VR-CBT With Inuit in Quebec
ConditionEmotion Regulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-60
SponsorDouglas Mental Health University Institute
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Self-identify as Inuk
Live in Montreal
be between 14 to 60 years of age
be proficient in English or French
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
VR-CBT
BehavioralThe 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
BehavioralThe previously developed commercial VR program involves guided relaxation and meditation techniques.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: VR-CBTExperimental treatment 1 intervention
Group B: Self-managementActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 minutesSecondary outcomes
1
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.2
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.3
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.4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Douglas Mental Health University Institute
Lead sponsor
Natural Sciences and Engineering Research Council, Canada
Collaborator
MedTeq
Collaborator
Douglas Foundation
Collaborator
McGill University
Collaborator
Source ClinicalTrials.gov