Title: Multisite Randomised Controlled Trial of Trauma-Focused Cognitive Behaviour Therapy for psychosis to reduce post-traumatic stress symptoms in people with co-morbid post-traumatic stress disorder and psychosis, compared to Treatment as Usual: the STAR (Study of Trauma And Recovery) trial
Funder: Department of Health and Social Care

Abstract: Aims: We will look at a specific talking therapy to help with the extreme psychological aftermath of having experienced a trauma (Post-Traumatic Stress Disorder; PTSD), in people with schizophrenia diagnoses (whose symptoms include hearing voices and having unusual beliefs). We aim to find out whether the therapy reduces PTSD and other symptoms, is safe and acceptable, and how much it costs._x000D_ _x000D_ Background: Many people with schizophrenia diagnoses have had traumatic experiences, both in childhood (such as physical and sexual abuse) and adulthood (such as assaults). About 15% also have a PTSD diagnosis, for instance constantly feeling fearful or on edge, having nightmares and ‘flashbacks’, where the event is relived in the here and now. These problems make psychotic symptoms more intense and long lasting, leading to worse outcomes and increased use of health services. There are effective talking therapies for PTSD, which consist of safely ‘reliving’ or ‘exposure’ to the trauma memories with the therapist. This works by allowing the brain to reprocess the trauma so that unwanted distressing memories such as flashbacks and nightmares are reduced. Up to now clinicians have been reluctant to treat people with schizophrenia diagnoses with exposure to the trauma memories, as they fear it might make the psychotic symptoms worse. However, recent studies, including by our group, have shown that such ‘Trauma-Focused’ therapies can be safe and helpful. National Institute for Health and Care Excellence (NICE) and three recent reviews have recommended that a large randomised controlled trial (RCT) should evaluate this therapy in the NHS, to fill a major gap in treatment for this population._x000D_ _x000D_ Design and methods: We will select 300 outpatients with both PTSD and schizophrenia diagnoses from five NHS mental health trusts, and allocate them randomly to either the Trauma Focused therapy, which is integrated with the standard psychological therapy for psychosis (Cognitive Behaviour Therapy for psychosis; CBTp) + usual treatment, or usual treatment alone. Therapy will last nine months with a trained therapist. We will assess PTSD symptoms (our main measure); therapy safety and acceptability; service use costs; psychosis symptoms; emotional well-being; suicidal ideation; substance abuse; psychological recovery; and social functioning. We will assess these four times: before allocation to the two groups; after 4 months (mid-way through therapy); after 9 months (end of therapy, the main time point at which the effectiveness of the new therapy will be compared to the control group); and after 24 months (to check if the effects last). The first 21 months will be a pilot study, to make sure recruitment, therapy and assessments are progressing to plan._x000D_ _x000D_ Patient and public involvement (PPI) and dissemination: PPI is included at three levels: consultation, collaboration and expert-by-experience led research. We have a long history of PPI in our clinics, research, training, and dissemination of our work. One outcome from this study will be to publish the final therapy manual. The applicants include a clinical-academic with lived experience, who will lead on all PPI aspects of the application, and all the leading UK experts in trauma and psychosis, who have lead roles on NICE committees and provide national training on talking therapies in psychosis. We are therefore well-placed to ensure the successful roll-out of the therapy, should the results be positive, ensuring immediate patient benefit.

Lay abstract: Research Question: What is the clinical and cost-effectiveness of trauma-focused cognitive behavioural therapy (CBT) for post-traumatic stress disorder (PTSD) in people with schizophrenia diagnoses? _x000D_ _x000D_ Background: People with schizophrenia diagnoses have high rates of trauma, with a PTSD prevalence rate of approximately 15%, which exacerbates psychotic symptoms such as delusions and hallucinations. Pilot studies have shown that trauma-focused psychological therapies can be safe and effective in such patients. The National Institute for Health and Care Excellence (NICE) and three recent reviews have recommended that a large randomised controlled trial (RCT) should evaluate this therapy in the NHS, to fill a major gap in treatment for this population._x000D_ _x000D_ Aims and Objectives: Our primary aim is to evaluate the clinical effectiveness of a trauma-focused therapy integrated with CBT for psychosis (TF-CBTp) on PTSD symptoms for people with current distressing PTSD and psychosis symptoms. TF-CBTp + usual treatment will be compared to usual treatment alone at the end of therapy. Our secondary aims are to compare the groups on cost-effectiveness, adverse events, and a range of secondary outcomes; to determine whether therapy effects endure 24 months post-randomisation; and to determine acceptability of the therapy in participants and therapists. _x000D_ _x000D_ Methods: The design is a rater blind, parallel arm, pragmatic RCT comparing TF-CBTp + usual treatment to usual treatment only. 300 adult outpatients with comorbid PTSD and schizophrenia diagnoses from five mental health Trusts (60 per site) will be randomly allocated to the two groups. Therapy will be manualised and last 9 months with a trained therapist. We will assess PTSD symptoms (primary outcome); percentage who show loss of PTSD diagnosis and clinically significant change; psychosis symptoms; mood, substance abuse and suicidal ideation; psychological recovery; social functioning; and service use costs, a total of four times: before randomisation, at 4 months (mid-therapy); at 9 months (end of therapy; primary end point); and at 24 months (15 months post-end of therapy) post-randomisation. Adverse events and therapy adherence will be monitored throughout. Therapy acceptability will be assessed through qualitative interviews with participants (N=35) and therapists (N=5-10). Trial data will be analysed following intention-to-treat principles using generalised linear mixed models and reported according to Consolidated Standards of Reporting Trials-Social and Psychological Interventions Statement. _x000D_ _x000D_ Timelines for delivery: The trial will last four years six months (54 months). Recruitment will occur over 22 months, following 4 months of setting up. There will be a further 24 months for therapy completion and follow-up, with the final 4 months for data cleaning, analyses, and final report. The internal pilot will last 21 months from the start of the study, to ensure integrity of trial recruitment and outcome data, and protocol safety and adherence._x000D_ _x000D_ Anticipated impact and dissemination:This application provides an internationally recognised UK team of experts to conduct an important study that is timely and of interest internationally. The proposed intervention has the potential to: provide significant benefits to patients in terms of reductions in distressing PTSD, psychosis, and other symptoms; overcome obstacles in treatment delivery in UK practice due to clinicians being reluctant to implement trauma-focused therapy; be cost-effective to the NHS through reduced service use. A further outcome from this study will be to publish the final therapy manual. We have lead roles on NICE committees and provide national training on talking therapies in psychosis, and are therefore well-placed to ensure the successful roll-out of the therapy, should the results be positive, ensuring immediate patient benefit.

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