Can Imagination Change Upsetting Memories of Trauma?
Phase: PHASE1
Conditions: Psychosis
Sponsor: King's College London

IRAS: 238377 
Version 1.2 
 
16/03/2018  
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1. Can imagination change upsetting memories of trauma? 
Protocol Short Title/ Acronym: Can imagination change upsetting memories of 
trauma? 
 
Trial Identifiers  
ISRCTN: 
 
REC Number: 
18/LO/0684 
UKCRN Number: 
 
Protocol Version 
Number: 
1.2 
Date: 
16/03/2018 
 
(Co) Sponsor(s) 
Name: 
Professor Reza Razavi, Vice President & Vice Principal (Research), King’s 
College London 
Address: 
Room 5.31, James Clerk Maxwell Building, Waterloo Campus, King's College 
London, London, SE1 8WA 
Telephone: 
020 7848 3224 
Fax: 
 
Email: 
reza.razavi@kcl.ac.uk 
 
Name: 
Jennifer Liebscher, R&D Department, South London & Maudsley Foundation 
Trust 
Address: 
Room W1.11, Institute of Psychiatry, Psychology & Neuroscience (IoPPN), De 
Crespigny Park, London, SE5 8AF 
Telephone: 
020 7848 0251 
Fax: 
 
Email: 
Jennifer.liebscher@kcl.ac.uk 
 
Student (Doctorate in Clinical Psychology) 
Name: 
Rachel Clarke 
Address: 
Addiction Sciences Building, Department of Psychology, Institute of Psychiatry, 
Psychology & Neuroscience, 4 Windsor Walk, London, SE5 8AF 
Telephone: 
07486854611 

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Fax: 
 
Email: 
Rachel.clarke@kcl.ac.uk 
 
Academic Supervisors 
 
Name: 
Dr Amy Hardy 
Position/ Role: 
First/Primary Supervisor & Chief Investigator 
Address: 
Henry Wellcome Building, Department of Psychology, Institute of Psychiatry, 
Psychology & Neuroscience, King’s College London, De Crespigny Park, 
London, SE5 8AF 
Telephone: 
0207 8485178 
Fax: 
0207 8485006 
Email: 
amy.hardy@kcl.ac.uk 
 
Name: 
Dr Rebecca Kelly 
Position/ Role: 
Second/Secondary Supervisor 
Address: 
PICuP Clinic, P079, Maudsley Psychology Centre, Denmark Hill, London, SE5 
8AZ 
Telephone: 
020 3228 3952 
Fax: 
 
Email: 
Rebecca.kelly@slam.nhs.uk 
 
 
2. Study Synopsis 
TITLE OF CLINICAL TRIAL: 
Can imagination change upsetting memories of trauma? 
Protocol Short Title/ Acronym: 
Can imagination change upsetting memories of trauma? 
Sponsor Name: 
King’s College London 
Chief Investigator: 
Rachel Clarke 
UKCRN Number: 
 
REC Number: 
 

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Medical Condition Or Disease 
Under Investigation: 
Psychosis 
Purpose Of Clinical Trial: 
Explore the feasibility and impact of imagery rescripting in 
individuals diagnosed with schizophrenia spectrum disorder or a 
mood disorder with psychotic features using a multiple baseline 
case series design 
Primary Objective: 
To explore the feasibility and impact of imagery rescripting as a 
therapeutic technique for traumatic memories in individuals with 
psychosis 
Secondary Objective(s): 
 
Trial Design: 
Nonconcurrent multiple baseline case series 
Endpoints: 
The project is completed once all the data has been analysed 
and submitted for publication. 
Sample Size: 
6-12 
Summary Of Eligibility Criteria: 
- Age 18-65 
- Diagnosis of a Schizophrenia-spectrum disorder or mood 
disorder with psychotic features 
- Able to identify an intrusive traumatic memory occurring at 
least twice in the past week, as assessed by the Post-Traumatic 
Stress Diagnostic Scale.  
- Sufficient English to participate in the project 
- Open to a care team within the Psychosis CAG 
Intervention (Description, 
frequency, details of delivery) 
Three sessions of Imagery Rescripting delivered by a therapist 
Maximum Duration Of Treatment Of 
A Subject: 
Three Weeks 
Version And Date Of Final Protocol: 
V1.2 16/03/2018 
Version And Date Of Protocol 
Amendments: 
N/A 
 
 
3. Revision History 
Document ID - (Document 
Title) revision X.Y 
Description of changes from previous revision 
Effective Date 
Protocol v1.0 
Chief investigator changed in line with IRAS to primary 
supervisor; appendices deleted for separate version 
controlled documents; included medical records will be 
accessed with participant’s permission; reworded 
section 10.3 surrounding participants giving consent to 
be contacted by the research team;  
11/03/2018 

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Protocol v1.1 
Changes made to recording device. 
14/03/2018 
4. Glossary of terms 
ImRs – Imagery Rescripting 
Psychosis – Individuals with a diagnosis of schizophrenia spectrum disorder or mood disorder with psychotic 
features 
5. Protocol Contents 
 
