DementiavrmdcNCT07103434
VR-based Mindfulness for Dementia Caregivers in the Home Environment (Mind-body Interventions)
A study testing VR Mindfulness intervention and Audio-based MBI in people with Dementia and Caregiver Burden of People With Dementia, run by The University of Hong Kong.
Trial summary
To explore the feasibility, acceptability, and potential effectiveness among dementia caregivers of the mindfulness-based interventions delivered by VR technology (VR-based MBI) in improving psychological well-being and caregiver-recipient relationship. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Caregiver Burden of People With Dementia
- What is being tested?
- VR Mindfulness intervention and Audio-based MBI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years or older;
- Primary informal caregivers who spend over four hours/day taking care of a community-dwelling person who has been clinically diagnosed with any type of mild-to-moderate dementia at least 6 months;
- Self-reported psychological distress
- Able to speak and read Cantonese.
Who cannot join
- Have practiced mindfulness-based intervention for at least 3 months in the past;
- Have hearing or visual impairment that cannot practice mindfulness via wearing VR
- glasses embedded in a mobile phone app;
- --Do not own a smart phone that can install the VR-based MBI app;
- Caring for a person with dementia living in a residential care setting;
- Caring a person with severe level of dementia;
Show all 12Show fewer
- Have been diagnosed with any mental disorder or on-site of psychotic disorders;
- Receiving any other type of mental health intervention;
- Participants with a history of motion sickness (due to the risk of VR triggering motion sickness)
- Unable to understand Cantonese.
- sickness)
- -Unable to understand Cantonese.
About this study
Official title: A Feasibility Study on the Efficacy of a VR-based Mindfulness Intervention for Dementia Caregivers in the Home Environment: A Pilot Randomized Control Trial
To explore the feasibility, acceptability, and potential effectiveness among dementia caregivers of the mindfulness-based interventions delivered by VR technology (VR-based MBI) in improving psychological well-being and caregiver-recipient relationship.
This study hypothesized that caregivers in the VR-based MBI group will have a greater improvement in psychological wellbeing than those in the audio-based MBI group and the waitlist care-as-usual group.
Read more
This is a 3-arm, parallel, single-blinded, pilot randomised control trial comparing VR-based MBI with audio-based MBI and care-as-usual. The target sample includes 90 caregivers of community-dwelling persons with dementia. Each arm (n=30) will receive an eight-week exercise with instruction, with outcome assessment at baseline, post-treatment,
and 2-month follow-up. Qualitative interviews will also be conducted to assess the feasibility and acceptance. The VR-based MBI group will engage in mindfulness exercises using a mobile app and VR technology, incorporating different natural environments. The intervention duration is eight weeks. The primary outcome is the caregivers' psychological well-being regarding depression, anxiety, and stress. The secondary outcomes include caregiver burden, mindfulness level, quality of life and caregiver-recipient relationship.
Following intention-to-treat analysis, quantitative data on effectiveness will be analysed using between-group t-tests and group-by-time effect size (Cohen's d). The six-step thematic analysis will be utilized for qualitative data. The intervention group will accept the VR-based MBI, rate the intervention as feasible and show significant improvements in outcome measurements.
- Conditions
- Dementia, Caregiver Burden of People With Dementia
- Being tested
- VR Mindfulness intervention, Audio-based MBI, Waitlist control
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR Mindfulness interventionBehavioural
Parallel randomized controlled trial
Audio-based MBIBehavioural
Parallel randomized controlled trial
Waitlist controlBehavioural
Parallel randomized controlled trial
| Study group | Role | What they receive |
|---|---|---|
| VR Mindfulness intervention | Experimental | Participants in this arm will have the VR-based MBI app developed by the research team and use wearing the JAPAN JTSK 6th generation upgraded version of 3D virtual reality glasses.
During briefing session, participants will engage in a 5-10 minute exercise within the VR environment, giving participants the opportunity to explore different natural sceneries provided in the app. This exercise aims to acclimate participants to the VR technology and allow them to select environments for their mindfulness practice at home.
Participants will be provided with the VR glasses to take home and practice mindfulness for approximately 10-15 minutes daily over the next eight weeks. The app will record their practice time for further analysis. Receives: Behavioral: VR Mindfulness intervention |
| Audio-based MBI | Experimental | Participants in the audio-based group attend a briefing session where they will receive information on mindfulness practice.
Participants will listen to the same 10-15 minute audio-based MBI instruction as provided in the VR-based MBI app everyday for the next eight weeks. The instructions in the audio will be the same as the instructions in the VR-based mindfulness app.
