What was the Study of Trauma and Recovery (STAR) trial?
The largest multi-site randomised controlled trial (RCT) to date of a trauma-focused therapy for people with co-occurring diagnoses of psychosis and PTSD
Funded by the National Institute for Health and Care Research (NIHR) and led by researchers at King’s College London and South London and Maudsley NHS Foundation Trust (SLaM).
The STAR trial evaluated if TF-CBTp is safe, acceptable, and effective for trauma survivors with distressing psychosis
The primary research question was:
Does TF-CBTp reduce PTSD symptoms (at the end of therapy) in people with distressing psychosis and PTSD symptoms?
The secondary research questions were:
Does TF-CBTp reduce psychosis symptoms, distress and functioning problems?
Is this therapy acceptable to participants and to therapists?
Do the effects last?
Is it cost effective?
What was the design?
Participants were allocated randomly to either Trauma-Focused Cognitive Behaviour Therapy for psychosis (TF-CBTp) plus usual treatment, or usual treatment alone.
Therapy lasted nine months with a trained therapist.
Following a baseline assessment, all participants were followed up at 4, 9 and 24 months.
Who participated?
305 people who were at least 18 years old and who met diagnostic criteria for Post-traumatic Stress Disorder and were experiencing distressing psychosis.
What happened in the STAR trial?
STAR trial protocol and analysis plans
STAR published protocol: Multi-site 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. Peters E, Hardy A, Dudley R et al. (2022). Trials Read more
STAR Trial Protocol: Read more
STAR Health Economics Analysis Plan (HEAP): Read more
STAR Statistical Analysis Plan (SAP): Read more
STAR Serious Adverse Events form (version 7): Read more