1. 
CAN IMAGINATION CHANGE UPSETTING MEMORIES OF TRAUMA? ...............................................1 
2. 
STUDY SYNOPSIS .....................................................................................................................................2 
3. 
REVISION HISTORY ..................................................................................................................................3 
4. 
GLOSSARY OF TERMS .............................................................................................................................4 
5. 
PROTOCOL CONTENTS ...........................................................................................................................4 
6. 
BACKGROUND & RATIONALE ................................................................................................................6 
7. 
TRIAL OBJECTIVES AND DESIGN ..........................................................................................................7 
7.1 
TRIAL OBJECTIVES .................................................................................................................................7 
7.1.1 
Primary endpoints .........................................................................................................................7 
7.1.2 
Secondary endpoints ....................................................................................................................7 
7.2 
TRIAL DESIGN ........................................................................................................................................7 
7.3 
TRIAL FLOWCHART .................................................................................................................................7 
The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) .................................................................7 
Mini-Trauma and Life Events Checklist (mini-TALE) ..................................................................................7 
8. 
TRIAL INTERVENTION ..............................................................................................................................8 
8.1 
THERAPY/INTERVENTION DETAILS ...........................................................................................................8 
8.2 
FREQUENCY AND DURATION OF INTERVENTION .........................................................................................8 
8.3 
INTERVENTION RECORDS ........................................................................................................................8 
8.4 
SUBJECT COMPLIANCE. ..........................................................................................................................9 
8.5 
STUDY ADHERENCE ................................................................................................................................9 
8.6 
5.5 CONCOMITANT MEDICATION ..............................................................................................................9 
9. 
RESEARCH ENVIRONMENT .....................................................................................................................9 
10. 
SELECTION AND WITHDRAWAL OF SUBJECTS ...............................................................................9 
10.1 
INCLUSION CRITERIA ...........................................................................................................................9 
10.2 
EXCLUSION CRITERIA ..........................................................................................................................9 
10.3 
SELECTION OF PARTICIPANTS ..............................................................................................................9 
10.4 
RANDOMISATION PROCEDURE / CODE BREAK ................................................................................... 10 
10.5 
WITHDRAWAL OF SUBJECTS ............................................................................................................. 10 
10.6 
EXPECTED DURATION OF TRIAL. ....................................................................................................... 10 
11. 
TRIAL PROCEDURES ......................................................................................................................... 10 
11.1 
BY VISIT .......................................................................................................................................... 10 
11.2 
LABORATORY TESTS ........................................................................................................................ 11 
12. 
ASSESSMENT OF EFFICACY ............................................................................................................ 11 
12.1 
PRIMARY EFFICACY PARAMETERS .................................................................................................... 11 

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30-minute semi-structured interview ........................................................................................................ 11 
12.2 
SECONDARY EFFICACY PARAMETERS ............................................................................................... 12 
Psychotic Symptom Rating Scales (PSYRATS; Haddock, McCarron, Tarrier, & Faragher, 1999) ......... 12 
The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS; Tennant et al., 2007) ............................ 12 
12.3 
PROCEDURES FOR ASSESSING EFFICACY PARAMETERS .................................................................... 12 
13. 
ASSESSMENT OF SAFETY ................................................................................................................ 12 
13.1 
BURDEN .......................................................................................................................................... 12 
13.2 
RISK OF DISTRESS ........................................................................................................................... 13 
13.3 
SPECIFICATION, TIMING AND RECORDING OF SAFETY PARAMETERS. .................................................. 13 
13.4 
PROCEDURES FOR RECORDING AND REPORTING ADVERSE EVENTS .................................................. 13 
13.4.1 
Adverse events that do not require reporting ............................................................................. 13 
13.5 
STOPPING RULES ............................................................................................................................ 13 
14. 
STATISTICS ......................................................................................................................................... 14 
14.1 
SAMPLE SIZE ................................................................................................................................... 14 
14.2 
RANDOMISATION .............................................................................................................................. 14 
14.3 
ANALYSIS ........................................................................................................................................ 14 
15. 
TRIAL STEERING COMMITTEE ......................................................................................................... 14 
16. 
DATA MONITORING COMMITTEE ..................................................................................................... 14 
17. 
DIRECT ACCESS TO SOURCE DATA AND DOCUMENTS .............................................................. 14 
18. 
ETHICS & REGULATORY APPROVALS ........................................................................................... 14 
19. 
QUALITY ASSURANCE ...................................................................................................................... 14 
20. 
DATA HANDLING ................................................................................................................................ 14 
21. 
DATA MANAGEMENT ......................................................................................................................... 15 
21.1 
ACCESS TO MEDICAL RECORDS ....................................................................................................... 15 
21.2 
PERSONAL DATA.............................................................................................................................. 15 
21.3 
AUDIO/VISUAL RECORDING .............................................................................................................. 15 
21.4 
MANUAL FILES ................................................................................................................................. 15 
21.5 
UNIVERSITY COMPUTERS ................................................................................................................. 15 
22. 
PUBLICATION POLICY ....................................................................................................................... 15 
23. 
INSURANCE / INDEMNITY .................................................................................................................. 15 
24. 
FINANCIAL ASPECTS ........................................................................................................................ 16 
25. 
SIGNATURES ...................................................................................................................................... 16 
26. 
REFERENCES ..................................................................................................................................... 16 
27. 
APPENDICES – SEE SEPARATE DOCUMENTS .............................................................................. 17 
27.1 
PARTICIPANT INFORMATION SHEET ................................................................................................... 17 
27.2 
CONSENT FORM ............................................................................................................................... 17 
27.3 
THERAPY INFORMATION SHEET ........................................................................................................ 17 
 

