VR-CBT With Inuit in Quebec

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-15

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Emotion Regulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study design is a proof-of-concept, two-arm RCT with a VR-assisted therapist -guided psychotherapy and self-management.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VR-CBT

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

Group Type EXPERIMENTAL

VR-CBT

Intervention Type BEHAVIORAL

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-management

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

Group Type ACTIVE_COMPARATOR

Self-management

Intervention Type BEHAVIORAL

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

Interventions

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VR-CBT

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).

Intervention Type BEHAVIORAL

Self-management

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).

Minimum Eligible Age

14 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No