A Virtual Reality-assisted Cognitive Behavior Therapy with Inuit in Quebec - a Proof-of-concept Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Emotion Regulation
- Sponsor
- Douglas Mental Health University Institute
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Emotion Regulation
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief 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.
Detailed 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).
Investigators
Martin Lepage
James McGill professor
Douglas Mental Health University Institute
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •does not identify as Inuk
- •youth below the age of 14 and adults above the age of
- •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).
Outcomes
Primary Outcomes
Emotion Regulation
Time Frame: Approximately 5 minutes
Difficulties in Emotion Regulation Scale-16 is a short, valid measure of emotion regulation, scored from 16(low difficulties)-80 (higher difficulties).
Secondary Outcomes
- emotional valence (momentary)(Approximately 1 hour testing session.)
- Psychiatric Symptoms (alcohol use disorder)(Administration time is between 2 minutes)
- Psychological distress and well being: Clinical outcome in routine evaluation outcome measure and 10 item (CORE- OM/10)(Approximately 10 minutes)
- Feasibility of interventions (attendance/useage)(10 weeks of intervention period (researcher recorded))
- Psychological distress and well being: Short/ Warwick Edinburgh Mental Wellbeing Scale(Approximately 10 minutes)
- skin conductance response(Approximately 1 hour testing session.)
- heart rate(Approximately 1 hour testing session.)
- anxiety (momentary)(Approximately 1 hour testing session.)
- heart rate variability(Approximately 1 hour testing session.)
- Psychiatric Symptoms (anxiety)(Administration time is around 3 minutes)
- emotional arousal (momentary)(Approximately 1 hour testing session.)
- Psychiatric Symptoms (depression)(Administration time is around 4 minutes)
- Psychiatric Symptoms (post traumatic stress disorder)(Administration time is between 2 minutes)
- Psychiatric Symptoms (substance use disorders)(Administration time is between 4 minutes)
- Feasibility of interventions (treatment completion)(10 weeks of intervention period (researcher recorded))