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6. Background & Rationale 
Intrusive images are a key mechanism in many disorders, including posttraumatic stress disorder (DSM-5, 
American Psychiatric Association, 2013) and other anxiety disorders (e.g. Hirsch & Holmes, 2007). Negative 
intrusive images are also common in individuals with psychosis, and are associated with memories (Morrison 
et al., 2002). Traumatic memories are argued to be central to the development and maintenance of PTSD 
(Ehlers & Clark, 2000), and are also proposed to play a role in some people’s experience of psychosis 
(Hardy, 2017; Morrison et al., 2002; Steel, 2015). 
Therapeutically, imagery interventions have been posited as effective techniques for individuals with a range 
of disorders characterised by negative imagery (Hackmann, Bennett-Levy, & Holmes, 2011; Holmes, Arntz, 
& Smucker, 2007). Imagery rescripting, an intervention where one changes the content of pre-existing 
traumatic memories, has been used as a therapeutic intervention with a variety of psychological disorders 
(Hackmann et al., 2011). In a recent meta-analysis of 19 trials on individuals with a variety of disorders, 
including posttraumatic stress disorder, social anxiety disorder and major depression, the large effect sizes 
suggest a high reduction in symptoms after therapy, and in comparison, to passive treatment controls 
(Morina, Lancee, & Arntz, 2016). Although the mechanism for change has yet to be identified, it has been 
argued that therapeutic change occurs due to a change in meaning given by the rescripted memory (Arntz, 
2012). 
In people with psychosis, there is currently limited, but promising, evidence for the use of imagery rescripting 
(Ison, Medoro, & Kuipers, 2014; Morrison et al., 2002; Schulze et al., 2013; Serruya & Grant, 2009; Sheaves 
et al., 2015). Many of these studies show that a brief intervention of imagery rescripting is a viable method of 
working with intrusive imagery in people with psychosis, however to date only Ison, Medoro, & Kuipers 
(2014) has looked at rescripting traumatic memories. However, as this project did not use a multiple-baseline 
design, it did not control fully for the effects of time. It also restricted its sample to voice hearers, which may 
not represent individuals with psychosis more generally. This project aims to explore the impact of imagery 
rescripting in individuals diagnosed with schizophrenia spectrum disorder or a mood disorder with psychotic 
features using a multiple baseline design. The imagery rescripting intervention will be provided over three 
weekly sessions and will focus on one traumatic memory chosen by the client. 
Burden: The burden placed on participants has been minimised as much as possible by carefully considering 
the inclusion of each measure in the case series. Furthermore, the assessment session can be split into 
several shorter sessions, should the participant wish. Breaks will be offered in each therapeutic and 
assessment session and the research therapist will support the participant to ensure that the delivery of the 
research and therapeutic procedures is acceptable to them and modify if needed. For example, participants 
will complete daily ratings about their memory via text, email, or phone. The research therapist will discuss 
with participants how many ratings (up to a maximum of four a day) they are able to complete, and how they 
would like to be prompted to answer them. This will be reviewed throughout the project. 
Risks: The focus of this project is distressing, traumatic memories, and participants will be required to focus 
on and discuss them during their participation which may be difficult. However, there is robust evidence to 
suggest that trauma-focused therapies can be safely applied in psychosis and that imagery rescripting can 
be used with this group to reduce distress associated with images (Ison et al., 2014; van den Berg et al., 
2016). Participants will be selected as they regularly experience intrusive trauma memories, and therefore 
the study will only focus on eliciting experiences which they already have. Further, the project supervisors 
have extensive experience of working with traumatic memories in psychosis and will be able to ensure the 
intervention is delivered safely and sensitively. Participants will be giving informed consent to participate in 
the study. 
Should the participant become distressed at any point and feel unable to continue with the therapy, then the 
study will be terminated, and the research therapist will discuss this with them. The supervisors of this project 
have extensive clinical experience in this group and will be available for consultation should this situation 
arise. In addition, the research therapist has experience working with this group of people and will manage 
the situation should it arise with the support of the supervisors. Information pertaining to risk will be shared 
as needed with the clinical team, in accordance with local risk management protocols. Coping strategies will 
be discussed with participants at the beginning of the intervention to support them in managing any distress 
that arises. 
Benefit: It is hoped that participants will benefit from the intervention, as research has previously suggested a 
positive effect of imagery rescripting in individuals with psychosis (Ison et al., 2014). However, participants 
will be given this information alongside the fact that this study is exploratory and therefore potential benefits 
cannot be guaranteed. Despite this, disclosure of trauma in a supportive, therapeutic context can be 

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beneficial on its own, with trauma-focused therapy for psychosis trials finding that even control group 
participants improve (Steel et al., 2017; van den Berg et al., 2015). 
7. Trial Objectives and Design  
7.1 
Trial Objectives 
7.1.1 Primary endpoints 
The overall aim of this project is to investigate the feasibility and impact of imagery rescripting as a 
therapeutic technique for traumatic memories in individuals with psychosis. 
7.1.2 Secondary endpoints 
 
7.2 
Trial Design  
A nonconcurrent multiple baseline case series (A1BA2) design will be utilised. Participants will be 
randomised to a baseline of 1-3 weeks symptom monitoring before receiving three sessions of ImRs and two 
weeks follow-up. 
7.3 
Trial Flowchart 
 
Recruitment 
visit 
Assessment 
visit 
Waitlist 
1-3 
weeks 
Treatment 
period 3 
weeks 
Week 1 
post 
treatment 
1-week 
appointment 
post-
treatment 
Week 2 
post-
treatment 
Patient 
information  
X 
 
