干预童年创伤经历者情绪可塑信念对情绪失调的影响

注册号:

Registration number:

ChiCTR2600116185 

最近更新日期:

Date of Last Refreshed on:

2026-01-06 16:33:50 

注册时间:

Date of Registration:

2026-01-06 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

干预童年创伤经历者情绪可塑信念对情绪失调的影响

Public title:

The Effect of Intervening in Emotion Malleability Beliefs on Emotion Dysregulation in Individuals with Childhood Trauma Experiences

注册题目简写:

English Acronym:

研究课题的正式科学名称:

童年创伤经历者情绪可塑信念对情绪失调的影响: 情绪调节策略的中介作用

Scientific title:

The Effect of Emotion Malleability Beliefs on Emotional Dysregulation in Individuals with Childhood Trauma: The Mediating Role of Emotion Regulation Strategies

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:

郭翠翠 

研究负责人:

夏瑞雪 

Applicant:

Guo Cuicui  

Study leader:

Xia Ruixue  

申请注册联系人电话:

Applicant telephone:

+86 177 5210 1620

研究负责人电话:

Study leader's
telephone:

+86 136 6931 0988

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:

guocc@lzufe.edu.cn

研究负责人电子邮件:

Study leader's E-mail:

xiarx9391@nwnu.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:

中国甘肃省兰州市榆中县和平镇薇乐大道4号

研究负责人通讯地址:

中国甘肃省兰州市安宁东路967号

Applicant address:

4 Weile Avenue, Heping Town, Yuzhong County, Lanzhou, Gansu Province, China

Study leader's address:

967 Andong East Road, Anning District, Lanzhou, Gansu Province, China

申请注册联系人邮政编码:

Applicant postcode:

730101

研究负责人邮政编码:

Study leader's postcode:

730070

申请人所在单位:

兰州财经大学

Applicant's institution:

Lanzhou University of Finance and Economics

研究负责人所在单位:

西北师范大学

Affiliation of the Leader:

Northwest Normal 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:

伦研批第(2024094)号

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:

西北师范大学心理学院科学研究伦理委员会

Name of the ethic committee:

Ethics Committee of Scientific Research, School of Psychology, Northwest Normal University

伦理委员会批准日期:

Date of approved by ethic committee:

2024-05-06 00:00:00

伦理委员会联系人:

丁小斌

Contact Name of the ethic committee:

Ding Xiaobin

伦理委员会联系地址:

中国甘肃省兰州市安宁东路967号

Contact Address of the ethic committee:

967 Andong East Road, Anning District, Lanzhou, Gansu Province, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 931 797 5316

伦理委员会联系人邮箱:

Contact email of the ethic committee:

psychology@nwnu.edu.cn

研究实施负责(组长)单位:

西北师范大学

Primary sponsor:

Northwest Normal University

研究实施负责(组长)单位地址:

中国甘肃省兰州市安宁东路967号

Primary sponsor's address:

967 Andong East Road, Anning District, Lanzhou, Gansu Province, 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):

甘肃

市(区县):

兰州

Country:

China

Province:

Gansu

City:

Lanzhou

单位(医院):

西北师范大学

具体地址:

中国甘肃省兰州市安宁东路967号

Institution
hospital:

Northwest Normal University

Address:

967 Andong East Road, Anning District, Lanzhou, Gansu Province, China

经费或物资来源:

甘肃省哲学社会科学规划项目(2023QN032)

Source(s) of funding:

Gansu Province Philosophy and Social Sciences Planning Project(2023QN032)

研究疾病:

情绪失调  

Target disease:

Emotional dysregulation

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:

0

研究设计:

随机平行对照 

Study design:

Parallel 

研究目的:

探讨干预情绪可塑信念对童年创伤经历者情绪失调的影响,分析情绪调节策略在其中的作用。  

Objectives of Study:

This study aims to examine how intervening in emotion malleability beliefs affects emotion dysregulation in individuals with childhood trauma and to analyze the mediating role of emotion regulation strategies.

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:

符合以下任一条件者将被排除。 1.当前正在接受系统的心理治疗或精神科药物治疗; 2.在初步接触或评估中,表现出即刻的、严重的自杀风险或精神病性症状,需立即转介至专业机构; 3.未完成全部后测评估(无论何种原因退出),其数据将从最终分析中剔除。

Exclusion criteria:

Participants will be excluded if they meet any of the following. 1. Currently receiving systematic psychotherapy or psychopharmacological treatment; 2.Exhibit immediate and severe suicidal risk or psychotic symptoms during initial contact or assessment, necessitating immediate referral to professional services; 3.Fail to complete all post-test assessments (regardless of reason for discontinuation); their data will be excluded from the final analysis.

