About the STAR Trial

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.

Evaluated if a Trauma-Focused therapy integrated with Cognitive Behaviour Therapy for psychosis (TF-CBTp) is safe, acceptable, and effective for people with distressing symptoms of PTSD and psychosis.

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).

RESEARCH QUESTIONS

Primary research question

Does TF-CBTp reduce PTSD symptoms (at the end of therapy) in people with distressing psychosis and PTSD symptoms?​

What we wanted to find out

Secondary research questions

  • 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?​

DESIGN

Who took part?

305 adults who met diagnostic criteria for PSTD and were experiencing distressing symptoms of psychosis.

How the trial was set up

38.9 yrs

Mean age

Standard deviation 12.4

56%

Women

171 women, 127 men, 7 did not say

76%

White

232 out of 305

100%

Reported repeated, multiple traumas

Every participant

What did we do?

  • Participants were allocated by chance to either Trauma-Focused Cognitive Behaviour Therapy for psychosis (TF-CBTp) plus their usual care, or their usual care alone.

  • Therapy lasted around nine months with a trained therapist.

MEASURES

What was assessed and how

Who took part?

All measures were taken at baseline and repeated at 4, 9 (end of therapy) and 24 months

The CAPS-5 at 9 months was the primary outcome.

PTSD

  • CAPS-5 - Clinician-Administered PTSD Scale for DSM-5 (primary outcome)

  • ITQ - International Trauma Questionnaire

  • PTCI-9 - Brief Posttraumatic Cognitions Inventory

  • DSPS - Dissociative Subtype of PTSD Scale

Psychosis

  • PSYRATS — Psychotic Symptom Rating Scales, for delusions and hallucinations across modalities

  • GPTS-R — Green et al. Paranoid Thoughts Scale, revised

Recovery, functioning and quality of life

  • CHOICE — psychological recovery

  • PSP — Personal and Social Performance Scale

  • EQ-5D-5L and ReQoL-10 — health-related quality of life

  • AD-SUS (modified) — Adult Service Use Schedule, for the health economic analysis

Emotional Wellbeing

  • DASS-21 — Depression Anxiety Stress Scales, short form

  • PSFS — Paykel Suicidal Feelings Scale

  • ASSIST — Alcohol, Smoking and Substance Involvement Screening Test

Process and acceptability

  • WAI-SR — Working Alliance Inventory, short form revised (therapy group only)

  • Qualitative interviews with participants and therapists

Protocol, registration & analysis plans

TRIAL DOCUMENTS

STAR was registered prospectively, and its protocol and pre-specified analysis plans are published in full

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 Statistical Analysis Plan (SAP) Read more

STAR Health Economics Analysis Plan (HEAP) Read more

STAR Serious Adverse Events form (version 7) Read more