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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Hong Kong Polytechnic University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

  • 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.

Treatment groups

189 Participants
are divided into 3 treatment groups
Group A: Closed-Loop and Neuroplasticity-Based Mindfulness ProgramExperimental treatment 1 intervention
Group B: Traditional Mindfulness Program (Without the Closed-Loop Approach)Active comparator 1 intervention
Group C: PsychoeducationActive comparator 1 intervention

Trial outcomes

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.

Time frame
6 months

Secondary outcomes

1

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.

Time frame
6 months
2

Peace of Mind in the Family Caregiver

The Peace of Mind Scale (PMS) consists of 7 items rated on a 5-point Likert scale (1 = not at all to 5 = all the time) that assess an internal state of peacefulness and harmony. Two items are reverse-scored. The total score ranges from 7 to 35, with higher scores indicating greater levels of peacefulness and harmony.

Time frame
6 months
3

Caregiving Burden in the Family Caregiver

The Zarit Burden Interview (ZBI) consists of 22 items that measure the impact of caregiving on physical health, emotional well-being, social life, and financial status. Items are rated on a 5-point Likert scale (0 = never to 4 = nearly always). Total scores range from 0 to 88, with higher scores indicating greater caregiving burden.

Time frame
6 months
4

Dyadic Relationship Between the Family Caregiver and the Care Recipient

The Dyadic Relationship Scale (DRS) measures the quality of the dyadic relationship between the family caregiver and the care recipient. This scale consists of two versions: the patient version (10 items) and the caregiver version (11 items). Both versions include two subscales: dyadic strain and positive dyadic interaction. They are rated on a 4-point Likert scale (1 = strongly disagree, 4 = strongly agree). Higher scores on each of these scales indicate higher levels of strain and positive interaction, respectively.

Time frame
6 months

Other outcomes

Locations

This trial has no locations.

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