VR-CBT With Inuit in Quebec

Emotion Regulation Clinical Trial

Official title:

A Virtual Reality-assisted Cognitive Behavior Therapy With Inuit in Quebec - a Proof-of-concept Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05631743
• Other study ID #: IUSMD 21-52
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: October 2023
• Source: Douglas Mental Health University Institute
• Contact: Karyne Anselmo, M.Sc.
• Phone: 514-761-6131
• Email: karyne.anselmo[@]douglas.mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2025
• Est. primary completion date: October 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Emotion Regulation

Intervention

Behavioral:
• 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).
• Self-management
The previously developed commercial VR program involves guided relaxation and meditation techniques.

Locations

Country	Name	City	State
Canada	Douglas Mental Health University Institute	Montreal	Quebec

Sponsors (5)

Lead Sponsor	Collaborator
Douglas Mental Health University Institute	Douglas Foundation, McGill University, MedTeq, Natural Sciences and Engineering Research Council, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emotion Regulation	Difficulties in Emotion Regulation Scale-16 is a short, valid measure of emotion regulation, scored from 16(low difficulties)-80 (higher difficulties).	Approximately 5 minutes
Secondary	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.	Approximately 1 hour testing session.
Secondary	heart rate variability	The participants undergo a psychophysiological reactivity testing paradigm, where we measure heart rate variability 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 as compared from relaxed (forest walk) to height exposure, increased heart rate variability.	Approximately 1 hour testing session.
Secondary	skin conductance response	The participants undergo a psychophysiological reactivity testing paradigm, where we measure skin conductance 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 decreased skin conductance response.	Approximately 1 hour testing session.
Secondary	anxiety (momentary)	The participants undergo a psychophysiological reactivity testing paradigm, involving 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). Visual analogue scales for anxiety are given during each segment of this test, scored 0 to 100 (not at all anxious- very anxious).	Approximately 1 hour testing session.
Secondary	emotional arousal (momentary)	The participants undergo a psychophysiological reactivity testing paradigm, involving 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). Visual analogue scales for emotional arousal are given during each segment of this test, scored 0-100 (very calm- very excited).	Approximately 1 hour testing session.
Secondary	emotional valence (momentary)	The participants undergo a psychophysiological reactivity testing paradigm, involving 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). Visual analogue scales for emotional valence are given during each segment of this test, scored 0-100 (very pleasant-very unpleasant).	Approximately 1 hour testing session.
Secondary	Psychiatric Symptoms (anxiety)	We will monitor any change in psychiatric symptom severity, and any loss/gain of probable psychiatric diagnosis (for screening measures), expecting severity of symptoms to decrease. Generalized Anxiety Disorder Scale-7 is a scale scored 0-21 (minimal anxiety to severe anxiety).	Administration time is around 3 minutes
Secondary	Psychiatric Symptoms (depression)	We will monitor any change in psychiatric symptom severity, and any loss/gain of probable psychiatric diagnosis (for screening measures), expecting severity of symptoms to decrease. Patient Health Questionnaire - 9 is a scale scored 0-27 (minimal to severe).	Administration time is around 4 minutes
Secondary	Psychiatric Symptoms (post traumatic stress disorder)	We will monitor any change in psychiatric symptom severity, and any loss/gain of probable psychiatric diagnosis (for screening measures), expecting severity of symptoms to decrease. Primary Care Screen for Post-Traumatic Stress Disorder for Diagnostic and Statistical Manual-5 (PC-PTSD-5) is a screening, measure where a score of 3 indicates probable post-traumatic stress.	Administration time is between 2 minutes
Secondary	Psychiatric Symptoms (alcohol use disorder)	We will monitor any change in psychiatric symptom severity, and any loss/gain of probable psychiatric diagnosis (for screening measures), expecting severity of symptoms to decrease. Alcohol Use Disorders Identification Test- C screens for probably alcohol use disorder with a score of 3 or 4.	Administration time is between 2 minutes
Secondary	Psychiatric Symptoms (substance use disorders)	We will monitor any change in psychiatric symptom severity, and any loss/gain of probable psychiatric diagnosis (for screening measures), expecting severity of symptoms to decrease. Drug Abuse Screening Test-10 is a scale scored from 0-10, with higher scores indicating more intensive assessment needed.	Administration time is between 4 minutes
Secondary	Psychological distress and well being: Clinical outcome in routine evaluation outcome measure and 10 item (CORE- OM/10)	We will monitor any change in psychological well-being, as measured by a scale for psychological distress (constituted by multiple subscales including well being). The scale can operate as a screening tool with a score of 10 or 11.	Approximately 10 minutes
Secondary	Psychological distress and well being: Short/ Warwick Edinburgh Mental Wellbeing Scale	We will monitor any change in psychological well-being, as measured by a scale which covers mental wellbeing as a feeling and function, expecting wellbeing to increase and distress to decrease. Higher scores indicate higher wellbeing (short version is scored 7-35; long version 14-70).	Approximately 10 minutes
Secondary	Feasibility of interventions (attendance/useage)	The number (percentages) of sessions attended (or completed at home) will serve as indicators of feasibility.	10 weeks of intervention period (researcher recorded)
Secondary	Feasibility of interventions (treatment completion)	Treatment completion (minimum of 7 sessions of VR in either arm) and drop-outs will serve as indicators of feasibility.	10 weeks of intervention period (researcher recorded)