 
 
 
 
 
Informed consent 
 
X 
 
 
 
 
 
30-minute Semi-
structured 
interview 
 
X 
 
 
 
 
 
Psychotic 
Symptom Rating 
Scale 
(PSYRATS) 
 
X 
 
 
 
 
 
The Warwick-
Edinburgh Mental 
Well-Being Scale 
(WEMWBS) 
 
x 
 
 
 
x 
 
The 
Posttraumatic 
Diagnostic Scale 
for DSM-5 (PDS-
5) 
 
x 
 
 
 
x 
 
Mini-Trauma and 
Life Events 
Checklist (mini-
TALE) 
 
x 
 
 
 
 
 
Credibility and 
Expectancy 
 
 
 
x 
 
 
 

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Questionnaire 
(CEQ) 
Client Satisfaction 
Questionnaire 
(CSQ-8) 
 
 
 
 
 
x 
 
Daily trauma 
index memory 
dimensions 
 
 
x 
 
x 
 
x 
Imagery 
Rescripting 
 
 
 
x 
 
 
 
 
 
8. Trial Intervention 
8.1 
 Therapy/Intervention Details 
Participants will receive three sessions of imagery rescripting. The first session will include psychoeducation, 
recapping the identified memory, practicing the protocol on a non-threatening memory, and recapping coping 
strategies. The next two sessions will include rescripting the memory and problem-solving the rescript ImRs 
protocol will be personalised to the participants needs, drawing on several imagery rescripting protocols (e.g. 
Arntz, Tiesema, & Kindt, 2007; Jung & Steil, 2013; Lee & James, 2011). 
8.2 
Frequency and duration of intervention 
Three weekly sessions of imagery rescripting will be delivered. Sessions will last approximately one hour, 
and no longer than 90 minutes. 
8.3 
Intervention records 
Access to medical records will be used to confirm the participants’ diagnosis. Furthermore, the researcher 
will need to access and add brief entries to the participant’s electronic medical records through the electronic 
Patient Journey System within SLaM. 
Personal Data 
This will be needed to contact participants both to arrange appointments and to contact them in the future 
should any relevant information arise. It will be stored separately from the anonymised data and it will not be 
possible to link this data to that which is collected during the project. 
Audio/Visual Recording 
Participants will be audio-recorded during their assessment and treatment, they will be asked to sign a 
separate consent form for this recording. The recording will be done on a password protected, encrypted 
mobile and the researcher will ensure no identifiable information is recorded. This mobile will be stored in a 
locked filing cabinet at King's College London when not being used by the research therapist, and recordings 
will be stored on Office 365 as soon as the research therapist returns to the office environment. GPS will be 
activated on the phone and remote lock and erase will be enabled. 
Manual Files 
All data will be collected using paper questionnaires and interviews - these will be identified using participant 
codes only and will not contain any identifiable information. These will be kept in a locked filing cabinet at 
King's College London. 
University Computers 
All data will be entered into Kings College London computers and password-protected. It will be stored in 
office 365 one drive which is a secure cloud-based service offered by the university. 
Direct Quotations 

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Consent for anonymised quotations from participants to be included in publications arising from the project 
will be 
included in the consent form. It will be clear to participants that this is optional. 
8.4 
Subject Compliance. 
Compliance will be assessed by recording therapy session attendance. 
8.5 
Study adherence 
The research therapist’s adherence to the intervention protocol will be ensured through training and 
supervision by the project supervisors.  Participant adherence to the intervention will be supported by the 
research therapist, with additional prompts to attend sessions and adhere to the intervention protocol 
provided as needed.  
8.6 
5.5 Concomitant Medication 
Concurrent medication and therapeutic treatment would not preclude participation in the project, however 
individuals who are receiving concurrent therapeutic treatment focusing on trauma will not be able to 
participate (because of the difficulty in attributing any change to the therapy approach being tested in this 
project).  
9. Research environment 
Potential participants will be recruited through liaison with the identified clinical teams or self-
referral.  The researchers will visit team meetings to introduce the research and give brief 
information.  Regular contact will be maintained with the teams to identify suitable participants.  
Recruitment leaflets about the research will be given to teams to distribute to potential clients, who 
can then be contacted by the research therapist if they say they are interested in participating. 
Posters will also be put up in identified teams’ waiting rooms. These will detail contact information 
for the research therapist, so that potential participants can contact the research therapist directly 
with their interest. The research therapist will ask the participant for an identified clinician to contact 
in order to check eligibility before meeting with the participant. Meetings with participants will be 
arranged in a community setting, either within South London and the Maudsley community 
outpatient setting or Kings College London University buildings. 
10. Selection and Withdrawal of Subjects  
10.1 Inclusion Criteria  
- 
Age 18-65 
- 
Diagnosis of a Schizophrenia-spectrum disorder or mood disorder with psychotic features 
- 
Able to identify an intrusive traumatic memory occurring at least twice in the past week, as assessed by 
the Post-Traumatic Stress Diagnostic Scale.  
- 
Sufficient English to participate in the project 
10.2 Exclusion Criteria  
- 
Concurrent trauma-focused psychological therapy 
- 
Primary diagnosis of learning disability, substance use or organic disorder 
- 
Acute suicide risk 
 