研究实施时间:

Study execute time:

From 2024-05-06 00:00:00 To 2026-03-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-01-11 00:00:00 To 2026-01-18 00:00:00

干预措施:

Interventions:

组别:

试验组

样本量:

64

Group:

Trial group

Sample size:

干预措施:

实验组将接受一个为期8次的干预课程。该方案的核心目标是培养和强化参与者的情绪可塑信念。干预内容围绕四个主题模块展开(每个模块2次课程)。内容涵盖了认识情绪、思维模式、情绪可塑信念、练习与应用等模块。

干预措施代码:

Intervention:

An 8-session intervention program will be delivered to the experimental group. The core objective of this protocol is to cultivate and strengthen participants' emotion malleability beliefs. The intervention content is structured around four thematic modules (two sessions per module). The content covers modules such as understanding emotions, thought patterns, beliefs about emotional plasticity, and practice and application.

Intervention code:

组别:

对照组

样本量:

64

Group:

Control group

Sample size:

干预措施:

对照组将接受一个为期8次的干预课程。该方案的内容是普通心理健康教育课程,包括心理健康常识,不涉及任何情绪及情绪可塑信念干预内容。

干预措施代码:

Intervention:

The control group will receive an 8-session intervention program. The content of this protocol is a general mental health education course, covering common mental health knowledge, and does not involve any content related to emotions or emotion malleability beliefs intervention.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

甘肃 

市(区县):

兰州 

Country:

China

Province:

Gansu

City:

Lanzhou

单位(医院):

兰州财经大学 

单位级别:

大学 

Institution
hospital:

Lanzhou University of Finance and Economics

Level of the institution:

University

测量指标:

Outcomes:

指标中文名:

情绪失调

指标类型:

主要指标

Outcome:

Emotional Dysregulation

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

情绪调节策略

指标类型:

主要指标

Outcome:

Emotion Regulation Strategies

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

情绪可塑信念

指标类型:

主要指标

Outcome:

Emotion Malleability Beliefs

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

童年创伤

指标类型:

主要指标

Outcome:

Childhood Trauma

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

社会经济地位

指标类型:

次要指标

Outcome:

Socioeconomic Status

Type:

Secondary 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

其它  

说明

Fate of sample:

0thers  

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 16 years
最大 Max age 25 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):

采用完全随机化分组。由独立研究人员(研究员A)使用抽签法生成随机分配序列:将写有“实验组”和“对照组”的卡片放入不透明容器,充分混匀后,按序号一次性抽签决定所有序号的组别。

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

Complete randomization will be adopted. An independent researcher(Researcher A) will generate the randomization sequence using a lottery method. Cards labeled "Experimental Group" and "Control Group" will be placed into an opaque container, thoroughly mixed, and then drawn all at once to determine the group assignment for each sequence number.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法:

对参与者设盲。两组参与者均接受为期8次、表面结构相似的团体课程。他们不知道自己被分配至“实验组”还是“对照组”,也不知道课程内容的差异。 由于干预内容在本质上存在差异(情绪可塑信念干预 vs. 一般心理健康教育),带领实验组课程的实施者知晓自己所执行的是研究的核心干预方案。对照组的课程由其他实施者带领,或通过使用标准化的中性课程手册,尽可能减少实施者期望效应。

Blinding:

Blinding of Participants: Participants will be blinded. Both groups will attend eight sessions of superficially similar group-based courses. They will be unaware of whether they are assigned to the "experimental group" or the "control group," as well as the differences in course content. Blinding of Intervention Implementers: Due to the inherent differences in intervention content (emotion malleability beliefs intervention vs. general mental health education), the instructors leading the sessions for the experimental group will be aware that they are delivering the study's core intervention protocol. To minimize instructor expectancy effects, the control group sessions will be led either by different instructors or by strictly following standardized neutral session protocols.

是否共享原始数据:

IPD sharing

否No

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):

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

None

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:

数据将由两名人员录入至SPSS数据库中进行比对与逻辑核查。

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

The data will be entered into an SPSS database by two independent personnel for cross-verification and logical checks.

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:

 2026-01-06 16:33:46