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Mental Health Wellness 1NCT05531513

The Effects of a Nature-Based Mindfulness-Compassion Intervention for Older Adults Delivered Using Virtual Reality

A study testing Virtual Reality (VR) Meditation and Psychoeducational Pamphlet in people with Mental Health Wellness 1 and Healthy Aging, run by McGill University at 2 sites in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The global population is aging at an unprecedented rate, increasing the necessity for effective interventions targeting the mental health needs of older adults. Virtual reality (VR) is a type of technology with the potential to improve mental health and well-being that allows users, via electronic devices such as… Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Mental Health Wellness 1, Healthy Aging
What is being tested?
Virtual Reality (VR) Meditation and Psychoeducational Pamphlet
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
2 sitesCanada
Study dates
21 Jul 2022to 1 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Must reside at a Résidence Enharmonie private residence for autonomous older adults in the Montreal, Quebec region
  • Must be 60 years of age or older
  • Ability to speak English or French

Who cannot join

  • History of recurrent migraines/seizures/Traumatic Brain Injury during the past year
  • Glaucoma or recovery phase of any eye surgery
  • Diagnosed epilepsy or severe vertigo

Trial locations and contacts

2 sites in 1 country.

Canada2 sites
  • Piero Corti Residence

    Montreal, Quebec, H1W1B2

  • Résidences Enharmonie - Résidence Alfredo-Gagliardi

    Montreal, Quebec

Other trials in Canada

About this study

Official title: The Effects of a Nature-Based Mindfulness-Compassion Intervention for Older Adults Delivered Using Virtual Reality: A Randomized Controlled Trial

The global population is aging at an unprecedented rate, increasing the necessity for effective interventions targeting the mental health needs of older adults. Virtual reality (VR) is a type of technology with the potential to improve mental health and well-being that allows users, via electronic devices such as headsets or goggles, to interact within simulated environments. VR programs using nature, mindfulness-meditation, and compassion may be more immersive and engaging, with research showing that these programs are effective at improving mental health and well-being outcomes in younger adults. However, evidence in this area for older adults is currently lacking.

The present project intends to pilot and examine a multi-user 360-High Definition (HD) video VR application, called "Toujours Dimanche", developed in partnership with Super Sublime, a Montreal-based not-for-profit company. This VR application aims to support older adults through incorporating elements of nature, mindfulness-meditation, and compassion via a 4-week program of twice weekly, 10 to 20-minute meditation sessions, for a total of 8 sessions. Thus, this study seeks to pilot, revise and iteratively evaluate, via randomized control trial (RCT) methodology, the acceptability, feasibility, and effectiveness of a multi-user 360-HD video VR application (Toujours Dimanche) at improving older adult mental health and well-being.

It is hypothesized that engagement with the 4-week VR-Meditation intervention will lead to lower scores on stress and negative affect and improved scores on well-being, positive affect, and mindfulness, in addition to increased scores on coping self-efficacy, connection with nature, embodied mindfulness, and self-compassion, over time and as compared to the active control group (who will receive psycho-educational pamphlets 1x/week for 4 weeks).

Read the detailed description

INTRODUCTION:

There is a need for effective health strategies to help older adults' psychological well-being; thus, the proposed study seeks to better understand how to support older adults' mental health through the use of a virtual reality (VR)-based nature, mindfulness-and-compassion meditation intervention.

Technology developed to meet older adults' quality of life needs, or Gerontechnology has been increasingly integrated into daily life routines and may have the potential to ameliorate treatment accessibility and quality. However, to maximize the effectiveness of these technology-based modalities, it is necessary to move beyond conventional telehealth methodologies and investigate fresh modalities of mental health provision for older adults, such as VR.

One way proposed to utilize VR 360-degree video technology most effectively is through the incorporation of natural settings in the VR experience. A growing body of research highlights the therapeutic efficacy of 360-degree nature videos, pointing to nature-based VR's capability to rapidly improve mood, as well as its potential to decrease physiological stress levels and enhance cognitive functioning.