10.3 Selection of Participants  

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This project will recruit 12 participants from teams in the Promoting Recovery care pathway, 
Psychosis CAG of SLaM NHS foundation trust. Potential participants will be recruited through 
liaison with the identified clinical teams or self-referral.  The researchers will visit team meetings to 
introduce the research and give brief information. Regular contact will be maintained with the 
teams to identify suitable participants.  A leaflet about the research will be given to teams to 
distribute to potential clients. Posters will also be posted in identified teams’ waiting rooms detailing 
the study and research therapist’s contact details to allow participants to self-refer to the project. 
The recruitment strategy will be flexible and adapted depending on the capacity of the team to be 
involved in the research at any given time. Initially, the recruitment focus will be on teams where 
the researchers already have clinical roles (e.g. PiCuP) with the possibility of recruitment from 
other services considered in close collaboration with service leads and managers. 
The researcher will liaise closely with clinicians and teams throughout the research.  The project 
supervisors and researchers all have trust contracts and the supervisors are very experienced at 
working with the service user group.  
Potential participants will only be approached by the research therapist when participants’ have 
given consent to their clinical care team to be approached, and when they have the capacity to 
consent. The first contact will only be to introduce the project and pass on the information sheet. 
Both written and verbal information will explain the purpose and potential efficacy of the 
intervention to participants but will be transparent that this study seeks to find out whether the 
intervention is effective for people with psychosis, and therefore positive outcomes are not 
guaranteed.  
The potential participant will have at least 24 hours to consider whether they wish to take part, 
during which the researcher will only contact them to answer questions if they wish. It will be made 
clear to participants that the intervention will take place after a wait-list time of 1-3 weeks.  
10.4 Randomisation Procedure / Code Break 
Participants will be randomised to a waitlist time of 1, 2, or 3 weeks. Randomisation will occur at assessment 
using a computer program.  
10.5 Withdrawal of Subjects  
Participants have the right to withdraw from the project at any time for any reason.  The investigator also has 
the right to withdraw participants from the project in the event of unanticipated distress, unanticipated risk to 
self or others, or lack of capacity.  It is understood by all concerned that an excessive rate of withdrawals can 
render the project uninterpretable; therefore, unnecessary withdrawal of participants should be avoided.  
Should a participant decide to withdraw from the project, all efforts will be made to report the reason for 
withdrawal as thoroughly as possible.  Should a participant withdraw from project, efforts will be made to 
continue to obtain follow-up data, with the permission of the participant. 
10.6 Expected Duration of Trial. 
The project is completed once all 12 participants have completed their final follow-up appointments, two 
weeks after finishing therapy. The project is anticipated to be complete before the end of September 2020 
11.  Trial Procedures  
11.1  By Visit 
Initial Assessment: The full battery of questionnaires will include a semi-structured interview to identify an 
intrusive trauma memory (adapted from Hackmann, Clark, & McManus, 2000), a measure of well-being (The 
Warwick-Edinburgh Mental Well-Being Scale, WEBWMS), traumatic events (Mini-Trauma and Life Events 
Checklist, Mini-TALE), posttraumatic stress disorder (The Posttraumatic Diagnostic Scale for DSM-5, PDS-
5), and psychosis symptoms (Psychotic Symptom Rating Scales, PSYRATS).  Four visual analogue scale 
questions will be completed daily by the participant throughout the project. These questions will focus on the 
participant’s conviction in the distressing appraisal, frequency, distress, and sense of control associated with 
the memory. The initial assessment will take approximately 90 minutes. The assessment can be split into 

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smaller sessions, as needed by the participant. Participants will be randomised following the initial 
assessment to their baseline waitlist time (one, two, or three weeks).  
For the duration of their participation, the participant will be contacted daily to answer the four visual 
analogue scale questions about their trauma memory. Participants will be introduced to the daily monitoring, 
and how to complete their ratings during the initial assessment. The research therapist will discuss with the 
participant whether they would prefer the questions to be texted, emailed, or delivered over the phone. 
Participants will be asked to return a number from 0 to 100 to rate each question using the medium agreed. 
This can be completed using their mobile phone, or a handset will be provided if required. Prompting 
participants to complete ratings will be discussed and the frequency of prompts will be contracted with the 
participant. This will allow the participant to decide how many prompts they wish, and whether they would 
like a courtesy call within the waitlist period, before barriers occur. The researcher will be flexible towards the 
participant's wishes and check in with the participant regularly, if they wish. 
 
Waitlist: The participant will wait for their assigned one, two, or three weeks. The decision about how long the 
participant waits will be made randomly by a computer. As described above, daily ratings will be completed 
within this time, with prompting and courtesy calls given as contracted with the participant. 
  
Imagery Rescripting (ImRs): Participants will receive three sessions of Imagery Rescripting. The first session 
will include educating the participant about the rescripting protocol, recapping the identified memory, 
practicing the protocol on a non-threatening memory, and discussing coping strategies. Measures of how 
well they expect the therapy to work will also be taken at this first ImRs session (Credibility and Expectancy 
Questionnaire, CEQ). To ensure there are no researcher effects to this measure, participants will rate 
confidentially and put their answer into an envelope that will not be opened until the participant has 
completed the study. 
The next two sessions will include using imagination to change the trauma memory and problem-solving any 
problems that occur. Once a ‘rescript’ the participant is satisfied with is identified, it will then be practiced 
repeatedly and adapted if necessary. Sessions will last approximately one hour, and no longer than 90 
minutes. Participants will continue daily measures during this time. 
 
