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Cognitive Analytic Therapy (CAT) for Psychosis Case Series

Main Sponsor University of Liverpool

Funders Association of Cognitive Analytic Therapy (ACAT)

Study Coordination Centre

NRES Reference

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Study Team

Chief Investigator: Dr Peter Taylor (Lecturer in Clinical Psychology)

Co‐investigators: Dr Claire Seddon (Consultant Clinical Psychologist), Dr Ranil Tan (Clinical Psychologist),

Dr Paul Hutton (Research Fellow), Dr Diane Griffiths (Clinical Psychologist),

Dr Alex Perry (Clinical Psychologist)

Statistician: N/A

Study Manager: Dr Peter Taylor

Study Coordination Centre

Study Coordinator : N/A

Address: N/A

Tel: N/A

E‐mail: N/A

Fax: N/A

Clinical Queries

Clinical queries should be directed to Peter Taylor who will direct the query to the appropriate person.

Sponsor

The University of Liverpool is the main research Sponsor for this Study.

For further information regarding the sponsorship conditions, please contact:

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Alex Astor

Head of Research Support – Health and Life Sciences

University of Liverpool

Research Support Office

2nd Floor Block D Waterhouse Building

3 Brownlow Street

Liverpool L69 3GL

sponsor@liv.ac.uk

Funder

Funding has been obtained from the Association for Cognitive Analytic Therapy.

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STUDY SUMMARY

This protocol describes the Cognitive Analytic Therapy (CAT) for Psychosis Case Series and provides information

about procedures for entering participants. Every care was taken in its drafting, but corrections or amendments

may be necessary. These will be circulated to investigators in the Study. Problems relating to this Study should be

referred, in the first instance, to the Chief Investigator.

This study will adhere to the principles outlined in the NHS Research Governance Framework for Health and Social

Care (2nd edition). It will be conducted in compliance with the protocol, the Data Protection Act and other

regulatory requirements as appropriate.

Glossary of Abbreviations

AEP Adverse Effects in Psychotherapy ( Self Report Measure)

CAT Cognitive Analytic Therapy

CBT Cognitive Behavioural Therapy

CCAT Competency of Cognitive Analytic Therapy measure

EIS Early Intervention Service

ITT Intent to Treat

PHQ9 Patient Health Questionnaire

PSQ The personality Structure Questionnaire

PANSS Positive and Negative Syndrome Scale

QPR Questionnaire about the Process of Recovery

RR Reciprocal Role

SOFAS The Social and Occupational Functioning Assessment Scale

TAU Treatment as Usual

WAI-SR The Working Alliance Inventory – Short Revised

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Keywords: Cognitive Analytic Therapy, Psychosis, Case Series

Title: Cognitive Analytic Therapy (CAT) for Psychosis Case Series

Design: Case Series

Aims: To determine the acceptability, feasibility and safety of using CAT with individuals

experiencing first episode psychosis

Outcome Measures: Adverse Effects in Psychotherapy (AEP) self-report measure,

The Questionnaire about the Process of Recovery – Version 2 (Law, Neil, Dunn, &

Morrison, 2014)

The Personality Structure Questionnaire (PSQ; Pollock, Broadbent, Clarke, Dorrian,

& Ryle, 2001)

Positive and Negative Symptom Scale (PANSS; Kay et al., 1987).

The Social and Occupational Functioning Assessment Scale (SOFAS; American

Psychiatric Association, 2000)

The Working Alliance Inventory – Short Revised (WAI-SR;Hatcher & Gillaspy, 2006)

The nine-item Patient-Health Questionnaire (PHQ9; Kroenke, Spitzer, & Williams,

2001)

Qualitative interview with participant about the experience of therapy

Brief telephone interview with care coordinator

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1. Population Eligibility:

Individuals within the first three years of contact with mental health services either meeting (detailed

inclusion/exclusion criteria elsewhere in this document):

a. ICD-10 criteria for schizophrenia-spectrum disorder, or

b. Meeting criteria for support from an Early Intervention Service (EIS).

Duration: We estimate that the study will be completed within two years.

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Table of Contents

1. Introduction 9

1.1 Background 9

1.2 Rationale for current study 11

2. Study Objectives 12

3. Study Design 13

3.1 Study Outcome Measures 14`

4. Participant Entry 17

4.1 Pre‐Registration Evaluations 17

4.2 Inclusion Criteria 17

4.3 Exclusion Criteria 18

4.4 Withdrawal Criteria 19

5. Adverse Events 19

5.1 Definitions 19

5.2 Reporting Procedures 20

6. Assessment And Follow‐Up 21

7. Statistics And Data Analysis 22

8. Regulatory Issues 23

8.1 Ethics Approval 23

8.2 Consent 24

8.3 Confidentiality 25

8.4 Indemnity 25

8.5 Sponsor 25

8.6 Funding 25

8.7 Audits And Inspections 26

9. Study Management 26

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10. End Of Study 26

11. Archiving 26

12. Publication Policy 26

13. References 27

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1. Introduction

1.1 Background: There is a growing use of “talking therapies” in the treatment of psychotic disorders.

Cognitive Behavioural Therapy (CBT) is arguably the most widely studied talking

therapy for treating psychosis, and is recommended for use in this population in

national guidelines (National Institute for health and Care Excellence, 2014). Whilst

there is support for this approach (Wykes, Steel, Everitt, & Tarrier, 2008) other

reviews have drawn less favourable conclusions (Jauhar et al., 2014; Sarin, Wallin,

& Widerlov, 2011). Effect sizes typically occur in the small to moderate range

(Hutton, Wood, Taylor, Sellers, & Morrison, submitted; Wykes et al., 2008). Thus,

whilst there is some indication that CBT is effective, results have been mixed and

effect sizes are still limited. Additionally, the importance of patient choice within the

NHS has been emphasized (Deprtment of Health, 2012), and choice is likely to be

an important factor in determining individual’s feelings towards the therapies they

are offered (Roe, Goldblatt, Baloush-Klienman, Swarbrick, & Davidson, 2009).

With these issues in mind it is vital that alternative therapies for those with

experiences of psychosis are considered and evaluated, with a focus on whether

these alternative therapies can produce larger treatment gains within this

population.

Cognitive Analytic Therapy (CAT; Ryle & Kerr, 2002) represents an alternative

talking therapy that has been under-studied in individuals with psychosis. CAT is an

integrative therapy, which draws upon many of the principles of cognitive and

behavioural therapy, but combines these with ideas from personal construct theory,

object relations theory and social developmental theory (Ryle & Kerr, 2002). CAT

includes a process of making links between individuals’ earlier experiences and

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current difficulties and identifying recurring patterns in how the individual relates to

others and themselves. With psychosis experiences such as paranoia, delusions

and hallucinations can be understood as extreme enactments of such patterns,

which have their roots in earlier experiences (Kerr, Birkett, & Chanen, 2003; Perry,

2012). CAT has grown in popularity amongst clinicians both in the UK and

elsewhere (e.g., Australia; Chanen et al., 2009; Gleeson et al., 2012). A recent

review suggests support for the efficacy of CAT in a variety of disorders, most often

complex presentations (e.g., personality disorder), but also notes that much of the

evidence involves small, practice-based research (Calvert & Kellett, in press).

A theoretical CAT model of psychosis has been developed and illustrated in

individual case studies (Kerr et al., 2003; Kerr, Crowley, & Beard, 2006; Margison,

2005; Perry, 2012). This model provides an account of how certain ways of relating

to self and others (referred to as ‘Reciprocal Roles’ [RRs]) develop over time and

are enacted in day-to-day life.

CAT shares many of the benefits of other therapeutic approaches such as CBT. For

example, the flexible and collaborative nature of CAT allows the therapy to draw on

personal history, psychotic experiences and problematic relationships with self

and/or others as determined by the client. Both CAT and CBT share the common

goal of improving life and well-being for patients. However, CAT also has a number

of characteristics which may make it particularly effective for working with those

experiencing psychosis.

1) Historically CAT has focused on the presence of interpersonal difficulties as a

rationale for its use. Many of the difficulties that are considered indicative of

psychosis are both inter and intrapersonal in nature (Berry, Wearden,

Barrowclough, & Liversidge, 2006; Penn et al., 2004). Therefore CAT is well

suited to this population.

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2) Difficult dynamics emerging between clients and both family members and staff

(including therapists) have been noted in psychosis and may contribute towards

relapse or a poorer course of treatment (Berry, Barrowclough, & Haddock,

2011). CAT provides a framework for understanding, naming and monitoring

such difficult interpersonal dynamics. This is an area where CAT arguably

differs to alternative models like CBT.

3) Increasingly research has supported the idea that psychosis is a normal

reaction to extreme life events, such as abuse or trauma (Read, van Os,

Morrison, & Ross, 2005). Despite this, many individuals carry beliefs of

defectiveness, stigma and shame associated with having psychosis, particularly

in the early stages of the disorder (Miller & Mason, 2005). CAT, as with other

therapeutic approaches, provides a means of helping individuals to reformulate

their psychosis (at least in part) in terms of their life experiences. CAT therefore

provides a more normalising and de-shaming account of a person’s

experiences. The dialogical component of CAT (making links between ‘self-self’

and ‘self-other’ relationships) may be particularly useful for this client group

because it can help to explain some of the processes by which ‘normal’

everyday experiences can lead to seemingly bizarre experiences. For example,

a malicious voice may result from early experiences of a critical other that

became internalised as an RR and then externalised as a voice – perhaps

because it was too painful, or because it was not consistent with the person’s

overall sense of self (Perry, 2012).

1.2 Rationale for Current Study

A trial of a therapy programme involving elements of CAT has been undertaken in

individuals with co-morbid personality disorders and psychosis (Gleeson et al.,

2012). However, no trials of CAT as the primary intervention for psychosis have yet

been undertaken. Whilst case series have already been conducted, these have

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been small (n = 4; Kerr, 2001) and lack clear outcomes. A larger case-series of CAT

for individuals with psychosis is lacking, and represents the next logical step in

developing the research evidence in this area (Craig et al., 2008). Such research

would be necessary in determining the acceptability and safety of CAT for this

population, paving the way for subsequent trials.

It has been observed that the initial years following the onset of psychosis can be

the most difficult. Suicidal feelings appear to be most pronounced in this period

(Nielssen & Large, 2009; Palmer, Pankratz, & Bostwick, 2005), and depression is

also common (Birchwood, 2003). Hence this may represent a clinically important

sub-group where CAT could be directed and evaluated. Early psychosis may

represent a ‘sensitive period’ for intervention (Bird et al., 2010). From a CAT

perspective, there may also be a value in working with earlier psychosis, when the

patterns of thinking, feeling and behaving are more open to change.

CAT is currently routinely used in a number of Early Intervention settings across the

North of England. The proposed research will not therefore be adding anything new

in terms of the therapy provided in these services but will instead be adding an

evaluative research component to the standard CAT already routinely provided by

these services. Therapy will be provided by the participant’s clinical team not the

researchers.

2. Study Objectives The primary aim of the case series will be to determine the acceptability/feasibility

and safety of using CAT with individuals experiencing first-episode psychosis.

A secondary aim will be to obtain an initial estimate of the potential size of the

therapeutic effects on a number of clinically important outcome measures (psychotic

symptoms, social function, perceptions of recovery).

3. Study Design

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Type of Study: Therapeutic Intervention, Case Series

Duration: Participants will be considered enrolled in the study when they have completed an

initial therapy session.

