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

NCT06880822 | Not Yet Recruiting

• 1 other identifier: HSEARS20240722001
• Study Type: interventional
• Target: 189
• Locations: 0 countries
• Sites: N/A

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.

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.

  6 months

Secondary Outcomes (12)

• Depressive Symptoms in the Family Caregiver

  6 months

• Peace of Mind in the Family Caregiver

  6 months

• Caregiving Burden in the Family Caregiver

  6 months

• Dyadic Relationship Between the Family Caregiver and the Care Recipient

  6 months

• Dispositional Mindfulness in the Family Caregiver

  6 months

Study Arms (3)

Closed-Loop and Neuroplasticity-Based Mindfulness Program

EXPERIMENTAL

Behavioral: Closed-Loop and Neuroplasticity-Based Mindfulness Program

Traditional Mindfulness Program (Without the Closed-Loop Approach)

ACTIVE COMPARATOR

Behavioral: Traditional Mindfulness Program (Without the Closed-Loop Approach)

Psychoeducation

ACTIVE COMPARATOR

Behavioral: Psychoeducation

Interventions

Closed-Loop and Neuroplasticity-Based Mindfulness Program 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.

Closed-Loop and Neuroplasticity-Based Mindfulness Program

Traditional Mindfulness Program (Without the Closed-Loop Approach) 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.

Traditional Mindfulness Program (Without the Closed-Loop Approach)

Psychoeducation 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.

Psychoeducation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Related Publications (1)

• 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.

  PMID: 40597419 DERIVED

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Central Study Contacts

Patrick Kor, PhD

CONTACT

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: March 12, 2025
• First Posted: March 18, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL