跳至主要内容
临床试验/NCT06346223
NCT06346223尚未招募不适用

Effect of a Single-Session Mindfulness-Based Intervention for Reducing Stress in Family Caregivers of People With Dementia: A Randomized Controlled Trial

The Hong Kong Polytechnic University0 个研究点目标入组 160 人开始时间: 2024年8月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
160
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 investigate the efficiency of a single-session mindfulness-based intervention for reducing stress and promoting psychological health in family caregivers of people with dementia. The single-session mindfulness intervention includes one 90-minute group-based session containing different mindfulness practices, psychoeducation and group sharing activities in the single-session mindfulness intervention. A self-practice tool kit with the teaching materials (e.g., recording of guided mindfulness activities) will be provided to the participants for home practice 20 minutes daily through an online platform and the participants will be told to develop the practice as a daily habit.

Participants will be randomly assigned to receive either the mindfulness intervention combined with psychoeducation or psychoeducation alone. Evaluations will be conducted at baseline (0 weeks), immediately post-intervention (8 weeks), and during a follow-up assessment (6 months). Both groups will complete the same assessments at the same time-points.

详细描述

The majority of people with dementia receive care from their family members, who assist them with daily activities and managing behavioral problems associated with the illness, such as wandering and agitation. The demanding nature of caregiving tasks, coupled with unpredictable symptoms related to the illness and limited time for other social activities, often leads to high levels of stress among caregivers. By increasing the caregivers' self-awareness in the present moment through the practice of mindfulness, the caregivers tend to step outside their negative experiences and thoughts through a process of decentering, leading to stress reduction. However, considering the growing number of caregivers for people with dementia, there may be insufficient resources to implement intensive mindfulness-based interventions with lengthy durations because most family caregivers are heavily engaged in various caregiving tasks, making a single-session mindfulness-based intervention more suitable for this population compared to a traditional mindfulness program. Although a few pilot studies have demonstrated some preliminary effects of single-session mindfulness-based interventions on promoting mental health, none of these studies focused on family caregivers of individuals with dementia but rather adolescents or adults in general. Further research is necessary to explore the effects of single-session mindfulness-based interventions on reducing stress among family caregivers of individuals with dementia, who experience chronic caregiving stress. Therefore, this study aims to investigate the effectiveness of a single-session mindfulness-based intervention in reducing stress among family caregivers of people with dementia. Additionally, the study will examine other secondary outcomes, such as the impact on the dyadic relationship between caregivers and care-recipients, as well as behavioral and psychological symptoms of dementia.

The target population for this study will be community-dwelling family caregivers of people with dementia. They will be recruited from five elderly centers through the collaboration of two local non-governmental organizations. Interested participants will be assessed for eligibility. After interested and eligible participants provide their consent, they will be randomly assigned to receive either the mindfulness intervention combined with psychoeducation or psychoeducation alone.

The single-session mindfulness intervention includes one 90-minute group-based session containing different mindfulness practices, psychoeducation and group sharing activities in the single-session mindfulness intervention. A self-practice tool kit with the teaching materials (e.g., recording of guided mindfulness activities) will be provided to the participants for home practice 20 minutes daily through an online platform and the participants will be told to develop the practice as a daily habit.

The control group will receive brief education on dementia with the same group size and of the same duration (90-minutes) as the sessions in the intervention arm. The nurse will deliver brief education (15 minutes) on dementia in the session, followed by group sharing and discussion on their daily caregiving experience. The caregivers in the control group will be provided with a toolkit with education materials about the common health problems of older adults and also be given access to a social media platform in which they can communicate and share their caregiving experiences with classmates.

The outcome measures assessed include perceived caregiving stress (primary), depressive symptoms, positive aspect of caregiving, dyadic relationship, trait mindfulness, neuropsychiatric symptoms. Feasibility measures include eligibility and enrollment, attendance rate, adherence to self-practice, and retention rate. Evaluations will be conducted at baseline (0 weeks), immediately post-intervention (8 weeks), and during a follow-up assessment (6 months). Both groups will complete the same assessments at the same time-points.

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 (Participant)

入排标准

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

入选标准

  • aged 18 or above;
  • family caregivers of an individual who has been residing in the community with a confirmed medical diagnosis of any type of dementia (from NGO record or the care-recipients' medical record);
  • have been providing care for at least 3 months prior to recruitment with the daily contact of at least 4 hours or more;
  • screened positive for caregivers' stress (a summed score of ≥ 25 as measured by the Caregiver Burden Inventory).

排除标准

  • have participated in any structured mind-body intervention, or structured psychosocial intervention 6 months prior to recruitment;
  • have acute psychiatric condition that are potentially life-threatening or would limit the caregivers' participation in the study (an answer of "yes" to any of the six questions of Columbia Suicide Severity Rating Scale).

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 Adherence to Self-Practice(6 months)
  • Feasibility of Retention Rate(6 months)
  • Depressive Symptoms in the Family Caregiver(6 months)
  • Feasibility of Eligibility and Enrollment(8 weeks)
  • Positive Aspect of Caregiving in the Family Caregiver(6 months)
  • Trait Mindfulness in the Family Caregiver(6 months)
  • Dyadic Relationship Between the Family Caregiver and the Care Recipient(6 months)
  • Neuropsychiatric Syndromes in the Care Recipient(6 months)
  • Feasibility of Attendance Rate(8 weeks)

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

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