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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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 d
• Поведенческое 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.
• Поведенческое 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 sessio

Первичные конечные точки

• Perceived Caregiving Stress in the Family Caregiver [Срок оценки: 6 months]

Вторичные конечные точки (12)

• Depressive Symptoms in the Family Caregiver [Срок оценки: 6 months]
• Peace of Mind in the Family Caregiver [Срок оценки: 6 months]
• Caregiving Burden in the Family Caregiver [Срок оценки: 6 months]
• Dyadic Relationship Between the Family Caregiver and the Care Recipient [Срок оценки: 6 months]
• Dispositional Mindfulness in the Family Caregiver [Срок оценки: 6 months]
• Physiological Stress in the Family Caregiver [Срок оценки: 6 months]
• Work Productivity and Activity Impairment in the Family Caregivers [Срок оценки: 6 months]
• Neuropsychiatric Syndromes in the Care Recipient [Срок оценки: 6 months]
• Feasibility of Eligibility and Enrollment [Срок оценки: 8 weeks]
• Feasibility of Attendance Rate [Срок оценки: 8 weeks]
• Feasibility of Engagement to Self-Practice [Срок оценки: 6 months]
• Feasibility of Retention Rate [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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

Идентификаторы

NCT: NCT06880822 · HSEARS20240722001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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