【ChiCTR2600116305】靜觀課程對有慢性壓力的長者的微生物群成效研究: 隨機對照試驗

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基本信息

登记号

ChiCTR2600116305

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

2026-01-08

临床申请受理号

靶点

适应症

Chronic stress

试验通俗题目

靜觀課程對有慢性壓力的長者的微生物群成效研究: 隨機對照試驗

试验专业题目

靜觀課程對有慢性壓力的長者的微生物群成效研究: 隨機對照試驗

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

联系人通讯地址

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临床试验信息

试验目的

Project Objectives (a maximum of 800 words in total for the project objectives) [Please list the objectives in point form] 1. To evaluate the efficacy of mindfulness-based training in enhancing gut microbiome diversity and beneficial bacteria in older adults with chronic stress. 2. To explore whether gut microbiota differences between MBOA and HEC are mediated by changes in mindfulness levels and moderated by perceived stress, depressive and anxiety symptoms, diet, sleep, and loneliness. Key issues and/or problems being addressed: Previous studies have shown that chronic stress is an important factor affecting gut microbiota composition and diversity, especially in older adults. Therefore, interventions designed to enhance the gut microbiota is most needed in older adults experiencing chronic stress. Mindfulness-based intervention is one of the candidates. Based on past studies, mindfulness-based interventions can effectively treat common mental health problems, including depression, chronic stress, and anxiety. However, there is limited evidence on its efficacy in enhancing gut microbiota and no randomized controlled studies have explored how it affects gut microbiota when compared to an active control. Therefore, this randomized control trial is designed to provide direct evidence for the impact of mindfulness-based interventions on gut microbiota in older adults. In addition, the moderating effects of perceived stress, depressive and anxiety symptoms, diet, sleep and loneliness will be explored, which will provide insight for the clinical application of mindfulness-based intervention.

试验分类

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试验类型

随机平行对照

试验分期

其它

随机化

Stratified randomisation will be conducted based on age (5-year range) to achieve demographic balance between the two arms. An experienced independent statistician will generate the randomisation sequence using computer-generated random numbers.

盲法

The research staff member who conducts the assessments or statistical analyses will be blinded to the group assignments.

试验项目经费来源

General Research Fund

试验范围

目标入组人数

实际入组人数

第一例入组时间

2026-01-01

试验终止时间

2027-12-31

是否属于一致性

入选标准

1. aged 60 or above; 2. being a Cantonese speaker; 3. having long-term care-giving responsibility for a first-degree relative with chronic condition; 4. scoring seven or above in the Caregiver Strain Index (CSI); 5. having no self-reported doctor’s diagnosis of psychiatric illnesses or impaired cognitive status.；

排除标准

1. having physical illness with moderate to-severe disability or mental illness (e.g., suicidal ideation, schizophrenia, psychosis) affecting his/her group enrolment; 2. under treatment for serious mental disorders or uncontrolled mood disorders; 3. participation in a structured mindfulness-based training program in the previous 2 years; 4. care recipients who had passed away before the study; 5. any use of antibiotics or probiotics in the past 6 months.；

研究者信息

研究负责人姓名

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试验机构

香港中文大學賽馬會公共衛生及基層醫療學院

研究负责人电话

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研究负责人邮编

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