007),

a number of psychosocial cognitive rehabilitation

approaches have emerged as effective methods for

addressing cognitive deficits in the disorder (McGurk

et al. 2007). One integrated approach to the remedi-

ation of social and non-social cognitive impairments in

schizophrenia that has been shown to be particularly

effective at improving cognition and functioning in

the disorder is cognitive enhancement therapy (CET;

Hogarty & Greenwald, 2006). In the initial CET study

* Address for correspondence: S. M. Eack, Ph.D., University of

Pittsburgh School of Social Work, 2117 Cathedral of Learning,

Pittsburgh, PA 15260, USA.

(Email: [email protected])

Psychological Medicine (2011), 41, 1253–1261. f Cambridge University Press 2010


with chronically ill patients, we demonstrated that

CET resulted in marked improvements in processing

speed, neurocognition and social cognition, as well

as social adjustment (Hogarty et al. 2004). A 1-year

follow-up study also showed that these improvements

could be maintained after the completion of treatment

(Hogarty et al. 2006). Recently, we tested the effects

of CET as an early intervention approach with 58

early-course schizophrenia out-patients, and again

found substantial improvements in neurocognition

(d=0.46) and social cognition (d=1.55), but not pro-
cessing speed, which was relatively preserved among

early-course patients. In addition, large (d=1.53) and
broad functional improvements were observed in

vocational functioning, activities of daily living and

other domains of social adjustment (Eack et al. 2009,

in press).

The effects of CET and other cognitive rehabilitation

approaches on functional outcome strongly support

the treatment of cognition as a critical mechanism for

functional improvement in schizophrenia. Unfortu-

nately, few studies have explicitly tested the degree to

which improvements in cognition contribute to func-

tional improvement. In the initial CET study with

chronically ill patients, we found that improvements

in processing speed served as a significant partial

mediator of CET effects on social adjustment (Hogarty

et al. 2006). Wykes et al. (2007) studied cognitive re-

mediation therapy among early-onset patients and

found that improvements in executive functioning,

working memory and planning were related to im-

proved social behavior; however, previous studies of

that intervention with chronic patients did not de-

monstrate a link between changes in neurocognitive

domains and functioning (Reeder et al. 2004, 2006).

To date, no studies have examined the effect of both

improved neurocognition and social cognition on

functional outcome during cognitive rehabilitation in


Having recently found substantial functional ben-

efits of CET in early schizophrenia during a 2-year

randomized trial (Eack et al. 2009), we now examine

the degree to which social-cognitive and neurocog-

nitive enhancement during this trial served as active

mechanisms of functional improvement in these early-

course patients. It was hypothesized that both im-

proved neurocognition and social cognition would

contribute to improvements in functioning, and

mediate the differential effects of CET on functional

outcome. Unlike our initial CET study (Hogarty et al.

2006), the mediational effects of improved processing

speed were not investigated, as this sample of early-

course patients demonstrated relatively preserved

performance in processing speed that did not change

with treatment (Eack et al. 2009).



Participants consisted of 58 early-course out-patients

with schizophrenia (n=38) or schizo-affective dis-
order (n=20), as assessed by the Structured Clinical
Interview for DSM-IV (First et al. 2002), treated in a

2-year trial of CET. The early course of schizophrenia

was defined for this research as no greater than 8 years

since the first emergence of psychotic symptoma-

tology. Eligible participants included individuals with

schizophrenia, schizo-affective, or schizophreniform

disorder stabilized on antipsychotic medications who

experienced their first psychotic symptom within the

past 8 years, were not abusing substances for at least

2 months prior to study enrollment, had an intelli-

gence quotient (IQ) o80, and exhibited significant
social and cognitive disability on the Cognitive Style

and Social Cognition Eligibility Interview (Hogarty

et al. 2004). The Cognitive Style and Social Cognition

Eligibility Interview is a structured interview measure

that was used to ensure that enrolled patients experi-

enced significant cognitive and functional disability

warranting treatment. Demographic and clinical

characteristics of CET and enriched supportive therapy

(EST) patients are presented in Table 1.


