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

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.

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