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

NCT04911010 | Unknown

• 1 other identifier: UHH-HSA-PEPSY
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

PEPSY; Prolonged Exposure; trauma psychotherapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• The Psychotic Symptom Rating Scales-AH-Distress factor score (PSYRATS-AH)

  6 months after baseline assessment

• Welleing

  6 months after baseline assessment

Study Arms (2)

Experimental: Prolonged Exposure + Treatment as usual

EXPERIMENTAL

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

Waiting-Controll-Group

NO INTERVENTION

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

Interventions

Prolonged Exposure 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).

Also known as: Trauma Therapy

Experimental: Prolonged Exposure + Treatment as usual

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Any substance addiction with continued use other than nicotine and / or caffeine addiction
• IQ of 70 or less
• Acute suicidality
• Pregnant women

Sponsors & Collaborators

• University of Hamburg-Eppendorf: lead

Study Sites (1)

University Hamburg

Hamburg, 20146, Germany

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Psychotic Disorders; Schizophrenia

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders

Central Study Contacts

Susanne Sarkar, Dr.

CONTACT

00494042838-9699; susanne.sarkar@uni-hamburg.de

Tania Lincoln, Prof. Dr.

CONTACT

+49 40 42838-5360; tania.lincoln@uni-hamburg.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Susanne Sarkar

Model Details: prospective, randomized, controlled, parallel-group, two-armed, multicentre, open trial

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 2, 2021
• Study Start: January 20, 2021
• Primary Completion: January 1, 2024
• Study Completion: September 1, 2025
• Last Updated: June 2, 2021

Record last verified: 2021-05

Locations

DE (1)