Participants were treated with either CET or an EST

control, both of which have been described in detail

elsewhere (Hogarty et al. 2004; Eack et al. 2009).

Briefly, CET is a comprehensive cognitive rehabili-

tation intervention designed to address the social

and non-social cognitive deficits that limit functional

recovery from schizophrenia. Patients treated with

CET complete approximately 60 h of computer-based

training in attention, memory, and problem-solving

and 45 small-group social-cognitive therapy sessions

designed to enhance perspective-taking, social context

appraisal, foresightfulness, and getting the ‘gist’ out

of social situations. EST is an illness management

and education approach based on personal therapy

(Hogarty, 2002), which provides patients with psy-

choeducation about schizophrenia and teaches ap-

plied coping strategies to reduce stress. EST is tailored

to the patient’s level of recovery, and begins with

weekly 30–60 min individual therapy sessions. As

patients progress through the treatment, increasingly

complex coping strategies are taught and applied, and

therapy sessions are provided on a biweekly basis.

All participants were maintained on antipsychotic

medications approved by the US Food and Drug

Administration for the treatment of schizophrenia

or schizo-affective disorder.

1254 S. M. Eack et al.



A comprehensive battery of paper-and-pencil and

computerized neuropsychological tests representing

the domains of verbal and working memory, executive

functioning, language ability, psychomotor speed and

neurological soft signs was used to assess the neuro-

cognitive mechanisms of CET effects on functional

outcome. These domains assessed reflect the promi-

nent areas of cognitive impairment in schizophrenia,

and are largely consistent with those outlined by

the Measurement and Treatment Research to Improve

Cognition in Schizophrenia (MATRICS) committee

(Green et al. 2004). Items from tests of these domains

were combined into an overall composite measure of

neurocognitive function, and included immediate and

delayed recall items from stories A and B of the

Revised Wechsler Memory Scale (Wechsler, 1987); List

A total recall, short-term free recall, and long-term

free recall from the California Verbal Learning Test

(Delis et al. 1987); digit span, digit symbol, picture

arrangement, and vocabulary items from the Revised

Wechsler Adult Intelligence Scale (Wechsler, 1981);

Trails B time to completion (Reitan & Waltson,

1985); perseverative and non-perseverative errors,

categories completed, and percentage of conceptual

responses from the Wisconsin Card Sorting Test

(Heaton et al. 1993); total move score and ratio of

initiation to execution (planning) time from the Tower

of London (W. C. Culbertson and E. A. Zillmer, Tower

of London-DX Manual, unpublished results); and

cognitive-perceptual and repetition-motor subscales

from the Neurological Evaluation Scale (Buchanan &

Table 1. Demographic and clinical characteristics of patients treated with CET or EST

Variable CET (n=31) EST (n=27) pa


Age, years 25.88 (6.46) 25.97 (6.26) 0.955

Male 0.617

n 20 20

% 65 74

Caucasian 0.662

n 21 19

% 68 70

Attended college 0.713

n 9 10

% 29 37

Not employed 0.772

n 8 7

% 26 26

Schizophrenia 0.916

n 21 17

% 68 63

Time since first psychotic symptom,


3.07 (2.34) 3.32 (2.16) 0.675

IQ 97.74 (7.66) 98.52 (9.74) 0.736


BPRS total 39.77 (9.21) 40.70 (10.64) 0.723

Wing Negative Symptoms Scale 18.35 (4.14) 18.15 (3.63) 0.842

Raskin Depression Scale 6.77 (2.77) 6.33 (1.98) 0.494

Covi Anxiety Scale 5.84 (2.08) 6.11 (2.22) 0.632


CPZ dose at baseline, mg 381.18 (271.99) 460.68 (335.05) 0.323

CPZ dose at year 1, mg 402.33 (332.93) 529.38 (374.13) 0.215

CPZ dose at year 2, mg 473.58 (384.43) 548.71 (402.05) 0.520

CET, Cognitive enhancement therapy; EST, enriched supportive therapy;

IQ, intelligence quotient; BPRS, Brief Psychiatric Rating Scale; CPZ, chlorpromazine.

