Mental Health Wellness 1NCT05818579
Virtual Reality for Mental Well-being in Older People With Physical Disabilities
A study testing Virtual reality experience in people with Mental Health Wellness 1 and Physical Disability, run by Tung Wah College at 1 site in Hong Kong.
Trial summary
Older adults living with physical disabilities in residential care homes are at elevated risk for depression and loneliness, which negatively impacts their quality of life. Immersive virtual reality is an evolving modality that engages older adults in therapeutically oriented activities to address these mental health… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mental Health Wellness 1, Physical Disability
- What is being tested?
- Virtual reality experience
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteHong Kong
- Study dates
- 15 Feb 2024to 14 May 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 60 years or above;
- LTCF residents; and
- Physical disability, defined as the Modified Barthel Index (MBI) score of ≤ 90 (i.e., moderately dependent or worse).
Who cannot join
- Probably dementia, as defined by a Montreal Cognitive Assessment (MoCA) score of < 20,
- Severe visual impairment, as defined by a lens-corrected visual acuity score of < 6/60,
- Severe hearing impairment, as defined by failed whispered voice test.
- Bilateral upper limb paralysis, as defined by the Medical Research Council Muscle Power Scale of < 4. or
- Participated in any virtual reality activities in the past six months or concurrently.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Therapeutic Virtual Reality Experience to Promote Mental Well-being in Older People Living With Physical Disabilities in Long-term Care Facilities
Older adults living with physical disabilities in residential care homes are at elevated risk for depression and loneliness, which negatively impacts their quality of life. Immersive virtual reality is an evolving modality that engages older adults in therapeutically oriented activities to address these mental health challenges. This study evaluated the effects of a nurse-led multi-disciplinary therapeutic immersive virtual reality programme, incorporating natural scenes, tourism, and reminiscence, on mental health outcomes. Simultaneously evaluating effectiveness and implementation demonstrates whether the program functions across diverse residential settings and how it can be sustained long-term. This approach delivers multi-level benefits: residents experience improved mood, well-being, and social support; care homes acquire an adaptable, engaging activity tailored to mobility and sensory limitations; and policymakers receive the practical guidance required to scale and maintain this evidence-based geriatric mental health intervention.
Read the detailed description
This study uses a single-blinded, two-parallel-group, 1:1 randomized controlled trial with a non-inferiority design. The study will be conducted in long-term care facilities (LTCFs), specifically Care \& Attention Homes for the Elderly and Nursing Homes under the governance of the Social Welfare Department in Hong Kong. Homes will be matched and randomized to intervention or usual care. Written informed consent will be obtained from all participants.
Intervention and Procedures
- Intervention: 6-week therapeutic virtual reality (VR) experience programme in addition to usual care.
- Control: usual care only (personal care, regular basic medical and nursing care, and social support).
The research team will not interfere with the routine services provided in either group.
Outcomes: mental well-being, depressive symptoms, loneliness, health-related quality of life, and perceived social support Assessments (T0: pre-treatment; T1: post-treatment): demographic data (age, gender, level of education, number of chronic illnesses, length of stay in the LTCF, prior VR experience) plus the outcomes above.
Quantitative Data Analysis: Baseline data summarized using means with standard deviations or frequencies with percentages (whole sample and by group). Generalized estimating equations (GEE) will test the five outcomes separately as dependent variables, with independent variables of group, timepoint, and group × timepoint interaction. Primary interpretation based on intention-to-treat analysis without covariate adjustment. Significance set at 0.05; missing data handled by multiple imputation, single imputation, or no imputation as appropriate.
Roles and Timeline
- Enrolment: recruitment, eligibility screening, and informed consent
- T0: pre-treatment demographic and outcome data collection
- Allocation: random assignment to intervention or control group
- Intervention period: implementation of the 6-week VR programme or usual care
- T1: post-treatment outcome data collection
This study evaluates the effectiveness of a therapeutic VR programme for older residents in LTCFs while maintaining usual care and minimizing interference with routine services.
