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Mindfulness-Based Intervention Using Consumer-Grade Wearable Devices with Biofeedback for Family Caregivers of People with Dementia

NCT06619938 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2024-10-01

No results posted yet for this study

Summary

The aim of this study is to investigate the effectiveness of a brief mindfulness training intervention using a consumer-grade wearable device with biofeedback for reducing stress and promoting psychological health in family caregivers of people with dementia.

The intervention includes two weekly sessions, each lasting 90 minutes, of brief mindfulness training. The intervention group will be provided with a wearable device that offers biofeedback, which aims to promote their mindfulness practice and help the caregivers cultivate a mindful attitude in their daily activities, leading to stress reduction. Participants in the intervention group will attend a 30-minute briefing session to learn how to use the wearable device and understand the parameters displayed on the device. The caregivers will be instructed to practice mindfulness for 30 minutes every day over the course of eight weeks.

Participants will be randomly assigned to receive either the mindfulness intervention combined with biofeedback or the mindfulness intervention alone. Evaluations will be conducted at three time-points: baseline (0 weeks), mid-intervention (4 weeks), and post-intervention (8 weeks). Both groups will complete the same assessments at each time-point.

Conditions

  • Caregiving Stress

Interventions

BEHAVIORAL

Mindfulness With Biofeedback

The intervention includes two weekly 90-minute sessions of brief mindfulness training, covering mindfulness practices, psychoeducation on caregiving, and group sharing. After the first session, participants receive a wearable device for biofeedback on RR, HR, HRV, EDA, and sleep patterns to support mindfulness practice and reduce stress. A 30-minute session teaches caregivers how to use the devices and understand the parameters. The study uses Fitbit Sense with Fitbit apps, employing PPG sensors. The Fitbit Sense connects to smartphones with the apps installed. Caregivers can: (1) view real-time RR, HR, HRV, and EDA on the device and trends on their phone; (2) receive mindfulness practice reminders; (3) access audio coaching; (4) set personal goals (e.g., 30 minutes of daily practice); (5) track practice duration; (6) rate daily stress; and (7) review sleep quality. After the second session, caregivers practice mindfulness for 30 minutes daily over eight weeks.

BEHAVIORAL

Mindfulness Without Biofeedback

The control group will receive two weekly sessions of brief mindfulness training, the same as the intervention group. After the 1st brief mindfulness training, the control group will receive a 30-minute briefing session on goal setting for mindfulness practice. Each caregiver will be asked to develop an action plan for continuous mindfulness practice. A mindfulness therapist will also discuss the challenges and solutions for developing a habit of mindfulness practice with the caregivers in the second session. Caregivers in the control group will be advised to practice mindfulness daily for 30 minutes over the course of eight weeks.

Sponsors & Collaborators

  • The Hong Kong Polytechnic University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-31
Primary Completion
2026-10-31
Completion
2026-10-31

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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 NCT06619938 on ClinicalTrials.gov