ChiCTR2500095292 版本V1.0 版本创建时间2025/01/06 08:46:25 中国临床试验注册中心

审核状态:

Project audit state:

通过审核

Successful

注册号:

Registration number:

ChiCTR2500095292 

最近更新日期:

Date of Last Refreshed on:

2025-01-06 08:46:19 

注册时间:

Date of Registration:

2025-01-06 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

表达性写作干预对人际宽恕的促进作用及其机制研究

Public title:

The Promoting Effect of Expressive Writing Intervention on Interpersonal Forgiveness and Its Mechanism

注册题目简写:

English Acronym:

研究课题的正式科学名称:

表达性写作干预对人际宽恕的促进作用及其机制研究

Scientific title:

The Promoting Effect of Expressive Writing Intervention on Interpersonal Forgiveness and Its Mechanism

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:

李文婕 

研究负责人:

尤瑾 

Applicant:

Wenjie Li  

Study leader:

Jin You 

申请注册联系人电话:

Applicant telephone:

+86 153 7769 6156

研究负责人电话:

Study leader's
telephone:

+86 188 0119 6981

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:

1778059553@qq.com

研究负责人电子邮件:

Study leader's E-mail:

jyou@whu.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:

湖北省武汉市武昌区八一路299号

研究负责人通讯地址:

湖北省武汉市武昌区八一路299号

Applicant address:

Wuhan University, No.299 Bayi Road, Wuchang District, Wuhan City, Hubei Province

Study leader's address:

Wuhan University, No.299 Bayi Road, Wuchang District, Wuhan City, Hubei Province

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:

武汉大学

Applicant's institution:

Wuhan University

研究负责人所在单位:

武汉大学

Affiliation of the Leader:

Wuhan 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:

WHU-HSS-IRB2023020

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:

武汉大学人文社会科学伦理委员会

Name of the ethic committee:

Ethics Committee of the Humanities and Social Sciences of Wuhan university

伦理委员会批准日期:

Date of approved by ethic committee:

2023-11-30 00:00:00

伦理委员会联系人:

汪信砚

Contact Name of the ethic committee:

Xinjian Wang

伦理委员会联系地址:

湖北省武汉市武昌区八一路299号

Contact Address of the ethic committee:

Wuhan University, No.299 Bayi Road, Wuchang District, Wuhan City, Hubei Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 27 6875 5607

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:

武汉大学

Primary sponsor:

Wuhan University

研究实施负责(组长)单位地址:

湖北省武汉市武昌区八一路299号

Primary sponsor's address:

Wuhan University, No.299 Bayi Road, Wuchang District, Wuhan City, Hubei Province

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

湖北

市(区县):

武汉

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

武汉大学心理系

具体地址:

湖北省武汉市武昌区八一路299号振华楼

Institution
hospital:

Department of Psychology of Wuhan University

Address:

Zhenhua building, Wuhan University, No.299 Bayi Road, Wuchang District, Wuhan City, Hubei Province

经费或物资来源:

武汉大学人文社科青年创新团队课题

Source(s) of funding:

Humanities and Social Sciences Youth Innovation Team Project of Wuhan University

研究疾病:

无  

Target disease:

None

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:

本研究将通过随机分组试验(RCT)在中国大学生中探索角色书信、情绪袒露和益处寻求指导语下的表达性写作对心理健康和人际关系结果的影响。  

Objectives of Study:

This study will explore the effects of role-lettering, emotional disclosure, and expressive writing in the context of benefit-seeking guidance on mental health and interpersonal outcomes in Chinese university students through randomized group trials (RCT).

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

1.两年内在人际交往中,经历过被人激怒、伤害或冒犯事件且至今仍为上述事件感到困扰且无法原谅对方,同时目前能够回忆起该冒犯事件的过程; 2.在读中国大学生。 3.能够到线下进行生理实验并能够使用电子设备完成干预内容。

Inclusion criteria

1. Have experienced an incident of being provoked, hurt or offended by someone in interpersonal interactions within two years and are still troubled by the above incident and are unable to forgive the other person, and are currently able to recall the process of the offensive incident; 2. Chinese university students. 3. Able to conduct physiological experiments offline and be able to use electronic devices to complete the intervention content.

