The Effects of an Integrated Mindfulness-based Tai Chi Chuan Program on Sleep Disturbance Among Community-dwelling Elderly People: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- the Insomnia Severity Index
研究概览
简要总结
The trial aims to evaluate the effects of an integrated form of mindfulness-based Tai Chi Chuan (MBTCC) program and the underlying mechanisms of the beneficial effects on sleep disturbance over 12-month follow-up in community-dwelling elderly people.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 60 years or above;
- •Classified as experiencing sleep disturbances (indication of poor sleep quality through a score >5 in the Pittsburgh Sleep Quality Index);
- •Primary education level or above and able to communicate in Cantonese;
- •Able to give informed consent; and
- •No previous experience with meditation or other mind-body techniques (e.g., tai chi or yoga).
排除标准
- •Comorbid diagnoses of schizophrenia, schizoaffective disorder, substance misuse, organic brain syndrome, or intellectual disabilities.
研究组 & 干预措施
Integrated mindfulness-based Tai Chi Chuan
MBTCC
干预措施: Integrated mindfulness-based Tai Chi Chuan (Behavioral)
Mindfulness-based intervention
MBI
干预措施: Mindfulness-based intervention (Behavioral)
Tai Chi Chuan
TCC
干预措施: Tai Chi Chuan (Behavioral)
Sleep Hygiene Education
SHE
干预措施: Sleep Hygiene Education (Behavioral)
结局指标
主要结局
the Insomnia Severity Index
时间窗: one year after T2 (T4)
This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.
the Insomnia Severity Index
时间窗: at baseline (T1)
This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.
the Insomnia Severity Index
时间窗: In the 8th week from baseline (T2)
This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.
the Insomnia Severity Index
时间窗: six months after T2 (T3)
This is a seven-item self-report questionnaire. A higher score represents greater insomnia severity.
次要结局
- Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)(one year after T2 (T4))
- the Multidimensional Assessment of Interoceptive Awareness scale(one year after T2 (T4))
- the Multidimensional Assessment of Interoceptive Awareness scale(at baseline (T1))
- the Multidimensional Assessment of Interoceptive Awareness scale(In the 8th week from baseline (T2))
- the Multidimensional Assessment of Interoceptive Awareness scale(six months after T2 (T3))
- Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)(at baseline (T1))
- Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)(In the 8th week from baseline (T2))
- Wrist ActiGraph GT9X (ActiGraph, Pensacola, USA)(six months after T2 (T3))