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

Study 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.

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

Conditions
-----------------
PTSD, Post Traumatic Stress Disorder, Psychotic Disorders, Psychosis, Schizophrenia

Intervention / Treatment
-----------------
* Behavioral: Prolonged Exposure


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective, randomized, controlled, parallel-group, two-armed, multicentre, open trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental: Prolonged Exposure + Treatment as usual<br>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<br>* 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).<br>* Other names: Trauma Therapy;|
| No Intervention: Waiting-Controll-Group<br>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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PEPSY, Prolonged Exposure, trauma psychotherapy