排除标准:

1.有既往精神病史(如抑郁症、焦虑症等)或在服用上述疾病相关的药物 2.有心血管疾病或其他疾病(如原发性高血压、心脏病、支气管哮喘、癫痫等)病史或在服用上述疾病相关的药物 3.正在参与其他心理咨询或心理干预

Exclusion criteria:

1. Have a history of previous psychiatric illness (such as depression, anxiety, etc.) or are taking medications related to the above diseases 2. Have a history of cardiovascular disease or other diseases (such as essential hypertension, heart disease, bronchial asthma, epilepsy, etc.) or are taking drugs related to the above diseases 3. Is participating in other psychological counseling or psychological interventions

研究实施时间:

Study execute time:

From 2023-12-05 00:00:00 To 2024-06-30 00:00:00  

征募观察对象时间:

Recruiting time:

From 2023-12-10 00:00:00 To 2024-03-15 00:00:00

干预措施:

Interventions:

组别:

日常写作组(对照组)

样本量:

29

Group:

Daily events group (control group)

Sample size:

干预措施:

书写日常客观生活事件

干预措施代码:

Intervention:

Write about the facts regarding daily events without emotion

Intervention code:

组别:

情绪袒露组

样本量:

30

Group:

Emotional disclosure group

Sample size:

干预措施:

书写有关冒犯事件内心深处的想法和感受

干预措施代码:

Intervention:

Write about the deepest feelings or thoughts regarding the transgression

Intervention code:

组别:

角色书信组

样本量:

29

Group:

Role-lettering group

Sample size:

干预措施:

写信给冒犯者并从冒犯者的视角回信

干预措施代码:

Intervention:

Write to the transgressor regarding the transgression and reply from the transgressor’s perspective

Intervention code:

组别:

益处寻求组

样本量:

28

Group:

Benefit-finding group

Sample size:

干预措施:

书写原谅冒犯者的益处

干预措施代码:

Intervention:

Write about the positive aspects of forgiving others for transgression

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

湖北 

市(区县):

武汉 

Country:

China

Province:

Hubei

City:

Wuhan

单位(医院):

武汉大学心理系 

单位级别:

大学 

Institution
hospital:

School of psychology of Wuhan University

Level of the institution:

University

测量指标:

Outcomes:

指标中文名:

自我报告问卷(人际关系结果):人际侵犯动机

指标类型:

主要指标

Outcome:

Self-report questionnaire(Interpersonal relationship outcomes):Transgression-Related Interpersonal Motivations

Type:

Primary indicator

测量时间点:

基线(T0),后测(T1),一个月随访(T2),三个月随访(T3)

测量方法:

Measure time point of outcome:

Baseline(T0), post-intervention(T1), 1 month follow-up(T2), 3 months follow-up(T3)

Measure method:

指标中文名:

自我报告问卷(人际关系结果):决定性宽恕

指标类型:

主要指标

Outcome:

Self-report questionnaire(Interpersonal relationship outcomes):Decision to forgive

Type:

Primary indicator

测量时间点:

基线(T0),后测(T1),一个月随访(T2),三个月随访(T3)

测量方法:

Measure time point of outcome:

Baseline(T0), post-intervention(T1), 1 month follow-up(T2), 3 months follow-up(T3)

Measure method:

指标中文名:

自我报告问卷(人际关系结果):情感性宽恕

指标类型:

主要指标

Outcome:

Self-report questionnaire(Interpersonal relationship outcomes)::Emotional forgive

Type:

Primary indicator

测量时间点:

基线(T0),后测(T1),一个月随访(T2),三个月随访(T3)

测量方法:

Measure time point of outcome:

Baseline(T0), post-intervention(T1), 1 month follow-up(T2), 3 months follow-up(T3)

Measure method:

指标中文名:

自我报告问卷(心理健康指标):情绪效价

指标类型:

主要指标

Outcome:

Self-report questionnaire (Mental health indicators):Affect Valuation

Type:

Primary indicator

测量时间点:

基线(T0),后测(T1),一个月随访(T2),三个月随访(T3)

