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Trauma-focused therapies for post-traumatic stress in psychosis: study protocol for the RE.PROCESS randomized
Simone R Burger1,2, Tineke van der Linden3,4, Amy Hardy5,6
1Department of Clinical Psychology, VU University and Amsterdam Public Health Research Institute, Room MF-B543, Van der Boechorstraat 7, Amsterdam, 1081 BT, the Netherlands. s.r.burger@vu.nl.
Trials
|October 5, 2022
Summary
This study compares three trauma-focused therapies (cognitive restructuring, prolonged exposure, eye movement desensitization and reprocessing) against a waiting list for individuals with psychosis and PTSD. It
Area of Science:
- Psychiatry and Clinical Psychology
- Trauma-Informed Care
- Mental Health Research
Background:
- Co-occurrence of Post-Traumatic Stress Disorder (PTSD) and psychotic disorders is common.
- Existing trauma-focused therapies (TFTs) like cognitive restructuring (CR), prolonged exposure (PE), and eye movement desensitization and reprocessing (EMDR) show promise but require direct comparison.
- Previous studies varied in methodology, necessitating a standardized, head-to-head comparison within a single context.
Purpose of the Study:
- To be the first randomized controlled trial (RCT) to directly compare the efficacy of CR, PE, and EMDR against a waiting list (WL) control.
- To evaluate these therapies in individuals with both psychosis and PTSD within a naturalistic treatment setting.
- To assess the impact of these interventions on PTSD symptom severity and diagnosis.
Main Methods:
- Pragmatic, single-blind, multicentre, superiority randomized controlled trial involving 200 participants.
- Inclusion criteria: age ≥ 16, full DSM-5 PTSD diagnosis (CAPS-5 score ≥ 23), and schizophrenia spectrum disorder.
- Participants randomly assigned to 16 sessions of CR, PE, EMDR, or WL, alongside treatment as usual (TAU) for psychosis; primary outcome assessed from baseline to 6-month follow-up.
Main Results:
- Primary objective: Compare effects of CR, PE, EMDR vs. WL on researcher-rated PTSD symptom severity from baseline to 6-month follow-up.
- Secondary objectives: Examine effects at mid-treatment, post-treatment, and 6-month follow-up.
- Further secondary objectives: Assess effects on clinician-rated PTSD diagnosis and self-rated (complex) PTSD symptoms.
Conclusions:
- This study represents the first RCT to directly compare CR, PE, and EMDR against TAU for PTSD symptoms in individuals with psychosis and PTSD.
- The trial will provide crucial data on the comparative effectiveness of these leading TFTs in a complex clinical population.
- Secondary analyses will explore impacts on broader clinical and functional outcomes, offering long-term perspectives.
Keywords:
Cognitive restructuringEMDR therapyPTSDProlonged exposurePsychosisTraumaTrauma-focused treatmentMore Related Videos
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