Effectiveness of Trauma Therapy Using Prolonged Exposure for the Treatment of Post-traumatic Stress Disorder (PTSD) in Patients With Comorbid Psychotic Disorder
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Post Traumatic Stress Disorder
- Sponsor
- University of Hamburg-Eppendorf
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Clinician-Administered PTSD Scale for DSM-5 (CAPS)
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
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.
Investigators
Susanne Sarkar
Dr. Susanne Sarkar
University of Hamburg-Eppendorf
Eligibility Criteria
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
Outcomes
Primary Outcomes
Clinician-Administered PTSD Scale for DSM-5 (CAPS)
Time Frame: 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.
Subjective PTSD symptoms
Time Frame: 6 months after baseline assessment
Posttraumtatic Stress Symptom Scale Self-Report (PSSI, Foa et al., 1993)
Secondary Outcomes
- Welleing(6 months after baseline assessment)
- The Psychotic Symptom Rating Scales-AH-Distress factor score (PSYRATS-AH)(6 months after baseline assessment)