Clinical trial NCT05631743: VR-CBT With Inuit in Quebec
Official title: A Virtual Reality-assisted Cognitive Behavior Therapy With Inuit in Quebec - a Proof-of-concept Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emotion Regulation
Keywords: virtual reality
cognitive behavioural therapy
Lead sponsor: Douglas Mental Health University Institute
Sponsor class: OTHER
Collaborators: name: Natural Sciences and Engineering Research Council, Canada
name: MedTeq
name: Douglas Foundation
name: McGill University
First posted: 2022-11-30
Enrollment: 40
Sex: ALL
Minimum age (years): 14
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study design is a proof-of-concept, two-arm RCT with a VR-assisted therapist -guided psychotherapy and self-management.
Primary purpose: TREATMENT

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).

Eligibility criteria: Inclusion Criteria:

1. Self-identify as Inuk
2. Live in Montreal
3. be between 14 to 60 years of age
4. be proficient in English or French
5. No history of cardiac conditions
6. No history of epilepsy
7. Can provide an emergency contact
8. Tolerance of VR headset
9. Tolerance of sensors
10. Has no current suicidal or homicidal risk
11. No history of psychosis or schizophrenia
12. Current stable mood
13. Is generally mentally stable
14. Score less than 8 on the Alcohol Use Disorders Identification Test C
15. Score less than 3 on the Drug Abuse Screen Test (10 item version)
16. Not have had any change in psychoactive medications during 4 weeks preceding screening and inclusion to the study

Exclusion Criteria:

1. does not identify as Inuk
2. youth below the age of 14 and adults above the age of 60.
3. self-reported history of psychosis or schizophrenia
4. current substance abuse, as measured by two screens (AUDIT-C, DAST-10)
5. other mental or physical condition that might preclude them from the trial (i.e., pre-existing heart conditions, convulsions, acute mental health risk).

Primary outcomes:
measure: Emotion Regulation
timeFrame: Approximately 5 minutes
Secondary outcomes:
measure: heart rate
timeFrame: Approximately 1 hour testing session.
measure: heart rate variability
timeFrame: Approximately 1 hour testing session.
measure: skin conductance response
timeFrame: Approximately 1 hour testing session.
measure: anxiety (momentary)
timeFrame: Approximately 1 hour testing session.
measure: emotional arousal (momentary)
timeFrame: Approximately 1 hour testing session.
measure: emotional valence (momentary)
timeFrame: Approximately 1 hour testing session.
measure: Psychiatric Symptoms (anxiety)
timeFrame: Administration time is around 3 minutes
measure: Psychiatric Symptoms (depression)
timeFrame: Administration time is around 4 minutes
measure: Psychiatric Symptoms (post traumatic stress disorder)
timeFrame: Administration time is between 2 minutes
measure: Psychiatric Symptoms (alcohol use disorder)
timeFrame: Administration time is between 2 minutes
measure: Psychiatric Symptoms (substance use disorders)
timeFrame: Administration time is between 4 minutes
measure: Psychological distress and well being: Clinical outcome in routine evaluation outcome measure and 10 item (CORE- OM/10)
timeFrame: Approximately 10 minutes
measure: Psychological distress and well being: Short/ Warwick Edinburgh Mental Wellbeing Scale
timeFrame: Approximately 10 minutes
measure: Feasibility of interventions (attendance/useage)
timeFrame: 10 weeks of intervention period (researcher recorded)
measure: Feasibility of interventions (treatment completion)
timeFrame: 10 weeks of intervention period (researcher recorded)
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Douglas Mental Health University Institute
state: Quebec
Study officials:
affiliation: Douglas Mental Health University Institute
name: Outi Linnaranta, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: