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 (RAPID)
Funder: Health and Care Research Wales (Welsh Government)

Abstract: Design: Randomised controlled effectiveness trial, with nested process evaluation to assess fidelity, adherence and factors that influence outcome. Setting: NHS psychological treatment settings across the UK. Target population: Adults with PTSD to a single traumatic event. Inclusion Criteria: DSM5[1] criteria for mild to moderate PTSD and regular access to the internet. Exclusion criteria: Psychosis, substance dependence, active suicide risk, inability to read and write fluently in English, previous trauma focused psychological treatment. Health technology: Web and app-based trauma-focused GSH with up to three hours therapist contact versus trauma focused cognitive therapy with up to 12 hours therapist contact. Measurement of costs and outcomes: The primary outcome will be reduction in score on the Clinician Administered PTSD Scale for DSM5 (CAPS5)[2]. Economic evaluation will be conducted from UK NHS, personal, social services and partial societal perspectives. Resource utilisation of services will be measured using the amended form of the CSSRI-EU[3]. Net incremental cost and the EQ5D-5L[4] will be used to generate an estimate of cost per quality adjusted life year (QALY) gained along with a series of cost-effectiveness ratios. The potential QALY gains will be used in a net–benefit analysis based on accepted NICE ‘value for money’ thresholds. Secondary outcomes will include depression[5], anxiety[6] and disability[7]. A process evaluation will be undertaken in parallel, in accordance with recent MRC guidance[8], to explore factors impacting on intervention delivery and outcome. This will explore context, reach, fidelity, exposure, recruitment, retention and adherence using both quantitative and qualitative methods. Sample size: Based on a non-inferiority margin of 5 points on CAPS5, and assuming a 1-sided 95% confidence interval (CI), 20% attrition, a common standard deviation of 10.3 (Phase II study), and 1% clustering, 192 participants are required for 90% power. It is estimated that around 20 participants and 8 therapists will be purposefully sampled before data saturation in the qualitative component of the process evaluation. Project timetable: During the first five months of the project, the programme website will be updated and the mobile application developed. NHS, Ethics and R&D approvals will be obtained. The therapists and study staff will be recruited and trained, centre and site agreements finalised and the project database designed and validated. Recruitment and randomisation will occur between months 6 and 25 with intervention delivery between months 7 and 29. Qualitative interviews and analysis will take place between months 5 and 37 and follow up interviews between months 10 and 37. Final analysis and paper/report writing will occur between months 37 and 40 with dissemination meetings being held in month 40. Recruitment from primary care therapists and mental health services were the most effective approaches for the Phase II study. These will be replicated along with effective techniques in other GSH studies. Recruitment at less than half of the rate achieved in the Phase II study will result in the sample being recruited to time and target. Expertise in team: The team is multidisciplinary with expertise from the PPI perspective, PTSD, primary care therapy, GSH, trial design, conduct and management, qualitative research, development and evaluation of complex interventions and health economics.

Lay abstract: Aim of the research: To determine if trauma-focused guided self-help (GSH) using a web-based programme provides a faster and cheaper treatment for post traumatic stress disorder (PTSD) than trauma-focused cognitive behavioural therapy (TFCBT), whilst being equally effective. Background to the research: PTSD is a common, often disabling mental disorder that can occur following major traumatic events such as abuse, assaults and accidents. Typical symptoms include distressing reliving in the form of nightmares or distressing thoughts, avoidance of reminders, distorted thoughts such as feeling guilty, self-blame and shame for being abused, or that the world is completely unsafe following an accident, and hyperarousal, for example through increased irritability and jumpiness. Recent news stories highlight the devastating impact that PTSD can have (e.g. the Savile Effect) and how the absence of timely intervention can lead to long-term suffering. They have also increased public awareness of PTSD and, potentially, the likelihood of presentation for help. The first choice treatments for PTSD are individual talking treatments (including TFCBT) of 12-16 hours duration. Unfortunately, the limited number of therapists available and length of treatment means that there are long NHS waiting lists of up to 18 months. PTSD sufferers may also have difficulty committing to weekly appointments, especially if they are working, have childcare commitments or are scared to go out alone or to new places. If equally effective treatments could be developed that take less time and can be largely undertaken in a flexible manner at home, this would improve accessibility, reduce waiting times and hence the burden of disease. GSH has the potential to address this gap. Design and methods: The proposed research is a randomised controlled trial of carefully developed GSH using a web- and app-based programme, with up to three hours contact with a therapist either in person, via internet video link or telephone, versus face to face TFCBT. Outcomes will include measures of PTSD, depression, anxiety, quality of life and disability. Information will be collected to estimate the costs of delivering the GSH and of the savings if it is successful from the perspective of the patient, their family, the health service and society as a whole. A sample of therapists and participants will be interviewed in more detail to explore the factors that influence acceptability, including what helps and hinders uptake, ability to complete the intervention and other factors associated with outcome. Interviewees will be encouraged to reflect, and provide accounts of their own experiences in their own words, allowing them to initiate and develop the topics that are important to them, while keeping the talk relevant to the research. Patient and public involvement (PPI): Two of the research team are former PTSD sufferers, one has been involved as a key member of the research team from the start. There will be an independent PPI member of the steering group and a PPI advisory group to advise on all aspects of the study. Dissemination: This will occur throughout the study through study webpages, social media, local and national media, publications and training targeted at key stakeholders including patients, the public, therapists and commissioners. The results will be presented to the participants through an end of study report and published in high quality, open access journals.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: MENTAL HEALTH