RAPID
Research type
Research Study
Full 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
IRAS ID
216979
Contact name
Jonathan I Bisson
Contact email
Duration of Study in the UK
3 years, 6 months, 1 days
Research summary
Research Summary
The aim of this research is 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. 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.\n\nThe 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. 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. 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 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.
Summary of Results
Guided internet-based cognitive behavioural therapy with a trauma focus was found to be non-inferior to and cheaper than face-to-face cognitive behavioural therapy with a trauma focus at 16 weeks.
REC name
Wales REC 3
REC reference
17/WA/0008
Date of REC Opinion
23 Feb 2017
REC opinion
Further Information Favourable Opinion