STAR Trial Demonstrates Trauma-Focused CBT Is Safe and Effective for PTSD in Patients with Psychosis, Challenging Decades of Clinical Exclusion
核心洞察
The landmark STAR trial, the largest multicenter RCT of trauma-focused therapy for co-occurring psychosis (搜索) and PTSD, enrolled 305 participants across five UK sites and found the integrated intervention both safe and highly effective.
Half of participants receiving trauma-focused CBT for psychosis (搜索) (CBTp) no longer met PTSD criteria post-therapy, compared to just over 20% in the treatment-as-usual arm, with a 6.5% therapy disengagement rate.
Significant improvements were observed across 22 of 27 assessed outcomes, including PTSD severity, paranoia, hallucinations, depression, anxiety, and suicidal ideation.
New research from the Institute of Psychiatry, Psychology & Neuroscience (IoPPN) at King's College London, published in The Lancet Psychiatry, has upended decades of clinical convention by demonstrating that trauma-focused cognitive behavioral therapy integrated with CBT for psychosis (搜索) (CBTp) is both safe and highly effective for individuals with co-occurring psychosis and post-traumatic stress disorder (搜索).
The STAR (Study of Trauma And Recovery) trial, funded by the National Institute for Health and Care Research (搜索) (NIHR) and led by researchers at King's IoPPN and South London and Maudsley NHS Foundation Trust (SLaM), recruited 305 participants, making it the largest multi-site randomized controlled trial to date of a trauma-focused therapy for this population.
A Treatment Gap Built on Assumption, Not Evidence
PTSD prevalence in people with psychosis (搜索) is up to five times that of the general population, with trauma symptoms often intertwined with psychotic experiences such as delusions and hallucinations. Despite this substantial disease burden, people with psychosis have historically been excluded from almost all PTSD research trials. Clinicians have been wary of delivering trauma-focused therapy in routine settings for fear of worsening psychotic symptoms.
"The field built a wall around a population and called the wall safety," notes commentary published alongside the trial results, pointing to a systematic review that identified psychosis (搜索) as the single most common exclusion criterion across CBT, EMDR, and group psychotherapy trials for PTSD. This exclusion predates any formal evidence of harm, as trauma-focused interventions were simply never tested in this group.
Robust Efficacy Across Multiple Domains
The STAR trial's integrated trauma-focused CBTp, delivered over nine months, produced striking results. Half of participants who received the therapy no longer met PTSD criteria post-treatment, compared to just over 20% in the treatment-as-usual arm. A similar pattern emerged for complex PTSD.
The primary outcome, PTSD symptom severity, demonstrated a moderate-to-large effect size. Overall, participants showed significant improvements in 22 out of 27 assessed outcomes, with additional effects ranging from large to small across psychosis (搜索) symptoms including paranoia and multisensory hallucinations, mood disorders such as depression, anxiety, and suicidal ideation, and broader psychological recovery.
Exceptional Acceptability and Safety
Therapy disengagement ran at just 6.5%, a figure the researchers describe as exceptionally low and one that would be remarkable in any psychiatric trial. This retention rate is particularly striking in a population that clinical convention has long treated as inherently difficult to engage.
Professor Emmanuelle Peters, Professor of Clinical Psychology at King's and the study's first author, stated: "It is now clear that trauma-focused therapies can be delivered safely and effectively for people with PTSD and psychosis (搜索). Our results are robust in demonstrating that this intervention, which includes working on the trauma memory directly, a focus on engagement, and a flexible approach tailored to the individual, is safe, highly acceptable and effective on a range of PTSD, psychosis, and emotional well-being outcomes."
Challenging the Sequencing Model
The trial's pragmatic, multicenter design directly challenges the implicit sequencing model that has governed dual-diagnosis care: stabilize the psychosis (搜索) first, address the trauma later. The STAR protocol did not wait for psychosis to fully remit before initiating trauma work. Instead, it integrated trauma-focused therapy with CBTp across the full nine-month treatment course.
This approach is consistent with the neurobiological overlap between trauma and psychosis (搜索), which share dysregulation in the hypothalamic-pituitary-adrenal axis and dopaminergic circuits. Treating psychotic symptoms in isolation while leaving trauma unaddressed means working against a system that continually re-activates the stress responses antipsychotics attempt to modulate.
Clinical Implementation and Patient Impact
Dr. Amy Hardy, Reader in Clinical Psychology at King's and joint-last author, emphasized the ethical dimension: "The results challenge a longstanding gap in mental healthcare, where people with psychosis (搜索) 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."
The PICuP Clinic at SLaM, led by Professor Peters, now provides trauma-focused CBTp and training in the intervention to clinicians. One participant, Shane, who now works as a Peer-Support Worker in the clinic, described his experience: "STAR therapy gave me the tools to make sense of experiences I had carried for years and change how I see myself and others. I didn't just learn ways to manage and reshape trauma memories — I rebuilt trust, confidence, and a sense of connection."
Dr. Nadine Keen, STAR joint-Therapy Lead, called the trial "a gamechanger for the psychological treatment of this highly complex and marginalized population," urging commissioners and services to prioritize implementation of trauma-focused CBTp.
Implications for Future Research
The findings carry immediate implications for clinical trial design. Psychosis (搜索) as a blanket exclusion criterion in PTSD intervention trials is no longer defensible as a safety rationale. Future trials that exclude active psychotic disorder must now provide an affirmative, evidence-based argument grounded in mechanism or prior harm signal, neither of which the current literature supports.
The trial involved over 120 people across five UK sites — London, Manchester, Newcastle, Oxford, and Sussex — and took five years to complete. Questions remain regarding generalizability to minoritized and linguistically isolated populations, as well as which psychosis (搜索) subgroups may drive the strongest treatment response, an area the field will be watching closely as secondary outcome analyses emerge.