Closed-Loop and Neuroplasticity-Based Mindfulness Program for Family Caregivers

NCT ID: NCT06880822

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 189 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2027-04-30

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.

Conditions

Caregiving Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Closed-Loop and Neuroplasticity-Based Mindfulness Program

Group Type: EXPERIMENTAL

Closed-Loop and Neuroplasticity-Based Mindfulness Program

Intervention Type: BEHAVIORAL

The intervention includes three weekly 90-minute face-to-face mindfulness training sessions and daily guided self-practice using a closed-loop, neuroplasticity-based mobile app over 8 weeks. Training integrates mindfulness practices (e.g., mindful eating, body scanning) to help caregivers apply mindfulness in daily life. During self-practice, participants listen to a lesson, monitor distractions, and refocus on their breathing. Initial trials start at 20 seconds, adjusting by 10% if focused or decreasing by 20% if distracted, helping participants regulate attention. Progress is stored to continue in later sessions, with instant feedback during trials and delayed feedback on overall progress. Facilitators provide weekly follow-ups via the app to monitor caregivers' progress.

Traditional Mindfulness Program (Without the Closed-Loop Approach)

Group Type: ACTIVE_COMPARATOR

Traditional Mindfulness Program (Without the Closed-Loop Approach)

Intervention Type: BEHAVIORAL

Family caregivers in the traditional mindfulness group will participate in general mindfulness practices (e.g., mindful eating, body scanning, and mindful walking) without the closed-loop approach. These practices aim to help caregivers learn mindfulness skills and integrate them into their everyday life. Sessions will be delivered through a mobile approach with the same group size, duration, and frequency as the intervention groups.

Psychoeducation

Group Type: ACTIVE_COMPARATOR

Psychoeducation

Intervention Type: BEHAVIORAL

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. This group will serve as a control for socialization and interaction aspects with peers and the interventionist (nurse). The self-directed learning will be delivered through a mobile approach, maintaining the same group size, duration, and frequency as the intervention groups. Educational content will include brief sessions on dementia care, caregiving skills, and group sharing of caregiving tasks.

Interventions

Closed-Loop and Neuroplasticity-Based Mindfulness Program

The intervention includes three weekly 90-minute face-to-face mindfulness training sessions and daily guided self-practice using a closed-loop, neuroplasticity-based mobile app over 8 weeks. Training integrates mindfulness practices (e.g., mindful eating, body scanning) to help caregivers apply mindfulness in daily life. During self-practice, participants listen to a lesson, monitor distractions, and refocus on their breathing. Initial trials start at 20 seconds, adjusting by 10% if focused or decreasing by 20% if distracted, helping participants regulate attention. Progress is stored to continue in later sessions, with instant feedback during trials and delayed feedback on overall progress. Facilitators provide weekly follow-ups via the app to monitor caregivers' progress.

Intervention Type: BEHAVIORAL

Traditional Mindfulness Program (Without the Closed-Loop Approach)

Family caregivers in the traditional mindfulness group will participate in general mindfulness practices (e.g., mindful eating, body scanning, and mindful walking) without the closed-loop approach. These practices aim to help caregivers learn mindfulness skills and integrate them into their everyday life. Sessions will be delivered through a mobile approach with the same group size, duration, and frequency as the intervention groups.

Intervention Type: BEHAVIORAL

Psychoeducation

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. This group will serve as a control for socialization and interaction aspects with peers and the interventionist (nurse). The self-directed learning will be delivered through a mobile approach, maintaining the same group size, duration, and frequency as the intervention groups. Educational content will include brief sessions on dementia care, caregiving skills, and group sharing of caregiving tasks.

Intervention Type: BEHAVIORAL

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

Patrick KOR Pui Kin

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Patrick Kor, PhD

Role: CONTACT

patrick.kor@polyu.edu.hk

27665622

References

Kor PPK, Chou KL, Tsang APL, Mak WWS, Galante J, Ho RTH, Wong SYS, Cheung DSK, Liu JYW, Zarit SH. Effects of a closed-loop mindfulness-based program for reducing stress in family caregivers of people with dementia: a study protocol of a randomized controlled trial. BMC Psychol. 2025 Jul 1;13(1):681. doi: 10.1186/s40359-025-02919-2.

Reference Type: DERIVED

PMID: 40597419 (View on PubMed)

Other Identifiers

HSEARS20240722001

Identifier Type: -

Identifier Source: org_study_id