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

University of Hamburg-Eppendorf

Status: Enrolling

Conditions: Psychotic Disorders; Post Traumatic Stress Disorder; PTSD; Schizophrenia; Psychosis

Treatments: Behavioral: Prolonged Exposure

Study type: Interventional

Funder types: Other

Identifiers

NCT04911010

UHH-HSA-PEPSY

Details and patient eligibility

About

Effectiveness of trauma therapy using prolonged exposure for the treatment of post-traumatic stress disorder (PTSD) in patients with comorbid psychotic disorder

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Experimental: Prolonged Exposure + Treatment as usual

Experimental group

Description:

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

Treatment:

Behavioral: Prolonged Exposure

Waiting-Controll-Group

No Intervention group

Description:

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