Values are given as mean (standard deviation).
a x2 Test or independent t test, two-tailed, for significant differences between CET

and EST participants.

Mechanisms of CET effects 1255

Heinrichs, 1989). Items were scaled to a common

metric and then averaged to form an overall neuro-

cognitive composite. The reliability of this composite

was good (Cronbach’s a=0.87).

Social cognition

Social cognition was assessed using the MATRICS-

recommended Mayer–Salovey–Caruso Emotional

Intelligence Test (MSCEIT; Mayer et al. 2003). The

MSCEIT is a performance-based measure of emotional

intelligence that requires participants to solve

emotionally laden problems regarding the perception,

facilitation, understanding and management of

emotion. In keeping with the developers’ adminis-

tration guidelines, patients completed the MSCEIT as

a computerized, self-administered test in this research.

The instrument consisting of 141 items across eight

distinct tasks forms the emotion perception, facili-

tation, understanding, and management branches

of Salovey & Mayer’s (1990) proposed four-branch

model of emotional intelligence. Although the

MATRICS committee only recommended the use of

the emotion management branch of the MSCEIT, all

four branches were used in this research. We have

previously shown the MSCEIT to be a reliable measure

of social cognition that is unique from both neuro-

cognitive function and symptomatology (Eack et al.

2010), and the MATRICS initiative has demonstrated

the test–retest reliability of the emotion management

branch of the instrument to be adequate (Nuechterlein

et al. 2008). Behavioral ratings of social cognition pre-

viously reported on were not considered for mediator

analyses, due to their completion by the same raters

who assessed functional outcome and were not blind

to treatment assignment.

Functional outcome

Functional outcome was assessed largely using field

standards of social adjustment and functioning in

schizophrenia. Measures included the Social Ad-

justment Scale-II (Schooler et al. 1979), Global Assess-

ment Scale (Endicott et al. 1976), Major Role Inventory

(Hogarty et al. 1974) and Performance Potential In-

ventory (Department of Health and Human Services,

1986; Hogarty et al. 2004). These measures have been

described in greater detail in previous reports (Eack

et al. 2009), and together they cover the broad domains

of social, vocational, family, sexual, independent liv-

ing, and leisure functioning. An overall composite in-

dex of functional outcome was used to avoid excessive

inference testing among the large number of items

gleaned from these instruments. This composite was

calculated by scaling individual functional outcome

items to a common metric and then averaging them

to form the functional outcome composite, which

displayed good internal consistency (Cronbach’s a=


Participants were recruited from out-patient services

at Western Psychiatric Institute and Clinic in

Pittsburgh, and nearby community clinics. Patients

who met eligibility requirements were randomly as-

signed to CET or EST and treated for 2 years in their

respective treatment condition. Cognitive and func-

tional assessments were performed prior to treatment

and then annually at 12 and 24 months using the

aforementioned measures by study clinicians or

trained neuropsychologists, who were not blind to

treatment assignment. However, assessors adminis-

tering the performance-based neurocognitive and

MSCEIT tests were blind to clinical assessments of

functional outcome. There were no significant differ-

ences between treatment groups with regard to

demographic and symptom characteristics at baseline,

attrition, or medication characteristics (Eack et al.

2009). Of the 58 patients randomized and treated,

49 and 46 completed 1 and 2 years of treatment, re-

spectively. All participants provided written informed

consent prior to participation, and the study was

reviewed annually by the University of Pittsburgh

Institutional Review Board.

