Seeking Safety group intervention for complex post-traumatic stress disorder: a feasibility randomised controlled trial

Research question Is it feasible and acceptable to undertake a randomised controlled trial (RCT) of the effectiveness and cost effectiveness of Seeking Safety as a treatment for complex post-traumatic stress disorder (CPTSD)? Background People with CPTSD present to NHS mental health services with acute symptoms of trauma, which they often manage with alcohol, drugs or other unsafe coping behaviours. Many are unable to be sufficiently stable to engage with psychological therapy. As a result, up to half of the caseloads of allied health professionals, such as nurses, occupational therapists and social workers in community mental health teams (CMHTs) are people experiencing symptoms of trauma but are unable to make progress towards recovery. Seeking Safety is a manualized group treatment for people with CPTSD and substance use which is widely used outside of the UK. It helps people to achieve stabilisation by creating a safe environment for them within a group; building skills and strategies to cope with trauma and co-existing mental health and unsafe behaviours; and fostering emotional stability and healthier choices. A pilot of Seeking Safety in the NHS has shown promising results, but some uncertainty exists about how best to undertake an RCT to evaluate its effectiveness and cost-effectiveness. Aims and Objectives This study aims to investigate whether it is feasible and acceptable to undertake an RCT of the effectiveness and cost-effectiveness of Seeking Safety as a treatment to improve mental health outcomes for individuals with CPTSD compared with a wait-list control. Specific objectives focus on feasibility of recruitment, randomisation, fidelity to Seeking Safety, and data collection, and the experiences of participants and staff. Methods 48 people with CPTSD from a mental health NHS Trust will be randomised to receive either Seeking Safety or to join a waiting list for it, in addition to routine care. Feasibility outcomes will be proportions of participants consenting; completing baseline measures and randomised; completing the intervention; and completing follow-up assessments. Outcome data will be collected at baseline, end of treatment and 6-month follow-up, and will include PTSD symptoms, substance use, mental wellbeing, social functioning and health-related quality of life. Data on resource use and cost will also be collected. In-depth interviews with participants, and practitioners delivering the intervention, will explore experiences of Seeking Safety and the research process. A brief online survey within participating CMHTs will investigate the intervention's wider impact. Progression to a full trial will be based on traffic light criteria around recruitment, intervention adherence and completion of follow-up data. Timelines for delivery (in months) 1-3: set-up 4-10: recruitment, baseline measures and randomisation 11-17: intervention 18-24: post-intervention and follow-up data collection; qualitative interviews 24-26: analysis and writing-up Anticipated Impact and Dissemination This study will assess the feasibility of conducting a full trial. If this finds that Seeking Safety is clinically effective and cost effective, it could provide a new treatment for CPTSD, reducing the need for psychological therapy or CMHT care. We will disseminate findings through an accessible report, peer-reviewed papers, online presentations and videos for social media.