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

NCT06619938 | Not Yet Recruiting

• 1 other identifier: TBA20240927
• Study Type: interventional
• Target: 260
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Perceived Caregiving Stress in the Family Caregiver

  The Perceived Stress Scale (PSS) comprises 10 items rated on a 5-point Likert Scale (0 = never to 4 = very often) to assess perceived stress levels. The total score varies from 0 to 40, with a higher score reflecting more perceived stress. Scores within the ranges of 0-13, 14-26, and 27-40 correspond to low, moderate, and high levels of perceived stress, respectively.

  8 Weeks

Secondary Outcomes (9)

• Depressive Symptoms in the Family Caregiver

  8 Weeks

• Heart Rate Variability (HRV) in the Family Caregiver

  8 Weeks

• Anxiety in the Family Caregiver

  8 Weeks

• Trait Mindfulness in the Family Caregiver

  8 Weeks

• Neuropsychiatric Syndromes in the Care Recipient

  8 Weeks

Study Arms (2)

Mindfulness Without Biofeedback

ACTIVE COMPARATOR

Behavioral: Mindfulness Without Biofeedback

Mindfulness With Biofeedback

EXPERIMENTAL

Behavioral: Mindfulness With Biofeedback

Interventions

Mindfulness With Biofeedback BEHAVIORAL

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.

Mindfulness With Biofeedback

Mindfulness Without Biofeedback BEHAVIORAL

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.

Mindfulness Without Biofeedback

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Family caregivers of an individual who has been residing in the community with a confirmed medical diagnosis of any type of dementia (from NGO record or the care-recipients\' medical record);
• Providing care for at least 4 hours or more per week;
• Able to speak Cantonese (for understanding all teaching materials and instructions).

You may not qualify if:

• Practicing or having recently learned meditation, mindfulness activities, and/or relaxation training in the last 6 months;
• Regularly using wearable devices;
• Diagnosed with a mental disorder such as bipolar disorder, schizophrenia, dementia, or depression in an acute phase.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

MeSH Terms

Conditions

Caregiver Burden

Interventions

Mindfulness; Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Mind-Body Therapies; Complementary Therapies; Therapeutics; Feedback, Psychological

Central Study Contacts

Patrick PK KOR, PhD

CONTACT

852+27665622; patrick.kor@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 28, 2024
• First Posted: October 1, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share