NCT05631743

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 30, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

July 15, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

2.3 years

First QC Date

October 21, 2022

Last Update Submit

February 10, 2025

Conditions

Emotion Regulation

Keywords

virtual realitycognitive behavioural therapy

Outcome Measures

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).

    Approximately 5 minutes

Secondary Outcomes (15)

  • heart rate

    Approximately 1 hour testing session.

  • heart rate variability

    Approximately 1 hour testing session.

  • skin conductance response

    Approximately 1 hour testing session.

  • anxiety (momentary)

    Approximately 1 hour testing session.

  • emotional arousal (momentary)

    Approximately 1 hour testing session.

  • +10 more secondary outcomes

Study Arms (2)

VR-CBT

EXPERIMENTAL

A trained psychotherapist provides CBT-VR for up to 10 sessions over 10 weeks.

Behavioral: VR-CBT

Self-management

ACTIVE COMPARATOR

Participants use a commercial VR application at home for guided self-management at their own pace over 10 weeks.

Behavioral: Self-management

Interventions

VR-CBTBEHAVIORAL

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).

VR-CBT
Self-managementBEHAVIORAL

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

Self-management

Eligibility Criteria

Age14 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Douglas Mental Health University Institute

Montreal, Quebec, h4h 1r3, Canada

RECRUITING

MeSH Terms

Conditions

Emotional Regulation

Interventions

Self-Management

Condition Hierarchy (Ancestors)

Self-ControlSocial BehaviorBehavior

Intervention Hierarchy (Ancestors)

RehabilitationHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Outi Linnaranta, MD, Ph.D

    Douglas Mental Health University Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Karyne Anselmo, M.Sc.

CONTACT

514-761-6131karyne.anselmo@douglas.mcgill.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study design is a proof-of-concept, two-arm RCT with a VR-assisted therapist -guided psychotherapy and self-management.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
James McGill professor

Study Record Dates

First Submitted

October 21, 2022

First Posted

November 30, 2022

Study Start

July 15, 2023

Primary Completion

October 31, 2025

Study Completion

December 31, 2025

Last Updated

February 12, 2025

Record last verified: 2025-02

Locations

CA(1)