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新型冠状病毒肺炎(COVID-19)爆发期间正念干预对改善人群身心健康的效果
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注册号:

Registration number:

ChiCTR2000031272 

最近更新日期:

Date of Last Refreshed on:

2020-03-26 

注册时间:

Date of Registration:

2020-03-26 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

新型冠状病毒肺炎(COVID-19)爆发期间正念干预对改善人群身心健康的效果 

Public title:

The effectiveness of mindfulness intervention in improving people's psychological and physical well-being during novel coronavirus pneumonia (COVID-19) outbreak 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

新型冠状病毒肺炎(COVID-19)爆发期间正念干预对改善人群身心健康的效果 

Scientific title:

The effectiveness of mindfulness intervention in improving people's psychological and physical well-being during novel coronavirus pneumonia (COVID-19) outbreak 

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:

郑雪 

研究负责人:

郑雪 

Applicant:

Zheng Xue 

Study leader:

Zheng Xue 

申请注册联系人电话:

Applicant telephone:

+86 17717830223 

研究负责人电话:

Study leader's telephone:

+86 17717830223 

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:

zhengxue.academic@gmail.com 

研究负责人电子邮件:

Study leader's E-mail:

zhengxue.academic@gmail.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

https://cn.ceibs.edu/zheng-michelle 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

https://cn.ceibs.edu/zheng-michelle 

申请注册联系人通讯地址:

上海浦东新区红枫路699号中欧国际工商学院 

研究负责人通讯地址:

上海浦东新区红枫路699号中欧国际工商学院 

Applicant address:

699 Hongfeng Road, Pudong New District, Shanghai, China 

Study leader's address:

699 Hongfeng Road, Pudong New District, Shanghai, China 

申请注册联系人邮政编码:

Applicant postcode:

201206 

研究负责人邮政编码:

Study leader's postcode:

201206 

申请人所在单位:

中欧国际工商学院 

Applicant's institution:

China European International Business School (CEIBS) 

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:

20200219 

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:

中欧工商管理学院伦理委员会 

Name of the ethic committee:

CEIBS Institutional Review Board 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-02-19 

伦理委员会联系人:

许斌 

Contact Name of the ethic committee:

Xu Bin 

伦理委员会联系地址:

上海浦东新区红枫路699号中欧国际工商学院 

Contact Address of the ethic committee:

699 Hongfeng Road, Pudong New District, Shanghai, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 21 28905602 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

xubin@ceibs.edu 

研究实施负责(组长)单位:

中欧国际工商学院 

Primary sponsor:

China European International Business School (CEIBS) 

研究实施负责(组长)单位地址:

上海浦东新区红枫路699号中欧国际工商学院 

Primary sponsor's address:

699 Hongfeng Road, Pudong New District, Shanghai, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

中欧工商管理学院研究经费 

Source(s) of funding:

CEIBS research fund 

研究疾病:

睡眠,心理压力和焦虑 

Target disease:

Sleep, stress and anxiety 

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 

研究目的:

我们的此项实验的目的是研究正念是否可以作为一个有效的心理干预方法来改善处在新型冠状肺炎爆发期中的人们的心理健康,睡眠和情绪等。 

Objectives of Study:

In the current research project, we aim to conduct a study to examine the effectiveness of mindfulness interventions in improving their psychological well-being among Wuhan residents during the lockdown due to the coronavirus breakout.  

药物成份或治疗方案详述:

被试会被分为两组,一组在10天的过程中每天早上跟着录音练习10分钟的正念,另一组在10天的过程中每天早上跟着录音练习10分钟的思绪漫游(实验控制组)。 

Description for medicine or protocol of treatment in detail:

We randomly divide subjects into two experimental groups: mindfulness exercise vs. mind-wandering exercise. Over the next 10 days, they will fill in a short morning survey and a short evening survey. In the morning survey, they will follow a 10-minute audio to practice either mindfulness or mind-wandering exercise.  

研究设计:

半随机对照 

Study design:

Quasi-randomized controlled 

纳入标准:

目前正在武汉经历1月23号开始的封城,在武汉长期居住的居民 

Inclusion criteria

Eligible participants are residents who were located in Wuhan during the lockdown starting from 23 January 2020 due to the Coronavirus breakout. The study was conducted for 12 days between 20 Feb to 2 March 

排除标准:

不在武汉的人以及没有完成10天正念练习或思绪漫游练习的人 

Exclusion criteria:

Participants who were not located in Wuhan when we conducted the study and those who did not practice mindfulness or mind-wandering exercise over the next 10 days. 

研究实施时间:

Study execute time:

From2020-02-20To 2020-03-02 

干预措施:

Interventions:

组别:

正念干预组

样本量:

60

Group:

mindfulness intervention group

Sample size:

干预措施:

每天练习10分钟正念

干预措施代码:

Intervention:

Mindfulness practice

Intervention code:

组别:

控制组

样本量:

50

Group:

control group

Sample size:

干预措施:

思绪漫游

干预措施代码:

Intervention:

mind-wandering practice

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

上海 

Country:

China 

Province:

Shanghai 

City:

Shanghai 

单位(医院):

中欧国际工商学院 

单位级别:

高校 

Institution
hospital:

CEIBS  

Level of the institution:

Higher education 

测量指标:

Outcomes:

指标中文名:

焦虑水平

指标类型:

主要指标 

Outcome:

Anxiety level

Type:

Primary indicator 

测量时间点:

晚上5点后

测量方法:

心理学量表

Measure time point of outcome:

after 5pm

Measure method:

psychological scale

指标中文名:

睡眠

指标类型:

主要指标 

Outcome:

Sleep

Type:

Primary indicator 

测量时间点:

早上8点后

测量方法:

心理学量表

Measure time point of outcome:

After 8am

Measure method:

psychological scale

指标中文名:

整体心理健康

指标类型:

附加指标 

Outcome:

overall psychological well-being

Type:

Additional indicator 

测量时间点:

晚上5点后

测量方法:

心理量表

Measure time point of outcome:

After 5pm

Measure method:

psychological scale

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

N.A.

Tissue:

N.A.

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

N.A.

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 22 years
最大 Max age 47 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):

主研究人员事先随机给两个匿名微信群分配了实验条件,一个群是正念干预组,一个群是思绪漫游实验控制组。研究助理不知道实验条件。在被试注册了实验后,该研究助理在不知道实验条件的前提下将被试加入两个群当中的一个。

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

The PI randomly assigned experimental conditions to two WeChat anonymous groups. To ensure the randomization of the study, research assistant who managed the study were blind to the treatment. People who were interested in participating the study scanned the QR code of the research assistant’s WeChat ID in

盲法:

受试者在参加实验的12天内对实验条件并不知情。在问卷和练习中,我们没有任何与实验条件相关的标记。

Blinding:

Subjects were blind to the experimental conditions during the 12 days of study. We did not label experimental conditions anywhere in surveys and audio practice.

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

https://psyarxiv.com/wuh94?fbclid=IwAR2eBzr6LKIHhnb_DxnTMDy62Kn140vs1STITswO-ISg5T2S40rzx2Q1khg

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

https://psyarxiv.com/wuh94?fbclid=IwAR2eBzr6LKIHhnb_DxnTMDy62Kn140vs1STITswO-ISg5T2S40rzx2Q1khg

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:

EXCEL表记录了受试者的随机分配的ID。电子数据存在SPSS里。

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

EXCEL recorded subjects' ID. Electronic data is kept in SPSS.

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-03-26
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