Trauma-focused Therapies for Posttraumatic stress In Psychosis: the RE.PROCESS randomised controlled trial
- Conditions
- psychosis / Post-traumatic stress disorderSchizophrenia10039628
- Registration Number
- NL-OMON54514
- Lead Sponsor
- Vrije Universiteit
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 160
• age 16+ years
• a lifetime diagnosis of a psychotic disorder in the schizophrenia spectrum,
confirmed by the Structured Clinical Interview for DSM-5 (SCID-5)
• meeting DSM-5 symptom criteria for PTSD (cluster B to H) on the
Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) with a minimum score >=23
• willingness to undergo randomisation and a trauma-focused intervention
• changes in antipsychotic or antidepressant medication regimen within 4 weeks
before the inclusion interview assessment (to control for medication effects)
• insufficient competence in the Dutch language
• severe intellectual impairment, defined as an estimated IQ of 70 or less
• not being able to travel (or be accompanied) to the outpatient service
• 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 <p>The main outcome is researcher-rated changes in severity of PTSD symptoms on<br /><br>the CAPS between baseline and 6-month follow-up. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Researcher-rated presence of PTSD diagnosis, self-rated severity of PTSD and<br /><br>severity of complex PTSD symptoms, posttraumatic cognitions, dissociation,<br /><br>depression, paranoia, auditory verbal hallucinations, social functioning,<br /><br>disruption of social functioning by PTSD symptoms, resilience, personal<br /><br>recovery, sexual functioning, adversities, and revictimization.</p><br>