Trauma-focused therapies for posttraumatic stress in psychosis

Not Applicable

• Conditions: Post-traumatic stress symptoms in patients with chronic post-traumatic stress disorder and a comorbid psychotic disorder in the schizophrenia spectrum; Mental and Behavioural Disorders; Post-traumatic stress disorder

• Registration Number: ISRCTN56150327
• Lead Sponsor: Vrije Universiteit Amsterdam

Brief Summary

2022 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36199107/ (added 06/10/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-18
• Last Update Posted: 19 December 2023
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Age 16+ years
2. A lifetime diagnosis of a psychotic disorder in the schizophrenia spectrum, confirmed by the Structured Clinical Interview for DSM-5 (SCID-5)
3. Full DSM-5 diagnostic criteria for chronic PTSD on the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) with a minimum score =23
4. Willingness to undergo randomisation and a trauma-focused therapy

Exclusion Criteria

1. Changes in antipsychotic or antidepressant medication regimen within 4 weeks before the inclusion interview assessment (to control for medication effects)
2. Insufficient competence in the Dutch language
3. Severe intellectual impairment, defined as an estimated IQ of 70 or less
4. Not being able to travel (or be accompanied) to the outpatient service
5. Not willing or able to learn to use a smartphone

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Researcher-rated changes in severity of PTSD symptoms as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). This will be measured at baseline, at 7 weeks (mid-treatment), 13 weeks (post-treatment), 6-month follow-up, 12-month follow-up, and 24-month follow-up.