Trauma therapies for young adults with psychotic disorders and post-traumatic stress symptoms
Tests whether Prolonged Exposure and EMDR can be delivered to young adults with psychosis.
Plain-language title generated from the registry record
Registry title: PS-Trauma - Development of Trauma Treatment for Patients With Co-morbid Psychotic Disorders and Traumas
Key facts
- Where
- Copenhagen, DenmarkSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 35 years old?
Source: NCT07242586, who can take part
Where in Denmark
- Mental Health Centre CopenhagenCopenhagen, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nikolai Albert
- Trial code
- NCT07242586
- Record updated
- 10 December 2025
- Original description
Overview:Read full original descriptionShow less
PS-Trauma: Udvikling af Traumebehandling Til Psykiatriske Patienter Med Psykoselidelse - et Pilotstudie.
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.
Inclusion: 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: Substance or alcohol abuse interfering with the therapy Indication of sever cognitive impairment Changes in antipsychotic treatment within the last month.