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

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

Study Overview

• Status: Recruiting
• Conditions: Psychotic Disorders; PTSD; Schizophrenia; Post Traumatic Stress Disorder; Psychosis
• Intervention / Treatment: Behavioral: Prolonged Exposure

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Susanne Sarkar, Dr.; Phone Number: 00494042838-9699; Email: susanne.sarkar@uni-hamburg.de
• Study Contact Backup: Name: Tania Lincoln, Prof. Dr.; Phone Number: +49 40 42838-5360; Email: tania.lincoln@uni-hamburg.de

Study Locations

• Germany
  • Hamburg, Germany, 20146
    • Recruiting
    • University Hamburg
    • Contact: Susanne Sarkar, Dr.; Phone Number: +49 40 42838-5374; Email: susanne.sarkar@uni-hamburg.de
    • Contact: Esther Wolfrom; Phone Number: +49 40 42838-5360; Email: klinische.psych@uni-hamburg.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental: Prolonged Exposure + Treatment as usual; Participants in this arm will receive 16 weekly sessions with Prolonged Exposure Therapy (RT) over 4 months in addition to their treatment as usual. Interventions: Behavioral: Prolonged Exposure Therapy Other: Treatment as usual	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).; Other Names: Trauma Therapy
NO_INTERVENTION: Waiting-Controll-Group; Treatment as usual Treatment as usual will include medication management, supportive brief counselling sessions and various types of psychosocial (e.g. social work guided support, peer support) and monitoring provided by Mental Health Services, with individual and family psychological therapies offered occasionally. Intervention: Other: Treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Subjective PTSD symptoms	Posttraumtatic Stress Symptom Scale Self-Report (PSSI, Foa et al., 1993)	6 months after baseline assessment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Hamburg-Eppendorf

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 20, 2021
• Primary Completion (ANTICIPATED): January 1, 2024
• Study Completion (ANTICIPATED): September 1, 2025

Study Registration Dates

• First Submitted: May 27, 2021
• First Submitted That Met QC Criteria: May 27, 2021
• First Posted (ACTUAL): June 2, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 2, 2021
• Last Update Submitted That Met QC Criteria: May 27, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Prolonged Exposure; PEPSY; trauma psychotherapy
• Additional Relevant MeSH Terms: Pathologic Processes; Schizophrenia Spectrum and Other Psychotic Disorders; Trauma and Stressor Related Disorders; Schizophrenia; Disease; Psychotic Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Mental Disorders
• Other Study ID Numbers: UHH-HSA-PEPSY

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No