MedTrace Logo

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

NCT07103434 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-08-05

No results posted yet for this study

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

BEHAVIORAL

VR Mindfulness intervention

Parallel randomized controlled trial

BEHAVIORAL

Audio-based MBI

Parallel randomized controlled trial

BEHAVIORAL

Waitlist control

Parallel randomized controlled trial

Sponsors & Collaborators

  • Lingnan University

    collaborator OTHER

  • Food and Health Bureau, Hong Kong

    collaborator OTHER_GOV

  • The University of Hong Kong

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2026-04-30
Completion
2026-12-31

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07103434 on ClinicalTrials.gov