PS-Trauma - Development of Trauma Treatment for Patients With Co-morbid Psychotic Disorders and Traumas

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.

Conditions

• SCHIZOPHRENIA 1 (Disorder)
• Schizotypal Disorder
• Post Traumatic Stress Symptoms

Interventions

BEHAVIORAL

Prolonged Exposure

Distinguishing Features - Prolonged Exposure (PE) Arm This intervention is distinguished by its exclusive reliance on systematic, therapist-guided exposure procedures grounded in emotional-processing theory. PE uses structured imaginal and in-vivo exposure to reduce avoidance and fear responses and does not employ bilateral stimulation, cognitive restructuring, or memory-processing elements characteristic of other trauma-focused approaches. The protocol follows a fixed sequence emphasizing habituation and extinction learning, making it operationally and mechanistically distinct from EMDR and from supportive or stabilization-oriented therapies used in similar clinical studies.

BEHAVIORAL

EMDR

Distinguishing Features - EMDR Arm This intervention is distinguished by its use of the standardized eight-phase EMDR protocol, which combines brief exposure to trauma memories with bilateral sensory stimulation to facilitate adaptive information processing. EMDR does not require prolonged or repeated imaginal exposure, fear-hierarchy construction, or systematic in-vivo exposure, differentiating it from PE and other exposure-based trauma treatments. Its mechanism centers on accelerating memory reprocessing rather than habituation, and the protocol includes unique components such as cognition rating, desensitization with bilateral stimulation, installation, and body scan procedures.

Sponsors & Collaborators

• Nikolai Albert

  lead OTHER

Principal Investigators

• Nikolai Albert · Mental Health Services in the Capital Region, Denmark

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-02

Primary Completion

2026-05-31

Completion

2026-06-30

Countries

• Denmark

Study Locations