VR-CBT With Inuit in Quebec

Douglas Mental Health University Institute15 enrolled

Overview

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.

In this protocol, the investigators present a proof-of-concept trial that will evaluate an active psychotherapy and self-management, both targeting emotion regulation skills. The study design is a two-arm randomized controlled trial. The investigators will recruit Inuit 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, a set of skills or competence that is impacted by traumatic experiences and mediates the effect of trauma on psychiatric symptoms. The investigators conducted a cultural adaptation of the therapy for Inuit with a co-design grounded in qualitative participatory methods. 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 include a psychophysiological reactivity paradigm pre-post treatment and self-reports of emotion regulation, anxiety, mood, substance use, functionality and quality of life. The investigators expect to see preliminary evidence that our VR-CBT can be more successful than guided VR relaxation with Calm Place (self-management) decreasing difficulties in emotion regulation, psychiatry symptoms, increasing well-being, and normalizing responses to stressful stimuli (reactivity).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

Interventions

VR-CBTBEHAVIORAL

The therapy is focused on emotion regulation through guided learning in virtual reality. The manual is a modified conventional cognitive behavioral therapy to include these aspects and the suggestions of an advisory committee of Inuit and non-Inuit health service providers (e.g., cultural adaptation).

Self-managementBEHAVIORAL

The previously developed commercial VR program involves guided relaxation and meditation techniques.

Eligibility

Sex: ALLMin age: 14 YearsMax age: 60 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Emotion Regulation

Difficulties in Emotion Regulation Scale-16 is a short, valid measure of emotion regulation, scored from 16(low difficulties)-80 (higher difficulties).

Time frame: Approximately 5 minutes

Secondary Outcomes

heart rate

The participants undergo a psychophysiological reactivity testing paradigm, where we measure heart rate (in beats per minute) during a baseline, forest walk and height exposure in VR. The paradigm testing will be done during the initial visit and the last visit after the end of the VR intervention (minimum of seven and maximum of ten weeks). We measure changes in reactivity and resting level responses as compared from relaxed (forest walk) to height exposure, expecting lower resting levels of heart rate.