Due to the complexities of employing CAT in services directed at individuals with

psychosis (as discussed elsewhere, Falchi, 2007) it is expected that the therapy

being provided will not be standard 16-session CAT in all cases. Instead, it is

expected that session number will vary depending on both client and service-related

factors. This variability in duration of therapy has been confirmed by clinical teams

who have agreed to support the research. As noted, the current case series will not

change the therapy from the CAT routinely offered by services and so the flexibility

in session number has been incorporated into the study. We expect the length of

therapy to vary from eight to 24 sessions, with the goal of reaching the reformulation

phase of therapy. Calvert & Kellett (2014) note that 24-sessions tend to be used in

more complex cases. Therapists will therefore have the option of extending the

therapy to 24 sessions where there is a clear clinical justification to do so. Such

instances will be monitored. CAT is specifically designed as a time-limited therapy

and so variations in treatment length will be reported and examined as part of the

case series. This flexibility is consistent with Medical Research Council guidance

for this level of investigation (Craig et al., 2008).

Number and type of subjects?

The sample will consist of individuals with first-episode psychosis (inclusion/exclusion criteria

below). As the goal of the current case series is to assess acceptability and safety rather than

to enable statistically generalizable inferences regarding therapeutic effect, a small sample of n

= 10 will be sought. This sample size is large enough to capture a variety of reactions to CAT

whilst being small enough to enable a fine-grained analysis of individual experiences. Based on

studies of CBT in psychosis, attrition (people withdrawing from the study) rates of between 18%

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and 26% (Morrison et al., 2012; Tarrier et al., 2004) are expected. Hence we will aim to recruit n

= 13 to account for this potential attrition.

3.1 Study Outcome Measures

The primary aim of the case series will be to determine the acceptability, feasibility

and safety of using CAT with individuals experiencing first-episode psychosis. In so

doing it aims to pave the way for subsequent trials

A secondary aim will be to obtain an initial estimate of the potential size of the

therapeutic effects on a number of clinically important outcome measures (psychotic

symptoms, social function, perceptions of recovery).

Feasibility/acceptability:

This will be assessed via the following:

Adapted from the criteria adopted by Gleeson et al (2012), we will judge the

intervention feasible based on whether (i) 75% of the sample reach the end of the

formulation stage of therapy (normally delivered at session 4 in CAT), and/or (ii)

40% of the sample complete the CAT intervention.

Acceptability will be the focus of the semi-structured, qualitative interview. Themes

will be generated by analyzing these data, representing participants’ experiences

(both positive and negative) of receiving the intervention.

Safety: Safety will be assessed via an Adverse Effects in Psychotherapy (AEP) self-report

measure, which participants will be asked to complete at the post-therapy

assessment points. This questionnaire asks participants about a variety of possible

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adverse experiences that may occur during psychotherapy.

Secondary Outcomes

Perceptions of Recovery: The Questionnaire about the Process of Recovery – Version 2 (Law, Neil, Dunn, &

Morrison, 2014) is a 15-item self-report measure that captures perceptions of

recovery within both interpersonal and intrapersonal domains. The measure was

developed through collaboration with service-users and its reliability and validity

have been supported (Law et al., 2014).

Personality Structure: The Personality Structure Questionnaire (PSQ; Pollock, Broadbent, Clarke, Dorrian,

& Ryle, 2001) is a brief, eight-item, tool, developed within the CAT model, which

assesses problems in the integration of distinct states of mind. The factor structure,

reliability and validity of this measure has been supported (Bedford, Davies, &

Tibbles, 2009; Pollock et al., 2001). The inclusion of this measure will provide an

insight into whether change occurs in mechanisms outlined in CAT theory.

Symptoms: Psychotic symptoms will be assessed with the Positive and Negative Symptom

Scale (PANSS; Kay et al., 1987). This is a 30-item semi-structured interview

assessing positive, negative and general symptoms of psychosis. The PANSS is

widely used and its validity and reliability has been supported (Kay et al., 1988). The

full PANSS will be undertaken at the pre-therapy appointment, but in order to

minimize participant burden the brief PANSS (Yamamoto, Inada, Shimodera,

Morokuma, & Furukawa, 2010) will be used at the post-therapy and two month

follow-up assessments. Change in the brief PANSS correlates highly with change in

the full PANSS (r = .93) suggesting minimal information loss. In the proposed

research the PANSS will be undertaken by raters trained in its use.

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Functioning: The Social and Occupational Functioning Assessment Scale (SOFAS; American

Psychiatric Association, 2000) is a measure of social and occupational functioning

that provides a score between 0 and 100, with higher scores indicating greater

functioning.

In-session Measures: These measures will be completed at the start of therapy sessions and then stored

in a sealed envelope so that therapists do not have access to the data (as this might

otherwise influence responses).

The Working Alliance Inventory – Short Revised (WAI-SR;Hatcher & Gillaspy, 2006)

will be used to provide an ongoing assessment of client’s perceptions of working

alliance within sessions. This is a brief 12-item self-report measure that captures

various aspects of the therapeutic alliance. Both the client and therapist versions of

this measure will be completed, providing both perspectives on the working alliance.

The factor structure and internal reliability of this measure has been supported

(Hatcher & Gillaspy, 2006; Munder, Wilmers, Leonhart, Linster, & Barth, 2010).

The nine-item Patient-Health Questionnaire (PHQ9; Kroenke, Spitzer, & Williams,

2001) will be used to provide an ongoing assessment of mood and distress. This is

a self-report measure of depressive symptoms, which also features one item

pertaining to suicidality. The factor structure and internal reliability of this measure

has been supported and its convergent validity with other measures of depression

demonstrated (Cameron, Crawford, Lawton, & Reid, 2008).

Clinician Feedback: During a phone-interview with participant’s key worker (or other professional

member of their clinical team) a brief measure will be completed assessing the

clinician’s perceptions of the uptake and influence of CAT principles in their work.

