VR-CBT With Inuit in Quebec

Study 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).

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

Conditions
-----------------
Emotion Regulation

Intervention / Treatment
-----------------
* Behavioral: VR-CBT
* Behavioral: Self-management


Participation Criteria
=================
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 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).

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study design is a proof-of-concept, two-arm RCT with a VR-assisted therapist -guided psychotherapy and self-management.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR-CBT<br>A trained psychotherapist provides CBT-VR for up to 10 sessions over 10 weeks. | Behavioral: VR-CBT<br>* 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).<br>|
| Active Comparator: Self-management<br>Participants use a commercial VR application at home for guided self-management at their own pace over 10 weeks. | Behavioral: Self-management<br>* The previously developed commercial VR program involves guided relaxation and meditation techniques.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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. | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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) | 
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
virtual reality, cognitive behavioural therapy