社交焦虑障碍的注意偏向矫正训练

注册号:

Registration number:

ChiCTR2200055568 

最近更新日期:

Date of Last Refreshed on:

2023-02-06 01:23:14 

注册时间:

Date of Registration:

2022-01-13 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

社交焦虑障碍的注意偏向矫正训练

Public title:

Attentional Bias Modification for Social Anxiety Disorder

注册题目简写:

English Acronym:

研究课题的正式科学名称:

社交焦虑障碍的注意偏向矫正训练

Scientific title:

Attentional Bias Modification for Social Anxiety Disorder

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:

蒋婧琪 

研究负责人:

钱铭怡 

Applicant:

Jiang Jingqi 

Study leader:

Qian Mingyi 

申请注册联系人电话:

Applicant telephone:

+86 13716667389

研究负责人电话:

Study leader's
telephone:

+86 13693031949

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:

justina940504@163.com

研究负责人电子邮件:

Study leader's E-mail:

qmy@pku.edu.cn

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:

北京市海淀区颐和园路5号

研究负责人通讯地址:

北京市海淀区颐和园路5号

Applicant address:

5 Yiheyuan Road, Haidian District, Beijing

Study leader's address:

5 Yiheyuan Road, Haidian District, Beijing

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:

北京大学

Applicant's institution:

Peking University

研究负责人所在单位:

北京大学

Affiliation of the Leader:

Peking University

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

2021-12-03

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:

北京大学心理与认知科学学院伦理及人体和动物保护委员会

Name of the ethic committee:

Committee for Protecting Human and Animal Subjects, School of Psychological and Cognitive Sciences, Peking University

伦理委员会批准日期:

Date of approved by ethic committee:

2021-12-03 00:00:00

伦理委员会联系人:

王垒

Contact Name of the ethic committee:

Wang Lei

伦理委员会联系地址:

北京市海淀区颐和园路5号北京大学心理与认知科学学院

Contact Address of the ethic committee:

School of Psychology and Cognitive Sciences, Peking University, 5 Yiheyuan Road, Haidian District, Beijing

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:

北京大学

Primary sponsor:

Peking University

研究实施负责(组长)单位地址:

北京市海淀区颐和园路5号

Primary sponsor's address:

5 Yiheyuan Road, Haidian District, Beijing

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(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京大学

具体地址:

海淀区颐和园路5号

Institution
hospital:

Peking University

Address:

5 Yiheyuan Road, Haidian District

经费或物资来源:

国家自然科学基金

Source(s) of funding:

National Natural Science Foundation of China

研究疾病:

社交焦虑障碍  

Target disease:

social 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:

注意回避是社交焦虑障碍的重要注意偏向,本研究将探索针对注意回避的注意偏差矫正训练是否可以减少社交焦虑的症状。  

Objectives of Study:

Attention avoidance is an important attentional bias in social anxiety disorder, and this study will explore whether attentional bias modification training for attention avoidance can reduce the symptoms of social anxiety.

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.除焦虑障碍、抑郁和/或恶劣心境以外的其他共病诊断;
2.自杀风险;
3.过去一年内服用过精神类药物;
4.过去六个月内接受过心理治疗。

Exclusion criteria:

1. Comorbid diagnoses besides anxiety disorders, major depression and/or dysthymia on MINI;
2. Reported risk of suicide;
3. Taking psychiatric medications in the past year;
4. Receiving psychological treatment in the past 6 months.

研究实施时间:

Study execute time:

From 2022-01-05 00:00:00 To 2022-12-03 00:00:00  

征募观察对象时间:

Recruiting time:

From 2022-01-13 00:00:00 To 2022-12-03 00:00:00

干预措施:

Interventions:

组别:

干预组

样本量:

20

Group:

Intervention group

Sample size:

干预措施:

注意偏向矫正训练

干预措施代码:

Intervention:

Attentional bias modification

Intervention code:

组别:

等待组

样本量:

20

Group:

Waiting group

Sample size:

干预措施:

等待一周后再开始注意偏向矫正训练

干预措施代码:

Intervention:

Wait one week before starting to Attentional bias modification

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

北京 

市(区县):

 

Country:

China

Province:

Beijing

City:

单位(医院):

北京大学 

单位级别:

大学 

Institution
hospital:

Peking University

Level of the institution:

University

测量指标:

Outcomes:

指标中文名:

社交交往焦虑量表

指标类型:

主要指标

Outcome:

Social Interaction Anxiety Scale

Type:

Primary indicator

测量时间点:

入组前、等待组干预前、干预后

测量方法:

问卷

Measure time point of outcome:

Pre-recruitment, waiting group pre-intervention, post-intervention

Measure method:

questionnaire

指标中文名:

社交恐怖量表

指标类型:

主要指标

Outcome:

Social Phobia Scale

Type:

Primary indicator

测量时间点:

入组前、等待组干预前、干预后

测量方法:

问卷

Measure time point of outcome:

Pre-recruitment, waiting group pre-intervention, post-intervention

Measure method:

questionnaire

指标中文名:

贝克抑郁量表

指标类型:

主要指标

Outcome:

Beck Depression Inventory

Type:

Primary indicator

测量时间点:

入组前、等待组干预前、干预后

测量方法:

问卷

Measure time point of outcome:

Pre-recruitment, waiting group pre-intervention, post-intervention

Measure method:

questionnaire

指标中文名:

安全行为频率评价问卷

指标类型:

主要指标

Outcome:

Subtle Avoidance Frequency Evaluation

Type:

Primary indicator

测量时间点:

入组前、等待组干预前、干预后

测量方法:

问卷

Measure time point of outcome:

Pre-recruitment, waiting group pre-intervention, post-intervention

Measure method:

questionnaire

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

其它  

说明

Fate of sample:

0thers  

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 18 years
最大 Max age 30 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):

研究人员使用计算机生成随机数字进行分组

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

The researchers used a computer to generate random numbers for the groups.

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:

No stated

Blinding:

No stated

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):

有需要的可以通过email向我们索取

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

We will email the data upon request

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:

数组采集: 问卷星;数据管理: SPSS

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

Data collection: wjx.cn; Data Management: SPSS

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2022-01-13 11:48:10