The only difference between the VR-based MBI and audio-based MBI groups will be the absence of VR technology in the audio-based group. Receives: Behavioral: Audio-based MBI |
| Usual Care (Waitlist control) | Other | The third group will be the waitlist control group, who will not attend any briefing session or engage in mindfulness-based interventions during the pilot period. Instead, they will have the opportunity to participate in activities provided by community service centres. The researcher will provide the VR-based MBI to the waitlist control group after they have completed the control period. Receives: Behavioral: Waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression, Anxiety, Stress scale
The Depression, Anxiety, Stress Scale-21 (DASS-21) is a widely used self-report questionnaire designed to assess the negative emotional states of depression, anxiety, and stress. The scale contains 21 items, with seven items allocated to each of the three subscales: Depression, Anxiety, and Stress. Respondents are asked to rate the extent to which they have experienced each symptom over the past week using a 4-point Likert scale, ranging from 0 ("Did not apply to me at all") to 3 ("Applied to me very much, or most of the time"). Higher scores indicate greater levels of emotional distress in the respective domains. The DASS-21 is a shortened version of the original 42-item scale and has demonstrated good reliability and validity across diverse populations. It is commonly used in both clinical and research settings to screen for and monitor changes in symptoms related to depression, anxiety, and stress.
Measured: Baseline (pre-test), immediately post-test, and 2 months post-test
The Chinese Version of the Personal Well-being (ONS4)
The Personal Well-being (ONS4) scale, originally developed by the UK Office for National Statistics (ONS), is a brief self-report measure used to assess subjective well-being across four core domains: life satisfaction, sense of worthwhileness, happiness, and anxiety. Each item is rated on a scale from 0 to 10, with higher scores reflecting greater well-being (except for anxiety, where higher scores indicate greater anxiety). The Chinese version of the ONS4 has been adapted and validated to ensure cultural relevance and linguistic accuracy for use among Chinese-speaking populations. This version maintains the original structure and scoring, allowing for reliable assessment of personal well-being in Chinese contexts. It is widely used in surveys and research to monitor overall well-being and mental health.
Measured: Baseline (pre-test), immediately post-test, and 2 months post-test
Secondary outcomes (4)
Cantonese Zarit Burden Scale Short Version
The Zarit Burden Interview (ZBI) is a widely used self-report instrument designed to assess the level of burden experienced by caregivers of individuals with chronic illnesses or disabilities. The short version of the ZBI consists of 12 items, each rated on a 5-point Likert scale ranging from 0 ("Never") to 4 ("Nearly Always"), with higher scores indicating greater caregiver burden.
The Cantonese version of the ZBI Short Version has been translated and culturally adapted to ensure its suitability for Cantonese-speaking populations. Validation studies have demonstrated that the Cantonese ZBI Short Version retains strong psychometric properties, including reliability and validity, comparable to the original version. This scale is commonly used in both clinical and research settings in Hong Kong and other Cantonese-speaking regions to evaluate caregiver stress and the impact of caregiving responsibilities.
Measured: Baseline (pre-test), immediately post-test, and 2 months post-test
EuroQol 5-Dimension 5-Level
The EUROHIS-QOL 5-Item Index is a brief, self-report measure designed to assess overall quality of life. Developed from the World Health Organization's Quality of Life instruments (WHOQOL), the EUROHIS-QOL consists of five items that capture core domains of quality of life: general quality of life, general health, energy, daily activities, and personal relationships. Respondents rate each item on a 5-point Likert scale, with higher scores indicating better quality of life. The EQ-5D-5L index scores range from -0.59 to 1, with 1 representing the best possible health state. The index is suitable for use in general populations as well as clinical and research contexts. It has been validated across various languages and cultures, demonstrating good reliability and construct validity as a concise tool for assessing quality of life.