Additionally, through its capacity to capture participants' attention and provide users the illusion of "being there" in the 3D computer-generated environment, VR may be particularly effective when incorporating mindfulness-based activities. Mindfulness can be described as the process of purposefully, and with acceptance, paying attention non-judgmentally to the present moment. By providing people with an interesting setting to practice mindfulness (e.g., simulated natural settings), limiting distractions from the real world, and increasing a sense of presence, VR may facilitate mindfulness practice. This is significant, given that mindfulness-based interventions (MBIs) are particularly suited to meet the needs of older adults. Together with mindfulness, self-compassion, defined as thinking, feeling, and acting kindly towards oneself, can be used as a complementary strategy in MBIs and has been shown to augment their effectiveness, with evidence linking self-compassion to improved well-being in later life.

Preliminary findings highlight that VR is a promising technology to support MBIs, with evidence pointing to an increase in well-being, self-compassion, and adherence among participants. However, to date, no study has tested mindfulness training using VR for older adults. Additionally, no study has looked at the combined effects of mindfulness training in natural settings using VR for older adults. The evaluation of a VR application with multi-user capability that incorporates evidence-based activities to improve well-being (e.g., nature, mindfulness, compassion) in older adults is thus a significant research-to-practice gap. Therefore, this study, with the support of an industry partnership with Super Sublime, aims to evaluate the feasibility and effectiveness of a multi-user VR-Meditation application (called Toujours Dimanche), at improving older adult well-being via nature-based mindfulness and compassion training. If this VR-Meditation program is found to be acceptable and satisfactory, as well as demonstrating actual effectiveness in enhancing older adult well-being, it will serve to promote positive mental health for older adults utilizing a technology that is accessible, and safe. The proposed project thus addresses a critical societal need by significantly enhancing older adults' capability to access natural settings, and engage in mindfulness and compassion techniques, through VR technology.

OBJECTIVES:

Compared to an active control group (Psychoeducational Pamphlet), to evaluate the feasibility and acceptability of a twice-weekly, 4-week VR-Meditation program, as well as its effects on stress, positive and negative affect, psychological well-being, mindfulness, coping self-efficacy, connection with nature, and self-compassion.

HYPOTHESIS:

It is hypothesized that engagement with the 4-week VR-Meditation intervention will lead to lower scores on stress and negative affect and improved scores on well-being, positive affect, and mindfulness, in addition to increased scores on coping self-efficacy, connection with nature, embodied mindfulness, and self-compassion, over time and as compared to the active control group (who will receive psycho-educational pamphlets 1x/week for 4 weeks).

METHODS:

In this RCT, we aim to recruit 30 participants aged 60 and over residing in private residences for autonomous older adults in the Montreal, Quebec area (under the administration of Résidences Enharmonie). Based on conventions set by Julious (2005) for pilot studies, 12 participants per group is the recommended sample size to assess intervention feasibility and refine estimates for use in larger scale efficacy trials. For the present study, 24 participants would need to be recruited to meet this recommendation. In order to account for attrition, we aim to recruit 30 participants, with support from the Résidences ENHARMONIE's team of recreation therapists.

Upon completion of the baseline measures, participants will be randomly assigned to one of two conditions: the experimental condition (VR-Meditation) or the active control condition (Psychoeducational Pamphlet).

Participants in the VR-Meditation condition will be asked to use the VR program for a period of 4 weeks (2 seated VR meditation sessions per week, approximately 20 minutes per session, total of 8 sessions). Participants will use Oculus Quest 2 VR Headsets for the meditation sessions and research assistants will guide participants' usage of the VR-Meditation app via Samsung Galaxy Tab S6 tablets.

Participants in the Psychoeducational Pamphlet group will receive weekly pamphlets for a total of 4 distinct pamphlets. Handouts will provide information about managing stress and enhancing well-being, without referencing nature, mindfulness or compassion (e.g., eating habits, sleep hygiene, relaxation training, art exercises). The handouts will be based on empirical findings and will be written in accessible language with visual charts and specific practices to facilitate their implementation by participants. Additionally, at the end of the study (i.e., after follow-up), Psychoeducation Pamphlet participants will receive access to the VR-Meditation program.

Both conditions will be asked to complete questionnaires at baseline (pre-participation; week 1), mid-point (week 3), post participation (week 5) and follow-up (week 9).

RESEARCH SETTING:

The experiment will take place in 2-3 private independent seniors' residences in the Montreal, Quebec area, managed by Residences Enharmonie, and in the presence of a trained co-researcher. The data collections will be conducted with the help of a trained co-researcher. The research team will also train the residence staff regarding how to use and monitor the VR headsets and to implement the Toujours Dimanche program with participants.

