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VR-CBT With Inuit in Quebec

NCT05631743 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-02-12

No results posted yet for this study

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.

Conditions

  • Emotion Regulation

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.

Sponsors & Collaborators

  • Natural Sciences and Engineering Research Council, Canada

    collaborator OTHER

  • MedTeq

    collaborator INDUSTRY

  • Douglas Foundation

    collaborator UNKNOWN

  • McGill University

    collaborator OTHER

  • Douglas Mental Health University Institute

    lead OTHER

Principal Investigators

  • Outi Linnaranta, MD, Ph.D · Douglas Mental Health University Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-15
Primary Completion
2025-10-31
Completion
2025-12-31

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05631743 on ClinicalTrials.gov