TOPLINE 

Adjunctive trauma-focused cognitive-behavioral therapy for psychosis (CBTp) was safe and associated with a greater reduction in the symptom severity of posttraumatic stress disorder (PTSD) in patients with psychosis and PTSD than treatment as usual (TAU) only, the largest trial involving this underserved population showed.

METHODOLOGY 

• The STAR, a parallel-group, pragmatic randomized controlled trial, was conducted at five sites in the UK from 2020 to 2024.
• Among more than 300 adults (mean age, 38.9 years; 56% women) with co-occurring PTSD and psychosis, 50.5% were randomly assigned to receive trauma-focused CBTp plus TAU, and 49.5% receivedTAU alone.
• CBTp included a focus on engagement, trauma memory reprocessing, and flexible stabilization and lasted 9 months. About 26 weekly or twice-weekly sessions occurred in the first 6 months, followed by monthly booster sessions over the next 3 months.
• The primary outcome was the total PTSD symptom severity score on the clinician-administered PTSD scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (CAPS-5). Secondary outcomes included safety, PTSD remission, clinically significant change in CAPS-5 score, and changes in psychosis symptoms and mood.

TAKEAWAY 

• Although both groups showed similar reductions in CAPS-5 scores at 4 months, the trauma-focused group had a significantly greater reduction at 9 months than the TAU-only group (adjusted mean difference, -8.67; P = .0003).
• PTSD remission was achieved by 50% vs 22% of the intervention group vs the control group (odds ratio [OR], 0.11; P = .0001), and a clinically significant reduction in CAPS-5 scores (≥ 15 points) was observed in 45% vs 27%, respectively.
• Overall, 81% of the secondary outcomes, including PTSD outcomes (except derealization and depersonalization), delusions, paranoia, hallucinations, suicidal ideation, depression, anxiety, stress, and psychological recovery, were significantly reduced in the intervention group vs the control group (P < .05 for all; effect size range, -0.26 to -0.82).
• Serious adverse events occurred in 34% vs 31% of the intervention group vs the control group, with none considered to be unexpected or related to the intervention.

IN PRACTICE 

“The results challenge a longstanding gap in mental healthcare, where people with psychosis have been excluded from trauma-focused therapies. Our findings demonstrate that this must change to ensure those historically denied access can receive evidence-based care,” co-investigator Amy Hardy, PhD, King’s College London, Institute of Psychiatry, Psychology & Neuroscience, London, England, said in a press release.

SOURCE 

The study was led by Emmanuelle Peters, PhD, King’s College London, Institute of Psychiatry, Psychology & Neuroscience. It was published online on June 23 in The Lancet Psychiatry.

LIMITATIONS 

The study was limited by a lack of an active control condition and long-term follow-up data, as well as the variable and unreliable psychosis diagnoses. Although the therapy was delivered by experienced therapists trained to competence with access to expert clinical supervision, this did not reflect the general mental health services.

DISCLOSURES 

The study was funded by the National Institute for Health and Care Research. Disclosure information for the investigators is available in the original study publication.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.