Measured: Baseline (pre-test), immediately post-test, and 2 months post-test
five-facet mindfulness questionnaire
The Five Facet Mindfulness Questionnaire (FFMQ) is a widely used self-report instrument designed to assess individual differences in mindfulness. Developed by Baer et al. (2006), the FFMQ consists of 39 items that measure five distinct facets of mindfulness: (1) Observing (noticing or attending to internal and external experiences), (2) Describing (labeling internal experiences with words), (3) Acting with Awareness (attending to one's activities in the moment), (4) Nonjudging of Inner Experience (taking a non-evaluative stance toward thoughts and feelings), and (5) Nonreactivity to Inner Experience (allowing thoughts and feelings to come and go without getting caught up in them). Each item is rated on a 5-point Likert scale ranging from 1 ("Never or very rarely true") to 5 ("Very often or always true"). Higher scores indicate a greater degree of mindfulness in the respective facet. The FFMQ has demonstrated good reliability and validity across diverse populations and is commonly used
Measured: Baseline (pre-test), immediately post-test, and 2 months post-test
Relationship Closeness Scale
The Relationship Closeness Scale (RCS) is a self-report instrument designed to assess the perceived closeness and interconnectedness between individuals in a relationship, such as romantic partners, friends, or family members. The scale typically consists of several items that measure aspects of emotional closeness, frequency of interaction, and the extent to which individuals influence each other's activities and decisions. Respondents rate each item on a Likert-type scale (e.g., from 1 = "Not at all true" to 7 = "Very true"), with higher scores indicating greater perceived closeness within the relationship. The RCS has demonstrated good reliability and validity in both research and applied settings and is often used to examine the quality and depth of interpersonal relationships.
Measured: Baseline (pre-test), immediately post-test, and 2 months post-test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study start1 Aug 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
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 DementiaStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Investigator
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Lingnan University, Food and Health Bureau, Hong Kong
- Responsible party
- Principal investigator, Qi Wang, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103434
- Sponsor's protocol ID
- 20250701
- Acronym
- vrmdc
- Status last verified
- Aug 2025
- First submitted
- 7 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang Q, Yu D, Wong G, Zhang D, Knapp M, Amoah PA, Li J, Shi C. A feasibility study on the efficacy of a VR-based mindfulness intervention for dementia caregivers in the home environment: A pilot randomized control trial protocol. PLoS One. 2026 Apr 29;21(4):e0347988. doi: 10.1371/journal.pone.0347988. eCollection 2026.
PubMed 42054400
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study on the Efficacy of a VR-based Mindfulness Intervention for Dementia Caregivers in the Home Environment: A Pilot Randomized Control Trial
- ClinicalTrials.gov ID
- NCT07103434
- Acronym / sponsor ID
- vrmdc / 20250701
- Conditions
- Dementia, Caregiver Burden of People With Dementia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Lingnan University, Food and Health Bureau, Hong Kong
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Aug 2025 (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.
To explore the feasibility, acceptability, and potential effectiveness among dementia caregivers of the mindfulness-based interventions delivered by VR technology (VR-based MBI) in improving psychological well-being and caregiver-recipient relationship.
This study hypothesized that caregivers in the VR-based MBI group will have a greater improvement in psychological wellbeing than those in the audio-based MBI group and the waitlist care-as-usual group.
This is a 3-arm, parallel, single-blinded, pilot randomised control trial comparing VR-based MBI with audio-based MBI and care-as-usual. The target sample includes 90 caregivers of community-dwelling persons with dementia. Each arm (n=30) will receive an eight-week exercise with instruction, with outcome assessment at baseline, post-treatment,
and 2-month follow-up. Qualitative interviews will also be conducted to assess the feasibility and acceptance. The VR-based MBI group will engage in mindfulness exercises using a mobile app and VR technology, incorporating different natural environments. The intervention duration is eight weeks. The primary outcome is the caregivers' psychological well-being regarding depression, anxiety, and stress. The secondary outcomes include caregiver burden, mindfulness level, quality of life and caregiver-recipient relationship.
Following intention-to-treat analysis, quantitative data on effectiveness will be analysed using between-group t-tests and group-by-time effect size (Cohen's d). The six-step thematic analysis will be utilized for qualitative data. The intervention group will accept the VR-based MBI, rate the intervention as feasible and show significant improvements in outcome measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| VR Mindfulness intervention | Experimental | Behavioral: VR Mindfulness interventionParticipants in this arm will have the VR-based MBI app developed by the research team and use wearing the JAPAN JTSK 6th generation upgraded version of 3D virtual reality glasses. During briefing session, participants will engage in a 5-10 minute exercise within the VR environment, giving participants the opportunity to explore different natural sceneries provided in the app. This exercise aims to acclimate participants to the VR technology and allow them to select environments for their mindfulness practice at home. Participants will be provided with the VR glasses to take home and practice mindfulness for approximately 10-15 minutes daily over the next eight weeks. The app will record their practice time for further analysis. |
| Audio-based MBI | Experimental | Behavioral: Audio-based MBIParticipants in the audio-based group attend a briefing session where they will receive information on mindfulness practice. Participants will listen to the same 10-15 minute audio-based MBI instruction as provided in the VR-based MBI app everyday for the next eight weeks. The instructions in the audio will be the same as the instructions in the VR-based mindfulness app. The only difference between the VR-based MBI and audio-based MBI groups will be the absence of VR technology in the audio-based group. |
| Usual Care (Waitlist control) | Other | Behavioral: Waitlist controlThe third group will be the waitlist control group, who will not attend any briefing session or engage in mindfulness-based interventions during the pilot period. Instead, they will have the opportunity to participate in activities provided by community service centres. The researcher will provide the VR-based MBI to the waitlist control group after they have completed the control period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 years or older;
- Primary informal caregivers who spend over four hours/day taking care of a community-dwelling person who has been clinically diagnosed with any type of mild-to-moderate dementia at least 6 months;
- Self-reported psychological distress
- Able to speak and read Cantonese.
