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临床试验/NCT06095037
NCT06095037尚未招募不适用

Examining the Effectiveness of Mindful Yoga in Enhancing Psychological Well-being Among Older Adults Discharged From Hospital and Their Caregivers: A Cluster Randomized Controlled Trial

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 668 人开始时间: 2025年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
668
试验地点
1
主要终点
The Depression, Anxiety, and Stress Scale

研究概览

简要总结

This study will adopt the intervention of mindful yoga to improve the psychological well-being of older adults who discharged from hospital and their caregivers in Hong Kong.

详细描述

In the proposed study, the investigators will conduct a fully powered, double-blind, and multicentered randomized controlled trial (RCT) of the efficacy of mindful yoga versus a psychoeducation control. The study sample will consist of older adults discharged from hospitals within the previous 3 months and their informal caregivers. The investigators will aim to determine: (1) the efficacy of mindful yoga in the study group versus the control group in improving the dyadic psychological well-being (as measured by depression, anxiety, stress, and meaning of life) of older adult-caregiver dyads (e.g., both actor and partner effects); (2) whether these improvements were maintained after 3 and 6 months; and (3) the lived experiences of older adults and their caregivers. The investigators hypothesize that: (1) mindful yoga will be more efficacious in improving outcomes compared with the control condition; (2) there will be both actor and partner effects of the intervention on the primary and secondary outcomes; and (3) these outcome improvements will be maintained at 3 and 6 months.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Older adults discharged from hospital
  • older adults aged 65 years or above;
  • individuals who have been discharged from a local hospital within the previous 3 months who qualify for the Pilot Scheme on Support for Elderly Persons Discharged from Public Hospitals after Treatment and are receiving services from community support services;
  • individuals with no mobility issues or who have limited mobility but can access the intervention sites using a wheelchair and are capable of practicing mindful yoga, even if in a wheelchair; and
  • individuals who can understand Cantonese.
  • Caregivers:
  • living with older adults during the transition period from hospital to home.

排除标准

  • Older adults discharged from hospital
  • older adults diagnosed with depression, anxiety, or stress disorders by certified doctors;
  • older adults diagnosed with severe dementia;
  • homebound older adults who face difficulty attending the intervention sites; and
  • older adults having a tech-enabled Hospital Admission Risk Reduction Program for the Elderly (HARRPE) score <0.17 or >0.
  • Caregivers:
  • Family caregivers who have been diagnosed with severe mental health issues will be excluded from the proposed study.

结局指标

主要结局

The Depression, Anxiety, and Stress Scale

时间窗: Through study completion, an average of 12 weeks

The total score ranges from 0 to 63. Higher score indicates higher level of depression, anxiety and stress

次要结局

  • The meaning in life scale(6 months follow-up)
  • The Depression, Anxiety, and Stress Scale(6 months follow-up)
  • Five Facet Mindfulness Questionnaire(6 months follow-up)

研究者

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

Xiaochen Zhou

Research Assistant Professor

The University of Hong Kong

研究点 (1)

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