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【ChiCTR2200061862】Pilot study on the effect of mindfulness on the changes in loneliness and psychological outcomes and their association with changes in microbiota and inflammatory markers

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基本信息

登记号

ChiCTR2200061862

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

2022-07-05

临床申请受理号

靶点

适应症

Loneliness

试验通俗题目

Pilot study on the effect of mindfulness on the changes in loneliness and psychological outcomes and their association with changes in microbiota and inflammatory markers

试验专业题目

Pilot study on the effect of mindfulness on the changes in loneliness and psychological outcomes and their association with changes in microbiota and inflammatory markers

申办单位信息

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申请人名称

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联系人邮编

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临床试验信息

试验目的

To examine whether the changes in loneliness and psychological outcomes are associated with changes in microbiota and inflammatory markers.

试验分类

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试验类型

病例对照研究

试验分期

其它

随机化

The randomisation will be conducted by an experienced independent statistician using computer generated random results, which will be kept in sealed, opaque envelopes by a research assistant who is not involved in the study. One research assistant will screen potential participants for eligibility through telephone.

盲法

Not stated

试验项目经费来源

The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong

试验范围

目标入组人数

实际入组人数

第一例入组时间

2022-06-17

试验终止时间

2025-06-27

是否属于一致性

入选标准

1. Adults aged 60 years and above; 2. Normal cognitive functioning such that they can understand the materials delivered in mindfulness training and can complete home practice each week; 3. Must have been on a stable dosage of psychiatric medications for at least three months because it can interfere with loneliness measurement, and 4. Have a validated Chinese six-item De Jong Gierveld Loneliness Scale >= score 3, suggesting loneliness.；

排除标准

1. Inability to communicate and understand Chinese, as the intervention will be conducted in Chinese; 2. Possession of a medical or mental health condition rendering him/her incapable of participating in the study; 3. Previous participation in mindfulness-based training.；

研究者信息

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试验机构

N/A

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