Key exclusion criteria (12 listed)
- Have practiced mindfulness-based intervention for at least 3 months in the past;
- Have hearing or visual impairment that cannot practice mindfulness via wearing VR
- glasses embedded in a mobile phone app;
- --Do not own a smart phone that can install the VR-based MBI app;
- Caring for a person with dementia living in a residential care setting;
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 |
|---|---|---|
| VR Mindfulness interventionParallel randomized controlled trial | Behavioural | VR Mindfulness intervention |
| Audio-based MBIParallel randomized controlled trial | Behavioural | Audio-based MBI |
| Waitlist controlParallel randomized controlled trial | Behavioural | Usual Care (Waitlist control) |
Primary outcome
Depression, Anxiety, Stress scale
Time frame: Baseline (pre-test), immediately post-test, and 2 months post-test
The Depression, Anxiety, Stress Scale-21 (DASS-21) is a widely used self-report questionnaire designed to assess the negative emotional states of depression, anxiety, and stress. The scale contains 21 items, with seven items allocated to each of the three subscales: Depression, Anxiety, and Stress. Respondents are asked to rate the extent to which they have experienced each symptom over the past week using a 4-point Likert scale, ranging from 0 ("Did not apply to me at all") to 3 ("Applied to me very much, or most of the time"). Higher scores indicate greater levels of emotional distress in the respective domains. The DASS-21 is a shortened version of the original 42-item scale and has demonstrated good reliability and validity across diverse populations. It is commonly used in both clinical and research settings to screen for and monitor changes in symptoms related to depression, anxiety, and stress.
The Chinese Version of the Personal Well-being (ONS4)
Time frame: Baseline (pre-test), immediately post-test, and 2 months post-test
The Personal Well-being (ONS4) scale, originally developed by the UK Office for National Statistics (ONS), is a brief self-report measure used to assess subjective well-being across four core domains: life satisfaction, sense of worthwhileness, happiness, and anxiety. Each item is rated on a scale from 0 to 10, with higher scores reflecting greater well-being (except for anxiety, where higher scores indicate greater anxiety). The Chinese version of the ONS4 has been adapted and validated to ensure cultural relevance and linguistic accuracy for use among Chinese-speaking populations. This version maintains the original structure and scoring, allowing for reliable assessment of personal well-being in Chinese contexts. It is widely used in surveys and research to monitor overall well-being and mental health.
4 secondary outcomes
Cantonese Zarit Burden Scale Short Version
Time frame: Baseline (pre-test), immediately post-test, and 2 months post-test
EuroQol 5-Dimension 5-Level
Time frame: Baseline (pre-test), immediately post-test, and 2 months post-test
five-facet mindfulness questionnaire
Time frame: Baseline (pre-test), immediately post-test, and 2 months post-test
Relationship Closeness Scale
Time frame: Baseline (pre-test), immediately post-test, and 2 months post-test
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2025.
- Derived from this study: PubMed 42054400Wang Q, Yu D, Wong G, Zhang D, Knapp M, Amoah PA, Li J, Shi C. A feasibility study on the efficacy of a VR-based mindfulness intervention for dementia caregivers in the home environment: A pilot randomized control trial protocol. PLoS One. 2026 Apr 29;21(4):e0347988. doi: 10.1371/journal.pone.0347988. eCollection 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing VR Mindfulness intervention and Audio-based MBI in people with Dementia and Caregiver Burden of People With Dementia, run by The University of 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 4 inclusion and 12 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: opening soon, as of the sponsor's last update on 5 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
Depression, Anxiety, Stress scale (time frame: Baseline (pre-test), immediately post-test, and 2 months post-test). The study lists 2 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 NCT07103434, 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 5 Aug 2025.