ChiCTR2600125746 版本V1.0 版本创建时间2026/05/30 17:35:03 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:

ChiCTR2600125746 

最近更新日期:

Date of Last Refreshed on:

2026-05-30 17:34:57 

注册时间:

Date of Registration:

2026-05-30 00:00:00 

注册号状态:

预注册

Registration Status:

Prospective registration

注册题目:

自我疏离写作对大学新生社交焦虑的影响:认知重评和自我关怀的中介作用

Public title:

The impact of self-distancing writing on social anxiety among college freshmen: the mediating role of cognitive reappraisal and self-compassion

注册题目简写:

自我疏离写作对大学新生社交焦虑的影响:一项随机对照试验

English Acronym:

The Impact of Self-Distancing Writing on Social Anxiety Among College Freshmen: A Randomized Controlled Trial

研究课题的正式科学名称:

自我疏离写作对大学新生社交焦虑的影响:一项随机对照试验

Scientific title:

The Impact of Self-Distancing Writing on Social Anxiety Among College Freshmen: A Randomized Controlled Trial

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:

杨朔安 

研究负责人:

杨朔安 

Applicant:

Yang Shuoan 

Study leader:

Yang Shuoan 

申请注册联系人电话:

Applicant telephone:

+86 151 0595 4743

研究负责人电话:

Study leader's telephone:

+86 151 0595 4743

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:

yangshuoan1995@126.com

研究负责人电子邮件:

Study leader's E-mail:

yangshuoan1995@126.com

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:

福建省漳州市芗城区县前直街36 号

研究负责人通讯地址:

福建省漳州市芗城区县前直街36 号

Applicant address:

No. 36, Xianqian Straight Street, Xiangcheng District, Zhangzhou City, Fujian Province

Study leader's address:

No. 36, Xianqian Straight Street, Xiangcheng District, Zhangzhou City, Fujian 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:

闽南师范大学艺术学院

Applicant's institution:

School of Art, Minnan Normal University

研究负责人所在单位:

闽南师范大学艺术学院

Affiliation of the Leader:

School of Art, Minnan Normal University

是否获伦理委员会批准:

是/Yes

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

2026YS-03-002

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:

闽南师范大学艺术学院伦理委员会

Name of the ethic committee:

Minnan Normal University, School of Art, Ethics Review Committee

伦理委员会批准日期:

Date of approved by ethic committee:

2026-03-15 00:00:00

伦理委员会联系人:

许樱睿

Contact Name of the ethic committee:

XUYINGRUI

伦理委员会联系地址:

福建省漳州市芗城区县前直街36 号

Contact Address of the ethic committee:

No. 36, Xianqian Straight Street, Xiangcheng District, Zhangzhou City, Fujian Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 150 5960 0182

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:

闽南师范大学艺术学院

Primary sponsor:

School of Art, Minnan Normal University

研究实施负责(组长)单位地址:

福建省漳州市芗城区县前直街36 号

Primary sponsor's address:

No. 36, Xianqian Straight Street, Xiangcheng District, Zhangzhou City, Fujian 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):

福建省

市(区县):

Country:

China

Province:

FUJIAN

City:

单位(医院):

闽南师范大学艺术学院

具体地址:

福建省漳州市芗城区县前直街36 号

Institution
hospital:

School of Art, Minnan Normal University

Address:

No. 36, Xianqian Straight Street, Xiangcheng District, Zhangzhou City, Fujian Province

经费或物资来源:

Source(s) of funding:

None

Target disease:

Social anxiety

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:

本研究旨在探讨两个主要目标:1. 比较自我疏离写作干预与传统表达性写作和中性写作对照对大学新生社交焦虑症状的影响;2. 检验认知重评和自我关怀是否在自我疏离写作与社交焦虑缓解的关系中发挥平行中介作用。基于上述理论,我们假设:1. 与传统表达性写作和中性写作对照相比,自我疏离写作能更有效地缓解社交焦虑症状;2. 自我疏离写作对社交焦虑缓解的影响将同时受到认知重评和自我关怀的调节。  

Objectives of Study:

the present study aimed to investigate two primary objectives:1. to compare the impact of a self-distanced writing intervention with both traditional expressive writing and a neutral writing control on social anxiety symptoms among college freshmen; 2. To examine whether cognitive reappraisal and self-compassion operate as parallel mediators in the relationship between SDW and social anxiety reduction. Based on the preceding rationale, we hypothesized that: 1. self-distanced writing would lead to greater reductions in social anxiety symptoms compared to both traditional expressive writing and the neutral writing control; 2. The effect of self-distanced writing on social anxiety reduction would be concurrently mediated by increases in cognitive reappraisal and self-compassion.