PROPOSED ANALYSIS:

Qualitative data will be analyzed using a process of recursive abstraction in order to summarize the information by theme. Descriptive statistics for continuous variables will include means and standard deviations, and categorical variables will be summarized using frequencies and proportions. Outcome measure scores will be compared between the intervention and control groups using a 2 x 4 mixed MANOVA with within-subject (time) and between-subject (group) factors. Correlational analyses will be used to assess the relationship between outcome variables at baseline. Additionally, multivariate analyses of covariance (MANCOVA) will be run controlling for baseline levels of mindfulness =and nature connectedness.

Being tested
Virtual Reality (VR) Meditation, Psychoeducational Pamphlet
Keywords
virtual reality, nature, mindfulness, compassion, Gerontechnology, well-being, mental health, older adults
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual Reality (VR) MeditationBehavioural

    Also called Toujours Dimanche

    The VR-Meditation intervention comprises an evidence-based 360-degree high-definition video VR application incorporating elements of nature, mindfulness and compassion. The VR-Meditation intervention is 4 weeks long and includes includes 4 different themes during the course of the program. Each week will focus on a distinct theme and will consist of two 20-minute VR sessions starting with a 10-minute guided meditation related to the weekly theme (one new meditation per week), followed by 10 minutes of open exploration of the virtual environment, for a total of 8 distinct sessions. The weekly themes are as follows:

    • Week 1 - Mindfulness of the Environment
    • Week 2 - Embodied Mindfulness
    • Week 3 - Embodied and Embedded Compassion
    • Week 4 - Mindfulness, Compassion, and the External Environment

    In addition to baseline measures, participants in the VR Meditation condition will be asked to complete measures at mid-point (week 3), post-intervention (week 5), and follow-up (week 9).

  • Psychoeducational PamphletBehavioural

    The Psychoeducational Pamphlet intervention is 4 weeks long. Participants receive 1 pamphlet per week for a total of 4 different pamphlets. Handouts will provide information about managing stress and enhancing well-being, without referencing nature, mindfulness or compassion (e.g., eating habits, sleep hygiene, relaxation training, art exercises). The handouts will be based on empirical findings and will be written in accessible language with visual charts and specific practices to facilitate their implementation by participants. At the end of the study (i.e., after follow-up), Psychoeducation Pamphlet participants will receive access to the VR-Meditation program.

    In addition to baseline measures, participants in the Psycho-educational Pamphlet condition will be asked to complete measures at mid-point (week 3), post-intervention (week 5), and follow-up (week 9).

Study groups in NCT05531513
Study groupRoleWhat they receive
Virtual Reality (VR) MeditationExperimentalThe VR Meditation intervention will be administered in Arm 1.
Receives: Behavioral: Virtual Reality (VR) Meditation
Psychoeducational PamphletsActive comparatorThe Psychoeducation Pamphlet intervention will be administered in Arm 2.
Receives: Behavioral: Psychoeducational Pamphlet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from Baseline in Scores on the Perceived Stress Scale (PSS)

    PSS is a 14-item scale used to measure the degree to which life events are experienced and appraised as stressful. It asks respondents how often they have felt certain ways in the past month, with responses ranging from 0 (never) to 4 (very often). English and French versions available.

    Measured: At baseline (week 1), mid-point (week 3), post-intervention (week 5) and follow-up (week 9)

  2. Change from Baseline in Scores on the Scale of Positive and Negative Experience (SPANE)

    SPANE is a 12-item questionnaire with six items to assess positive feelings and six items to assess negative feelings. Participants are asked to rate their levels of affect using a 5-point scale ranging from 1 (rarely or never) to 5 (very often or always). English and French versions available.

    Measured: At baseline (week 1), mid-point (week 3), post-intervention (week 5) and follow-up (week 9)

  3. Change from Baseline in Scores on the Flourishing Scale (FS)

    The FS is a brief 8-item measure assessing participants' self-perceived success (e.g., purpose, self-esteem, relationships, optimism) and provides a single psychological well-being score. Participants are asked to rate their levels of well-being on a 7-point scale ranging from 1 (strongly disagree) to 7 (strongly agree). English and French versions available.