- Conditions
- Mental Health Wellness 1, Physical Disability
- Being tested
- Virtual reality experience
- Keywords
- Mental wellbeing, Virtual reality, Physical disability, Older people
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality experienceOther
The VR experience is launched on the participants using all-in-one VR head-mount devices. Tablet computers are used to optimize the settings by the intervention facilitators. Each session lasts for approximately one hour with 10 minutes spent on the briefing, 20 minutes spent on the VR experience, and 30 minutes spent on the post-VR group discussion. There are two sessions per week. The whole course lasts for six weeks and there are a total of 12 sessions.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality | Experimental | The investigators will administer a virtual reality experience programme to promote mental wellbeing of the participants Receives: Other: Virtual reality experience |
| Usual care | No intervention | The investigators will not provide any interventions to the participants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental well-being
Well-being will be measured by the World Health Organization-Five Well-Being Index (WHO-5). Total scores range from 0 to 100, where higher scores mean better subjective well-being and higher quality of life.
Measured: 6 weeks
Secondary outcomes (4)
Depressive symptoms
Depressive symptoms will be measured by Patient Health Questionnaire-9 (PHD-9). Total scores range from 0 to 27, where higher scores mean more severe depressive symptoms.
Measured: 6 weeks
Loneliness
Loneliness will be measured by the Chinese version of the 6-item De Jong Gierveld Loneliness Scale. Total scores range from 0 to 6, where higher scores mean more severe feelings of loneliness.
Measured: 6 weeks
Health-related quality of life
The Hong Kong version of the EuroQol 5-dimensions instrument with a five-level scale will be used to measure health-related quality of life. Health states are expressed as a 5-digit code, where "11111" indicates perfect health across all dimensions and "55555" indicates the worst possible health state.
Measured: 6 weeks
Perceived social support
Perceived social support will be measured by the Chinese version of the Multiple Scale of Perceived Social Support Scale (PSSS). Total scores range from 12 to 84, where higher scores mean a higher level of the individual's perception of social support.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start15 Feb 2024
- Primary completion14 Feb 2025
- Study completion14 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health Wellness 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tung Wah College
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese University of Hong Kong, Pok Oi Hospital, Golden Age Foundation Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05818579
- Sponsor's protocol ID
- MHI2_0071
- Status last verified
- Apr 2023
- First submitted
- 5 Apr 2023
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data will be provided upon request.
Publications
Kwan RYC, Ng F, Lam LCW, Yung RC, Sin OSK, Chan S. The effects of therapeutic virtual reality experience to promote mental well-being in older people living with physical disabilities in long-term care facilities. Trials. 2023 Aug 26;24(1):558. doi: 10.1186/s13063-023-07592-7.
PubMed 37633916
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Therapeutic Virtual Reality Experience to Promote Mental Well-being in Older People Living With Physical Disabilities in Long-term Care Facilities
- ClinicalTrials.gov ID
- NCT05818579
- Acronym / sponsor ID
- MHI2_0071
- Conditions
- Mental Health Wellness 1, Physical Disability
- Keywords
- Mental wellbeing, Virtual reality, Physical disability, Older people
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Tung Wah CollegeUniversity, hospital or other
- Collaborators
- Chinese University of Hong Kong, Pok Oi Hospital, Golden Age Foundation Limited
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 14 Feb 2025 (actual)
- Study completion
- 14 May 2025 (actual)
- First posted
- 19 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Older adults living with physical disabilities in residential care homes are at elevated risk for depression and loneliness, which negatively impacts their quality of life. Immersive virtual reality is an evolving modality that engages older adults in therapeutically oriented activities to address these mental health challenges. This study evaluated the effects of a nurse-led multi-disciplinary therapeutic immersive virtual reality programme, incorporating natural scenes, tourism, and reminiscence, on mental health outcomes. Simultaneously evaluating effectiveness and implementation demonstrates whether the program functions across diverse residential settings and how it can be sustained long-term. This approach delivers multi-level benefits: residents experience improved mood, well-being, and social support; care homes acquire an adaptable, engaging activity tailored to mobility and sensory limitations; and policymakers receive the practical guidance required to scale and maintain this evidence-based geriatric mental health intervention.
