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: study protocol for the STAR (Study of Trauma And Recovery) trial

Trials

Eleanor Longden¹  Anthony Morrison¹  Robert Dudley²  Doug Turkington²  Laura Potts³  Richard Emsley³  Elizabeth Kuipers⁴  Sarah Swan⁴  Raphael Underwood⁴  Amy Hardy⁴  Emmanuelle Peters⁴  Nadine Keen⁴  Margaret Heslin⁵  Sarah Byford⁵  Craig Steel⁶  Samantha Bowe⁷  Nick Grey⁸  Kathryn Greenwood⁸  David Fowler⁸  Filippo Varese⁹ 

[1] Complex Trauma and Resilience Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Manchester Academic Health Science Centre;Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust;Department of Biostatistics and Health Informatics, Institute of Psychiatry, Psychology & Neuroscience, King’s College London;Department of Psychology, Institute of Psychiatry, Psychology & Neuroscience, King’s College London;Health Service & Population Research, Institute of Psychiatry, Psychology & Neuroscience, King’s College London;Oxford Centre for Psychological Health, Oxford Health NHS Foundation Trust;Psychosis Research Unit, Greater Manchester Mental Health NHS Foundation Trust, Manchester Academic Health Science Centre;Research and Development, Sussex Partnership NHS Foundation Trust;School of Health Sciences, University of Manchester, Manchester Academic Health Science Centre;

关键词: Post-traumatic stress disorder (PTSD);    Psychosis;    Schizophrenia-spectrum disorder;    Trauma;    Cognitive behaviour therapy;    Trauma-focused therapy;   

DOI  :  10.1186/s13063-022-06215-x

来源: DOAJ

【 摘 要 】

Abstract Background People with psychosis have high rates of trauma, with a post-traumatic stress disorder (PTSD) prevalence rate of approximately 15%, which exacerbates psychotic symptoms such as delusions and hallucinations. Pilot studies have shown that trauma-focused (TF) psychological therapies can be safe and effective in such individuals. This trial, the largest to date, will evaluate the clinical effectiveness of a TF therapy integrated with cognitive behaviour therapy for psychosis (TF-CBTp) on post-traumatic stress symptoms in people with psychosis. The secondary aims are to compare groups on cost-effectiveness; ascertain whether TF-CBTp impacts on a range of other meaningful outcomes; determine whether therapy effects endure; and determine acceptability of the therapy in participants and therapists. Methods Rater-blind, parallel arm, pragmatic randomised controlled trial comparing TF-CBTp + treatment as usual (TAU) to TAU only. Adults (N = 300) with distressing post-traumatic stress and psychosis symptoms from five mental health Trusts (60 per site) will be randomised to the two groups. Therapy will be manualised, lasting 9 months (m) with trained therapists. We will assess PTSD symptom severity (primary outcome); percentage who show loss of PTSD diagnosis and clinically significant change; psychosis symptoms; emotional well-being; substance use; suicidal ideation; psychological recovery; social functioning; health-related quality of life; service use, a total of four times: before randomisation; 4 m (mid-therapy); 9 m (end of therapy; primary end point); 24 m (15 m after end of therapy) post-randomisation. Four 3-monthly phone calls will be made between 9 m and 24 m assessment points, to collect service use over the previous 3 months. Therapy acceptability will be assessed through qualitative interviews with participants (N = 35) and therapists (N = 5–10). An internal pilot will ensure integrity of trial recruitment and outcome data, as well as therapy protocol safety and adherence. 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. Discussion The proposed intervention has the potential to provide significant patient benefit in terms of reductions in distressing symptoms of post-traumatic stress, psychosis, and emotional problems; enable clinicians to implement trauma-focused therapy confidently in this population; and be cost-effective compared to TAU through reduced service use. Trial registration ISRCTN93382525 (03/08/20)

【 授权许可】

Unknown