VR-based Mindfulness for Dementia Caregivers in the Home Environment (Mind-body Interventions)

NCT07103434 | Not Yet Recruiting

• 1 other identifier: 20250701
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Dementia; Caregiver Burden of People With Dementia

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline (pre-test), immediately post-test, and 2 months post-test

Secondary Outcomes (4)

• Cantonese Zarit Burden Scale Short Version

  Baseline (pre-test), immediately post-test, and 2 months post-test

• EuroQol 5-Dimension 5-Level

  Baseline (pre-test), immediately post-test, and 2 months post-test

• five-facet mindfulness questionnaire

  Baseline (pre-test), immediately post-test, and 2 months post-test

• Relationship Closeness Scale

  Baseline (pre-test), immediately post-test, and 2 months post-test

Study Arms (3)

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.

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.

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.

Behavioral: Waitlist control

Interventions

VR Mindfulness intervention BEHAVIORAL

Parallel randomized controlled trial

VR Mindfulness intervention

Audio-based MBI BEHAVIORAL

Parallel randomized controlled trial

Audio-based MBI

Waitlist control BEHAVIORAL

Parallel randomized controlled trial

Usual Care (Waitlist control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
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• Unable to understand Cantonese.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Lingnan University: collaborator
• Food and Health Bureau, Hong Kong: collaborator

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Due to the nature of this trial, neither the staff, participants nor care provider can be masked to allocation. The data analyst will be blinded after study completion by having the intervention group information coded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Study Record Dates

• First Submitted: July 7, 2025
• First Posted: August 5, 2025
• Study Start: August 1, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 5, 2025

Record last verified: 2025-08