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Completed

NCT Number: NCT05631743

VR-CBT With Inuit in Quebec

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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Key information

Conditions

Emotion Regulation Behavior Emotional Regulation Self-Control Social Behavior

Age range

14 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Douglas Mental Health University Institute

Montreal, Quebec, h4h 1r3, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • No history of psychosis or schizophrenia
  • Current stable mood
  • Is generally mentally stable
  • Score less than 8 on the Alcohol Use Disorders Identification Test C
  • Score less than 3 on the Drug Abuse Screen Test (10 item version)
  • Not have had any change in psychoactive medications during 4 weeks preceding screening and inclusion to the study

Exclusion criteria

  • does not identify as Inuk
  • youth below the age of 14 and adults above the age of 60.
  • 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).

Treatment and study plan

VR-CBT

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

Behavioral

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

Primary outcomes

  1. 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

  1. heart rate

    Time frame: Approximately 1 hour testing session.

    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.

  2. heart rate variability

    Time frame: Approximately 1 hour testing session.

    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.

  3. skin conductance response

    Time frame: Approximately 1 hour testing session.

    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.

  4. anxiety (momentary)

    Time frame: Approximately 1 hour testing session.

    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).

  5. emotional arousal (momentary)

    Time frame: Approximately 1 hour testing session.

    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).

  6. emotional valence (momentary)

    Time frame: Approximately 1 hour testing session.

    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).

  7. Psychiatric Symptoms (anxiety)

    Time frame: Administration time is around 3 minutes

    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).

  8. Psychiatric Symptoms (depression)

    Time frame: Administration time is around 4 minutes

    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).

  9. Psychiatric Symptoms (post traumatic stress disorder)

    Time frame: Administration time is between 2 minutes

    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.

  10. Psychiatric Symptoms (alcohol use disorder)

    Time frame: Administration time is between 2 minutes

    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.

  11. Psychiatric Symptoms (substance use disorders)

    Time frame: Administration time is between 4 minutes

    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.

  12. Psychological distress and well being: Clinical outcome in routine evaluation outcome measure and 10 item (CORE- OM/10)

    Time frame: Approximately 10 minutes

    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.

  13. Psychological distress and well being: Short/ Warwick Edinburgh Mental Wellbeing Scale

    Time frame: Approximately 10 minutes

    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).

  14. Feasibility of interventions (attendance/useage)

    Time frame: 10 weeks of intervention period (researcher recorded)

    The number (percentages) of sessions attended (or completed at home) will serve as indicators of feasibility.

  15. Feasibility of interventions (treatment completion)

    Time frame: 10 weeks of intervention period (researcher recorded)

    Treatment completion (minimum of 7 sessions of VR in either arm) and drop-outs will serve as indicators of feasibility.

Sponsors and collaborators

Lead sponsor

Douglas Mental Health University Institute

Other

Collaborators

  • Douglas Foundation
  • McGill University
  • MedTeq
  • Natural Sciences and Engineering Research Council, Canada

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 30, 2022
Registry last updated
Aug 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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