RecruitingNot ApplicableNCT05631743

VR-CBT With Inuit in Quebec

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


Sponsor

Douglas Mental Health University Institute

Enrollment

40 participants

Start Date

Jul 15, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 14 YearsMax Age: 60 Years

Inclusion Criteria16

  • 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 Criteria5

  • 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).

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Interventions

BEHAVIORALVR-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).

BEHAVIORALSelf-management

The previously developed commercial VR program involves guided relaxation and meditation techniques.


Locations(1)

Douglas Mental Health University Institute

Montreal, Quebec, Canada

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NCT05631743


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