Post-intervention follow-up: Participants will continue to complete daily measures about the memory for two 
weeks. During this time, at the end of the first week, participants will be asked to meet with the research 
therapist to assess their posttraumatic stress disorder symptoms (PDS-5), their level of wellbeing 
(WEBWMS), and how satisfied they were with the intervention (Client Satisfaction Questionnaire, CSQ-8). 
 
This concludes the participant's involvement in the research. 
 
Overall, participation will last a minimum of six and a maximum of eight weeks. During this time, participants 
will meet with the research therapist five times. That includes three times for therapy and twice to answer 
questions. The research therapist will also be contacting participants every day to answer four questions, 
either over the phone, by text or email. 
11.2 Laboratory Tests 
NA 
12. Assessment of Efficacy  
12.1  Primary Efficacy Parameters 
30-minute semi-structured interview and daily questions on dimensions of the index memory 
Adapted from Hackmann, Clark, & McManus's (2000) work on social phobia, also used in Ison et al. (2014). 
This consists of a series of standardised questions asking clients to identify an index intrusive traumatic 
memory. The dimensions of this index memory will be assessed during the interview, including; conviction in 
the distressing appraisal, frequency, distress, and sense of control associated with the memory. A visual 
analogue scale ranging from 0 to 100 will be used. 

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12.2 Secondary Efficacy Parameters 
Psychotic Symptom Rating Scales (PSYRATS; Haddock, McCarron, Tarrier, & Faragher, 1999) 
The PSYRATS was developed to measure dimensions of delusional beliefs (6 item Delusions Scale) and 
auditory hallucinations (11 item Auditory Hallucination Scale).  The six items on the auditory hallucination 
sub-scale consists of items such as negative content, frequency, loudness, intensity and amount of distress 
and degree of disruption and control. The six-item delusion subscale consists of items such as duration and 
amount of pre-occupation, intensity and amount of distress and disruption, and degree of conviction. All 
items are rated on a five-point scale of increasing severity (0= No problem to 4 = Maximum severity). The 
PSYRATS has been shown to have good validity and reliability, with sensitivity to change (Haddock et al., 
1999). This project will use the PSYRATS to describe the project sample. 
The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS; Tennant et al., 2007) 
The WEMWBS assessed wellbeing on 14 items rated on a 5-point Likert scale, ranging from “none of the 
time” to “all of the time”. A total score ranging from 14-70 is calculated. Higher scores indicate higher levels 
of mental wellbeing. WEWBS shows high reliability, low social desirability, and confirmatory factor analysis 
supported the single-factor hypothesis (Tennant et al., 2007). It also shows high correlations with other well-
being scales and low to moderate positive correlation with overall health (Tennant et al., 2007). 
The Posttraumatic Diagnostic Scale for DSM-5 (PDS-5; Foa et al., 2016) 
A 49-item self-report measure including all DSM-IV symptom criteria. 20 of these items asks participants to 
rate symptoms, and two questions relate to distress and interference. It has high face validity, internal 
consistency and reliability (Foa et al., 2016). This project will use the symptom section assessed over the 
past week, in order to measure change over time. 
Credibility and Expectancy Questionnaire (CEQ) (Borkovec & Nau, 1972; Devilly & Borkovec, 2000) 
Is a 6-item self-report instrument that measures treatment credibility, and client expectancy for 
improvement. The CEQ has high internal consistency (a = 0.79–0.90). Retest reliability is r = 0.82 for the 
expectancy factor and r = 0.75 for the credibility factor (Devilly & Borkovec, 2000). The first four items are 
rated based on cognitive appraisal of the treatment (e.g. At this point, how successfully do you think this 
treatment will be in reducing your symptoms?), whereas the last two items are rated based on feelings 
about the treatment. To reduce demand characteristics, client forms will be sealed in an envelope upon 
completion, and clients will be told that the therapist will only see the forms after they have finished 
participation. 
Client Satisfaction Questionnaire (CSQ-8) (Larsen et al., 1979) 
An eight-item version, to evaluate patient satisfaction. The sum of the responses to the CSQ-8 ranges from 8 
to 32, with higher scores indicating greater satisfaction. The CSQ-8 has demonstrated high internal 
consistency across a large number of studies (Attkisson & Greenfield, 1999). 
12.3 Procedures for Assessing Efficacy Parameters 
N/A 
13. Assessment of Safety  
13.1 Burden 
The burden placed on participants has been minimised as much as possible by carefully considering the 
inclusion of each measure in the case series. Furthermore, the assessment session can be split into several 
shorter sessions, should the participant wish. Breaks will be offered in each therapeutic and assessment 
session and the research therapist will support the participant to ensure that the delivery of the research and 
therapeutic procedures is acceptable to them and modify if needed. For example, participants will complete 
daily ratings about their memory via text, email, or phone. The research therapist will discuss with 
participants how many ratings (up to a maximum of four a day) they are able to complete, and how they 
would like to be prompted to answer them. This will be reviewed throughout the project. 

