Today is 2020-12-01

Effects of an online mindfulness-based intervention on quality of life and psychological symptoms in novel coronavirus pneumonia (COVID-19) patients in China: a randomized controlled trial
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注册号:

Registration number:

ChiCTR2000037524 

最近更新日期:

Date of Last Refreshed on:

2020-10-26 

注册时间:

Date of Registration:

2020-08-29 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于网络的正念干预对中国新型冠状病毒肺炎(COVID-19)患者的生活质量和心理状态的影响:一项随机对照试验 

Public title:

Effects of an online mindfulness-based intervention on quality of life and psychological symptoms in novel coronavirus pneumonia (COVID-19) patients in China: a randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

武汉COVID-19患者及重要康复影响因素纵向研究项目 

Scientific title:

Longitudinal research project of Wuhan novel coronavirus pneumonia (COVID-19) patients and important rehabilitation factors 

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:

司明玉 

研究负责人:

苏小游 

Applicant:

Mingyu Si 

Study leader:

Xiaoyou Su 

申请注册联系人电话:

Applicant telephone:

+86 17639219176 

研究负责人电话:

Study leader's telephone:

+86 10-65105830 

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:

myu_si@163.com 

研究负责人电子邮件:

Study leader's E-mail:

suxiaoyou@hotmail.com 

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:

中国北京市东城区东单三条5号 

研究负责人通讯地址:

中国北京市东城区东单三条5号 

Applicant address:

5 Third DongDan Lane, Dongcheng District, Beijing, China 

Study leader's address:

5 Third DongDan Lane, Dongcheng District, Beijing, 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:

中国医学科学院北京协和医学院群医学及公共卫生学院 

Applicant's institution:

College of medicine and public health, Peking Union Medical College, Chinese Academy of Medical Sciences 

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:

IPB-2020-22 

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:

中国医学科学院病原生物学研究所伦理审查委员会 

Name of the ethic committee:

The EthicaI Review Committee of Institute of Pathogen Biology, Chinese Academy of Medical Sciences 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-08-02 

伦理委员会联系人:

翟晓梅 

Contact Name of the ethic committee:

Xiaomei Zhai 

伦理委员会联系地址:

北京市东城区东单三条48号 

Contact Address of the ethic committee:

48 Third DongDan Lane, Dongcheng District, Beijing, China 

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:

中国医学科学院 

Primary sponsor:

Chinese Academy of Medical Sciences 

研究实施负责(组长)单位地址:

北京市东城区东单三条9号 

Primary sponsor's address:

9 Third DongDan Lane, Dongcheng District, Beijing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京市

市(区县):

北京市

Country:

China

Province:

Beijing

City:

Beijing

单位(医院):

中国医学科学院

具体地址:

北京市东城区东单三条9号

Institution
hospital:

Chinese Academy of Medical Sciences

Address:

9 Third DongDan Lane, Dongcheng District, Beijing, China

经费或物资来源:

中国医学科学院医学与健康科技创新工程(2020-I2M-1-001) 

Source(s) of funding:

Innovation Fund for Medical Sciences sponsored by Chinese Academy of Medical Sciences(2020-I2M-1-001) 

研究疾病:

新型冠状病毒肺炎(COVID-19) 

Target disease:

Novel Coronavirus Pneumonia (COVID-19) 

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:

探索性研究/预试验 

Study phase:

研究目的:

评估新冠肺炎患者康复出院后的心理及睡眠状况,以随机对照研究的形式检验基于网络的正念训练的心理干预效果。 

Objectives of Study:

To evaluate the psychological and sleep status of patients with COVID-19 after recovery, and to test the effect of psychological intervention based on online mindfulness-based training in the form of a randomized controlled study. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1)18岁以上; 2)有新冠肺炎患病史; 3)可以读懂中国字; 4)可独立配合医生完成各种量表测评及相应的检测; 5)有随身手机或平板等移动通讯装备; 6)移动装备可以随时上网; 7)患者本人全过程知情同意,并按伦理委员会要求签署电子版知情同意书。 

Inclusion criteria

1. Subjects over 18 years old; 2. Patients with novel coronavirus pneumonia history; 3. Those who can read Chinese characters; 4. Those who can independently cooperate with doctors to complete various scales and corresponding tests; 5. Subjects with mobile communication equipment such as mobile phones or tablets; 6. Mobile equipment can be connected to the Internet at any time; 7. The patient himself had informed consent in the whole process and signed the electronic informed consent form according to the requirements of the ethics committee. 

排除标准:

1)合并有严重的精神类疾病、或自杀倾向者; 2)患有严重的心、脑、肺、肾、肝脏等内科疾病或肿瘤患者; 3)不能配合调查、干预的患者; 4)处于孕期或哺乳期的妇女。 符合上述任一项者,即予排除。 

Exclusion criteria:

1. Patients with severe mental illness or suicidal tendency; 2. Patients with serious heart, brain, lung, kidney, liver and other medical diseases or tumors; 3. Patients who can not cooperate with the investigation and intervention; 4. Pregnant or lactating women. Those who meet any of the above items shall be excluded. 

研究实施时间:

Study execute time:

From2020-09-01To 2020-12-31 

征募观察对象时间:

Recruiting time:

From2020-08-29To 2020-08-31 

干预措施:

Interventions:

组别:

干预组

样本量:

800

Group:

Intervention group

Sample size:

干预措施:

正念训练

干预措施代码:

Intervention:

Mindfulness-based interventions (MBIs)

Intervention code:

组别:

对照组

样本量:

800

Group:

Control group

Sample size:

干预措施:

与干预组内容无关的健康知识科普

干预措施代码:

Intervention:

Health education

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北省 

市(区县):

武汉市 

Country:

China 

Province:

Hubei 

City:

Wuhan 

单位(医院):

武汉市金银谭医院 

单位级别:

三级甲等 

Institution
hospital:

Wuhan Jinyintan Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

心理状态

指标类型:

主要指标 

Outcome:

Psychological status

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

睡眠状态

指标类型:

主要指标 

Outcome:

Sleep status

Type:

Primary 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:

组织:

Sample Name:

None

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

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 years
最大 Max age 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):

使用计算机软件生成随机分配表

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

Use the statistical software to generate a random number table

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

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):

中国临床试验注册中心的ResMan原始数据共享平台(IPD共享平台) http://wwww.medresman.org:22280/login.aspx

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

IPD Sharing Platform

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:

数据采集包括基线、干预后及随访问卷数据,采用网络问卷星平台回收数据进行管理。

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

Data collection includes baseline, post-intervention and follow-up questionnaire data, and the data management was powered by www.wjx.cn.

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2020-08-29
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