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

Not Applicable

Recruiting

• Conditions: Psychosis; Post Traumatic Stress Disorder; Psychotic Disorders; PTSD; Schizophrenia
• Interventions: Behavioral: Prolonged Exposure

• Registration Number: NCT04911010
• Lead Sponsor: University of Hamburg-Eppendorf

Brief 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.

Study Timeline

• Study Start: 2021-01-20
• Status Verified: 2021-05
• Study First Submitted: 2021-05-27
• Study First Submitted QC: 2021-05-27
• Last Update Submitted: 2021-05-27
• Study First Posted: 2021-06-02
• Last Update Posted: 2021-06-02
• Primary Completion: 2024-01
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental: Prolonged Exposure + Treatment as usual	Prolonged Exposure	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

Primary Outcome Measures

Name	Time	Method
Subjective PTSD symptoms	6 months after baseline assessment	Posttraumtatic Stress Symptom Scale Self-Report (PSSI, Foa et al., 1993)
Clinician-Administered PTSD Scale for DSM-5 (CAPS)	6 months after baseline assessment	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.

Secondary Outcome Measures

Name	Time	Method
Welleing	6 months after baseline assessment	Wellbeing: Short Warwick-Edinburgh Mental Wellbeing Scale (SWEMWBS, NHS Health Scotland, University of Warwick and University of Edinburgh, 2007)
The Psychotic Symptom Rating Scales-AH-Distress factor score (PSYRATS-AH)	6 months after baseline assessment	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.

Trial Locations

Locations (1)

University Hamburg; 🇩🇪 Hamburg, Germany