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13.2 Risk of Distress 
The focus of this project is distressing, traumatic memories, and participants will be required to focus on and 
discuss them during their participation which may be difficult. However, there is robust evidence to suggest 
that trauma-focused therapies can be safely applied in psychosis and that imagery rescripting can be used 
with this group to reduce distress associated with images (Ison et al., 2014; van den Berg et al., 2016). 
Participants will be selected as they regularly experience intrusive trauma memories, and therefore the study 
will only focus on eliciting experiences which they already have. Further, the project supervisors have 
extensive experience of working with traumatic memories in psychosis and will be able to ensure the 
intervention is delivered safely and sensitively. Participants will be giving informed consent to participate in 
the study. 
Should the participant become distressed at any point and feel unable to continue with the therapy, then the 
study will be terminated, and the research therapist will discuss this with them. The supervisors of this project 
have extensive clinical experience in this group and will be available for consultation should this situation 
arise. In addition, the research therapist has experience working with this group of people and will manage 
the situation should it arise with the support of the supervisors. Information pertaining to risk will be shared 
as needed with the clinical team, in accordance with local risk management protocols. Coping strategies will 
be discussed with participants at the beginning of the intervention to support them in managing any distress 
that arises. 
13.3 Specification, Timing and Recording of Safety Parameters.  
N/A 
13.4 Procedures for Recording and Reporting Adverse Events 
Safety and adverse event assessment and monitoring: It is an important subsidiary goal of the case series 
to establish the safety of the intervention, and we will also take all appropriate steps during the conduct of 
the case series for ensuring participant safety. The occurrence of adverse events (AEs) will be monitored 
actively and systematically.  AEs are defined as including deaths; self-harm; serious violent incidents; 
complaints about therapy; referrals to crisis care or admission to psychiatric hospital during therapy. A 
standard method of reporting will be employed, categorising events by severity (five grades, A-E). 
Investigators will also determine relatedness of an event to the intervention based on a temporal 
relationship, as well as whether the event is unexpected or unexplained given the participant’s clinical 
course, previous conditions and history, and concomitant treatments, in five categories from ‘not related’ 
to ‘related’ (following Linden 2013). The following will be considered as serious adverse events (SAE, 
Categories A-C): All deaths (category A), incidents which acutely jeopardise the health or psychological 
wellbeing of the individual, resulting in immediate hospital admission and/or permanent disability (category 
B), or resulting in injury requiring immediate medical attention (category C). These SAEs will include but 
are not limited to: 1) Hospital admissions; 2) Home treatment team involvement; 3) Suicide attempts; 4) 
Any violent incident necessitating police involvement (whether victim or accused); 5) Self-harming 
behaviour; 6) All deaths. Reasons for withdrawal from the study will also be recorded. Furthermore, in the 
event of any AEs and participant withdrawal, the research therapist will review participant clinical notes 
and contact clinicians for any important additional information. For the final reports of the case series, the 
numbers, types and severity of AEs, as well as discontinuations, will be reported, using descriptive 
statistics. 
13.4.1 Adverse events that do not require reporting 
There are no AEs or SAEs that will not be reported for the case series.  The period for reporting will 
commence when participants provide informed consent and continue until the final follow-up questions are 
completed.  
13.5 Stopping Rules 
The trial may be prematurely discontinued by the Sponsor or Chief Investigator on the basis of new safety 
information or other reasons given by the ethics committee.  

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14. Statistics 
Through using a multiple baseline case series design, a waitlist period will control for demand characteristics 
and effects of time, talking about previous trauma and completing measures. Furthermore, a protocol has 
been developed for the assessments in order to ensure consistency. Data will not be analysed until all data 
is collected. Finally, this project will be registered on clinicaltrials.gov, ensuring that the method and data-
analysis is predetermined. 
 
14.1 Sample Size 
12 participants. 
14.2 Randomisation 
N/A 
14.3 Analysis 
Planned analyses include; descriptive statistics, visually inspecting graphs, the Tau statistic, and reliable 
change (Jacobson & Truax, 1991).  
15. Trial Steering Committee  
N/A 
16. Data Monitoring Committee  
N/A 
17. Direct Access to Source Data and Documents 
The Investigator(s) will permit project-related monitoring, audits and REC review by providing the 
Sponsor(s), and REC direct access to source data and other documents. 
18. Ethics & Regulatory Approvals 
The project will be conducted in compliance with the principles of the Declaration of Helsinki (1996), the 
principles of GCP and in accordance with all applicable regulatory requirements including but not limited to 
the Research Governance Framework and the Mental Capacity Act 2005. 
This protocol and related documents will be submitted for review to South London and the Maudsley 
Research Ethics Committee (REC) 
The research therapist will submit a final report at conclusion of the trial to the CAG, REC, and the 
Sponsor  
It is expected that the all approvals will be completed, and the research will commence on 01/05/2018. 
19. Quality Assurance 
Monitoring of this trial will be to ensure compliance with Good Clinical Practice and scientific integrity will be 
managed by the project team. Research supervisors will listen to part or full therapy session recordings to 
ensure they meet a high-quality standard. 
 
20. Data Handling  
The Chief Investigator will act as custodian for the trial data. The following guidelines will be strictly adhered 