Items will cover a) perceptions of change in understanding of clients’ difficulties, b)

perceptions of change in empathy towards clients, c) perceptions of adoption/use of

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CAT ideas, d) perception of improvement in team-working culture. In addition to

seeking ratings for each item on a seven-point scale anchored from “not at all”, to

“very much so”, clinicians will be asked to give examples in response to each item if

possible. Notes will be taken on clinician’s responses by the researcher.

Additional Measures: Demographics: Age, Gender, Ethnicity, Education, Employment, Income, to be

completed at baseline assessment. Employment and Income will be reassessed at

subsequent assessment points.

Medical history: Past and current diagnoses, comorbid difficulties including prior

suicide attempt or substance abuse, to be recorded at baseline.

Medication: Current medication, including dose and type, will be recorded at the

baseline, post-therapy and follow-up assessment points.

4. Participant Entry

4.1 Pre‐Registration Evaluations

Individuals who consent to take part in the study will be invited to undergo an initial

interview with a researcher prior to the start of therapy, whereby baseline measures

will be completed. This interview will take place either at the University, in a local

community setting (e.g., GP surgery or health centre) or at the participant’s home.

Participants will be considered enrolled in the study after they have attended an

initial therapy session. Follow-up assessments and interviews will therefore be

attempted with participants even if they do not attend any further therapy sessions.

It is important to try and follow-up such individuals who drop out of therapy in order

to gain a clearer understanding about how such individuals progress and so avoid

making inaccurate assumptions about what happens to people who choose to leave

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therapy (Wood, White, & Thompson, 2004).

4.2 Inclusion Criteria

: 1. In contact with mental health services,

Either meeting:

a) ICD-10 criteria for schizophrenia-spectrum disorder (schizophrenia, schizo-

affective disorder, delusional disorder)

OR

b) Meeting criteria for support from an Early Intervention Service (EIS),

operationally defined as a PANSS scores > 4 on hallucinations or delusions or

>4 on conceptual disorganization, grandiosity or suspiciousness. These criteria

are adapted from those used by Morrison and colleagues (2012).

2. In their first episode of psychosis

Operationally defined as being within the first three years of initial contact with adult

mental health services.

3. Aged 18 years or older

4. Deemed capable of providing informed consent by their clinical team.

5. Help-seeking

This will be screened for with the question, “Do you currently feel you need or would

like any support or help for the problems you are facing?” Those that respond

negatively will not be included in the study.

4.3 Exclusion Criteria:

The presence of an identified co-morbid intellectual disability or autistic spectrum

disorder as determined by the individual’s clinical team.

Previous receipt of CAT.

Participants must also be clinically stable (i.e., no hospitalisation for psychosis

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within the past month).

4.4 Withdrawal Criteria

It will be made clear to all participants that whilst the study is running they can leave

the project at any time, without detriment to themselves, and, if they wish, have their

data destroyed. Participants may choose to continue with therapy even if they leave

the study. Moreover, participants will have the option of no longer attending therapy

but to continue to remain involved in the research as long as they have attended at

least one session. This should limit the impact that the decision to reimburse

participants for taking part in research interviews will have on their decision to

attend therapy or not.

Where an adverse event is judged to be a probable consequence of therapy, the

possibility of withdrawing the participant from therapy will be discussed with the

participant and the clinical team. Withdrawal will be undertaken if it is judged not

likely to lead to further harm and with the knowledge and consent of the client and

their care team. The client will still be provided with support as part of the usual

treatment provided by the service. This may include monitoring or provision of

alternative therapies by the service (e.g., CBT, Counselling). The client will have the

option of remaining involved in the research component of the study, and attending

assessment interviews as long as these are not deemed by the client or their

clinician as a possible contributor to the adverse event.

5. Adverse Events

5.1 Definitions

Adverse Events (AE) are defined here as any untoward, time-limited, worsening in

participants’ mental state. Serious Adverse Events (SAE) are here defined as any

untoward events that are life-threatening or involve a significant worsening of the

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participants mental state or leads to a persistent increase in disability or incapacity.

The occurrence of any additional unexpected SAE or AE during the course of the

study will be monitored and recorded. As one of the objectives of the study is to

determine the safety of CAT for this population, we will put in place specific

monitoring procedure for a number of specific AEs and SAEs. These include the

following: Suicide, attempted suicide, a suicidal crisis - defined as an explicit plan

for serious self-injury (Calgary Depression Rating Scale for Schizophrenia, item 8,

rating > 2), serious symptomatic exacerbation (clinically significant increases in

PANSS score).

The Calgary depression scale for Schizophrenia (Addington, Addington, & Maticka-

Tyndale, 1993), item eight, will therefore be used to assess levels suicidal ideation

at the baseline, post-therapy and follow-up assessment points.

Episodes of hospitalization will also be monitored.

5.2 Reporting Procedures

5.2.1 Non Serious AEs

All non-serious AE will be recorded in the study AE log and will also be reported to

the Chief Investigator as soon as is possible. Where uncertain, researchers will be

encouraged to contact the Chief Investigator to clarify if an event qualifies as an AE.

5.2.2 Serious AEs

In the case of SAEs, a SAE form will be completed and faxed to the Chief

Investigator within 24 hours. However, physical ill-health (excluding instances of

self-inflicted injury) and associated hospitalisations do not need reporting as SAEs.

All SAEs will be reported to the Liverpool central Research Ethics Committee where

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in the opinion of the Chief Investigator, the event was

- ‘related’,i.e., resulted from the administration of any of the research procedures;

and

- ‘unexpected’ , i.e . an event that is not listed in the protocol as an expected

occurrence

Reports of related and unexpected SAE s will be submitted within 15 days of the

Chief Investigator becoming aware of the event, using the NRESS AE form for non‐

IMP studies. The Chief Investigator will also notify the Sponsor of all SAEs.

Local investigator will report any SAEs as required by the Research Ethics

Committee, Sponsor and/ or Research & Development Office.

Contact details for reporting SAEs

Fax : 0151 794 5537 , for the attention of Dr Peter Taylor

Please send SAE forms to: Dr Peter Taylor

Lecturer in Clinical Psychology

Institute of Psychology, Health & Society

Room 2.12

Whelan Building

Brownlow Hill

University of Liverpool

L69 3GB

Tel : 015179 45025 (Mon to Fri [excluding Wednesday] 8.00 – 16.00)

Tel (mobile, out of office): 07751708995 (Wednesdays 8.00 – 16.00)

6. Assessment and Follow‐Up

Participants will be considered enrolled in the study after they have attended an

initial therapy session. Follow-up assessments and interviews will therefore be

attempted with participants even if they do not attend any further sessions. It is

important to try and follow-up such individuals who drop out of therapy in order to

gain a clearer understanding about how such individuals progress and so avoid

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making inaccurate assumptions about missing data (Wood, White, & Thompson,

2004).

Participants will be invited to complete a post-therapy interview at 16-weeks (the

typical length for CAT; Ryle & Kerr, 2002). A fixed assessment point has been

adopted to allow comparability across cases, but the length of therapy may vary on

an individual basis and so may extend beyond this assessment point in some

cases. A separate qualitative interview will also be undertaken, within three weeks

of the end of therapy, focusing on participants’ experience of the therapy and their

perceptions of its benefits and disadvantages, and will last between 40 minutes and

one hour. A follow-up assessment will also be undertaken three months after the

post-therapy interview and will focus in particular on identifying any subsequent

adverse events or deterioration and determining whether treatment gains have been

maintained.

In addition to the above assessments, participants will be asked to complete in

therapy measures on a bi-session basis during the course of treatment. These brief

assessments will be limited to approximately 5-10 minutes in length to reduce

burden on the participant. They will provide an additional assessment of adverse

events (i.e., distress, suicidality) and therapy process (i.e., working alliance).

CAT may have benefits not only for the individual client but also for their clinical

team, in terms of making sense of the client’s difficulties (Kellett, Wilbram, Davis, &

Hardy, 2014). Hence a telephone interview, lasting approximately 20 minutes, will

be undertaken with the client’s key worker, within three weeks of the end of therapy.

This interview will focus on the extent to which CAT principles and ideas have

influenced or informed the practice of those in the client’s clinical team, and whether

this contribution is perceived as beneficial.

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7. Statistics and Data Analysis

Patterns of change in the primary and secondary outcome measures will be

graphed and corresponding effect size estimates and associated confidence

intervals calculated. Clinically significant change will be determined for the PANSS

using the criterion of a 11-point change based upon the work of Hermes and

colleagues (Hermes, Sokoloff, Stroup, & Rosenheck, 2012). Clinically significant

change for other measures will be determined using Jacobsen &Truax’s(1991)

criteria. Particular attention will paid to the number of adverse events, such as

deterioration in symptoms (see above). In such cases this information will be linked

with the individual’s responses on the adverse events measure. Data from the

qualitative interviews will be analysed using a thematic analysis (Bowling, 2000;

Braun & Clarke, 2006) in order to identify key themes reflecting participants’

experiences and perceptions of the intervention. Background information and

quantitative data concerning any change that participants experienced during the

course of the study will be used to contextualise qualitative accounts providing a

more holistic, mixed-method approach to analysis.

8. Regulatory Issues

8.1 Ethics Approval

The Chief Investigator will obtain approval from an NHS Research Ethics Committee via the Integrated Research

Application System (IRAS) prior to the start of the study. The study will be submitted for Site Specific Assessment

(SSA) at each participating NHS Trust. The Chief Investigator will obtain a copy of the Trust R&D approval letter

before accepting participants into the study. The study will be conducted in accordance with the recommendations

for physicians involved in research on human subjects adopted by the 18th World Medical Assembly, Helsinki 1964

and later revisions.

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8.2 Consent

Participants will be recruited through Early Intervention and Community Mental Health Services. Eligible individuals

will be told about the study by a member of their clinical team (and provided with a copy of the Participant

Information Sheet) and will be invited to be contacted by the researcher to hear more about the study. The

researchers will be in regular telephone and face-to-face contact with the clinical team and the contact details of

interested individuals will be passed on at these times. A researcher will then contact the potential participant,

describe the study, answer any further questions, and if the individual is interested in taking part, ask some brief

eligibility questions (“How old are you?”, “Do you currently feel you need or would like any support or help for the

problems you are facing?”, “Have you had a stay in hospital as a result of your current difficulties in the past

month?”). If the participant meets these eligibility criteria and still wishes to take part the researcher will arrange a

time and place for a face-to-face meeting. The researcher will also seek verbal consent at this point to contact the

individual’s clinical team in order to confirm their eligibility (e.g., ask about diagnosis, symptoms and when they first

came into contact with services). The teams will be informed of the eligibility criteria in advance and it is expected

that only eligible individuals will be informed about the study, but these additional checks will be undertaken to

ensure these criteria are adhered to.

In the first face-to-face meeting with the researcher consent will be sought, after the individual has had time to ask

any further questions about the study. Notably, all potential participants will be given at least 24 hours to read the

participant information sheet before consent is sought. It will be made clear that the decision to take part will not

affect the treatment they receive (participants will still be able to receive therapy, including CAT from the service

even if they do not take part in the study). It will also be made clear that participants will have the option to remain

involved in some aspects of the research even if they drop out of treatment. Consent to take part will be taken by a

researcher.

It will be made clear to all participants that whilst the study is running they can leave the project at any time, without

detriment to themselves, and, if they wish, have their data destroyed. Participants may choose to continue with

therapy even if they leave the study. Moreover, participants will have the option of no longer attending therapy but to

continue to remain involved in the research as long as they have attended at least one session.

