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Evaluation of the Effectiveness of Mindfulness Practice held in the CUHK Thomas Jing Center for Mindfulness Research and Training
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注册号：

Registration number：

 ChiCTR2000029118 

最近更新日期：

Date of Last Refreshed on：

 2020-01-14 17:50:41 

注册时间：

Date of Registration：

 2020-01-14 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Evaluation of the Effectiveness of Mindfulness Practice held in the CUHK Thomas Jing Center for Mindfulness Research and Training

Public title：

Evaluation of the Effectiveness of Mindfulness Practice held in the CUHK Thomas Jing Center for Mindfulness Research and Training

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Evaluation of the Effectiveness of Mindfulness Practice held in the CUHK Thomas Jing Center for Mindfulness Research and Training

Scientific title：

Evaluation of the Effectiveness of Mindfulness Practice held in the CUHK Thomas Jing Center for Mindfulness Research and Training

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：

Qi Wang 

研究负责人：

Prof. Samuel Wong 

Applicant：

Qi Wang 

Study leader：

Prof. Samuel Wong 

申请注册联系人电话：

Applicant telephone：

 +852 22528764

研究负责人电话：

Study leader's
telephone：

+852 22528753

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：

 vickyqiwang@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)：

 https://www.cuhkcmrt.cuhk.edu.hk/en-gb

申请注册联系人通讯地址：

4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T., Hong Kong, China

研究负责人通讯地址：

R409, 4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T., Hong Kong, China

Applicant address：

4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T., Hong Kong, China

Study leader's address：

R409, 4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T., Hong Kong, China

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

Applicant's institution：

Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學

Affiliation of the Leader：

Chinese University of Hong Kong

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：

 SBRE-19-203

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：

Survey and Behavioural Research Ethics Committee

Name of the ethic committee：

Survey and Behavioural Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-12-27 00:00:00

伦理委员会联系人：

Secretary

Contact Name of the ethic committee：

Secretary

伦理委员会联系地址：

Room 301, Pi Ch'iu Building, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong, China

Contact Address of the ethic committee：

Room 301, Pi Ch'iu Building, The Chinese University of Hong Kong, Shatin, New Territories, Hong Kong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 39434209

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 fssc02@eservices.cuhk.edu.hk

研究实施负责（组长）单位：

N/A

Primary sponsor：

N/A

研究实施负责（组长）单位地址：

N/A

Primary sponsor's address：

N/A

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中國

省(直辖市)：

香港特別行政區

市(区县)：

Country：

China

Province：

Hong Kong Special Administrative Region

City：

单位(医院)：

香港中文大學

具体地址：

4/F, Jockey Club School of Public Health, Prince of Wales Hospital

Institution
hospital：

Chinese University of Hong Kong

Address：

4/F, Jockey Club School of Public Health, Prince of Wales Hospital

经费或物资来源：

Self-funded

Source(s) of funding：

Self-funded

研究疾病：

Mental Health  

Target disease：

Mental Health

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

The aim of the study is to measure and evaluate the effectiveness of the mindfulness practice groups that will be held in the center and see if there will be any significant change in the outcome measures.  

Objectives of Study：

The aim of the study is to measure and evaluate the effectiveness of the mindfulness practice groups that will be held in the center and see if there will be any significant change in the outcome measures.

药物成份或治疗方案详述：

Mindfulness-based intervention groups, such as Mindfulness-based Stress Reduction (MBSR; Kabat-Zinn, 2005), and Mindfulness-based Cognitive Therapy (MBCT; Segal, Williams, & Teasdale, 2002) have been proved to be effective on a variety of health outcomes (Gotink et al., 2015), such as reducing psychological disorders, including stress, depression, anxiety, coping with illness and pain (Khoury et al., 2013), and increasing positive moods and compassion for self and others (Khoury, Sharma, Rush, & Fournier, 2015), as well as enhancing attention, focus, and memory (Chiesa, Calati, & Serretti, 2011). With these benefits that contribute to individuals' psychological well-being, this study tries to conduct a large scale study to examine people's improvement in mental health after participating in mindfulness based interventions. This study aims at evaluating the effectiveness of mindfulness practice groups that will be held in the CUHK Thomas Jing Center for Mindfulness Research and Training, by analyzing individuals' pre-test and post-test ratings on the scales of measuring individuals self-report of general psychological well-being, depression, and anxiety. The center will only provide the venue for other NGOs' to do their own mindfulness related intervention and the center will not involve in any direct mindfulness interventions or groups. After the participants come to the CUHK Thomas Jing Center for Mindfulness Research and Training and before the start of their mindfulness sessions, surveys with questionnaires of mental health will be provided to participants. After participants finished mindfulness sessions, surveys with questions of mental health will be provided to participants again for evaluating the effectiveness of mindfulness in improving psychological well-being.  

