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Trauma-focused Therapies for Posttraumatic stress In Psychosis: the RE.PROCESS randomised controlled trial

Trauma-focused Therapies for Posttraumatic stress In Psychosis: the RE.PROCESS randomised controlled trial - RE.PROCESS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON54514
Enrollment
160
Registered
2019-03-27
Start date
2019-06-24
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

psychosis / Post-traumatic stress disorder Schizophrenia

Interventions

The PE, EMDR and CR groups will receive a maximum of 16 sessions of treatment. The third group will be a waiting list group up to the 6-month follow-up, after which they may choose to receive treatm

Sponsors

Vrije Universiteit
Lead Sponsor

Eligibility

Age
16 Years to 64 Years

Inclusion criteria

Inclusion criteria: • 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

Exclusion criteria

Exclusion criteria: • 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

Design outcomes

Primary

MeasureTime frame
The main outcome is researcher-rated changes in severity of PTSD symptoms on the CAPS between baseline and 6-month follow-up.

Secondary

MeasureTime frame
Researcher-rated presence of PTSD diagnosis, self-rated severity of PTSD and severity of complex PTSD symptoms, posttraumatic cognitions, dissociation, depression, paranoia, auditory verbal hallucinations, social functioning, disruption of social functioning by PTSD symptoms, resilience, personal recovery, sexual functioning, adversities, and revictimization.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026