Data analysis

Mechanisms of functional improvement during CET

were analysed using path analysis based on the me-

diator-analytic framework for clinical trials outlined

by Kraemer et al. (2002). This framework is based on

seminal work by Baron & Kenny (1986), where a series

of linear models are used to evaluate the impact of

treatment assignment or choice (CET v. EST) on an

outcome (improved functional outcome) through an

intermediate treatment response or putative mediator

(improved cognition). In a clinical trial, treatment as-

signment or choice has k levels corresponding to the

number of treatment groups in the trial (in this case,

two levels, CET or EST). In order to demonstrate that

improved cognition is a mediator between treatment

assignment and improved functional outcome, several

conditions must be met.

First, treatment assignment must be associated with

outcome response, that is, assignment to CET v. EST

must have a direct impact on changes in functional

outcome (criterion A). This condition is otherwise

known as a main effect of treatment on outcome, and

establishes that the type of treatment provided

(e.g. CET v. EST) is associated with different changes

in outcome (e.g. individuals in CET improve more on

1256 S. M. Eack et al.

functional outcome than those in EST). Second, treat-

ment assignment must be associated with response to

an intermediate outcome or mediator, that is, assign-

ment to CET v. EST must have a direct impact on

changes in cognition (criterion B). This condition es-

tablishes that the type of treatment provided is also

associated with a differential response on the putative

mediator (e.g. individuals in CET improve more on

cognition than those in EST). Third, changes in the

mediator must be associated with changes in the out-

come, or changes in cognition must have a direct im-

pact on changes in functional outcome (criterion C).

This condition demonstrates the interrelationship be-

tween improvement on the mediator and improved

outcome. Linear models used to assess this relation-

ship across treatment groups first adjust for treatment

assignment to remove the possibility of an illusory

association between the mediator and outcome, simply

because of their shared relationship with treatment

assignment (which is given from criteria A and B).

Finally, the direct effect of treatment assignment on

changes in outcome must be reduced, after accounting

for the association between changes in the mediator

and changes in the outcome. That is, the relationship

between assignment to CET v. EST and changes in

functional outcome will be reduced (i.e. partially ex-

plained by the mediator) or eliminated (i.e. entirely

explained by the mediator) after adjusting for the as-

sociation between changes in cognition and changes in

functional outcome (criterion D). When criterion D is

met, the direct effect of treatment assignment on

changes in outcome is reduced because the total effect

of treatment is partitioned into its direct and indirect

(through the mediator) components.

Within the context of this research, these principles

of mediation were applied to examine whether treat-

ment assignment to CET (v. EST) resulted in improved

functional outcome, and whether this differential

functional improvement was mediated by the ben-

eficial effect of treatment assignment to CET on neuro-

cognition and social cognition. To accomplish this, a

series of path analyses employing linear mixed-effects

growth models was used to show that, consistent with

previous reports from this trial (Eack et al. 2007, 2009),

treatment assignment to CET resulted in greater im-

provement in functional outcome (criterion A) and the

putative mediators, neurocognition and social cog-

nition (criterion B), compared with EST. Next, mixed-

effects models examined the association between

changes in neurocognition and social cognition, and

changes in functional outcome (criterion C), by pre-

dicting functional outcome from the neurocognition

composite and MSCEIT branch scores over the

course of the study (i.e. time-varying covariates) after

adjusting for treatment assignment (Singer & Willet,

2003). Finally, the adjusted direct effect of CET on

functional outcome after controlling for cognitive

change was obtained from these models, as well as

the indirect effect of treatment assignment to CET

on functional outcome through improved cognition

(criterion D).

