VR-based Mindfulness for Dementia Caregivers in the Home Environment (Mind-body Interventions)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: VR Mindfulness intervention, Audio-based MBI, Waitlist control.
- Who it may be relevant to
- Registry conditions: Dementia, Caregiver Burden of People With Dementia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Behavioral VR Mindfulness intervention
Parallel randomized controlled trial - Behavioral Audio-based MBI
Parallel randomized controlled trial - Behavioral Waitlist control
Parallel randomized controlled trial
Primary outcome measures
- Depression, Anxiety, Stress scale [Time frame: Baseline (pre-test), immediately post-test, and 2 months post-test]
- The Chinese Version of the Personal Well-being (ONS4) [Time frame: Baseline (pre-test), immediately post-test, and 2 months post-test]
Secondary outcome measures (4)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
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;
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
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. PMID 42054400
Identifiers
NCT: NCT07103434 · 20250701