跳至主要内容
临床试验/NCT06880822
NCT06880822尚未招募不适用

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

The Hong Kong Polytechnic University0 个研究点目标入组 189 人开始时间: 2025年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
189
主要终点
Perceived Caregiving Stress in the Family Caregiver

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • •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).

研究组 & 干预措施

Traditional Mindfulness Program (Without the Closed-Loop Approach)

Active Comparator

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

Closed-Loop and Neuroplasticity-Based Mindfulness Program

Experimental

干预措施: Closed-Loop and Neuroplasticity-Based Mindfulness Program (Behavioral)

Psychoeducation

Active Comparator

干预措施: Psychoeducation (Behavioral)

结局指标

主要结局

Perceived Caregiving Stress in the Family Caregiver

时间窗: 6 months

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.

次要结局

  • Feasibility of Retention Rate(6 months)
  • 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)
  • Physiological Stress in the Family Caregiver(6 months)
  • Work Productivity and Activity Impairment in the Family Caregivers(6 months)
  • Neuropsychiatric Syndromes in the Care Recipient(6 months)
  • Feasibility of Eligibility and Enrollment(8 weeks)
  • Feasibility of Attendance Rate(8 weeks)
  • Feasibility of Engagement to Self-Practice(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Patrick KOR Pui Kin

Assistant Professor

The Hong Kong Polytechnic University

相似试验

Closed-Loop and Neuroplasticity-Based Mindfulness... | 临床试验