It is important to note that both treatment groups

(CET and EST) are included in all of these models, as

CET-specific effects or the true effect of CET on both

cognition and functional outcome can only be esti-

mated in contrast to a control condition. This is one of

the core principles of experimental designs and ran-

domized clinical trials (Campbell & Stanley, 1963),

where improvement within the CET group alone

could be a function of many different factors other

than the specific elements of the treatment (e.g. re-

peated testing effects, the provision of skilled clin-

icians, the use of supportive therapy). The use of a

randomized control condition is designed to control

for these factors, and EST in particular is designed to

control for the non-specific effects of supportive treat-

ment. As such, only improvements in CET that exceed

those of patients treated with EST can be considered

true, CET-specific treatment effects, and it is these

CET-specific effects that are the subject of mediator

analyses. In fact, because of this property of rando-

mized controlled trials, the examination of mediators

in the context of clinical trials is particularly advan-

tageous, as the source of differential change in both

the outcome and mediator is known and inferences

regarding causality are considerably strengthened

(Kraemer et al. 2002).

All mixed-effects models employed intent-to-treat

analyses with all 58 patients who received any

exposure to their respective treatment condition.

Missing data were handled using the expectation-

maximization approach (Dempster et al. 1977). In

addition, all models adjusted for the potential con-

founding effects of age, gender, illness duration and

IQ at baseline, as well as current medication dose.

Only confounders that demonstrated a significant

effect on outcome change were retained to conserve

power. Model coefficients are presented using z-scale

transformations to ease interpretation and coefficient

comparisons. The size and significance of mediation

effects was estimated using the MacKinnon et al. (2002)

asymptotic z’ test of indirect effects.


Mediating effects of neurocognitive and

social-cognitive improvement on functional change

Neurocognitive and social-cognitive correlates and

mediators of functional improvement among

Mechanisms of CET effects 1257

early-course patients participating in a 2-year trial of

CET are presented in Table 2. Neurocognitive com-

posite improvement was significantly related to im-

provements in functional outcome, with patients who

experienced larger neurocognitive gains during the

course of the trial also experiencing a greater func-

tional response. With regard to social cognition, of the

four branches of the MSCEIT that were examined, only

the emotion management branch demonstrated a sig-

nificant longitudinal relationship with functional

change. Fig. 1 presents the results of path models ex-

amining the mediating effect of overall neurocognitive

and emotion management improvement on functional

outcome. As shown in Fig. 1a, CET exerted a signi-

ficant effect on the neurocognitive composite, which in

turn was directly related to improved function. This

cascade of neurocognitive change proved to signi-

ficantly mediate the robust direct effects of CET on

functional outcome (z’=1.55, n=58, p=0.040). A
similar pattern of results was observed for the MSCEIT

emotion management branch, where CET had its lar-

gest effects, which again was related to functional

improvement and significantly mediated the effects

of CET on functioning (zk=1.58, n=58, p=0.037, see
Fig. 1b). When examining the relative impact of neuro-

cognitive and social-cognitive improvement on func-

tional outcome concurrently, improved emotion

management continued to demonstrate a significant

direct effect on functional improvement [B=0.14, de-
grees of freedom (df)=86, p=0.045], whereas the effect
of neurocognitive change on functioning was only mar-

ginal, but of similar magnitude (B=0.14, df=86, p=
0.055). Interestingly, overall changes inneurocognition

were not associated with improvements in the

MSCEIT managing emotions subscale (B=0.07,
df=87, p=0.459), although improved neurocognition
was significantly associated with improvements in the

MSCEIT understanding emotions subscale (B=0.22,
df=87, p=0.009). Together, these findings indicate
largely independent improvements in both neurocog-

nition and social cognition, particularly emotion man-

agement, as mechanisms of functional change during

CET in early-course schizophrenia.

Table 2. Associations between changes in neurocognition and social cognition and improved functional outcome (n=58)a


DFunctional outcome

Direct effectb Mediator effectc

B S.E. t df p zk

DNeurocognition composite 0.15 0.07 2.14 89 0.035 1.55*

DSocial cognition (MSCEIT)

DPerceiving emotions x0.07 0.07 x1.08 87 0.281 x0.99
DFacilitating emotions x0.05 0.06 x0.77 87 0.443 x0.63
DUnderstanding emotions x0.00 0.07 x0.02 87 0.983 x0.02
DManaging emotions 0.15 0.07 2.11 87 0.037 1.58*

S.E., Standard error; df, degrees of freedom; MSCEIT, Mayer–Salovey–Caruso Emotional Intelligence Test.
a Results are based on mixed-effects growth models with a single cognition variable as the primary covariate, adjusting for

age, gender, intelligence quotient, illness duration, medication dose, and treatment assignment.
b Direct effects represent direct relationships between changes in cognition and changes in functional outcome.
c Mediator effects represent the intervening effect of changes in cognition on cognitive enhancement therapy effects on

functional outcome.