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to: 
Patient data will be anonymised.(amend as required) 
• 
All anonymised data will be stored on a password protected computer. 
• 
All trial data will be stored in line with the Data Protection Act. 
• 
and archived in line with Sponsor requirements 
21. Data Management 
Data will be collected on paper files, and stored on computer software, including Microsoft excel and SPSS 
21.1 Access to Medical Records 
In order to confirm the diagnosis given to the participants and to record their participation in the project for 
their care team the researcher will need to access the patient's electronic medical records, with the consent 
of the participant, through the electronic Patient Journey System within SLaM.  
21.2 Personal Data 
Information such as names, addresses and telephone numbers will be needed to contact participants both to 
arrange appointments and complete measures between appointments. It will be stored separately from the 
anonymised data and it will not be possible to link this data to that which is collected during the project.  
21.3 Audio/Visual Recording 
Participants will be audio-recorded during their therapy and assessment sessions, they will be asked to sign 
a separate consent form for these recordings. Participants will be recorded using a password protected, 
encrypted mobile phone and the research therapist will ensure no identifiable information beyond the 
memories themselves is recorded. This mobile will be stored in a locked filing cabinet at Kings College 
London when not in use by the research therapist, and recordings will be stored on Office 365 as soon as the 
research therapist returns to the office environment. GPS will be activated on the phone and remote lock and 
erase will be enabled.  
21.4 Manual Files 
All data will be collected using paper questionnaires and interviews - these will be identified using participant 
codes only and will not contain any identifiable information.  
21.5 University Computers 
All data will be entered onto Kings College London computers and password-protected 
22. Publication Policy  
This project is part of a doctoral thesis and will be written up as part of the written requirement. It is intended 
that the results of the project will be reported and disseminated at international conferences and in peer-
reviewed scientific journals.  
23. Insurance / Indemnity  
The lead sponsor, King's College London, will take primary responsibility for ensuring that the design of the 
project meets appropriate standards and that arrangements are in place to ensure appropriate conduct and 
reporting. King's College London also provides cover under its No Fault Compensation Insurance, which 
provides for payment of damages or compensation in respect of any claim made by a research subject for 
bodily injury arising out of participation in a clinical trial or healthy volunteer study (with certain restrictions). 
The co-sponsor, South London and Maudsley NHS Foundation Trust, takes responsibility for ensuring that 
appropriate standards, conduct and reporting are adhered to regarding its facilities and staff involved with the 
project. 

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24. Financial Aspects  
This project is conducted for part-fulfilment of the Doctorate in Clinical Psychology thesis – it will receive 
£1000 funding from the course for this purpose.  
 
25. Signatures 
 
 
______________________________________ 
_________________________ 
Chief Investigator 
Date 
Print name 
 
 
______________________________________ 
_________________________ 
Statistician (if applicable) 
Date 
Print name 
 
 
 
26. References  
Arntz, A., Tiesema, M., & Kindt, M. (2007). Treatment of PTSD: A comparison of imaginal exposure with and 
without imagery rescripting. Journal of Behavior Therapy and Experimental Psychiatry, 38, 345–370. 
Attkisson, C. C., & Greenfield, T. (1999). The Client Satisfaction Questionnaire-8. In M. Maruish (Ed.), The 
Use of Psychological Testing for Treatment Planning and Outcomes Assessment (Second Edi, pp. 
1333–1346). New Jersey: Lawrence Erlbaum Associates. 
Borkovec, T., & Nau, S. (1972). Credibility of analogue therapy rationales. Journal of Behavior Therapy and 
Experimental Psychiatry, 3(4), 257–260. http://doi.org/10.1016/0005-7916(72)90045-6 
Devilly, G. J., & Borkovec, T. D. (2000). Psychometric properties of the credibility/expectancy questionnaire. 
Journal of Behavior Therapy and Experimental Psychiatry, 31(2), 73–86. Retrieved from 
http://www.ncbi.nlm.nih.gov/pubmed/11132119 
Foa, E. B., McLean, C. P., Zang, Y., Zhong, J., Powers, M. B., Kauffman, B. Y., … Knowles, K. (2016). 
Psychometric properties of the Posttraumatic Diagnostic Scale for DSM–5 (PDS–5). Psychological 
Assessment, 28(10), 1166–1171. http://doi.org/10.1037/pas0000258 
Hackmann, A., Clark, D. M., & McManus, F. (2000). Recurrent images and early memories in social phobia. 
Behaviour Research and Therapy, 38(6), 601–610. http://doi.org/10.1016/S0005-7967(99)00161-8 
Haddock, G., McCarron, J., Tarrier, N., & Faragher, E. B. (1999). Scales to measure dimensions of 
hallucinations and delusions: the psychotic symptom rating scales (PSYRATS). Psychological 
Medicine, 29(4), 879–89. 
Ison, R., Medoro, L., & Kuipers, E. (2014). The Use of Rescripting Imagery for People with Psychosis Who 
Hear Voices. Behavioural and Cognitive Psychotherapy, 42(2), 129–142. 
http://doi.org/10.1017/S135246581300057X 
Jung, K., & Steil, R. (2013). A randomized controlled trial on cognitive restructuring and imagery modification 
to reduce the feeling of being contaminated in adult survivors of childhood sexual abuse suffering from 
posttraumatic stress disorder. Psychotherapy and Psychosomatics, 82(4), 213–20. 
http://doi.org/10.1159/000348450 
Larsen, D. L., Attkisson, C. C., Hargreaves, W. A., & Nguyen, T. D. (1979). Assessment of client/patient 
satisfaction: development of a general scale. Evaluation and Program Planning, 2(3), 197–207. 
Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/10245370 
Lee, D., & James, S. (2011). The compassionate-mind guide to recovering from trauma and PTSD : using 
compassion-focused therapy to overcome flashbacks, shame, guilt, and fear. New Harbinger 

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Publications. 
Tennant, R., Hiller, L., Fishwick, R., Platt, S., Joseph, S., Weich, S., … Stewart-Brown, S. (2007). The 
Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health and 
Quality of Life Outcomes, 5, 63. http://doi.org/10.1186/1477-7525-5-63 
 
27. Appendices – see separate documents 
27.1 Participant Information Sheet 
27.2 Consent form 
27.3 Therapy Information Sheet