Clinical Trial

VR-CBT With Inuit in Quebec

Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated February 12, 2025 (before its estimated October 31, 2025 completion). Its status may not reflect the trial's current state.
Summary
The study design is a two-arm randomized controlled pilot trial. The investigators will recruit Inuit in Montreal and randomly assign them to two treatment groups (n=20 each). The active psychotherapy group will receive a ten-week manualized virtual reality (VR) assisted cognitive-behavioral psychotherapy (VR-CBT) at the clinic and guided by a psychotherapist. The VR-CBT will aim at improving emotion regulation. The comparison group will use a VR self-management program, Calm Place, for guided relaxation during ten weeks at home. To evaluate outcome in both groups, the researchers will measure self-reports of emotion regulation, affect, distress and well-being, as well as a psychophysiological reactivity paradigm pre-post treatment.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-11-28; most recent amendment 2025-02-10.
Status change: Not Yet Recruiting → Recruiting 2023-10-31
Trial Details
NCT Number NCT05631743
Lead Sponsor Douglas Mental Health University Institute
Collaborators: Natural Sciences and Engineering Research Council, Canada, MedTeq, Douglas Foundation, McGill University
Conditions Emotion Regulation
Enrollment 40 participants
Start Date 2023-07-15
Primary Completion 2025-10-31 (estimated)
Study Completion 2025-12-31 (estimated)
Updated on ClinicalTrials.gov 2025-02-12