← Back to all trials
Not Yet Recruiting
NCT05631743
VR-CBT With Inuit in Quebec
Conditions: Emotion Regulation
Sex: All
Ages: 14 Years – 60 Years
Phase: NA
Enrollment: 40
Sponsor: Douglas Mental Health University Institute
Location: Canada
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:Self-identify as InukLive in Montrealbe between 14 to 60 years of agebe proficient in English or FrenchNo history of cardiac conditionsNo history of epilepsyCan provide an emergency contactTolerance of VR headsetTolerance of sensorsHas no current suicidal or homicidal riskNo history of psychosis or schizophreniaCurrent stable moodIs generally mentally stableScore less than 8 on the Alcohol Use Disorders Identification Test CScore 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 studyExclusion Criteria:does not identify as Inukyouth below the age of 14 and adults above the age of 60.self-reported history of psychosis or schizophreniacurrent 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).
Source: ClinicalTrials.gov (NCT05631743). StuddyBuddy aggregates publicly available trial information.