Clinical trial NCT04911010: Effectiveness of Trauma Therapy in Patients With PTSD and Comorbid Psychotic Disorder
Official title: Effectiveness of Trauma Therapy Using Prolonged Exposure for the Treatment of Post-traumatic Stress Disorder (PTSD) in Patients With Comorbid Psychotic Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Post Traumatic Stress Disorder
Psychotic Disorders
Psychosis
Schizophrenia
PTSD
Keywords: PEPSY
Prolonged Exposure
trauma psychotherapy
Lead sponsor: University of Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2021-06-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, randomized, controlled, parallel-group, two-armed, multicentre, open trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Clinician-Administered PTSD Scale for DSM-5 (CAPS)
timeFrame: 6 months after baseline assessment
measure: Subjective PTSD symptoms
timeFrame: 6 months after baseline assessment
Secondary outcomes:
measure: The Psychotic Symptom Rating Scales-AH-Distress factor score (PSYRATS-AH)
timeFrame: 6 months after baseline assessment
measure: Welleing
timeFrame: 6 months after baseline assessment
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Hamburg
Study officials:
References: