ChiCTR2600116305 版本V1.0 版本创建时间2026/01/08 09:23:46 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2600116305 

最近更新日期：

Date of Last Refreshed on：

 2026-01-08 09:23:24 

注册时间：

Date of Registration：

 2026-01-08 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

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

Public title：

Effects of mindfulness-based training on the microbiome of older adults with chronic stress: A randomised controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

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

Scientific title：

Effects of mindfulness-based training on the microbiome of older adults with chronic stress: A randomised controlled trial

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

NGAI CHUN HO 

研究负责人：

黃仰山 

Applicant：

NGAI CHUN HO 

Study leader：

Wong Yeung Shan, Samuel 

申请注册联系人电话：

Applicant telephone：

 +852 2252 8463

研究负责人电话：

Study leader's
telephone：

+852 2252 8463

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 alfonsengai@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 yeungshanwong@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

香港新界沙田威爾斯親王醫院香港中文大學賽馬會公共衛生及基層醫療學院426室

研究负责人通讯地址：

香港新界沙田威爾斯親王醫院香港中文大學賽馬會公共衛生及基層醫療學院426室

Applicant address：

Rm 426, JC School of Public Health and Primary Care, Prince of Wales Hospital, N.T, H.K, 32 Ngan Shing St, Sha Tin, Hong Kong

Study leader's address：

Rm 426, JC School of Public Health and Primary Care, Prince of Wales Hospital, N.T, H.K, 32 Ngan Shing St, Sha Tin, Hong Kong

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

香港中文大學賽馬會公共衛生及基層醫療學院

Applicant's institution：

JC School of Public Health and Primary Care, CUHK

研究负责人所在单位：

香港中文大學賽馬會公共衛生及基層醫療學院

Affiliation of the Leader：

JC School of Public Health and Primary Care, CUHK

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2025.091

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

香港中文大學 – 新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

The Joint CUHK-NTEC CREC

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-03-26 00:00:00

伦理委员会联系人：

Envy Lee

Contact Name of the ethic committee：

Envy Lee

伦理委员会联系地址：

香港沙田威爾斯親王醫院呂志和臨床醫學大樓8樓 香港中文大學 – 新界東醫院聯網臨床研究倫理 聯席委員會

Contact Address of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee 8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital Shatin, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3505 3935

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

香港中文大學賽馬會公共衛生及基層醫療學院

Primary sponsor：

JC School of Public Health and Primary Care, CUHK

研究实施负责（组长）单位地址：

香港新界沙田威爾斯親王醫院香港中文大學賽馬會公共衛生及基層醫療學院

Primary sponsor's address：

JC School of Public Health and Primary Care, Prince of Wales Hospital, N.T, H.K, 32 Ngan Shing St, Sha Tin, Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

University Grants Committee

具体地址：

7/F., Shui On Centre, 6-8 Harbour Road, Wanchai, Hong Kong SAR, People's Republic of China.

Institution
hospital：

University Grants Committee

Address：

7/F., Shui On Centre, 6-8 Harbour Road, Wanchai, Hong Kong SAR, People's Republic of China.

经费或物资来源：

General Research Fund

Source(s) of funding：

General Research Fund

研究疾病：

Chronic stress  

Target disease：

Chronic stress

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

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.  

Objectives of Study：

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.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

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.

Inclusion criteria

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.

Exclusion criteria：

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.

研究实施时间：

Study execute time：

从 From 2026-01-01 00:00:00至 To 2027-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-01-15 00:00:00 至 To 2027-12-31 00:00:00

干预措施：

Interventions：

组别：

Mindfulness-based intervention for older adults

样本量：

 69

Group：

Mindfulness-based intervention for older adults

Sample size：

干预措施：

8-week Mindfulness-based intervention for older adults

干预措施代码：

Intervention：

8-week Mindfulness-based intervention for older adults

Intervention code：

组别：

Health Education Control

样本量：

 69

Group：

Health Education Control

Sample size：

干预措施：

Psychoeducation program aiming to provide health-related education

干预措施代码：

Intervention：

Psychoeducation program aiming to provide health-related education

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 New Territories East Cluster 

