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

NCT ID: NCT07103434

Last Updated: 2025-08-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

VR Mindfulness intervention

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.

Group Type: EXPERIMENTAL

VR Mindfulness intervention

Intervention Type: BEHAVIORAL

Parallel randomized controlled trial

Audio-based MBI

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.

Group Type: EXPERIMENTAL

Audio-based MBI

Intervention Type: BEHAVIORAL

Parallel randomized controlled trial

Usual Care (Waitlist control)

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.

Group Type: OTHER

Waitlist control

Intervention Type: BEHAVIORAL

Parallel randomized controlled trial

Interventions

VR Mindfulness intervention

Parallel randomized controlled trial

Intervention Type: BEHAVIORAL

Audio-based MBI

Parallel randomized controlled trial

Intervention Type: BEHAVIORAL

Waitlist control

Parallel randomized controlled trial

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lingnan University

OTHER

Sponsor Role: collaborator

Food and Health Bureau, Hong Kong

OTHER_GOV

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Qi Wang

Research Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

20250701

Identifier Type: -

Identifier Source: org_study_id