Actively Recruiting
A Virtual Reality-assisted Cognitive Behavior Therapy With Inuit in Quebec - a Proof-of-concept Randomized Controlled Trial
Led by Douglas Mental Health University Institute · Updated on 2025-02-12
40
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
Sponsors
D
Douglas Mental Health University Institute
Lead Sponsor
N
Natural Sciences and Engineering Research Council, Canada
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating two different approaches to improve emotion regulation skills among Inuit individuals in Montreal. This proof-of-concept study is a randomized controlled trial comparing a manualized virtual reality-assisted cognitive-behavioral therapy (VR-CBT) guided by a psychotherapist to a self-managed virtual reality relaxation program called Calm Place. The study aims to address difficulties in regulating emotions, which are affected by traumatic experiences and can contribute to psychiatric symptoms. Participants will be randomly assigned to one of two groups of 20 people each. The first group will receive up to 10 weekly sessions of VR-CBT at the clinic, guided by a trained psychotherapist. The second group will use the Calm Place VR program at home for relaxation and meditation over the same 10-week period at their own pace. The VR-CBT therapy has been culturally adapted with input from Inuit community members and health providers to better suit participants' needs. Throughout the study, participants will complete self-report measures on emotion regulation, anxiety, mood, substance use, functionality, and quality of life before and after treatment. They will also undergo a psychophysiological reactivity test involving heart rate, skin conductance, and emotional responses to stressful stimuli. Researchers will monitor attendance and treatment completion during the 10-week intervention. The main outcome measured is emotion regulation, with additional assessments of psychiatric symptoms and well-being.
CONDITIONS
Brief Title
VR-CBT With Inuit in Quebec
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Self-identify as Inuk
- Live in Montreal
- Be between 14 to 60 years of age
- Be proficient in English or French
- No history of cardiac conditions
- No history of epilepsy
- Can provide an emergency contact
- Tolerance of VR headset
- Tolerance of sensors
- Has no current suicidal or homicidal risk
- No history of psychosis or schizophrenia
- Current stable mood
- Is generally mentally stable
- Score less than 8 on the Alcohol Use Disorders Identification Test C
- Score less than 3 on the Drug Abuse Screen Test (10 item version)
- Not have had any change in psychoactive medications during 4 weeks preceding screening and inclusion to the study
You will not qualify if you...
- Does not identify as Inuk
- Youth below the age of 14 and adults above the age of 60
- Self-reported history of psychosis or schizophrenia
- Current substance abuse, as measured by two screens (AUDIT-C, DAST-10)
- Other mental or physical condition that might preclude them from the trial (i.e., pre-existing heart conditions, convulsions, acute mental health risk)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 10 weeks
Participants receive either virtual reality-assisted cognitive behavioral therapy guided by a psychotherapist at the clinic or use a virtual reality self-management program at home to improve emotion regulation over ten weeks.
Up to 10 in-person sessions for VR-CBT group or use at home at own pace for self-management group
Duration - Short-term post-treatment
Participants complete assessments including psychophysiological testing and self-reports to evaluate emotion regulation, psychiatric symptoms, and well-being after treatment.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Douglas Mental Health University Institute
Montreal, Quebec, Canada, h4h 1r3
Actively Recruiting
Research Team
K
Karyne Anselmo, M.Sc.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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