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检索试验 按国家、省（市）统计 按疾病代码统计 按试验实施单位统计 按试验主办单位统计 按经费或物资来源统计 按征募研究对象情况统计 按注册状态统计 按干预措施统计 按伦理委员会统计 按研究类型统计
A randomized, controlled clinical trail: The effects of mindfulness-based cognitive therapy on generalized anxiety disorder and health service utilization in primary care
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注册号：

Registration number：

 ChiCTR-TRC-10000907 

最近更新日期：

Date of Last Refreshed on：

 2015-08-29 21:55:50 

注册时间：

Date of Registration：

 2010-06-18 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

A randomized, controlled clinical trail: The effects of mindfulness-based cognitive therapy on generalized anxiety disorder and health service utilization in primary care

Public title：

A randomized, controlled clinical trail: The effects of mindfulness-based cognitive therapy on generalized anxiety disorder and health service utilization in primary care

注册题目简写：

English Acronym：

研究课题的正式科学名称：

A randomized, controlled clinical trail: The effects of mindfulness-based cognitive therapy on generalized anxiety disorder and health service utilization in primary care

Scientific title：

A randomized, controlled clinical trail: The effects of mindfulness-based cognitive therapy on generalized anxiety disorder and health service utilization in primary care

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：

CUHK_CCT00267

申请注册联系人：

Rebecca Wong 

研究负责人：

Professor Samuel Yeung Shan WONG 

Applicant：

Rebecca Wong 

Study leader：

Professor Samuel Yeung Shan WONG 

申请注册联系人电话：

Applicant telephone：

 +852 2252 8741

研究负责人电话：

Study leader's
telephone：

+852 2252 8774

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：

 rebeccawong@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)：

 http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00267

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00267

申请注册联系人通讯地址：

Room 426, School of Public Health, CUHK

研究负责人通讯地址：

4/F Division of Family Medicine and Primary H

Applicant address：

Room 426, School of Public Health, CUHK

Study leader's address：

4/F Division of Family Medicine and Primary Health Care, School of Public Health and Primary Care, CUHK

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：

CUHK

Applicant's institution：

CUHK

研究负责人所在单位：

Affiliation of the Leader：

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：

 CUHK

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

CUHK

Name of the ethic committee：

CUHK

伦理委员会批准日期：

Date of approved by ethic committee：

 2009-09-11 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

School of Public Health, Chinese University, HK

Primary sponsor：

School of Public Health, Chinese University, HK

研究实施负责（组长）单位地址：

4/F Division of Family Medicine and Primary Health Care, School of Public Health and Primary Care, CUHK

Primary sponsor's address：

4/F Division of Family Medicine and Primary Health Care, School of Public Health and Primary Care, CUHK

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 SAR

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

Health and Health Service Research Fund, The Food and Health Bureau, Hong Kong SAR

具体地址：

Health and Health Service Research Fund, The Food and Health Bureau, Hong Kong SAR

Institution
hospital：

Health and Health Service Research Fund, The Food and Health Bureau, Hong Kong SAR

Address：

Health and Health Service Research Fund, The Food and Health Bureau, Hong Kong SAR

经费或物资来源：

Health and Health Service Research Fund, The Food and Health Bureau, Hong Kong SAR

Source(s) of funding：

Health and Health Service Research Fund, The Food and Health Bureau, Hong Kong SAR

研究疾病：

generalized anxiety disorder  

Target disease：

generalized anxiety disorder

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：

.  

Objectives of Study：

.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

1) past participation in an MBSR or MBCT group;
2) illiterate subjects as they will not be able to complete the meditation diary;
3) psychiatric and medical comorbidities that are potentially life threatening (i.e. psychosis. Suicidal ideation, terminal medical illness) or those expected to severely limit patient participation or adherence (e.g. psychosis, current substance abuse, dementia, pregnancy);
4) those already seeing a psychiatrist, a cognitive behavioural therapist or psychotherapists/counselors;
5) commencement of psychotropic medication within 2 months.

Exclusion criteria：

1) past participation in an MBSR or MBCT group;
2) illiterate subjects as they will not be able to complete the meditation diary;
3) psychiatric and medical comorbidities that are potentially life threatening (i.e. psychosis. Suicidal ideation, terminal medical illness) or those expected to severely limit patient participation or adherence (e.g. psychosis, current substance abuse, dementia, pregnancy);
4) those already seeing a psychiatrist, a cognitive behavioural therapist or psychotherapists/counselors;
5) commencement of psychotropic medication within 2 months.

研究实施时间：

Study execute time：

从 From 2010-07-01 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2010-07-01 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：

Two groups

样本量：

 228

Group：

Two groups

Sample size：

干预措施：

mindfulness-based cognitive therapy versus Psycho-education group (PEG) based on cognitive behavioural therapy principles / Waitlist control

干预措施代码：

Intervention：

mindfulness-based cognitive therapy versus Psycho-education group (PEG) based on cognitive behavioural therapy principles / Waitlist control

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong SR 

市(区县)：

  

Country：

China

Province：

Hong Kong SR

City：

单位(医院)：

 School of Public Health, Chinese University 

单位级别：

 School of Public Health, Chinese University 

Institution
hospital：

School of Public Health, Chinese University

Level of the institution：

School of Public Health, Chinese University

测量指标：

Outcomes：

指标中文名：

Anxiety symptoms will be measured using the Chinese version Beck Anxiety Inventory and the validated Chinese version Penn State Worry Questionnaire.

指标类型：

主要指标

Outcome：

Anxiety symptoms will be measured using the Chinese version Beck Anxiety Inventory and the validated Chinese version Penn State Worry Questionnaire.

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Depressive symptoms will be measured by the validated Chinese version of the Centre for Epidemiological Studies-Depression Scale (CES-D).

指标类型：

次要指标

Outcome：

Depressive symptoms will be measured by the validated Chinese version of the Centre for Epidemiological Studies-Depression Scale (CES-D).

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Health related quality of life will be measured by the validated Chinese version Medical Outcomes Study Short-Form Health Survey (SF-12).

指标类型：

次要指标

Outcome：

Health related quality of life will be measured by the validated Chinese version Medical Outcomes Study Short-Form Health Survey (SF-12).

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” will be measured by the Five Facet Mindfulness Questionnaire.

指标类型：

次要指标

Outcome：

“Mindfulness” will be measured by the Five Facet Mindfulness Questionnaire.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Health service utilization including visits to primary care doctors (both private and public) and hospitalizations will be recorded.

指标类型：

次要指标

Outcome：

Health service utilization including visits to primary care doctors (both private and public) and hospitalizations will be recorded.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

The frequency and duration of practice of both MBSR and PEG in each group will be documented

指标类型：

次要指标

Outcome：

The frequency and duration of practice of both MBSR and PEG in each group will be documented

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

medication use including changes in medication will be monitored at 3 month interval.

指标类型：

次要指标

Outcome：

medication use including changes in medication will be monitored at 3 month interval.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Response rate (enrolment of subjects), retention rate (number and proportion attended each class) of the MBCT and the psycho-education group will be documented.

指标类型：

次要指标

Outcome：

Response rate (enrolment of subjects), retention rate (number and proportion attended each class) of the MBCT and the psycho-education group will be documented.

Type：

Secondary 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：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 21 岁 years
最大 Max age 65 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）：

random

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

random

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：

Blinding：

Single-blind

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

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）：

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

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：

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

数据与安全监察委员会：

Data and Safety Monitoring Committee：

注册人：

Name of Registration：

  2015-07-03 18:30:38
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