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Title of the Trial RAPIDTFCBT – Draft Protocol V1 - 19 August 2016 TITLE OF THE TRIAL: Pragmatic Randomised controlled trial of a trauma-focused guided self help Programme versus Individual Trauma- Focused Cognitive Behavioural Therapy for post traumatic stress disorder (RAPIDTFCBT) PROTOCOL VERSION NUMBER AND DATE: Version 1.1 – 8 August 2016 SPONSOR: Cardiff University IRAS NUMBER: ISRCTN NUMBER: SPONSOR’S NUMBER: FUNDER’S NUMBER: HTA 14/192/97 This protocol has regard for the HRA guidance and order of content 1 RAPIDTFCBT – Draft Protocol V1 - 19 August 2016 SIGNATURE PAGE The undersigned confirm that the following protocol has been agreed and accepted and that the Chief Investigator agrees to conduct the trial in compliance with the approved protocol and will adhere to the GCP guidelines, the Sponsor’s SOPs, and other regulatory requirements as amended. I agree to ensure that the confidential information contained in this document will not be used for any other purpose other than the evaluation or conduct of the clinical investigation without the prior written consent of the Sponsor I also confirm that I will make the findings of the study publically available through publication or other dissemination tools without any unnecessary delay and that an honest accurate and transparent account of the study will be given; and that any discrepancies from the study as planned in this protocol will be explained. For and on behalf of the Study Sponsor: Signature: ………………………………………………………. Date: ....../....../...... Name (please print): ………………………………………….. Position: ………………………………………………………… Chief Investigator: Signature: ………………………………………………………. Date: ....../....../...... Name (please print): ………………………………………….. Statistician: Signature: ………………………………………………………. Date: ....../....../...... Name (please print): ………………………………………….. 2 RAPIDTFCBT – Draft Protocol V1 - 19 August 2016 KEY TRIAL CONTACTS Chief Investigator Professor Jonathan I Bisson Institute of Psychological Medicine and Clinical Neurosciences Cardiff University School of Medicine Hadyn Ellis Building Maindy Road Cardiff, CF24 4HQ Tel: +44 (0)29 20688486 Email: [email protected] Trial Manager Claire Bartlett South East Wales Trials Unit Cardiff University School of Medicine Neuadd Meirionnydd Heath Park Cardiff CF14 4YS Tel: +44 (0)29 20687620 Email: [email protected] Sponsor Cardiff University Research and Innovation Services Cardiff University 7th Floor, McKenzie House 30-36 Newport Road Cardiff, CF24 0DE Tel: +44(0)29 2087 9277 Email: [email protected] Funder National Institute for Health Research Evaluation Trials and Studies Coordinating Centre University of Southampton Alpha House, Enterprise Road Southampton, SO16 7NS Tel: +44 (0)23 80595586 Email: [email protected] Clinical Trials Unit South East Wales Trials Unit Cardiff University School of Medicine Neuadd Meirionnydd Heath Park Cardiff CF14 4YS Tel: +44 (0)29 20687620 Email: [email protected] 3 RAPIDTFCBT – Draft Protocol V1 - 19 August 2016 TRIAL SUMMARY Trial Title Pragmatic randomised controlled trial of a trauma- focused guided self help programme versus individual trauma-focused cognitive behavioural therapy for post traumatic stress disorder Short Title RAPIDTFCBT Clinical Phase III Trial Design Randomised controlled effectiveness trial, with nested process evaluation to assess fidelity, adherence and factors that influence outcome. Trial Participants Adults with PTSD to a single traumatic event Planned Sample 192 Size Treatment duration 8-12 weeks Follow up duration 12 months post randomisation Planned Trial Period 36 months Objectives Outcome Measures Primary To determine if, for patients with CAPS-5, PTSD, is a GSH programme at EQ5D-5L least equivalent in effectiveness and cost-effective relative to individual TFCT as judged by reduced symptoms of PTSD and improved quality of life. Secondary To determine, for patients with IES-R PTSD, the impact of a GSH WSAS programme on functioning, PHQ-9 symptoms of depression, GAD-7 symptoms of anxiety, alcohol use AUDIT-O MSPSS and perceived social support. CSSRI-EU To determine what factors may impact effectiveness and successful roll-out of GSH for PTSD in the NHS, if the GSH programme is shown to be effective. 