Description for medicine or protocol of treatment in detail：

Mindfulness-based intervention groups, such as Mindfulness-based Stress Reduction (MBSR; Kabat-Zinn, 2005), and Mindfulness-based Cognitive Therapy (MBCT; Segal, Williams, & Teasdale, 2002) have been proved to be effective on a variety of health outcomes (Gotink et al., 2015), such as reducing psychological disorders, including stress, depression, anxiety, coping with illness and pain (Khoury et al., 2013), and increasing positive moods and compassion for self and others (Khoury, Sharma, Rush, & Fournier, 2015), as well as enhancing attention, focus, and memory (Chiesa, Calati, & Serretti, 2011). With these benefits that contribute to individuals' psychological well-being, this study tries to conduct a large scale study to examine people's improvement in mental health after participating in mindfulness based interventions. This study aims at evaluating the effectiveness of mindfulness practice groups that will be held in the CUHK Thomas Jing Center for Mindfulness Research and Training, by analyzing individuals' pre-test and post-test ratings on the scales of measuring individuals self-report of general psychological well-being, depression, and anxiety. The center will only provide the venue for other NGOs' to do their own mindfulness related intervention and the center will not involve in any direct mindfulness interventions or groups. After the participants come to the CUHK Thomas Jing Center for Mindfulness Research and Training and before the start of their mindfulness sessions, surveys with questionnaires of mental health will be provided to participants. After participants finished mindfulness sessions, surveys with questions of mental health will be provided to participants again for evaluating the effectiveness of mindfulness in improving psychological well-being.  

纳入标准：

Inclusion criteria

排除标准：

People who are in a critical period and have difficulty in filling the questionnaire will be excluded from the study.

Exclusion criteria：

People who are in a critical period and have difficulty in filling the questionnaire will be excluded from the study.

研究实施时间：

Study execute time：

从 From 2020-02-01 00:00:00至 To 2030-01-08 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-02-01 00:00:00 至 To 2030-01-08 00:00:00

干预措施：

Interventions：

组别：

Case series

样本量：

 3000

Group：

Case series

Sample size：

干预措施：

Mindfulness based intervention

干预措施代码：

Intervention：

Mindfulness based intervention

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 香港中文大學 

单位级别：

 大學 

Institution
hospital：

Chinese University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Mental health

指标类型：

主要指标

Outcome：

Mental health

Type：

Primary indicator

测量时间点：

测量方法：

Questionnaire WHO-5

Measure time point of outcome：

Measure method：

Questionnaire WHO-5

指标中文名：

Depression

指标类型：

主要指标

Outcome：

Depression

Type：

Primary indicator

测量时间点：

测量方法：

Questionnaire PHQ-9

Measure time point of outcome：

Measure method：

Questionnaire PHQ-9

指标中文名：

Anxiety

指标类型：

主要指标

Outcome：

Anxiety

Type：

Primary indicator

测量时间点：

测量方法：

Questionnaire GAD-7

Measure time point of outcome：

Measure method：

Questionnaire GAD-7

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

No

组织：

Sample Name：

No

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

The data collected from the questionnaire will be destroyed after 3 years of the study.

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 18 岁 years
最大 Max age 70 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

N/A

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

This is not a randomized control trial.

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：

N/A

Blinding：

N/A

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）：

Data will be available by request to the Principle Investigator after the end of the study

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

Data will be available by request to the Principle Investigator after the end of the study

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：

The study's purpose and procedures will be explained in detail to study participants. A consent form will be signed before data collection. Assessments will be conducted before and after the participants joining the mindfulness-based intervention. Participants will complete the questionnaire by pen and paper. Only the research personnel who are responsible for this project will have access to the information.

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

The study's purpose and procedures will be explained in detail to study participants. A consent form will be signed before data collection. Assessments will be conducted before and after the participants joining the mindfulness-based intervention. Participants will complete the questionnaire by pen and paper. Only the research personnel who are responsible for this project will have access to the information.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2020-01-14 17:50:41
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