VR-CBT with Inuit in Quebec

Douglas Mental Health University Institute

Status: Enrolling

Conditions: Emotion Regulation

Treatments: Behavioral: VR-CBT; Behavioral: Self-management

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05631743

IUSMD 21-52

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 40 estimated patients

Sex: All

Ages: 14 to 60 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

VR-CBT

Experimental group

Description:

A trained psychotherapist provides CBT-VR for up to 10 sessions over 10 weeks.

Treatment:

Behavioral: VR-CBT

Self-management

Active Comparator group

Description:

Participants use a commercial VR application at home for guided self-management at their own pace over 10 weeks.

Treatment:

Behavioral: Self-management