PS-Trauma: Udvikling af Traumebehandling Til Psykiatriske Patienter Med Psykoselidelse - et Pilotstudie.
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.
• 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