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

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)

“It hurt but it helped”: A mixed methods audit of the implementation of trauma- focused cognitive-behavioral therapy for psychosis

“…Although the thematic analysis suggests that benefits were linked to the therapy experience, the study design was uncontrolled and it is not possible to conclusively determine if the effects of tf-CBTp are attributable to therapy or time. However, the learning from therapy delivery in this audit has contributed to the therapy protocol for the Study of Trauma & Recovery, which is a currently recruiting multisite RCT of tf-CBTp ( 71 ) and will be the first to provide robust evidence of the effectiveness and cost-effectiveness of this therapy compared to treatment as usual, as well as investigating mechanisms of change. The STAR trial will also investigate potential moderators of therapy outcome, such as demographics, trauma history and therapy dose, furthering understanding of potential confounders of therapeutic effects.…”

Identifying types of problems and relative priorities in the problem lists of participants in CBT for psychosis trials

“…For example, if a person with psychosis wants to prioritise something like stigma or PTSD, it would make sense to recruit them into trials specific to those goals. There are already several examples of such trials (Birchwood et al ., 2014; Freeman et al ., 2021; Peters et al ., 2022).…”

Cognitive behavioural therapy for psychosis: The end of the line or time for a new approach?

“…A meta-analysis of PTSD treatments (including CBT and EMDR) found just small effects for people with psychosis (Brand et al, 2018), though emerging evidence from case series of trauma interventions such as reliving and imagery rescripting which target memories linked to current psychotic symptoms show more promising results (e.g. Ison et al, 2014;Keen et al, 2017;Paulik et al, 2019Paulik et al, , 2022, and are incorporated in the current CBTp STAR trial for psychosis and PTSD (Peters et al, 2022).…”