* p<0.05.


0.23* 0.15*




0.28* 0.15*





(1=Yes; 0=No)

(1=Yes; 0=No)

Fig. 1. Neurocognitive (a) and social-cognitive (b) mediators

of the effects of cognitive enhancement therapy (CET) on

functional outcome in early-course schizophrenia (n=58).
Regression weights on the right of the slash (/) represent

direct effects of CET on functional outcome after adjusting for

the mediator (* p<0.05, ** p<0.01).

1258 S. M. Eack et al.

Mediating effects of improvement in individual

neurocognitive tasks on functional change

Having found evidence for improvements in overall

neurocognitive ability as a significant mediator of CET

effects on functioning at the composite level, we pro-

ceeded to conduct a series of exploratory analyses to

examine the degree to which individual neurocog-

nitive tests contributed to this effect. Results revealed

that improved delayed recall on the Wechsler Memory

Scale (B=0.13, df=82, p=0.029) and long-term free
recall on the California Verbal Learning Test (B=0.12,
df=87, p=0.036) were significantly related to greater
functional improvement, and reduced time to complete

Trails B (B=x0.16, df=87, p=0.010) and perseverative
(B=x0.12, df=88, p=0.017) and non-perseverative
(B=x0.10, df=87, p=0.033) errors on the Wisconsin
Card Sorting Test were also associated with greater

functional gains. Despite several direct relationships

between changes in verbal memory, executive func-

tion domains, and improved functional outcome, de-

creases in Trails B time to completion proved to be the

only significant neurocognitive mediator of CET ef-

fects on functioning (z’=1.62, n=58, p=0.036). Such
results suggest the importance of verbal memory and

executive functioning improvement to functional out-

come in early-course schizophrenia, and point to im-

proved executive performance as a key neurocognitive

mediator of CET effects on functioning.


Cognition has emerged as a key target of schizo-

phrenia treatment, and a variety of psychosocial cog-

nitive rehabilitation programs have been developed

and shown to be effective at improving both cognition

and functional outcome in the disorder (McGurk et al.

2007). Unfortunately, the mechanisms of functional

improvement that accrue from these interventions re-

main largely unknown, and thus the degree to which

targeting cognition results in meaningful gains in

functioning is not clear. We conducted a first investi-

gation of the neurocognitive and social-cognitive

mechanisms of functional improvement during a

2-year trial of CET for patients in the early course of

schizophrenia. Overall, improvements in neurocog-

nitive composite scores were significantly associated

with improved functioning, which partially mediated

the effect of CET on functional outcome. Of the four

branches of the MSCEIT that were examined, only

the MATRICS-recommended emotion management

branch proved to be a significant mediator of CET

effects on functioning. Exploratory analyses of indi-

vidual neurocognitive tests also revealed significant

relationships between verbal memory, executive

function, and functional improvement, with decreased

Trails B time to completion exerting a significant

mediating effect on functioning. Such findings signify

both neurocognitive and social-cognitive improve-

ment, particularly in the domains of executive per-

formance and emotion management, as mechanisms

of functional improvement during cognitive rehabili-

tation in early schizophrenia.

The results of this investigation support previous

cross-sectional and naturalistic longitudinal studies

documenting the importance of both neurocognition

and social cognition to functional outcome in schizo-

phrenia (Sergi et al. 2006; Brekke et al. 2007, 2009).

Consistent with previous studies (Green et al. 2000),

verbal memory improvements were the most reliable

neurocognitive predictors of functional change in this

research, and may represent an important neurocog-

nitive precursor for benefiting most from treatment

strategies used in CET, such as active thinking, giving

feedback, responding to coaching, and abstracting the

social gist. Improvements in social cognition also

proved to be important contributors to functional

outcome and mediated CET effects on functioning.

Unfortunately, despite growing evidence on the im-

portance of social cognition to functional outcome

(Couture et al. 2006), the majority of cognitive rehabili-

tation approaches do not address social-cognitive


Although the results of this research begin to pro-

vide some evidence of a mediational relationship

between changes in neurocognition, social cognition,

and functional outcome within the context of a clinical

trial, it is important to remember that not all mediators

are causal mechanisms (Kraemer et al. 2002). In ad-

dition, correlational analyses of change cannot dis-

ambiguate the direction of mediational relationships,

and it is possible that a bidirectional relationship exists

between improved cognition and functioning. The

clear identification of causality and directionality with

regard to a mediator requires a priori studies designed

to manipulate the presence or absence of a putative

mechanism. This research lays the foundation for such

studies, by identifying a need for controlled trials that

examine the functional effects of treating neurocog-

nition and social cognition either alone or jointly.

Further, both social-cognitive and neurocognitive im-

provements were only partial mediators of functional

improvement, which indicates the presence of other

active mechanisms of functional change. These may

include such factors as increased socialization or

decreased anxiety and negative symptoms.

In addition, although a modest number of inference

tests were conducted when examining associations

between cognitive and functional change, corrections

for multiple inference testing were not conducted and

Mechanisms of CET effects 1259

these results would not have survived type I error

corrections. As such, care will need to be taken when

interpreting these findings until confirmation from

future studies. Finally, it is also important to note that

the measurement of social cognition in this study was

restricted to the MSCEIT, and that future studies will

need to expand to broader measures of social cog-

nition. It should be noted, however, that these findings

do support the recommendations of the MATRICS

committee to use the emotion management branch

of the instrument, which we have previously observed

to be the most sensitive to social-cognitive treatment

effects (Eack et al. 2007).

In summary, this first study of the effects of im-

proved neurocognition and social cognition on func-

tional outcome during a randomized trial of cognitive

rehabilitation for early schizophrenia found that im-

provements in neurocognitive and social-cognitive

domains both served as significant mediators of

functional improvement. These results suggest that

functional recovery from the illness might best be

promoted through the early application of cognitive

rehabilitation programs that target both social and

non-social cognition.


This work was supported by grant no. KL2 RR024154

from the National Center for Research Resources

(NCRR), a component of the National Institutes of

Health (NIH) and NIH Roadmap for Medical Research,

and its contents are solely the responsibility of the au-

thors and do not necessarily represent the official view

of NCRR or NIH. Information on NCRR is available at

http://www.ncrr.nih.gov/. Information on Re-engin-

eering the Clinical Research Enterprise can be obtained

from http://nihroadmap.nih.gov/clinicalresearch/

overview-translational.asp. In addition, this work was

supported by NIH grants MH-79537 (S.M.E.) and MH-

60902 (M.S.K.). We thank the late Gerard E. Hogarty for

his leadership and direction as co-principal investi-

gator of this study, and Susan Cooley, Anne Louise

DiBarry, Konasale Prasad, Haranath Parepally, Debra

Montrose, Diana Dworakowski, Mary Carter and Sara

Fleet for their help in various aspects of the study.

Declaration of Interest



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APA Literature Review Table Rubric

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Articles appropriate to PICOT

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5 primary research articles appropriate to PICOT

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5 primary research articles are included with table


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PICOT statement: young adults 18 and older receiving treatments for schizophrenia at the Sentara Northern Virginia medical center. Is cognitive behavioral therapy more effective in managing/controlling schizophrenia than psychoeducation in a two-year period in this population?


Research question

Study design

Sample size and method

Independent variables and measures

Dependent variables and measures


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