NCT04911010

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: University of Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Post Traumatic Stress Disorder
• Psychotic Disorders
• Psychosis
• Schizophrenia
• PTSD

Interventions

Type	Name	Description
BEHAVIORAL	Prolonged Exposure	In the intervention condition, patients are treated with prolonged exposure in 16 hours of individual therapy immediately after the baseline measurement. The 16 individual therapeutic sessions take place 1 to 2 sessions per week over a period of 7 to 16 weeks. The individual therapeutic sessions are recorded on video with camera focus on the therapist. Parts of the prolonged exposure procedure (reliving the traumatic memory) are recorded on tape (via the patient's personal smartphone) so that the patient can listen to the recording as homework at home. The patients then take part in a post-treatment study diagnosis (T1).

Timeline

• Start date: 2021-01-20
• Primary completion: 2024-01-01
• Completion: 2025-09-01
• First posted: 2021-06-02
• Last updated: 2021-06-02

Locations

1 site across 1 country: Germany