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

Emmanuelle Peters, Amy Hardy, Robert Dudley, Filippo Varese, Kathryn Greenwood, Craig Steel, Richard Emsley, Nadine Keen, Samantha Bowe, Sarah Swan, Raphael Underwood, Eleanor Longden, Sarah Byford, Laura Potts, Margaret Heslin, Nick Grey, Doug Turkington, David Fowler, Elizabeth Kuipers, Anthony Morrison

Research output: Contribution to journalArticlepeer-review

10 Citations (Scopus)

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).

Original languageEnglish
Pages (from-to)429
JournalTrials
Volume23
Issue number1
DOIs
Publication statusPublished - 23 May 2022

Keywords

  • Adult
  • Cognitive Behavioral Therapy/methods
  • Comorbidity
  • Humans
  • Multicenter Studies as Topic
  • Pragmatic Clinical Trials as Topic
  • Psychotic Disorders/diagnosis
  • Quality of Life
  • Randomized Controlled Trials as Topic
  • Stress Disorders, Post-Traumatic/diagnosis

Fingerprint

Dive into the research topics of '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'. Together they form a unique fingerprint.

Cite this