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Recruiting NCT05631743

VR-CBT With Inuit in Quebec

Trial Parameters

Condition Emotion Regulation
Sponsor Douglas Mental Health University Institute
Study Type INTERVENTIONAL
Phase N/A
Enrollment 40
Sex ALL
Min Age 14 Years
Max Age 60 Years
Start Date 2023-07-15
Completion 2025-10-31
Interventions
VR-CBTSelf-management

Brief 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.

Eligibility Criteria

Inclusion Criteria: 1. Self-identify as Inuk 2. Live in Montreal 3. be between 14 to 60 years of age 4. be proficient in English or French 5. No history of cardiac conditions 6. No history of epilepsy 7. Can provide an emergency contact 8. Tolerance of VR headset 9. Tolerance of sensors 10. Has no current suicidal or homicidal risk 11. No history of psychosis or schizophrenia 12. Current stable mood 13. Is generally mentally stable 14. Score less than 8 on the Alcohol Use Disorders Identification Test C 15. Score less than 3 on the Drug Abuse Screen Test (10 item version) 16. Not have had any change in psychoactive medications during 4 weeks preceding screening and inclusion to the study Exclusion Criteria: 1. does not identify as Inuk 2. youth below the age of 14 and adults above the age of 60. 3. self-reported history of psychosis or schizophrenia 4. current substance abuse, as measured by two screens (AUDIT-C, DAST-10) 5. other mental or physical condition that might preclude them f

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