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临床试验/NCT07714681
NCT07714681已完成不适用

Developing and Testing a Brief Mindfulness Just-in-time Adaptive Intervention for Reducing Stress of Dementia Caregivers

Education University of Hong Kong1 个研究点 分布在 1 个国家目标入组 195 人开始时间: 2024年11月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
195
试验地点
1
主要终点
Perceived Stress

研究概览

简要总结

  1. To determine an effective decision rule for delivering brief mindfulness prompts as a function of caregivers' real-time stress state, including whether prompt delivery affects subsequent stress and affect and whether this effect varies by stress state at the decision point.
  2. To determine an effective JITAI decision rule to deliver a brief mindfulness intervention depending the current state of stress of caregivers and to examine if the adaptive model of machine learning algorithm generate higher receptivity of the brief intervention than the static and control model at the end of the four weeks.
  3. To evaluate the feasibility, acceptability, and preliminary effects of the brief mindfulness just-in-time adaptive intervention on perceived stress and related caregiver outcomes.

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
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

入选标准

  • family dementia caregivers aged 18 above
  • family caregiver of an individual with a confirmed medical diagnosis of any type of dementia who has been residing in the community
  • having been providing care for ADLs and IADLs for at least 20 hours per week for at least one year prior to recruitment
  • have a smartphone
  • have moderate to high stress

排除标准

  • Having participated in any structured mind-body intervention, cognitive therapy, or structured psychosocial intervention in the 6 months prior to recruitment
  • Having acute psychiatric and medical comorbidities that are potentially life-threatening (e.g. suicidal ideation) or that limit the caregivers participation or adherence (e.g. acute psychosis).

结局指标

主要结局

Perceived Stress

时间窗: baseline and immediately after intervention

14-item perceived stress scale. Items are rated on a 5-point Likert scale, ranging from 0-56,with higher scores indicating greater perceived stress.

次要结局

  • Depressive Symptoms(baseline and immediately after intervention)
  • caregiving burden(baseline and immediately after intervention)
  • Positive Aspect of Caregiving(baseline and immediately after intervention)
  • sleep quality(baseline and immediately after intervention)
  • quality of life(baseline and immediately after intervention)
  • Mindfulness(baseline and immediately after intervention)

研究者

发起方
Education University of Hong Kong
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chou Kee Lee

Chair Professor of Social Policy

Education University of Hong Kong

研究点 (1)

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