    Measured: At baseline (week 1), mid-point (week 3), post-intervention (week 5) and follow-up (week 9)

  4. Change from Baseline in Scores on the General Self-Efficacy Scale (GSE)

    The GSE is a 10-item scale that measures an individual's confidence in their ability to effectively cope with life challenges. Participants are asked to rate statements on a 4-point scale ranging from 1 (not at all true) to 4 (exactly true). English and French versions available.

    Measured: At baseline (week 1), mid-point (week 3), post-intervention (week 5) and follow-up (week 9)

Secondary outcomes (4)
  1. Change from Baseline in Scores on the Five Facet Mindfulness Questionnaire-Short Form (FFMQ-24)

    The FFMQ-24 is a 24-item self-report measure derived from the longer 39-item measure assessing five specific facets of mindfulness: acting with awareness, describing, observing, non-reactivity, and non-judgmental acceptance. Participants rate their responses on a 5-point scale ranging from 1 (never or very rarely true) to 5 (very often or always true). English and French versions available.

    Measured: At baseline (week 1), mid-point (week 3), post-intervention (week 5) and follow-up (week 9)

  2. Change from Baseline in Scores on the Connectedness to Nature Scale (CNS)

    The CNS is a 14-item measure assessing individuals' sense of "oneness" with their natural environment. Items are rated on a 5-point scale ranging from 1 (strongly disagree) to 5 (strongly agree). English and French versions available.

    Measured: At baseline (week 1), mid-point (week 3), post-intervention (week 5) and follow-up (week 9)

  3. Change from Baseline in Scores on the Embodied Mindfulness Questionnaire (EMQ)

    The EMQ is a 24-item questionnaire assessing five dimensions of individual levels of embodied mindfulness: detachment from automatic thinking, awareness of the body, connection with the body, awareness of the mind-body connection, and acceptance of feelings and bodily sensations. Participants rate their responses on a 5-point scale ranging from 1 (almost never) to 6 (almost always). English version only.

    Measured: At baseline (week 1), mid-point (week 3), post-intervention (week 5) and follow-up (week 9)

  4. Change from Baseline in Scores on the Self-Compassion Questionnaire-Self (CQS)

    The CQS is a newly developed 20-item questionnaire that assesses individual levels of self-compassion and is based on thinking, feeling, acting, and interpersonal components. Participants rate their responses on a 5-point scale ranging from 1 (almost never) to 5 (almost always). English version only.

    Measured: At baseline (week 1), mid-point (week 3), post-intervention (week 5) and follow-up (week 9)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Sep 2022
  2. Study start21 Jul 2022
  3. Primary completion1 Nov 2023
  4. Study completion1 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
After providing consent, potential participants will complete an initial screening with the demographic intake form. Participants who do not meet inclusion or exclusion criteria will be informed that they will be unable to participate in the current study. Participants who meet study criteria will then be asked to complete the baseline survey containing the battery of outcome measures. Upon completion of the baseline measures, participants will be randomly assigned to one of two conditions: the experimental (Virtual Reality) condition or the active control (Psychoeducational Pamphlet) condition. Randomization will occur using a computerized random number generator following a matched random assignment via block procedure. An individual at arm's length (not involved with the intervention, assessment, or analysis) will perform the randomization. Control group participants will be allowed access to the virtual reality program after follow-up data collection is completed (after Week 9).
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05531513
Sponsor's protocol ID
McGill University
Status last verified
Feb 2024
First submitted
5 Sep 2022
Last updated
15 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Sadowski I, Meilleur-Bedard M, Khoury B. A Novel Virtual Reality-Based Nature Meditation Program for Older Adults' Mental Health: Results from a Pilot Randomized Controlled Trial. Clin Gerontol. 2025 Jul-Sep;48(4):663-683. doi: 10.1080/07317115.2025.2482089. Epub 2025 Mar 28.

    PubMed 40152067

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality (VR) Meditation and Psychoeducational Pamphlet in people with Mental Health Wellness 1 and Healthy Aging, run by McGill University at 2 sites in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Scores on the Perceived Stress Scale (PSS) (time frame: At baseline (week 1), mid-point (week 3), post-intervention (week 5) and follow-up (week 9)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05531513, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.

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