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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 35
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Denmark
Mental Health Centre Copenhagen
RECRUITING
Copenhagen
Contact Information
Primary
Nikolai Albert, MD, PhD
nikolai.albert@regionh.dk
+45 29925014
Backup
Rikke Hilker, MD, PhD
rikke.hilker@regionh.dk
+45 25775745
Time Frame
Start Date: 2025-10-02
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 20
Treatments
Active_comparator: Prolonged Exposure
Prolonged Exposure (PE) Arm:~Participants assigned to PE receive up to 12 weekly individual sessions delivered by trained clinicians following the standard PE manual. Treatment focuses on repeated, systematic confrontation with trauma-related memories (imaginal exposure) and avoided situations (in-vivo exposure) to reduce fear, distress, and maladaptive avoidance. Sessions include psychoeducation, breathing retraining, development of an exposure hierarchy, and structured review of homework assignments. Therapists monitor symptom fluctuations closely and coordinate with the OPUS clinical team. PE is provided in addition to participants' usual OPUS care, and all sessions follow predefined safety and fidelity procedures.
Active_comparator: EMDR
Eye Movement Desensitization and Reprocessing (EMDR) Arm:~Participants assigned to EMDR receive up to 12 weekly individual sessions delivered by certified EMDR therapists using the standard eight-phase protocol. Treatment targets distressing trauma memories through brief, repeated exposure combined with bilateral stimulation (e.g., eye movements or tactile taps) to facilitate adaptive information processing. Sessions include history taking, identification of target memories, assessment of negative and positive cognitions, desensitization, installation, and body scan procedures. Therapists monitor symptom changes throughout and coordinate with OPUS clinicians as needed. EMDR is provided alongside usual OPUS care, with adherence ensured through protocol-based supervision and fidelity checks.
Sponsors
Leads: Nikolai Albert

This content was sourced from clinicaltrials.gov