NCT06893393

Brief Summary

The goal of the (observational or clinical) trial is to assess the use of the virtual application Toujours Dimanche for individuals hospitalized in a psychiatric care unit. The main questions it aims to answer are:

  • Is it feasible and acceptable for individuals currently hospitalized to use virtual reality during their stay?
  • What are the effects on mental health of the virtual reality application in individuals hospitalized in psychiatric care?
  • What are the barriers and facilitators of using the virtual reality application in a psychiatric ward from the perspective of service users and health care providers? Researchers will compare virtual reality users to control group (treatment as usual only) to see if the use of the application affects social and emotional well-being in the context of hospitalisation in psychiatry. In the first phase, participants will: \- Be invited to participate in focus groups to assess their interest in the application. In the second phase, participants will:
  • Complete baseline questionnaires on their connection to nature and social and emotional well-being.
  • Use the virtual reality application over a 15 day period alongside treatment as usual.
  • Complete post-intervention questionnaires and a survey on their use and opinions of the application. Healthcare provider feedback phase \- Healthcare providers working on the unit will be invited to share their perception of the impact of implementing the virtual application on the unit through surveys which will be sent by email.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
98

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2024

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 27, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

March 18, 2025

Last Update Submit

March 31, 2025

Conditions

Keywords

implementationvirtual realityinpatient psychiatric carenaturevirtual travelscomplex mood disorders

Outcome Measures

Primary Outcomes (7)

  • Perceived Stress Scale

    The Perceived Stress Scale (PSS), a 10-item self-report questionnaire assessing subjective stress using a Likert scale from 1 (never) to 5 (very often) (Cohen \& Williamson, 1988). For the current study, the questionnaire will be modified to adjust the timeframe for the assessment of perceived stress from one moth to two weeks.

    Change from baseline (15 days post)

  • Kessler Psychological Distress Scale

    The Kessler Psychological Distress Scale (K10) (Kessler et al., 2002) is a 10-item self-report questionnaire assessing distress through questions about anxiety and depression. The 10 items are rated on a Likert scale ranging from 1 (None of the time) to 5 (All the time).

    Change from baseline (15 days post)

  • Beck Anxiety Scale

    The Beck Anxiety Scale (BAI; (Beck et al., 1988)) is a self-report questionnaire that includes 21 items rated on a Likert scale of 0 (not at all) to 3 (Severely).

    Change from baseline (15 days post)

  • The connectedness to nature scale

    The connectedness to nature scale (CNS) (Mayer \& Frantz, 2004) is a 14 self-report item questionnaire that assesses individuals' trait levels of feeling emotionally connected to the natural world.

    Change from baseline (15 days post)

  • PHQ-9

    Depressive symptoms will be assessed using the PHQ-9. This 9-item self-report questionnaire assesses depressive symptoms in the last two weeks, rated on a Likert scale ranging from 0 (not at all) to 3 (nearly every day)

    Change from baseline (15 days post)

  • Warwick-Edinburgh Mental Well-being Scale

    Wellbeing will be assessed with the Warwick-Edinburgh Mental Well-being Scale (WEMWBS), a 14-item self-report questionnaire using a Likert scale from 1 (never) to 5 (all the time).

    Change from baseline (15 days post)

  • De Jong Gierveld Loneliness Scale - short version

    Social isolation will be assessed with the De Jong Gierveld Loneliness Scale - short version (DJGLS). This 6-item self-report questionnaire assess overall, emotional, and social loneliness using a Likert scale ranging from 0 (not lonely) to 11 (extremely lonely).

    Change from baseline (15 days post)

Study Arms (2)

Toujours Dimanche users

EXPERIMENTAL

Participants who will use the virtual reality application Toujours Dimanche in the context of their hospitalization in psychiatric care. Participants will receive treatment as usual and will be able to use the application at their leisure for a period of 15 days.

Device: Virtual travel-into-nature application Toujours Dimanche

Control group

NO INTERVENTION

Participants will not use the virtual reality application Toujours Dimanche. Will receive treatment as usual.

Interventions

The use of the virtual travel-into-nature application which features real natural environments from the Eastern Canada area.

Toujours Dimanche users

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being 18 years old or older
  • Being hospitalized in a psychiatric unit at the time of the study
  • Being relatively clinically stable, according to the treating psychiatrist
  • Being free of uncorrected visual impairments
  • Being able to speak or read French or English

You may not qualify if:

  • Current photosensitive epilepsy or a history of seizures
  • Previous history of severe motion sickness or cyber-sickness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Douglas Mental Health University Institute

Montreal, Quebec, H4H 1R3, Canada

Location

Related Publications (3)

  • Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.

    PMID: 18042300BACKGROUND
  • Gierveld JDJ, Tilburg TV. A 6-Item Scale for Overall, Emotional, and Social Loneliness: Confirmatory Tests on Survey Data. Research on Aging 2006;28(5):582-598.

    BACKGROUND
  • Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.

    PMID: 11556941BACKGROUND

Related Links

Study Officials

  • Élisabeth Thibaudeau, Ph.D.

    Laval University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: One group will have access to the virtual reality application Toujours Dimanche alongside their treatment as usual during their hospitalization in psychiatric care, the other will be a control group and will only receive treatment as usual.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Scientific Director

Study Record Dates

First Submitted

March 18, 2025

First Posted

March 25, 2025

Study Start

March 11, 2024

Primary Completion

August 13, 2024

Study Completion

August 27, 2024

Last Updated

April 3, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

The data from this project are collected with people hospitalized in only one specific unit at the Douglas hospital and sharing their individual data might comprise their confidentiality.

Locations