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Stress and neuropsychiatric symptoms/disorders (i.e. functional brain diseases): COVID-19 as a source of stress
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注册号:

Registration number:

ChiCTR2000039079 

最近更新日期:

Date of Last Refreshed on:

2020-10-16 

注册时间:

Date of Registration:

2020-10-16 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

应激与神经精神症状/障碍(脑功能性疾病):以新冠(COVID-19)疫情为应激源 

Public title:

Stress and neuropsychiatric symptoms/disorders (i.e. functional brain diseases): COVID-19 as a source of stress 

注册题目简写:

应激与神经精神症状 

English Acronym:

SaNPS 

研究课题的正式科学名称:

应激与神经精神症状/障碍(脑功能性疾病):以新冠(COVID-19)疫情为应激源 

Scientific title:

Stress and neuropsychiatric symptoms/disorders (i.e. functional brain diseases): COVID-19 as a source of stress 

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:

王红星 

研究负责人:

王红星 

Applicant:

Hongxing Wang 

Study leader:

Hongxing Wang 

申请注册联系人电话:

Applicant telephone:

+86 13911127385 

研究负责人电话:

Study leader's telephone:

+86 13911127385 

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:

hxwang8888@126.com 

研究负责人电子邮件:

Study leader's E-mail:

hxwang8888@126.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

Neuropsychiatry Section of Department of Neurology, Xuanwu Hospital, Capital Medical University 

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:

北京市西城区长椿街45号 

研究负责人通讯地址:

赤峰市宁城县天义镇中京街/北京市西城区长椿街45号 

Applicant address:

45 Changchun Street, Xicheng District, Beijing, China 

Study leader's address:

Zhongjing Street, Ningcheng County, Chifeng City, Inner Mongolia; 45 Changchun Street, Xicheng District, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100053 

研究负责人邮政编码:

Study leader's postcode:

024200/100053 

申请人所在单位:

首都医科大学宣武医院 

Applicant's institution:

Xuanwu Hospital, Capital Medical University 

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:

No. NC-IRB20200101 

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:

宁城县中心医院 

Name of the ethic committee:

Ningcheng Center Hospital, Ningcheng, China 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-01-04 

伦理委员会联系人:

李冬宁 

Contact Name of the ethic committee:

Dongning Li 

伦理委员会联系地址:

赤峰市宁城县天义镇中京街 

Contact Address of the ethic committee:

Zhongjing Street, Tianyi Town, Ningcheng County, Chifeng City, Inner Mongolia, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 047 64236666 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

ldn163@sina.com 

研究实施负责(组长)单位:

宁城县中心医院 

Primary sponsor:

Ningcheng Center Hospital, Ningcheng, China 

研究实施负责(组长)单位地址:

赤峰市宁城县天义镇中京街 

Primary sponsor's address:

Zhongjing Street, Tianyi Town, Ningcheng County, Chifeng City, Inner Mongolia, 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):

内蒙古自治区

市(区县):

赤峰市

Country:

China

Province:

Inner Mongolia Autonomous Region

City:

Chifeng City

单位(医院):

宁城县中心医院

具体地址:

赤峰市宁城县天义镇中京街

Institution
hospital:

Ningcheng Center Hospital, Ningcheng, China

Address:

Zhongjing Street, Tianyi Town, Ningcheng County, Chifeng City, Inner Mongolia, China

国家:

中国

省(直辖市):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学宣武医院

具体地址:

北京市西城区长椿街45号

Institution
hospital:

Xuanwu Hospital, Capital Medical University

Address:

45 Changchun Street, Xicheng District, Beijing

经费或物资来源:

研究者发起研究 

Source(s) of funding:

Investigator Initiated Research Program (IIRP) 

研究疾病:

应激 

Target disease:

Stress related disorders 

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:

其它 

Study phase:

N/A 

研究目的:

通过对新冠疫情下不同人群面对新冠疫情时的各种反应来研究和探讨从正常到异常的发展过程以及神经精神症状的变化特征,寻找其可能的预测因素或/和危险因素。 

Objectives of Study:

To study the development process from normal to abnormal and the characteristics of neuropsychiatric symptoms through various reactions of different populations in the face of COVID-19, and explore its possible predictors and/and risk factors. 

