Trauma treatment for young adults with psychotic disorders and PTSD symptoms
Official title: PS-Trauma: Udvikling af Traumebehandling Til Psykiatriske Patienter Med Psykoselidelse - et Pilotstudie.
Run by Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital · NCT07242586 · Data updated 2026-11-12
This pilot will try two trauma therapies—Prolonged Exposure (PE) and EMDR—on young adults in early psychosis care who have post-traumatic stress symptoms to see if they can be delivered safely and are acceptable.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 35 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital Academic / other |
| Locations | 1 site (Copenhagen, Denmark) |
| Status | Recruiting |
| Started | October 2, 2025 |
| Main results expected | May 31, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | December 10, 2025 |
| Trial ID | NCT07242586 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) enrolled in the OPUS early-intervention program with a schizophrenia-spectrum diagnosis, clinically significant PTSD symptoms (PCL-5 > 31), Danish language ability, and stable antipsychotic treatment are ideal candidates.
✕Probably not a fit
Patients with active substance or alcohol misuse that interferes with therapy, severe cognitive impairment, recent changes in antipsychotic medication, or who are not enrolled in OPUS or Danish-speaking may not benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, parallel-group pilot tests the feasibility and acceptability of delivering Prolonged Exposure (PE) versus EMDR to people with schizophrenia-spectrum diagnoses and clinically significant post-traumatic stress symptoms enrolled in the OPUS early-intervention program. Twenty participants receiving usual OPUS care will be randomized to one of the two trauma-focused treatments, with close clinical monitoring and standardized fidelity checks. Primary outcomes are feasibility metrics (recruitment, retention, session attendance, and intervention fidelity) and acceptability to patients and clinicians, not clinical efficacy. Results will inform whether a larger randomized controlled trial is practical and how it should be designed.
Why it matters
Potential benefit: If successful, this approach could expand access to evidence-based trauma therapy for people with psychosis and reduce trauma-related symptoms and distress within early-intervention services.
How similar studies have gone: Emerging trials and case series indicate PE and EMDR can be delivered safely to people with psychosis under close monitoring, but large randomized efficacy trials in early-intervention settings remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * over 18 years of age Diagnosis within schizophrenia spectrum (ICD10 F2X) PTSD symptoms equivalent to above 31 on the PCL-5 Included in Early intervention services (OPUS) Talks and understands Danish Exclusion Criteria: * Substance or alcohol abuse interfering with the therapy Indication of sever cognitive impairment Changes in antipsychotic treatment within the last month
Where it's running
-
Mental Health Centre Copenhagen
Copenhagen, Denmark, Denmark Recruiting
Study contacts
- Principal investigator: Nikolai Albert — Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
- Study coordinator: Nikolai Albert, MD, PhD
- Email: nikolai.albert@regionh.dk
- Phone: +45 29925014
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.