An interventional study of VR-CBT and Self-management in Emotion Regulation, sponsored by Douglas Mental Health University Institute. Completed at 1 site in Canada. Open to participants aged 14 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-08-27.
Sponsored by Douglas Mental Health University Institute · Not applicable, Interventional, and Treatment
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.
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).
225 studies on the registry are indexed under Emotional Regulation; 122 are open to participants now.
This study's enrollment of 15 is below the median of 73 across 212 interventional studies indexed under Emotional Regulation.
Browse Emotional Regulation studies →Douglas Mental Health University Institute is the lead sponsor of 38 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
A trained psychotherapist provides CBT-VR for up to 10 sessions over 10 weeks.
Behavioral: VR-CBT
Participants use a commercial VR application at home for guided self-management at their own pace over 10 weeks.
Behavioral: Self-management
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).
The previously developed commercial VR program involves guided relaxation and meditation techniques.
Emotion Regulation
Difficulties in Emotion Regulation Scale-16 is a short, valid measure of emotion regulation, scored from 16(low difficulties)-80 (higher difficulties).
Time frame: Approximately 5 minutes
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.
Time frame: Approximately 1 hour testing session.
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.
Time frame: Approximately 1 hour testing session.
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.
Time frame: Approximately 1 hour testing session.
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).
Time frame: Approximately 1 hour testing session.
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).
Time frame: Approximately 1 hour testing session.
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).
Time frame: Approximately 1 hour testing session.
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).
Time frame: Administration time is around 3 minutes
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).
Time frame: Administration time is around 4 minutes
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.
Time frame: Administration time is between 2 minutes
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.
Time frame: Administration time is between 2 minutes
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.
Time frame: Administration time is between 4 minutes
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.
Time frame: Approximately 10 minutes
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).
Time frame: Approximately 10 minutes
Feasibility of interventions (attendance/useage)
The number (percentages) of sessions attended (or completed at home) will serve as indicators of feasibility.
Time frame: 10 weeks of intervention period (researcher recorded)
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.
Time frame: 10 weeks of intervention period (researcher recorded)
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
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Douglas Mental Health University Institute