VR-CBT With Inuit in Quebec

Recruiting now · Not applicable

Conditions studied: Emotion Regulation

In brief

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.

Key facts

Study ID

NCT05631743

Run by

Douglas Mental Health University Institute

People needed

40

Starts

2023-07-15

Expected to finish

2025-12-31

Last updated by the study team

2025-02-12

Who can join

Age: 14 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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).

Where it is running

• Douglas Mental Health University Institute — Montreal, Quebec, Canada (enrolling)

Full record on ClinicalTrials.gov

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