跳至主要内容
临床试验/NCT04861610
NCT04861610招募中不适用

Mindfulness-Based Intervention for Caregivers of Frail Older Chinese Adults: Testing an Intergenerational Caregiving Model

The Hong Kong Polytechnic University2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2021年5月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
240
试验地点
2
主要终点
Depression

研究概览

简要总结

This is study to investigate the effects of a brief mindfulness-based program for frail older adults caregivers.

详细描述

The proposed study is a multi-site, three-arm randomized controlled trial of a mindfulness-based intervention for Chinese family caregivers in Hong Kong. Effects of the intervention will be compared with those of an evidence-based psychoeducation program, and treatment-as-usual. 240 caregivers of frail elderly with moderate to severe levels of frailty, will be recruited and randomly assigned to mindfulness-based intervention, psychoeducation, and treatment-as-usual experimental conditions. Overall program effectiveness will be analyzed on measures of caregiver burden, depression, anxiety, positive caregiving experience, spirituality, family conflict, and the biomarker of heart rate variability. Measures on coping styles, experiential avoidance, and self-efficacy will be explored to see if they mediate the changes to participant improvements in outcomes. 6-month follow-up will be included to investigate the maintenance effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Caregivers of frail elderly based on a professional's assessment of Clinical Frailty Scale with a score of 6, indicating a moderate level of frailty or above (Rockwood et al., 2005)
  • Caregivers being adult children or children in-law of the elder care receiver
  • Caregivers who are experiencing caregiver burden at the time of study, with scores of 8 or above in Zarit Burden Interview-4

排除标准

  • impairment, which may present difficulties in comprehending the content of the program
  • Spouses, siblings, or friends will be excluded
  • Caregivers of elders with moderate to severe dementia will be excluded and the Clinical Dementia Rating Scale will be administered
  • Caregivers who had participated in an eight week Mindfulness-Based Stress Reduction or equivalent

结局指标

主要结局

Depression

时间窗: Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up

assessed by a self-reported measure The Center for Epidemiologic Studies Depression Scale, 10 items, sum of scores from 0 to 30, the higher the score, the more severe in the depression symptoms

次要结局

  • Caregiver burden(Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up.)
  • Spiritual well-being(Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up.)
  • Anxiety(Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up)
  • family conflicts(Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up)
  • Heart rate variability(Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up.)
  • Coping styles(Change from pre-intervention, to 1-month follow-up, and to 6-month follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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