NCT07103434

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

A Feasibility Study on the Efficacy of a VR-based Mindfulness Intervention for Dementia Caregivers in the Home Environment: A Pilot Randomized Control Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	VR Mindfulness intervention	Parallel randomized controlled trial
BEHAVIORAL	Audio-based MBI	Parallel randomized controlled trial
BEHAVIORAL	Waitlist control	Parallel randomized controlled trial

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-04-30
• Completion: 2026-12-31
• First posted: 2025-08-05
• Last updated: 2025-08-05