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NOT YET RECRUITING
NCT07103434
NA

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

Sponsor: The University of Hong Kong

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2025-08-01

Completion Date

2026-12-31

Last Updated

2025-08-05

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

VR Mindfulness intervention

Parallel randomized controlled trial

BEHAVIORAL

Audio-based MBI

Parallel randomized controlled trial

BEHAVIORAL

Waitlist control

Parallel randomized controlled trial