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

NCT ID: NCT04911010

Last Updated: 2021-06-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-20
• Study Completion Date: 2025-09-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental: Prolonged Exposure + Treatment as usual

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

Group Type: EXPERIMENTAL

Prolonged Exposure

Intervention Type: BEHAVIORAL

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).

Waiting-Controll-Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Prolonged Exposure

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).

Intervention Type: BEHAVIORAL

Other Intervention Names

Trauma Therapy

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Hamburg-Eppendorf

OTHER

Sponsor Role: lead

Responsible Party

Susanne Sarkar

Dr. Susanne Sarkar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hamburg

Hamburg, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Susanne Sarkar, Dr.

Role: CONTACT

susanne.sarkar@uni-hamburg.de

00494042838-9699

Tania Lincoln, Prof. Dr.

Role: CONTACT

tania.lincoln@uni-hamburg.de

+49 40 42838-5360

Facility Contacts

Susanne Sarkar, Dr.

Role: primary

susanne.sarkar@uni-hamburg.de

+49 40 42838-5374

Esther Wolfrom

Role: backup

klinische.psych@uni-hamburg.de

+49 40 42838-5360

Other Identifiers

UHH-HSA-PEPSY

Identifier Type: -

Identifier Source: org_study_id