V e r s i o n 1 , 0 7 / 1 2 / 2 0 1 4 P a g e | 25

As each participant will be invited to up to four research meetings, consent will be taken again at each meeting, and

a new consent form completed, to accommodate the possibility of individuals changing their minds.

8.3 Confidentiality

Research related data will be stored in a pseudo anonymized format on a separate database to participants'

identifiable personal information. During the course of the study it will be possible to match personal identifiable

information to other study information via a personal reference number. Storing personal data and research data

separately in this way will help maintain confidentiality. All data will be stored on a password protected and

encrypted database on the University of Liverpool M drive. Upon completing the final assessment or withdrawing

from the study, the linking reference number will be destroyed. Personal data will also be destroyed, except in the

instance where participants wish to receive feedback about the study, in which case participant contact details will

be stored (in a format where it cannot be linked to any participant data) in a password-protected and encrypted

electronic file on the University of Liverpool M drive, until the completion of the study. Hence upon completion from

the study or withdrawal, all data will be made anonymous. The Chief Investigator will preserve the confidentiality of

participants taking part in the study and is registered under the Data Protection Act.

Participant personal information will not be shared with any other organisations or individuals. The exception to this

will be in situations where there is a concern regarding risk to the participant or to others, where contacting other

professionals (e.g., the participant's clinical team, the crisis and home treatment team) would be necessary to avoid

harm. In such situations participants will be made aware that confidentiality is being breached, with the exception of

cases where informing participants of this information could itself increase the level of risk of harm. Potential

participants will be informed of the possible necessity to break confidentiality prior to being asked for consent to take

part in the study. It should be noted that breaches of confidentiality may also occur where potential risk becomes

apparent in a therapy session and it is necessary for the researchers to be informed of this risk (for example, where

the participant has expressed strong hostile feelings towards a researcher, the research team will need to be aware

of this before further research meetings are arranged). The possibility of breaches of confidentiality of this nature

will also be discussed with the potential participant prior to consent being sought, and is also outlined in the PIS.

A risk assessment will be undertaken and updated in relation to visiting participants for research meetings (See safe

working policy). This is stated in the Participant information sheet. Further detail on the type of information that will

V e r s i o n 1 , 0 7 / 1 2 / 2 0 1 4 P a g e | 26

be sought as part of the risk assessments is outlined in the Safe Working Policy, included with this proposal.

8.4 Indemnity

The University of Liverpool holds Indemnity and insurance cover with Marsh UK LTD, which apply to this study.

8.5 Sponsor

The University of Liverpool will act as the main Sponsor for this study. Delegated responsibilities will be assigned to

the NHS trusts taking part in this study.

8.6 Funding

Funding has been obtained from the Association for Cognitive Analytic Therapy (ACAT). Participants will be

reimbursed with shopping coupons for their involvement in the baseline, post therapy and follow up assessments, as

these assessments are additional to the normal service clients would otherwise receive. Participants will receive a

£10 coupon for each assessment. Participants will be able to withdraw from therapy but remain involved in the

research component of the study if they wish, and so the reimbursement should not leave participants feeling

pressured to remain in therapy if they do not wish to.

Research assistants will be paid on an hourly basis at a Band 6 rate for their involvement in recruitment and

assessment.

8.7 Audits

The study may be subject to inspection and audit by the University of Liverpool under their remit as sponsor and

other regulatory bodies to ensure adherence to GCP and the NHS Research Governance Framework for Health and

Social Care (2nd

edition).

9. Study Management

The day‐to‐day management of the study will be coordinated through Dr Peter Taylor.

10. End of Study

The study will come to an end when all enrolled participants (n = 13) have either completed the two-month post-

V e r s i o n 1 , 0 7 / 1 2 / 2 0 1 4 P a g e | 27

therapy follow-up, or alternatively have decided to withdraw from the study.

11. Archiving

Data and all appropriate documentation will be stored for 10 years after the completion of the study. Data will be

stored in an anonymous form.

12. Publication Policy

The results of the study will be written-up and submitted for publication within a peer-reviewed journal. In addition the

results of the project will be presented at a national conference. A half-day event will also be held at the University of

Liverpool, to which a variety of stakeholders including researchers, clinicians and service-users and carers will be

invited, where the results of the project will also be disseminated. Finally, a press-release concerning the results of

the project will be undertaken from the University of Liverpool.

13. References

Addington, D., Addington, J., & Maticka-Tyndale, E. (1993). Assessing depression in schizophrenia: The Calgary

Depression Scale. The British Journal of Psychiatry, 163 (suppl. 22), 39-44.

American Psychiatric Association. (2000). Diagnostic and statistical manual of mental disorders (4th, text revision

ed.). Washington, DC: Author.

Bedford, A., Davies, F., & Tibbles, J. (2009). The Personality Structure Questionnaire (PSQ): A cross-validation with

a large clinical sample. Clinical Psychology & Psychotherapy, 16(1), 77-81. doi: 10.1002/cpp.603

Bennett, D., & Parry, G. (2004). A measure of psychotherapeutic competence derived from cognitive analytic

therapy. Psychotherapy Research, 14(2), 176-192. doi: 10.1093/ptr/kph016

Berry, K., Barrowclough, C., & Haddock, G. (2011). The role of expressed emotion in relationships between

psychiatric staff and people with a diagnosis of psychosis: A review of the literature. Schizophr Bull, 37(5),

958-972. doi: 10.1093/schbul/sbp162

Berry, K., Wearden, A., Barrowclough, C., & Liversidge, T. (2006). Attachment styles, interpersonal relationships and

psychotic phenomena in a non-clinical student sample. Personality and Individual Differences, 41(4), 707-

718. doi: http://dx.doi.org/10.1016/j.paid.2006.03.009

V e r s i o n 1 , 0 7 / 1 2 / 2 0 1 4 P a g e | 28

Birchwood, M. (2003). Pathways to emotional dysfunction in first-episode psychosis. The British Journal of

Psychiatry, 182(5), 373-375. doi: 10.1192/bjp.02.153

Bird, V., Premkumar, P., Kendall, T., Whittington, C., Mitchell, J., & Kuipers, E. (2010). Early intervention services,

cognitive-behavioural therapy and family intervention in early psychosis: Systematic review. British Journal

of Psychiatry, 197(5), 350-356. doi: 10.1192/bjp.bp.109.074526

Bowling, A. (2000). Research Methods in Health. Buckingham: Open University Press.

Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3(2), 77-

101. doi: 10.1191/1478088706qp063oa

Calvert, R., & Kellett, S. (in press). Cognitive analytic therapy: A review of the outcome evidence base for treatment.

Psychology & Psychotherapy. doi: 10.1111/papt.12020

Cameron, I. M., Crawford, J. R., Lawton, K., & Reid, I. C. (2008). Psychometric comparison of PHQ-9 and HADS for

measuring depression severity in primary care. British Journal of General Practice, 58(546), 32-36. doi:

10.3399/bjgp08X263794

Chanen, A. M., McCutcheon, L., Germano, D., Nistico, H., Jackson, H., & McGorry, P. D. (2009). The HYPE clinic:

An early intervention service for borderline personality disorder. urnal of Psychiatric Practice, 15, 163-172.

doi: 10.1097/01.pra.0000351876.51098.f0

Craig, P., Diepe, P., Macintyre, S., Michie, S., Nazareth, I., & Petticrew, M. (2008). Developing and evaluating

complex interventions: New guidance. www.mrc.ac.uk/complexinterventionsguidance

Deprtment of Health. (2012). Liberating the NHS: NO decision about me, without me Retrieved from

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/216980/Liberating-the-NHS-

No-decision-about-me-without-me-Government-response.pdf

Edwards, I. R., & Aronson, J. K. (2000). Adverse drug reactions: definitions, diagnosis, and management. The

Lancet, 356, 1255-1259. doi: 10.1016/S0140-6736(00)02799-9

Falchi, V. (2007). Using CAT in an assertive outreach team: A reflection on current issues. Reformulation, Summer,

11-17.

Gleeson, J. F. M., Chanen, A., Cotton, S. M., Pearce, T., Newman, B., & McCutcheon, L. (2012). Treating co-

occurring first-episode psychosis and borderline personality: A pilot randomized controlled trial. Early

Intervention in Psychiatry, 6(1), 21-29. doi: 10.1111/j.1751-7893.2011.00306.x

V e r s i o n 1 , 0 7 / 1 2 / 2 0 1 4 P a g e | 29

Hatcher, R. L., & Gillaspy, J. A. (2006). Development and validation of a revised short version of the Working

Alliance Inventory. Psychotherapy Research, 16(1), 12-25. doi: 10.1080/10503300500352500

Hermes, E. D., Sokoloff, D., Stroup, T. S., & Rosenheck, R. A. (2012). Minimum clinically important difference in the

Positive and Negative Syndrome Scale with data from the Clinical Antipsychotic Trials of Intervention

Effectiveness (CATIE). Journal of Clinical Psychiatry, 73(4), 526-532. doi: 10.4088/JCP.11m07162

Horvath, A. O., Del Re, A. C., Flückiger, C., & Symonds, D. (2011). Alliance in individual psychotherapy.

Psychotherapy. 48, 9–16. doi: 10.1037/a0022186

Horvath, A. O., & Symonds, B. D. (1991). Relation between working alliance and outcome in psychotherapy: A meta-

analysis. . Journal of Counseling Psychology, 38, 139-149. doi: 10.1037/0022-0167.38.2.139

Hutton, P. (2013). Cognitive-behavioural therapy for schizophrenia: A critical commentary on the Newton-Howes and

Wood meta-analysis. Psychology and Psychotherapy, 86, 139–145. doi: 10.1111/papt.12009

Hutton, P., Wood, L., Taylor, P. J., Sellers, R., & Morrison, A. P. (submitted). The longer-term benefits of cognitive

behavioural therapy for schizophrenia: A reply to Jauhar et al.

Jacobsen, N. S., & Truax, P. (1991). Clinical significance: A statistical approach to defining meaningful change in

psychotherapy research. Journal of Consulting and Clinical Psychology, 59, 12-19. doi: 10.1037/0022-

006X.59.1.12

Jauhar, S., McKenna, P. J., Radua, J., Fung, E., Salvador, R., & Laws, K. R. (2014). Cognitive-behavioural therapy

for the symptoms of schizophrenia: Systematic review and meta-analysis with examination of potential bias.

British Journal of Psychiatry, 204(1), 20-29. doi: 10.1192/bjp.bp.112.116285

Kellett, S., Wilbram, M., Davis, C., & Hardy, G. (2014). Team consultancy using cognitive analytic therapy: A

controlled study in assertive outreach. J Psychiatr Ment Health Nurs. doi: 10.1111/jpm.12123

Kerr, I. B. (2001). Brief cognitive analytic therapy for post-acute manic psychosis on a psychiatric intensive care unit.

Clinical Psychology & Psychotherapy, 8(2), 117-129. doi: 10.1002/cpp.251

Kerr, I. B., Birkett, P. B., & Chanen, A. (2003). Clinical and service implications of a cognitive analytic therapy model

of psychosis. Aust N Z J Psychiatry, 37(5), 515-523.

Kerr, I. B., Crowley, V., & Beard, H. (2006). A cognitive analytic therapy-based approach to psychotic disorder. In J.

O. Johannessen, B. V. Martindale & J. Cullberg (Eds.), Evolving Psychosis (pp. 172-184). London: ISPS.

V e r s i o n 1 , 0 7 / 1 2 / 2 0 1 4 P a g e | 30

Klingberg, S., Wittorf, A., Meisner, C., Wolwer, W., Wiedemann, G., Herrlich, J., . . . Buchkremer, G. (2010).

