NCT07242586 PS-Trauma - Development of Trauma Treatment for Patients With Co-morbid Psychotic Disorders and Traumas
| NCT ID | NCT07242586 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Nikolai Albert |
| Condition | SCHIZOPHRENIA 1 (Disorder) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-10-02 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-10-02 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Overview: People with psychotic disorders frequently have a history of traumatic events such as neglect, bullying, or physical and sexual abuse. Many experience significant symptoms of post-traumatic stress, but trauma-focused treatment is rarely offered in standard psychiatric care. This pilot study investigates whether two established trauma therapies can be delivered safely and acceptably to young adults with psychotic disorders receiving care in the OPUS early-intervention program. Objectives: The main aim is to evaluate the feasibility and acceptability of two trauma-focused treatments-Prolonged Exposure (PE) and Eye Movement Desensitization and Reprocessing (EMDR)-in patients with psychotic disorders and post-traumatic stress symptoms. The study is not designed to test treatment efficacy but to determine whether a larger randomized controlled trial is practical. Study Design: This is a pilot and feasibility study. Twenty OPUS patients with a diagnosis within the schizophrenia spectrum and clinically relevant PTSD symptoms will be randomly assigned to either PE or EMDR. All participants continue their usual OPUS care while attending weekly trauma-focused therapy sessions. Assessments: At baseline and follow-up, participants complete clinical interviews and questionnaires assessing trauma symptoms, psychotic symptoms, functioning, well-being, recovery experiences, and possible negative effects. Instruments include the PCL-5, CAPS-5, Mini-TALE, PANSS-6, PSP, WHO-5, Brief INSPIRE-O, NEQ, and CSQ. Primary Feasibility Outcomes: Recruitment: At least 80% of the planned sample enrolled within 6 months. Retention: At least 70% completing ≥12 therapy sessions. Acceptability: Participant satisfaction measured with the Client Satisfaction Questionnaire (CSQ). Eligibility: Inclusion: Age ≥18 Diagnosis within the schizophrenia spectrum (ICD-10: F20-F29) PTSD symptom score \>31 on PCL-5 Current OPUS patient Sufficient Danish language skills Exclusion: Substance use that prevents participation (e.g., attending sessions intoxicated) Severe cognitive impairment Recent changes in antipsychotic medication (within 1 month) Risks and Safety: Temporary increases in PTSD symptoms may occur when beginning trauma therapy; this pattern is well documented and typically followed by improvement. Previous studies show no higher risk of serious adverse events among patients with psychosis receiving trauma treatment compared with those who do not. Participants are closely monitored, and the study team works in continuous collaboration with OPUS clinicians. If a participant experiences significant clinical deterioration, the therapy can be paused or stopped, and supportive measures will be provided. Potential Benefits: Participants may experience a reduction in trauma-related symptoms and gain access to a treatment that is not otherwise routinely offered to patients with psychotic disorders. The study may help improve future care for this underserved population. Funding: The study is funded by the Nektar Foundation and conducted at the CORE Research Unit, Mental Health Services Copenhagen.
Eligibility 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
Contact & Investigator
Nikolai Albert
PRINCIPAL INVESTIGATOR
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital
Frequently Asked Questions
Who can join the NCT07242586 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 35 Years, studying SCHIZOPHRENIA 1 (Disorder). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07242586 currently recruiting?
Yes, NCT07242586 is actively recruiting participants. Contact the research team at nikolai.albert@regionh.dk for enrollment information.
Where is the NCT07242586 trial being conducted?
This trial is being conducted at Copenhagen, Denmark.
Who is sponsoring the NCT07242586 clinical trial?
NCT07242586 is sponsored by Nikolai Albert. The principal investigator is Nikolai Albert at Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital. The trial plans to enroll 20 participants.
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