测量方法:

Measure time point of outcome:

Baseline(T0), post-intervention(T1), 1 month follow-up(T2), 3 months follow-up(T3)

Measure method:

指标中文名:

心电指标

指标类型:

主要指标

Outcome:

ECG indicators

Type:

Primary indicator

测量时间点:

干预期间

测量方法:

Measure time point of outcome:

During intervention

Measure method:

指标中文名:

血阻指标

指标类型:

主要指标

Outcome:

Impedance Cardiography

Type:

Primary indicator

测量时间点:

干预期间

测量方法:

Measure time point of outcome:

During intervention

Measure method:

指标中文名:

自我报告问卷(个人特质):一般人际目标

指标类型:

次要指标

Outcome:

Self-report questionnaire (Personal traits):Brief Symptom Inventory

Type:

Secondary indicator

测量时间点:

基线

测量方法:

Measure time point of outcome:

Baseline

Measure method:

指标中文名:

自我报告问卷(个人特质):趋近回避动机

指标类型:

次要指标

Outcome:

Self-report questionnaire (Personal traits):Approach-Avoidance Motivation Scale

Type:

Secondary indicator

测量时间点:

基线

测量方法:

Measure time point of outcome:

Baseline

Measure method:

指标中文名:

自我报告问卷(个人特质):容忍

指标类型:

次要指标

Outcome:

Self-report questionnaire (Personal traits):Forbearance

Type:

Secondary indicator

测量时间点:

基线

测量方法:

Measure time point of outcome:

Baseline

Measure method:

指标中文名:

自我报告问卷(心理健康指标):焦虑抑郁水平

指标类型:

主要指标

Outcome:

Self-report questionnaire (Mental health indicators): Anxiety and depression levels

Type:

Primary indicator

测量时间点:

基线(T0),后测(T1),一个月随访(T2),三个月随访(T3)

测量方法:

Measure time point of outcome:

Baseline(T0), post-intervention(T1), 1 month follow-up(T2), 3 months follow-up(T3)

Measure method:

指标中文名:

自我报告问卷-人口统计学信息

指标类型:

次要指标

Outcome:

Self-report questionnaire - Demographic information

Type:

Secondary indicator

测量时间点:

基线

测量方法:

Measure time point of outcome:

Baseline

Measure method:

指标中文名:

写作材料检验(写作指导语)

指标类型:

次要指标

Outcome:

Writing materials inspection (Writing guidelines)

Type:

Secondary indicator

测量时间点:

第一次写作(T1),第二次写作(T2),第三次写作(T3)

测量方法:

Measure time point of outcome:

First writing (T1), second writing (T2), third writing (T3)

Measure method:

指标中文名:

写作材料检验(写作评价)

指标类型:

次要指标

Outcome:

Writing materials inspection (Writing evaluation)

Type:

Secondary indicator

测量时间点:

第一次写作(T1),第二次写作(T2),第三次写作(T3)

测量方法:

Measure time point of outcome:

First writing (T1), second writing (T2), third writing (T3)

Measure method:

指标中文名:

写作材料检验(感受测量)

指标类型:

次要指标

Outcome:

Writing materials inspection (Perception measurement)

Type:

Secondary indicator

测量时间点:

第一次写作(T1),第二次写作(T2),第三次写作(T3)

测量方法:

Measure time point of outcome:

First writing (T1), second writing (T2), third writing (T3)

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

其它  

说明

Fate of sample:

0thers  

Note:

征募研究对象情况:

Recruiting status:

结束

/Completed

年龄范围:

Participant age:

最小 Min age 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):

由研究小组主试以外的研究人员用计算机产生随机数来进行随机化分配。

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

Researchers other than the main test of the research group used a computer to generate random numbers for randomization allocation.

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:

双盲,对研究者和研究参与者设盲

Blinding:

Double-blind, blinding the investigator and study participants

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):

研究结束后,通过ResMan(www.medresman.org.cn)方式共享

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

After the end of the study, it was shared by ResMan (www.medresman.org.cn).

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:

CRF;EDC

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

CRF;EDC

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:

 2025-01-06 08:46:19