Virtual reality therapy for emotion regulation in Inuit
A Virtual Reality-assisted Cognitive Behavior Therapy With Inuit in Quebec - a Proof-of-concept Randomized Controlled Trial
This study is testing if virtual reality therapy can help Inuit people in Montreal better manage their emotions and feel less stressed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 14 Years to 60 Years |
| Sex | All |
| Sponsor | Douglas Mental Health University Institute Academic / other |
| Locations | 1 site (Montreal, Quebec) |
| Trial ID | NCT05631743 on ClinicalTrials.gov |
What this trial studies
This pilot trial evaluates the effectiveness of virtual reality-assisted cognitive-behavioral therapy (VR-CBT) for improving emotion regulation among Inuit individuals in Montreal. Participants will be randomly assigned to either an active psychotherapy group receiving VR-CBT guided by a psychotherapist or a comparison group using a VR self-management program called Calm Place for relaxation. The study aims to assess changes in emotion regulation, distress, and overall well-being through self-reports and psychophysiological measures before and after the treatment. The therapy has been culturally adapted for Inuit participants, ensuring relevance and engagement.
Who should consider this trial
Good fit: Ideal candidates are Inuit individuals aged 14 to 60 living in Montreal who are proficient in English or French and have stable mental health.
Not a fit: Patients with a history of psychosis, current substance abuse, or those outside the age range of 14 to 60 may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance emotion regulation skills and overall mental well-being for Inuit individuals facing emotional challenges.
How similar studies have performed: While the use of VR in therapy is gaining traction, this specific culturally adapted approach for Inuit is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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 from the trial (i.e., pre-existing heart conditions, convulsions, acute mental health risk).
Where this trial is running
Montreal, Quebec
- Douglas Mental Health University Institute — Montreal, Quebec, Canada (Recruiting)
Study contacts
- Principal investigator: Outi Linnaranta, MD, Ph.D — Douglas Mental Health University Institute
- Study coordinator: Karyne Anselmo, M.Sc.
- Email: karyne.anselmo@douglas.mcgill.ca
- Phone: 514-761-6131
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.