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

Overview

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).

Interventions

• Behavioral VR-CBT
  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).
• Behavioral Self-management
  The previously developed commercial VR program involves guided relaxation and meditation techniques.

Primary outcome measures

• Emotion Regulation [Time frame: Approximately 5 minutes]

Secondary outcome measures (12)

• heart rate [Time frame: Approximately 1 hour testing session.]
• heart rate variability [Time frame: Approximately 1 hour testing session.]
• skin conductance response [Time frame: Approximately 1 hour testing session.]
• anxiety (momentary) [Time frame: Approximately 1 hour testing session.]
• emotional arousal (momentary) [Time frame: Approximately 1 hour testing session.]
• emotional valence (momentary) [Time frame: Approximately 1 hour testing session.]
• Psychiatric Symptoms (anxiety) [Time frame: Administration time is around 3 minutes]
• Psychiatric Symptoms (depression) [Time frame: Administration time is around 4 minutes]
• Psychiatric Symptoms (post traumatic stress disorder) [Time frame: Administration time is between 2 minutes]
• Psychiatric Symptoms (alcohol use disorder) [Time frame: Administration time is between 2 minutes]
• Psychiatric Symptoms (substance use disorders) [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) [Time frame: Approximately 10 minutes]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 1 center

• Douglas Mental Health University Institute — Montreal

Identifiers

NCT: NCT05631743 · IUSMD 21-52

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