Detailed description
This study uses a single-blinded, two-parallel-group, 1:1 randomized controlled trial with a non-inferiority design. The study will be conducted in long-term care facilities (LTCFs), specifically Care \& Attention Homes for the Elderly and Nursing Homes under the governance of the Social Welfare Department in Hong Kong. Homes will be matched and randomized to intervention or usual care. Written informed consent will be obtained from all participants.
Intervention and Procedures
- Intervention: 6-week therapeutic virtual reality (VR) experience programme in addition to usual care.
- Control: usual care only (personal care, regular basic medical and nursing care, and social support).
The research team will not interfere with the routine services provided in either group.
Outcomes: mental well-being, depressive symptoms, loneliness, health-related quality of life, and perceived social support Assessments (T0: pre-treatment; T1: post-treatment): demographic data (age, gender, level of education, number of chronic illnesses, length of stay in the LTCF, prior VR experience) plus the outcomes above.
Quantitative Data Analysis: Baseline data summarized using means with standard deviations or frequencies with percentages (whole sample and by group). Generalized estimating equations (GEE) will test the five outcomes separately as dependent variables, with independent variables of group, timepoint, and group × timepoint interaction. Primary interpretation based on intention-to-treat analysis without covariate adjustment. Significance set at 0.05; missing data handled by multiple imputation, single imputation, or no imputation as appropriate.
Roles and Timeline
- Enrolment: recruitment, eligibility screening, and informed consent
- T0: pre-treatment demographic and outcome data collection
- Allocation: random assignment to intervention or control group
- Intervention period: implementation of the 6-week VR programme or usual care
- T1: post-treatment outcome data collection
This study evaluates the effectiveness of a therapeutic VR programme for older residents in LTCFs while maintaining usual care and minimizing interference with routine services.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Experimental | Other: Virtual reality experienceThe investigators will administer a virtual reality experience programme to promote mental wellbeing of the participants |
| Usual care | No intervention | –The investigators will not provide any interventions to the participants. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 60 years or above;
- LTCF residents; and
- Physical disability, defined as the Modified Barthel Index (MBI) score of ≤ 90 (i.e., moderately dependent or worse).
Key exclusion criteria (5 listed)
- Probably dementia, as defined by a Montreal Cognitive Assessment (MoCA) score of < 20,
- Severe visual impairment, as defined by a lens-corrected visual acuity score of < 6/60,
- Severe hearing impairment, as defined by failed whispered voice test.
- Bilateral upper limb paralysis, as defined by the Medical Research Council Muscle Power Scale of < 4. or
- Participated in any virtual reality activities in the past six months or concurrently.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality experienceThe VR experience is launched on the participants using all-in-one VR head-mount devices. Tablet computers are used to optimize the settings by the intervention facilitators. Each session lasts for approximately one hour with 10 minutes spent on the briefing, 20 minutes spent on the VR experience, and 30 minutes spent on the post-VR group discussion. There are two sessions per week. The whole course lasts for six weeks and there are a total of 12 sessions. | Other | Virtual reality |
Primary outcome
Mental well-being
Time frame: 6 weeks
Well-being will be measured by the World Health Organization-Five Well-Being Index (WHO-5). Total scores range from 0 to 100, where higher scores mean better subjective well-being and higher quality of life.
4 secondary outcomes
Depressive symptoms
Time frame: 6 weeks
Loneliness
Time frame: 6 weeks
Health-related quality of life
Time frame: 6 weeks
Perceived social support
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Derived from this study: PubMed 37633916Kwan RYC, Ng F, Lam LCW, Yung RC, Sin OSK, Chan S. The effects of therapeutic virtual reality experience to promote mental well-being in older people living with physical disabilities in long-term care facilities. Trials. 2023 Aug 26;24(1):558. doi: 10.1186/s13063-023-07592-7.
- Individual participant dataSharing planned: Undecided. The data will be provided upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality experience in people with Mental Health Wellness 1 and Physical Disability, run by Tung Wah College at 1 site in Hong Kong.
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 5 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 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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?
Mental well-being (time frame: 6 weeks). 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 NCT05818579, 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 3 Nov 2026; AzTrials last refreshed its copy on 6 Nov 2026.