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. 年龄在18至20岁之间;2. 在自评版利博维茨社交焦虑量表(LSAS-SR;Liebowitz,1987)上的得分达到38分或以上。38分是使用自评版量表在中国人群中识别具有临床意义的社交焦虑障碍的最佳敏感性和特异性平衡点(He、Zhang和Xiao,2004);3. 愿意提供书面知情同意书。

Inclusion criteria

1. age between 18 and 20 years; 2. a score of 38? or higher on the self-reported Liebowitz Social Anxiety Scale (LSAS-SR; Liebowitz, 1987). This cutoff of 38 represents the optimal balance of sensitivity and specificity for identifying clinically significant social anxiety disorder in Chinese populations using the self-report version (He, Zhang, & Xiao, 2004); 3. willingness to provide written informed consent.

排除标准:

1. 目前正在接受焦虑或抑郁的心理治疗或药物治疗;2. 有严重精神疾病史(例如,精神分裂症、双相情感障碍);3. 无法理解研究流程或问卷。

Exclusion criteria:

1. current participation in psychotherapy or pharmacotherapy for anxiety or depression; 2. a history of severe mental illness (e.g., schizophrenia, bipolar disorder); 3. inability to comprehend the study procedures or questionnaires.

研究实施时间:

Study execute time:

From 2026-03-26 00:00:00 To 2026-07-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2026-06-01 00:00:00 To 2026-07-31 00:00:00  

干预措施:

Interventions:

组别:

自我疏离写作(SDW)小组

样本量:

63

Group:

Self-Distanced Writing (SDW) Group:

Sample size:

干预措施:

参与者被要求以自我疏离的旁观者视角,描述最近一次令他们感到焦虑的社交情境。指导语如下:“请回忆最近一次令您感到焦虑或不安的社交情境。在接下来的20分钟里,请您尝试以旁观者或朋友的视角分析并描述这件事。请使用‘他/她’(或您自己的名字)来指代自己。请专注于分析当时的情境、您的想法和感受,就像您在帮助朋友理解他/她的经历一样。”

干预措施代码:

Intervention:

Participants were instructed to write about a recent, anxiety-provoking social situation from a self-distanced, observer-like perspective. The instructions were: "Please recall a recent social situation that made you feel anxious or troubled. For the next 20 minutes, we ask you to try to analyze and write about this event from the perspective of an observer or a friend. Please use ‘he/she’ (or your own name) to refer to yourself. Please focus on analyzing the situation, your thoughts, and feelings at that time, as if you were helping a friend understand his or her experience."

Intervention code:

组别:

传统表达性写作(EW)小组

样本量:

62

Group:

Traditional Expressive Writing (EW) Group

Sample size:

干预措施:

参与者进行经典的表达性写作(Pennebaker,1997):“请回忆最近一次让你感到焦虑或不安的社交情境。在接下来的20分钟里,请你写下你对这段经历最深层的感受和想法。请用‘我’来写作。”

干预措施代码:

Intervention:

Participants engaged in classic expressive writing (Pennebaker, 1997): "Please recall a recent social situation that made you feel anxious or troubled. For the next 20 minutes, we ask you to write about your very deepest emotions and thoughts regarding this experience. Use ‘I’ to write. "

Intervention code:

组别:

中性写作(NW)对照组

样本量:

62

Group:

Neutral Writing (NW) Control Group:

Sample size:

干预措施:

参与者完成了一项基于事实、不带情绪色彩的写作任务,以控制非特异性因素: “请尽可能详细、客观地描述您过去 24 小时内的所有活动。请避免描述您的感受或对这些活动的评价。”

干预措施代码:

Intervention:

Participants completed a fact-based, non-emotional writing task to control for non-specific factors :"Please describe, in as much detail and as objectively as possible, all your activities over the past 24 hours. