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

Schizophrenia Clinical Trial

— PEPSY  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04911010
• Other study ID #: UHH-HSA-PEPSY
• Status: Recruiting
• Phase: N/A
• Start date: January 20, 2021
• Est. completion date: September 2025

Study information

• Verified date: May 2021
• Source: University of Hamburg
• Contact: Susanne Sarkar, Dr.
• Phone: 00494042838-9699
• Email: susanne.sarkar[@]uni-hamburg.de
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2025
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• have a diagnosis of a Post Traumatic Stress Disorder (PTSD spectrum disorder (ICD-10, F43.1, confirmed by SCID-5 and CAPS)

• have a diagnosis of a schizophrenia spectrum disorder (ICD-10, F2, confirmed by SCID-5)

• patients will be reporting distressing AH for at least six months (to be beyond the startle and adjustment phase ) and score = 3 on either item 8 or item 9 of the PSYRATS-AH;

• be = 18 years of age

• good knowledge of the German language

• Willingness to participate in randomization and trauma-focused therapy

Exclusion Criteria:

• Changes in neuroleptic or antidepressant therapy within the last 4 weeks (exclusion of drug effects)

• Any substance addiction with continued use other than nicotine and / or caffeine addiction

• IQ of 70 or less

• Acute suicidality

• Pregnant women

Related Conditions & MeSH terms

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

Intervention

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).

Locations

Country	Name	City	State
Germany	University Hamburg	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Hamburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician-Administered PTSD Scale for DSM-5 (CAPS)	The severity of the PTSD symptoms associated distress. The distress factor score of the CAPS is the primary outcome as this is what has been prioritized by patients and is relevant to functioning. Confirmatory analysis will be conducted based on the intent-to-treat population (ITT), defined on the basis of the ITT principle. The aim is to show that the intervention group is superior to the control meaning that the mean score at 6 months adjusted for the baseline value is lower in the intervention group than in the control group. Lower scores indicate less distress.	6 months after baseline assessment
Primary	Subjective PTSD symptoms	Posttraumtatic Stress Symptom Scale Self-Report (PSSI, Foa et al., 1993)	6 months after baseline assessment
Secondary	The Psychotic Symptom Rating Scales-AH-Distress factor score (PSYRATS-AH)	Auditory hallucination associated distress. The distress factor score of the PSYRATS-AH is the secondary outcome. The aim is to show that the intervention group is superior to the control meaning that the mean score at 6 months adjusted for the baseline value is lower in the intervention group than in the control group. Lower scores indicate less distress.	6 months after baseline assessment
Secondary	Welleing	Wellbeing: Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS, NHS Health Scotland, University of Warwick and University of Edinburgh, 2007)	6 months after baseline assessment