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注册号: Registration number: |
ChiCTR2600125712 |
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最近更新日期: Date of Last Refreshed on: |
2026-05-29 16:23:12 |
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注册时间: Date of Registration: |
2026-05-29 00:00:00 |
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注册号状态: |
补注册 |
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Registration Status: |
Retrospective registration |
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注册题目: |
压力事件与主观压力感的关系:成长型思维和压力增强思维的调节作用与干预 |
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Public title: |
The Relationship Between Stressful Events and Perceived Stress: The Moderating Role and Interventions of Growth Mindset and Stress-Enhancing Mindset |
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注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
协同思维对初中生压力的缓解作用:机制与干预研究 |
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Scientific title: |
The Relieving Effect of Collaborative Thinking on Junior Middle School Students' Stress: Mechanism and Intervention Research |
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研究课题代号(代码): Study subject ID: |
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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: |
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申请注册联系人: |
赵梦鸽 |
研究负责人: |
马红宇 |
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Applicant: |
Mengge Zhao |
Study leader: |
Hongyu Ma |
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申请注册联系人电话: Applicant telephone: |
+86 157 3719 2847 |
研究负责人电话:
Study leader's |
+86 27 6786 8680 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
18570018933@163.com |
研究负责人电子邮件: Study leader's E-mail: |
mahy@ccnu.edu.cn |
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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): |
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申请注册联系人通讯地址: |
湖北省武汉市洪山区珞喻路152号 |
研究负责人通讯地址: |
湖北省武汉市洪山区珞喻路152号 |
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Applicant address: |
No. 152 Luoyu Road, Hongshan District, Wuhan, Hubei Province, China |
Study leader's address: |
No. 152 Luoyu Road, Hongshan District, Wuhan, Hubei Province, China |
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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: |
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申请人所在单位: |
华中师范大学 |
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Applicant's institution: |
Central China Normal University |
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研究负责人所在单位: |
华中师范大学 |
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Affiliation of the Leader: |
Central China Normal University |
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是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
CCNU-IRB-202311037b |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
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批准本研究的伦理委员会名称: |
华中师范大学生命科学伦理审查委员会 |
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Name of the ethic committee: |
The Ethics Committee of Central China Normal University |
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伦理委员会批准日期: Date of approved by ethic committee: |
2023-11-03 00:00:00 | ||
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伦理委员会联系人: |
马红宇 |
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Contact Name of the ethic committee: |
Hongyu Ma |
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伦理委员会联系地址: |
湖北省武汉市洪山区珞喻路152号 |
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Contact Address of the ethic committee: |
No. 152 Luoyu Road, Hongshan District, Wuhan, Hubei Province, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 27 6786 8680 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
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研究实施负责(组长)单位: |
华中师范大学 |
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Primary sponsor: |
Central China Normal University |
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研究实施负责(组长)单位地址: |
湖北省武汉市洪山区珞喻路152号 |
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Primary sponsor's address: |
No. 152 Luoyu Road, Hongshan District, Wuhan, Hubei Province, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
研究者自筹,无需额外资助 |
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Source(s) of funding: |
All costs are borne solely by the investigator (self-funded), and no extra funding is needed |
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研究疾病: |
压力 |
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Target disease: |
Stress |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
探索性研究/预试验 | ||||||||||||||||||||||
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Study phase: |
0 |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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研究目的: |
以成长思维和压力增强思维为主要的干预变量,对压力水平较高的初中生进行团体心理辅导,通过提高成长思维和压力增强思维,从而降低学生的压力感。 |
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Objectives of Study: |
Taking growth mindset and stress-enhanced mindset as the main intervention variables, group psychological counseling is given to junior high school students with high stress level. By improving growth mindset and stress-enhanced mindset, students' sense of stress is reduced |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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纳入标准: |
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Inclusion criteria |
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排除标准: |
1.经班主任或心理教师评估,当前存在重度抑郁、自伤/自杀风险、精神病性症状或物质滥用(需转介专业医疗机构,不适合入组干预)。 2.在过去3个月内经历过重大创伤事件(如亲人去世、严重事故、校园暴力导致PTSD症状)。 3.正在接受其他系统性的心理干预(如每周一次心理咨询或认知行为团体),其效果可能与本研究干预混淆。 4.既往参加过成长思维、压力增强思维或压力管理为主题的正规团体课程(避免练习效应)。 5.有智力障碍、阅读障碍或自闭症谱系障碍(未矫正)影响理解问卷与干预内容。 6.计划在本研究干预期间转学或长期请假,无法完成全部测量与课程。 |
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Exclusion criteria: |
1. According to the assessment of the class teacher or psychological teacher, there are severe depression, risk of self-injury/suicide, psychotic symptoms or substance abuse (need to be referred to professional medical institutions, not suitable for group intervention). 2. Experienced major traumatic events in the past 3 months (such as the death of relatives, serious accidents, and PTSD symptoms caused by school violence). 3. They are receiving other systematic psychological interventions (such as weekly psychological counseling or cognitive behavior groups), and their effects may be confused with the intervention in this study. 4. Have participated in regular group courses with the theme of growth thinking, stress enhancement thinking or stress management (to avoid the practice effect). 5. Mental retardation, dyslexia or autism spectrum disorder (uncorrected) affect the understanding of the questionnaire and intervention content. 6. It is planned to transfer or take a long-term leave during the intervention period of this study, and it is impossible to complete all the measurements and courses |
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研究实施时间: Study execute time: |
从 From 2023-11-06 00:00:00至 To 2023-12-30 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2023-11-06 00:00:00 至 To 2023-11-09 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
结束 /Completed |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
由不参与干预实施的独立统计人员采用计算机(R软件的blockrand包)生成区组随机序列(区组大小固定为4,分配比例1:1,共6个区组) |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
Independent statisticians who did not participate in the intervention implementation used computers (blockrand package of R software) to generate a random sequence of blocks (block size is fixed at 4, allocation ratio is 1: 1, a total of 6 blocks). |
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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 |
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盲法: |
无 |
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Blinding: |
None |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
是Yes |
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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): |
数据存放与获取:通过临床试验公共管理平台ResMan(www.medresman.org.cn)公开查询:日期:2024年5月 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
This study has been completed and will be shared immediately from April 25th, 2026. The shared data is de-identified original data (IPD), including desensitized demographic data, baseline, intervention data and research plan, and does not contain any private information that can identify the subject. Data storage and acquisition: public inquiry through clinical trial public management platform RESMAN (www.medresman.org.cn). |
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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: |
本研究以纸质问卷为原始资料,采用Excel建立电子数据库,经双人交叉复核录入,严格开展数据质控。电子资料加密备份、权限管控,研究结束后数据已锁定归档,原始问卷与电子数据可双向溯源,数据管理规范合规。 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
In this study, the paper questionnaire was used as the original data, and the electronic database was established by Excel. After double cross-checking, the data quality control was strictly carried out. Electronic data encryption backup, authority control, after the study, the data has been locked and archived, the original questionnaire and electronic data can be traced back in both directions, and the data management is standardized and compliant. In this study, the paper questionnaire was used as the original data, and the electronic database was established by Excel. After double cross-checking, the data quality control was strictly carried out. Electronic data encryption backup, authority control, after the study, the data has been locked and archived, the original questionnaire and electronic data can be traced back in both directions, and the data management is standardized and compliant. |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
有/Yes |