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

NCT07242586 | Recruiting

• 1 other identifier: H-25038884
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

First episode psychosis; Trauma; Schizophrenia; psychotherapy; prolonged exposure; EMDR

Outcome Measures

Primary Outcomes (2)

• Recrutment

  80% of planed participants will be included within 6 months

  6 months

• Retensionrate

  A minimum of 70% of participants will conclude the therapy sessions

  8 months

Study Arms (2)

Prolonged Exposure

ACTIVE COMPARATOR

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.

Behavioral: Prolonged Exposure

EMDR

ACTIVE COMPARATOR

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.

Behavioral: EMDR

Interventions

EMDR BEHAVIORAL

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.

EMDR

Prolonged Exposure BEHAVIORAL

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.

Prolonged Exposure

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Substance or alcohol abuse interfering with the therapy Indication of sever cognitive impairment Changes in antipsychotic treatment within the last month

Sponsors & Collaborators

• Nikolai Albert: lead

Study Sites (1)

Mental Health Centre Copenhagen

Copenhagen, Denmark, 2900, Denmark

RECRUITING

MeSH Terms

Conditions

Schizotypal Personality Disorder; Wounds and Injuries; Schizophrenia

Interventions

Eye Movement Desensitization Reprocessing

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Nikolai Albert

  Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nikolai Albert, MD, PhD

CONTACT

+45 29925014; nikolai.albert@regionh.dk

Rikke Hilker, MD, PhD

CONTACT

+45 25775745; rikke.hilker@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 21, 2025
• Study Start: October 2, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Depending on the national Archives the data will deposited within a year of completion of the study (07.31.2027)
• Access Criteria: Access to data is based on review by the Danish national archives and are not decided by the researchers

Locations

DK (1)