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

December 3, 2025 updated by: Nikolai Albert

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This pilot study evaluates the feasibility, acceptability, and procedural integrity of delivering trauma-focused psychotherapy to individuals with schizophrenia-spectrum disorders who exhibit clinically significant post-traumatic stress symptoms. Although traumatic experiences are common in this population, trauma-focused treatment remains underutilized in routine psychiatric services due to concerns regarding symptom destabilization, insufficient clinician training, and uncertainty about optimal therapeutic approaches. Emerging evidence indicates that established trauma-focused modalities-specifically Prolonged Exposure (PE) and Eye Movement Desensitization and Reprocessing (EMDR)-can be safely delivered in patients with psychosis when accompanied by close clinical monitoring. Nevertheless, feasibility and implementation data in early-intervention settings remain limited.

The present study is designed as a randomized, parallel-group feasibility trial conducted within the OPUS early-intervention program. The overarching aim is to determine whether a larger powered efficacy trial is practicable. The study systematically evaluates recruitment and retention rates, session attendance, intervention fidelity, acceptability, and the logistical compatibility of trauma-focused treatment with existing OPUS care structures. The pilot nature of the study means that statistical analyses are exploratory and focused on estimating parameters needed for the design of a subsequent definitive trial (e.g., variability of symptom change, pre-post correlations, and event rates).

Participants are randomized 1:1 to either PE or EMDR and receive up to 12 weekly individual sessions in addition to standard OPUS treatment. Therapists are certified in the respective modalities and receive protocol-specific supervision to ensure adherence. Treatment progression follows established manuals: PE focuses on imaginal and in-vivo exposure to trauma memories and avoided situations, whereas EMDR employs bilateral stimulation during structured processing of traumatic material. Both approaches incorporate ongoing risk monitoring, review of symptom trajectories, and coordination with OPUS clinicians.

Assessments are conducted at baseline and after treatment completion. Instruments include structured diagnostic interviews for trauma and psychosis, clinician-rated symptom scales, patient-reported outcomes (trauma symptoms, well-being, recovery experience), functioning measures, and standardized adverse-event reporting tools. Particular emphasis is placed on quantifying temporary symptom fluctuations often observed during trauma therapy, documenting any clinically significant deterioration, and evaluating whether such fluctuations differ across treatment arms.

Safety procedures include predetermined criteria for pausing or discontinuing therapy, rapid communication channels with OPUS teams, and access to supportive interventions when needed. Existing evidence suggests that trauma-focused treatment does not increase the risk of psychotic relapse or severe adverse events compared with non-exposed controls; the study therefore aims to replicate and refine these safety observations within the OPUS context.

Feasibility outcomes include: (1) proportion of eligible patients successfully recruited; (2) proportion of participants completing ≥12 sessions; (3) treatment adherence rated through fidelity checklists; (4) participant-reported acceptability and satisfaction; and (5) operational practicality, including therapist burden, integration with OPUS scheduling, and need for additional support structures. These metrics will inform the design parameters for a future multicenter randomized controlled trial.

Overall, this pilot study seeks to generate high-quality feasibility data on the integration of trauma-focused psychotherapy into early-intervention services for individuals with psychotic disorders. Findings will guide the refinement of recruitment strategies, safety procedures, intervention delivery, and outcome assessment protocols to support a subsequent adequately powered trial aimed at evaluating clinical efficacy.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Denmark
    • Denmark
      • Copenhagen, Denmark, Denmark, 2900
        • Recruiting
        • Mental Health Centre Copenhagen
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nikolai Albert, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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 Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Recrutment
Time Frame: 6 months
80% of planed participants will be included within 6 months
6 months
Retensionrate
Time Frame: 8 months
A minimum of 70% of participants will conclude the therapy sessions
8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Nikolai Albert

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nikolai Albert, Mental Health Services in the Capital Region, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 2, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 21, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-25038884

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

If accepted the data will be deposited in the Danish National Archives

IPD Sharing Time Frame

Depending on the national Archives the data will deposited within a year of completion of the study (07.31.2027)

IPD Sharing Access Criteria

Access to data is based on review by the Danish national archives and are not decided by the researchers

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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