NCT Number: NCT05631743
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.
Interested in participating?
Request Info14 year–60 year
All sexes
Interventional
Not applicable
Montreal, Quebec, h4h 1r3, Canada
Location status: Recruiting
Elisabeth Thibaudeau, PhD
SUB_INVESTIGATOR
Karyne Anselmo, MSc
CONTACT
514-761-6131 ext. 3296
Martin Lepage, PhD
SUB_INVESTIGATOR
Outi Linnaranta, MD, PhD
PRINCIPAL_INVESTIGATOR
Quinta Seon, MSc
CONTACT
514-761-6131 ext. 3009
Quinta Seon, MSc
SUB_INVESTIGATOR
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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).
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.
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.
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.
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).
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).
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).
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).
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).
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.
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.
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.
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.
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).
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.
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.
Contact information is provided by the study sponsor or research team.
Douglas Mental Health University Institute
Other
A Virtual Reality-assisted Cognitive Behavior Therapy With Inuit in Quebec - a Proof-of-concept Randomized Controlled Trial
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