单位级别：

 General Outpatient Clinics (GOPCs) and Family Medicine 

Institution
hospital：

New Territories East Cluster

Level of the institution：

General Outpatient Clinics (GOPCs) and Family Medicine

测量指标：

Outcomes：

指标中文名：

Changes in gut microbiome

指标类型：

主要指标

Outcome：

Changes in gut microbiome

Type：

Primary indicator

测量时间点：

测量方法：

alpha and beta diversity indices (e.g., Chao1 and Shannon) of the gut microbiome, taxonomic abundances, and functional pathways, especially gut-brain modules

Measure time point of outcome：

Measure method：

alpha and beta diversity indices (e.g., Chao1 and Shannon) of the gut microbiome, taxonomic abundances, and functional pathways, especially gut-brain modules

指标中文名：

gut microbiome biomarkers for responders or non-responders to the intervention

指标类型：

次要指标

Outcome：

gut microbiome biomarkers for responders or non-responders to the intervention

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Mindfulness levels

指标类型：

附加指标

Outcome：

Mindfulness levels

Type：

Additional indicator

测量时间点：

测量方法：

FFMQ

Measure time point of outcome：

Measure method：

FFMQ

指标中文名：

Depressive symptoms

指标类型：

附加指标

Outcome：

Depressive symptoms

Type：

Additional indicator

测量时间点：

测量方法：

Geriatric Depression Scale-Short Form (GDS-15)

Measure time point of outcome：

Measure method：

Geriatric Depression Scale-Short Form (GDS-15)

指标中文名：

Anxiety symptoms

指标类型：

附加指标

Outcome：

Anxiety symptoms

Type：

Additional indicator

测量时间点：

测量方法：

Chinese version of the State-Trait Anxiety Inventory (STAI)

Measure time point of outcome：

Measure method：

Chinese version of the State-Trait Anxiety Inventory (STAI)

指标中文名：

Stress

指标类型：

附加指标

Outcome：

Stress

Type：

Additional indicator

测量时间点：

测量方法：

Chinese version Global Measure of PSS

Measure time point of outcome：

Measure method：

Chinese version Global Measure of PSS

指标中文名：

Sleep

指标类型：

附加指标

Outcome：

Sleep

Type：

Additional indicator

测量时间点：

测量方法：

Insomnia Severity Index

Measure time point of outcome：

Measure method：

Insomnia Severity Index

指标中文名：

Loneliness

指标类型：

附加指标

Outcome：

Loneliness

Type：

Additional indicator

测量时间点：

测量方法：

Chinese six-item De Jong Gierveld Loneliness Scale

Measure time point of outcome：

Measure method：

Chinese six-item De Jong Gierveld Loneliness Scale

指标中文名：

Dietary questionnaire

指标类型：

附加指标

Outcome：

Dietary questionnaire

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Social support

指标类型：

附加指标

Outcome：

Social support

Type：

Additional indicator

测量时间点：

测量方法：

Multidimensional Scale of Perceived Social Support (MSPSS)

Measure time point of outcome：

Measure method：

Multidimensional Scale of Perceived Social Support (MSPSS)

指标中文名：

Physical activity

指标类型：

附加指标

Outcome：

Physical activity

Type：

Additional indicator

测量时间点：

测量方法：

Physical Activity Scale for the Elderly (PASE)

Measure time point of outcome：

Measure method：

Physical Activity Scale for the Elderly (PASE)

指标中文名：

Body Mass Index

指标类型：

附加指标

Outcome：

Body Mass Index

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Stool

组织：

Stool

Sample Name：

Stool

Tissue：

Stool

人体标本去向

 使用后销毁  

说明

Participants will receive a self-collection faecal package along with instructional materials and a video guide. Stool samples will be collected and transferred to the laboratory for further processing.

Fate of sample：

Destruction after use  

Note：

Participants will receive a self-collection faecal package along with instructional materials and a video guide. Stool samples will be collected and transferred to the laboratory for further processing.

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 60 岁 years
最大 Max age 100 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

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.

Randomization Procedure (please state who generates the random number sequence and by what method)：

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.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

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

Blinding：

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

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

Available upon request after trial completion

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Available upon request after trial completion

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

NA

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

NA

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-01-08 09:23:24