The STAR (Study of Trauma And Recovery) trial v1.01
Research type
Research Study
Full 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
IRAS ID
275697
Contact name
Emmanuelle Peters
Contact email
Sponsor organisation
Institute of Psychiatry, Psychology & Neuroscience, Kings College London
ISRCTN Number
ISRCTN93382525
Duration of Study in the UK
4 years, 9 months, 30 days
Research summary
Our aim is to look at whether a specific talking therapy to help with the extreme psychological aftermath of having experienced a trauma (Post-Traumatic Stress Disorder; PTSD) is effective in people with psychosis (whose symptoms include hearing voices and having unusual beliefs). Many such individuals have had multiple traumatic experiences, both in childhood and adulthood. Around 15% develop PTSD as a result, for instance constantly feeling fearful or on edge, having nightmares and ‘flashbacks’, where the event is relived in the here and now. Recent small studies, including by our group, have shown that therapies focusing on the trauma can be safe and helpful in people with psychosis symptoms. We aim to find out in a definitive study whether this therapy reduces PTSD and other symptoms, is safe and acceptable, and how much it costs.
To test this research question we will select 300 patients with both PTSD and schizophrenia-spectrum 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) + Treatment As Usual (TAU), or TAU alone. Therapy will last nine months (m) 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 4m (mid-way through therapy); after 9m (end of therapy, the main time point at which the effectiveness of the new therapy will be compared to the control group); and after 24m (to check if the effects last). The first 21m will be a pilot study, to make sure recruitment, therapy and assessments are progressing to plan.
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
20/LO/0853
Date of REC Opinion
24 Jun 2020
REC opinion
Favourable Opinion