4 RAPIDTFCBT – Draft Protocol V1 - 19 August 2016 TRIAL MANAGEMENT Trial Steering Committee (TSC): A TSC will be established and meet at least annually. The TSC will comprise of an independent chair who has expertise in both trials and PTSD and two other independent members including a user representative who has had lived experience with PTSD and a clinician working with people with PTSD. The TSC will determine at their first meeting whether a separate Data Monitoring and Ethics Committee (DMEC) is required, or whether the TSC will also fulfil this remit. TSC members will be required to sign up to the remit and conditions as set out in the TSC Charter. Trial Management Group (TMG): A TMG will be established and meet monthly. The TMG will include the chief investigator (CI), all other investigators, and central project team (trial and data managers, trial administrator, statistician) to discuss the progression and day-to-day management issues of the trial. TMG members will be required to sign up to the remit and conditions as set out in the TMG Charter. Roles and Responsibilities: The trial manager will be responsible for the day to day running and coordination of the study and will be accountable to the CI. Site research workers supervised by the site lead will be responsible for recruitment, the conduct of eligibility and follow up assessments and data collection. Data will be securely stored locally and entered on a secure electronic recording system and checked by the trial manager for errors and data completion prior to transfer to the trial statistician. The trial statistician will be responsible for cleaning the data, conducting the analysis and sending the data to the DMEC. The South East Wales Trials Unit will provide a secure allocation of trial participants to treatment and will be responsible for the minimisation process. They will also provide a comprehensive data management service including devising the electronically secure recording system. 5 RAPIDTFCBT – Draft Protocol V1 - 19 August 2016 List of Contents Page no. Title page 1 Research reference numbers 1 Signature page 2 Key trial contacts 3 Trial summary 4 Trial management 5 List of contents 6 List of abbreviations 7 Trial flow chart 8 Study Protocol 1. Background and rationale 9 2. Aims and objectives 11 3. Trial design 11 4. Study setting 11 5. Eligibility criteria 12 6. Trial procedures 12 7. Trial interventions 18 8. Statistics and data analysis 21 9. Plan of investigation and timetable 24 10. Ethical and regulatory considerations 26 11. Dissemination policy 27 12. References 28 13. Appendices 33 6 RAPIDTFCBT – Draft Protocol V1 - 19 August 2016 LIST OF ABBREVIATIONS AUDIT-O Alcohol Use Disorders Identification Test CAPS-5 Clinician Administered PTSD Scale CI Chief Investigator CMHT Community Mental Health Team CRF Case Report Form CSSRI-EU Client Socio Demographic and Service Receipt Inventory (European Version) CVUHB Cardiff and Vale University Health Board DMEC Data Monitoring and Ethics Committee DSM-5 Diagnostic and Statistical Manual of Mental Disorders (5th Edition) EMDR Eye Movement Desensitisation and Reprocessing EQ5D-5L Euroqol- 5D GAD-7 General Anxiety Disorder-7 GCP Good Clinical Practice GSH Guided Self Help HCL Healthcare Learning HTA Health Technology Assessment IAPT Improving Access to Psychological Therapies ICF Informed Consent Form IES-R Impact of Event Scale (Revised) ISF Investigator Site File ISRCTN International Standard Randomised Controlled Trials Number KTP Knowledge Transfer Partnership MRC Medical Research Council MSPSS Multidimensional Scale for Perceived Social Support NCMH National Centre for Mental Health NHS R&D National Health Service Research & Development NICE National Institute for Health and Care Excellence PHQ-9 Patient Health Questionnaire-9 PI Principal Investigator PIS Participant Information Sheet PTSD Post Traumatic Stress Disorder RCT Randomised Control Trial REC Research Ethics Committee SEWTU South East Wales Trials Unit SOP Standard Operating Procedure TFCBT Trauma Focused Cognitive Behavioural Therapy TFCT Trauma Focused Cognitive Therapy TFPT Trauma Focused Psychological Therapy TMG Trial Management Group TSC Trial Steering Committee TMF Trial Master File WSAS Work and Social Adjustment Scale 7 RAPIDTFCBT – Draft Protocol V1 - 19 August 2016 TRIAL FLOW CHART 8 RAPIDTFCBT – Draft Protocol V1 - 19 August 2016 STUDY PROTOCOL 1. Background and Rationale Post traumatic stress disorder (PTSD) is a common mental disorder that may develop following exposure to exceptionally threatening or horrifying events. Characteristic symptoms include persistent intrusive recollections, avoidance of trauma-related stimuli, emotional numbing and hyper-arousal1,2. About 3% of the adult population suffer from current PTSD3 and average symptom duration is normally prolonged in those who are untreated4. PTSD is associated with substantial co-morbidity4,5-8, and significant economic burden9,10. A number of psychological approaches have been developed to treat PTSD. Evidence suggests that the most effective approaches are those that are based on trauma focused cognitive behavioural therapy (TFCBT) (including trauma focused cognitive therapy) and eye movement desensitization and reprocessing (EMDR)11. TFCBT typically involves some degree of structured exposure to and
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