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.
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).
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.
Parallel
Mindfulness With Biofeedback
BehavioralThe 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 Without Biofeedback
BehavioralThe 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.
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.
Depressive Symptoms in the Family Caregiver
The Center for Epidemiologic Studies Depression Scale (CESD) comprises 20 items rated on a 4-point Likert scale (0 = rarely or none of the time to 3 = most or almost all the time) to assess the severity of depressive symptoms experienced in the past week. The total score ranges from 0 to 60, with a higher score indicating more severe depressive symptoms. Scores within the ranges of 0-14, 15-21, and 22-60 correspond to low, mild to moderate, and a potential indication of major depression, respectively.
Heart Rate Variability (HRV) in the Family Caregiver
HRV will be measured as a biomarker of stress. The interpretation of HRV will follow the Guidelines for Standard Measurement and Interpretation of HRV (European Society of Cardiology and the North American Society of Pacing and Electrophysiology) using the frequency-domain method.
Anxiety in the Family Caregiver
The Hospital Anxiety and Depression Scale-Anxiety (HADS-A) measures generalized anxiety, including tension, worry, fear, panic, difficulties in relaxing, and restlessness. It consists of 7 items and is rated on a 4-point Likert scale. A higher score on the HADS-A suggests a higher level of anxiety.
Trait Mindfulness in the Family Caregiver
The Five-Facet Mindfulness Questionnaire-Short Form measures trait mindfulness. It consists of 20 items that assess five domains of mindfulness: observing, describing, acting with awareness, nonjudging, and nonreacting. Each domain comprises 4 items and is rated on a 5-point Likert scale (1 = never, 5 = very often). The facet score for each domain is the average of the four items, with higher scores (range = 1-5) indicating higher levels of mindfulness.
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