药物成份或治疗方案详述:

其中,对于纳入的人群进行观察,对于愿意接收心理干预的患者,继续进行团体心理治疗干预(使用幸福治疗方法),以观察其效果。 

Description for medicine or protocol of treatment in detail:

Among them, for the population who are willing to receive group psychotherapy,we will assess its potential effect. 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1) 年龄≥14岁; 2) 性别不限; 3) 婚姻不限; 4) 教育程度不限; 5) 职业等均不限。 

Inclusion criteria

1) Aged >=14 years old; 2) No gender limit; 3) Unlimited marriage status; 4) Unlimited education level; 5) No restriction on occupation/job classification. 

排除标准:

1) 非医务人员排除在医院工作的医生和护士人群(排除原因是:该人群因在医院工作,掌握医疗相关知识); 2) 拒绝知情同意者。 

Exclusion criteria:

1) Non-medical personnel/workers exclude doctors and nurses who work in hospitals (the reason for the exclusion is: the person who work in hospitals may have medical-related knowledge on preventing COVID-19); 2) Those who refuse informed consent. 

研究实施时间:

Study execute time:

From2020-01-04To 2021-01-04 

征募观察对象时间:

Recruiting time:

From2020-01-13To 2020-12-31 

干预措施:

Interventions:

组别:

药物干预组

样本量:

200

Group:

drug group

Sample size:

干预措施:

常规助睡眠药物

干预措施代码:

Intervention:

Common Sleep Aid Drugs

Intervention code:

组别:

心理干预组

样本量:

200

Group:

Psychotherapy group

Sample size:

干预措施:

团队心理干预

干预措施代码:

Intervention:

group wellbeing therapy

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

失眠严重指数量表总分

指标类型:

主要指标 

Outcome:

total score of the insomnia severity index (ISI)

Type:

Primary indicator 

测量时间点:

入组和/或随访

测量方法:

量表评估

Measure time point of outcome:

baseline and/or follow-up

Measure method:

ISI

指标中文名:

焦虑和抑郁

指标类型:

主要指标 

Outcome:

total score of anxiety and depression

Type:

Primary indicator 

测量时间点:

入组和/或随访

测量方法:

量表评估

Measure time point of outcome:

baseline and/or follow-up

Measure method:

PHQ-4

指标中文名:

躯体症状评估

指标类型:

主要指标 

Outcome:

score of somatization

Type:

Primary indicator 

测量时间点:

入组和/或随访

测量方法:

量表评估

Measure time point of outcome:

baseline and/or follow-up

Measure method:

SCI-90

指标中文名:

症状量表

指标类型:

主要指标 

Outcome:

Socre of Symptom Questionnaire (SQ)

Type:

Primary indicator 

测量时间点:

入组和/或随访

测量方法:

量表评估

Measure time point of outcome:

baseline and/or follow-up

Measure method:

SQ

指标中文名:

压力和稳态情况

指标类型:

主要指标 

Outcome:

socre of the Psycho-Social Index (PSI)

Type:

Primary indicator 

测量时间点:

入组和/或随访

测量方法:

量表评估

Measure time point of outcome:

baseline and/or follow-up

Measure method:

the Psycho-Social Index

指标中文名:

社会支持情况

指标类型:

主要指标 

Outcome:

Score of the Social Support Rating Scale (SSRS)

Type:

Primary indicator 

测量时间点:

入组和/或随访

测量方法:

量表评估

Measure time point of outcome:

baseline and/or follow-up

Measure method:

the Social Support Rating Scale (SSRS)

指标中文名:

人格特征

指标类型:

附加指标 

Outcome:

personality

Type:

Additional indicator 

测量时间点:

入组

测量方法:

量表评估-艾森克人格问卷简式量表中国版

Measure time point of outcome:

baseline

Measure method:

EPQ-RSC)

指标中文名:

创伤后应激障碍的发生

指标类型:

附加指标 

Outcome:

incidence of PTSD

Type:

Additional indicator 

测量时间点:

入组和/或随访

测量方法:

量表评估

Measure time point of outcome:

baseline and/or follow-up

Measure method:

PTSD Checklist-Civilian Version (PCL-C)/Impact of Event Scale-Revised(IES-R)

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

blood

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 14 years
最大 Max age 75 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):

由独立的统计学者产生随机分配数字表。

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

An independent statistician generates a table of randomly assigned numbers for different groups.

盲法:

未说明

Blinding:

Not stated

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):

向作者索要

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

directly contact the lead author for primary data

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:

数据是基于微信或/和问卷星网络平台的调查数据

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

The data is based on the survey of WeChat or/and the Wenjuanxing network platform

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-10-16
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