Clinical trial NCT06880822: Closed-Loop and Neuroplasticity-Based Mindfulness Program for Family Caregivers
Official title: Effects of a Closed-Loop and Neuroplasticity-Based Mindfulness Program for Reducing Stress in Family Caregivers of People with Dementia: a Randomized Controlled Trial with a Process Evaluation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Caregiving Stress
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 189
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to evaluate the effectiveness of a closed-loop and neuroplasticity-based mindfulness program for reducing stress among family caregivers of people with dementia. Participants will be randomly assigned to one of three groups: the closed-loop and neuroplasticity-based mindfulness program, a traditional mindfulness program, or brief education on dementia care. The closed-loop and neuroplasticity-based mindfulness program will include three weekly face-to-face training sessions (90 minutes each) and daily guided self-practice over 8 weeks via a mobile application. The traditional mindfulness program will not include the closed-loop approach but will feature general mindfulness practices with the same group size, duration, and frequency as the closed-loop program. The family caregivers in the control group will receive self-directed e-learning on dementia care with support from a registered nurse experienced in dementia care or elderly care, maintaining the same group size, duration, and frequency as the intervention groups. Evaluations will be conducted at baseline (0 weeks), immediately post-intervention (8 weeks), and during a follow-up assessment (6 months). All groups will complete the same assessments at the same time points.

Detailed description: Demanding caregiving tasks and uncertainty about disease progression cause high levels of stress in family caregivers of people with dementia (PWD), threatening their health and dyadic relationships. While mindfulness-based interventions (MBI) have shown promise in reducing stress, several limitations exist. Most studies used intensive training (weekly 150-minute sessions for 8 weeks), which was demanding for family caregivers and led to high attrition rates (10.5%-17.2%). Additionally, a wandering mind during practice has been the most challenging aspect of mindfulness. Traditional mindfulness practices lack quantifiable metrics of success or performance feedback, making engagement and long-term compliance difficult. Recent studies of online mindfulness programs found they typically duplicated real-world practices, encountering similar implementation challenges. Furthermore, the manualized protocol (e.g., 45 minutes of daily practice) was often unachievable for many caregivers, leading to frustration. Mindfulness training should adapt to individual abilities. To address these limitations, the investigators propose integrating a closed-loop and neuroplasticity-based approach in mindfulness training.

The study will recruit community-dwelling family caregivers of people with dementia from three local nongovernmental organizations (NGOs) providing dementia care services in Hong Kong. After eligibility assessment and consent, participants will be randomly assigned to one of three groups: the closed-loop and neuroplasticity-based mindfulness program, a traditional mindfulness program, or brief education on dementia care.

The closed-loop and neuroplasticity-based mindfulness program comprises three weekly face-to-face mindfulness training sessions (90 minutes each) and daily guided self-practice through a mobile application over 8 weeks. The face-to-face training will incorporate the mobile application and various mindfulness practices to help caregivers integrate mindfulness skills into daily life. Facilitators will provide weekly mobile device follow-up to monitor progress.

Family caregivers in the traditional mindfulness group will practice general mindfulness techniques without the closed-loop approach. These practices will be delivered through a mobile approach with identical group size, duration, and frequency as the intervention group.

The brief education on dementia care group will receive self-directed e-learning supported by an experienced registered nurse. This control group will maintain the same group size, duration, and frequency as the intervention groups. Educational content will include sessions on dementia care, caregiving skills, and group sharing.

Outcome measures include perceived caregiving stress (primary outcome), depressive symptoms, peace of mind, caregiving burden, dyadic relationship, dispositional mindfulness, physiological stress, neuropsychiatric symptoms, and caregiving-related productivity loss. Feasibility measures include eligibility and enrollment, attendance rate, self-practice engagement, and retention rate. Evaluations will occur at baseline (0 weeks), post-intervention (8 weeks), and follow-up (6 months). All groups will complete identical assessments at the same time points.

Eligibility criteria: Inclusion Criteria:

* Age 18 or above;
* Family caregiver of an individual who has been living in the community with a confirmed medical diagnosis of any type of dementia (verified through NGO records or care recipient's medical records) for more than one year;
* Living in the same household as the care recipient;
* Providing care with daily contact of 4 hours or more.

Exclusion Criteria:

* Has participated in any structured mind-body intervention or structured psychosocial intervention within 6 months prior to recruitment;
* Has an acute psychiatric condition that is potentially life-threatening or would limit participation in the study (indicated by answering "yes" to any of the six questions on the Columbia Suicide Severity Rating Scale).

Primary outcomes:
measure: Perceived Caregiving Stress in the Family Caregiver
timeFrame: 6 months
Secondary outcomes:
measure: Depressive Symptoms in the Family Caregiver
timeFrame: 6 months
measure: Peace of Mind in the Family Caregiver
timeFrame: 6 months
measure: Caregiving Burden in the Family Caregiver
timeFrame: 6 months
measure: Dyadic Relationship Between the Family Caregiver and the Care Recipient
timeFrame: 6 months
measure: Dispositional Mindfulness in the Family Caregiver
timeFrame: 6 months
measure: Physiological Stress in the Family Caregiver
timeFrame: 6 months
measure: Work Productivity and Activity Impairment in the Family Caregivers
timeFrame: 6 months
measure: Neuropsychiatric Syndromes in the Care Recipient
timeFrame: 6 months
measure: Feasibility of Eligibility and Enrollment
timeFrame: 8 weeks
measure: Feasibility of Attendance Rate
timeFrame: 8 weeks
measure: Feasibility of Engagement to Self-Practice
timeFrame: 6 months
measure: Feasibility of Retention Rate
timeFrame: 6 months
Other outcomes:
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