Effectiveness of Trauma Therapy in Patients With PTSD and Comorbid Psychotic Disorder — PEPSY  

Schizophrenia Clinical Trial

Official title: Effectiveness of Trauma Therapy Using Prolonged Exposure for the Treatment of Post-traumatic Stress Disorder (PTSD) in Patients With Comorbid Psychotic Disorder

Status Recruiting

Clinical Trial Summary

Effectiveness of trauma therapy using prolonged exposure for the treatment of post-traumatic stress disorder (PTSD) in patients with comorbid psychotic disorder

Clinical Trial Description

Background and goals: Patients with psychotic disorders often report traumatizing experiences in their biography and show symptoms of a trauma-related disorder. It is assumed that around 30 percent of patients with a psychotic disorder also meet the criteria for PTSD. For the vast majority of patients, psychosis is the focus of mostly pharmacological treatment, while PTSD is not part of the therapy. In a first randomized controlled study, van den Berg's Dutch working group was able to show that psychosis patients with comorbid PTSD who were given a classic trauma exposure procedure showed a high response to PTSD symptoms (van den Berg et al., 2015). It is also important that in this study the trauma exposure did not lead to an increase in psychotic symptoms or undesirable side effects (e.g. suicidality). In order to examine the question of the generalizability of the effects, a randomized controlled study in the German-speaking health care system is necessary. In the following efficacy study in which psychosis patients with PTSD are treated using prolonged exposure. METHODS AND RESULTS: It is a multicenter, controlled, prospective, randomized study (RCT). It is investigated whether trauma therapy reduces PTSD and psychosis symptoms compared to the Treatment-As-Usual Waiting Group (TAU). The primary endpoint is the severity of the PTSD symptoms between the baseline measurement and the 6-month follow-up. Secondary endpoints are subjective PTSD symptoms, paranoia, hallucinations, and wellbeing. ;

Related Conditions & MeSH terms

• Disease
• Mental Disorders
• Post Traumatic Stress Disorder
• Psychosis
• Psychotic Disorders
• PTSD
• Schizophrenia
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

• NCT number: NCT04911010
• Study type: Interventional
• Source: University of Hamburg
• Contact: Susanne Sarkar, Dr.
• Phone: 00494042838-9699
• Email: susanne.sarkar@uni-hamburg.de
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2021
• Completion date: September 2025