Cognitive behavioural therapy versus supportive therapy for persistent positive symptoms in psychotic

disorders: The POSITIVE Study, a multicenter, prospective, single-blind, randomised controlled clinical trial.

Trials, 11, 123. doi: 10.1186/1745-6215-11-123

Kroenke, K., Spitzer, R. L., & Williams, J. B. W. (2001). The PHQ-9. Journal of General Internal Medicine, 16(9),

606-613. doi: 10.1046/j.1525-1497.2001.016009606.x

Law, H., Neil, S. T., Dunn, G., & Morrison, A. P. (2014). Psychometric properties of the Questionnaire about the

Process of Recovery (QPR). Schizophrenia Reseach, 156(2-3), 184-189. doi: 10.1016/j.schres.2014.04.011

Margison, F. (2005). Integrating approaches to psychotherapy in psychosis. Australian and New Zealand Journal of

Psychiatry, 39, 972–981. doi: 10.1111/j.1440-1614.2005.01715.x

Miller, R., & Mason, S. E. (2005). Shame and guilt in first-episode schizophrenia and schizoaffective disorders.

Journal of Contemporary Psychotherapy, 35(2), 211-221. doi: 10.1007/s10879-005-2701-4

Morrison, A. P., Hutton, P., Wardle, M., Spencer, H., Barratt, S., Brabban, A., . . . Turkington, D. (2012). Cognitive

therapy for people with a schizophrenia spectrum diagnosis not taking antipsychotic medication: An

exploratory trial. Psychological Medicine, 42(05), 1049-1056. doi: doi:10.1017/S0033291711001899

Munder, T., Wilmers, F., Leonhart, R., Linster, H. W., & Barth, J. (2010). Working Alliance Inventory-Short Revised

(WAI-SR): Psychometric properties in outpatients and inpatients. Clin Psychol Psychother, 17(3), 231-239.

doi: 10.1002/cpp.658

National Institute for health and Care Excellence. (2014). Psychosis and schizophrenia in adults: Treatment and

management Retrieved from http://publications.nice.org.uk/psychosis-and-schizophrenia-in-adults-

treatment-and-management-cg178/recommendations#first-episode-psychosis-2

Nielssen, O. B., & Large, M. M. (2009). Untreated psychotic illness in the survivors of violent suicide attempts. Early

Interv Psychiatry, 3(2), 116-122. doi: 10.1111/j.1751-7893.2009.00117.x

Palmer, B. A., Pankratz, S., & Bostwick, J. M. (2005). The lifetime risk of suicide in schizophrenia: A rexamination.

Archives of General Psychiatry, 62, 247-253. doi: 10.1001/archpsyc.62.3.247

Penn, D. L., Mueser, K. T., Tarrier, N., Gloege, A., Cather, C., Serrano, D., & Otto, M. W. (2004). Supportive therapy

for schizophrenia: Possible Mechanisms and implications for adjunctive psychosocial treatments. Schizophr

Bull, 30(1), 101-112.

V e r s i o n 1 , 0 7 / 1 2 / 2 0 1 4 P a g e | 31

Perry, A. (2012). CAT with people who hear distressing voices. Reformulation, summer, 16-22.

Pollock, P. H., Broadbent, M., Clarke, S., Dorrian, A., & Ryle, A. (2001). The personality structure questionnaire

(PSQ): A measure of the multiple self states model of identity disturbance in cognitive analytic therapy.

Clinical Psychology & Psychotherapy, 8(1), 59-72. doi: 10.1002/cpp.250

Read, J., van Os, J., Morrison, A. P., & Ross, C. A. (2005). Childhood trauma, psychosis and schizophrenia: A

literature review with theoretical and clinical implications. Acta Psychiatry Scandinavica, 112(5), 330-350.

doi: 10.1111/j.1600-0447.2005.00634.x

Roe, D., Goldblatt, H., Baloush-Klienman, V., Swarbrick, M., & Davidson, L. (2009). Why and how people decide to

stop taking prescribed psychiatric medication: Exploring the subjective process of choice. Psychiatric

Rehabilitation Journal, 33(1), 38-46. doi: 10.2975/33.1.2009.38.46

Ryle, A., & Kerr, I. B. (2002). Introducing cognitive analytic therapy: Principles and practice. Oxford: Wiley-Blackwell.

Sarin, F., Wallin, L., & Widerlov, B. (2011). Cognitive behavior therapy for schizophrenia: A meta-analytical review of

randomized controlled trials. Nord J Psychiatry, 65(3), 162-174. doi: 10.3109/08039488.2011.577188

Tarrier, N., Lewis, S., Haddock, G., Bentall, R., Drake, R., Kinderman, P., . . . Dunn, G. (2004). Cognitive-

behavioural therapy in first-episode and early schizophrenia: 18-month follow-up of a randomised controlled

trial The British Journal of Psychiatry, 184, 231-239. doi: 10.1192/bjp.184.3.231

Wood, A. M., White, I. R., & Thompson, S. G. (2004). Are missing outcome data adequately handled? A review of

published randomized controlled trials in major medical journals. Clinical Trials, 1(4), 368-376. doi:

10.1191/1740774504cn032oa

Wykes, T., Steel, C., Everitt, B., & Tarrier, N. (2008). Cognitive behavior therapy for schizophrenia: Effect sizes,

clinical models, and methodological rigor. Schizophr Bull, 34(3), 523-537. doi: 10.1093/schbul/sbm114

Yamamoto, N., Inada, T., Shimodera, S., Morokuma, I., & Furukawa, T. A. (2010). Brief PANSS to assess and

monitor the overall severity of schizophrenia. Psychiatry and Clinical Neurosciences, 64(3), 262-267. doi:

10.1111/j.1440-1819.2010.02081.x

V e r s i o n 1 , 0 7 / 1 2 / 2 0 1 4 P a g e | 32