【ChiCTR2100049074】The effects of an integrated mindfulness-based Tai Chi Chuan program on sleep disturbance among community-dwelling elderly people: A randomized controlled trial

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基本信息

登记号

ChiCTR2100049074

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2021-07-20

临床申请受理号

靶点

适应症

Older people with sleep disturbance

试验通俗题目

The effects of an integrated mindfulness-based Tai Chi Chuan program on sleep disturbance among community-dwelling elderly people: A randomized controlled trial

试验专业题目

The effects of an integrated mindfulness-based Tai Chi Chuan program on sleep disturbance among community-dwelling elderly people: A randomized controlled trial

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临床试验信息

试验目的

1. To evaluate the effects of an integrated mindfulness-based Tai Chi Chuan (MBTCC) program on the improvement of insomnia and other secondary outcomes over a 12-month follow-up period, by comparing it to a sleep hygiene education (SHE) control group among community dwelling elderly individuals experiencing sleep disturbances. 2. To explore the mediating roles of rumination, arousal level, psychological and physical function as mechanisms underlying the beneficial effects of the MBTCC group on insomnia severity. 3. To identify and understand the therapeutic ingredients and conditions that contribute to the beneficial effects of the intervention through a qualitative evaluation.

试验分类

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试验类型

随机平行对照

试验分期

探索性研究/预试验

随机化

After the initial baseline assessment, participants will be randomly assigned to one of the study arms using a list of computer-generated random numbers. The generation of random numbers and their assignment will be performed by a statistician who is unaware of the study aims.

盲法

Not stated

试验项目经费来源

Health and Medical Research Fund

试验范围

目标入组人数

107

实际入组人数

第一例入组时间

2021-07-01

试验终止时间

2024-06-30

是否属于一致性

入选标准

(1) aged 60 years or above; (2) classified as experiencing sleep disturbances (indication of poor sleep quality through a score >5 in the Pittsburgh Sleep Quality Index); (3) primary education level or above and able to communicate in Cantonese; (4) able to give informed consent; (5) no previous experience with meditation or other mind-body techniques (e.g., tai chi or yoga).；

排除标准

People with a comorbid diagnosis of schizophrenia, schizoaffective disorder, substance misuse, organic brain syndrome, or intellectual disability will be excluded.；

研究者信息

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试验机构

The Hong Kong Polytechnic University

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