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

The University of Hong Kong (HKU)

Status: Not yet enrolling

Conditions: Caregiver Burden of People With Dementia; Dementia

Treatments: Behavioral: VR Mindfulness intervention; Behavioral: Audio-based MBI; Behavioral: Waitlist control

Study type: Interventional

Funder types: Other

Identifiers

NCT07103434

20250701

Details and patient eligibility

About

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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

90 participants in 3 patient groups

VR Mindfulness intervention

Experimental group

Description:

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.

Treatment:

Behavioral: VR Mindfulness intervention

Audio-based MBI

Experimental group

Description:

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.

Treatment:

Behavioral: Audio-based MBI

Usual Care (Waitlist control)

Other group

Description:

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.

Treatment:

Behavioral: Waitlist control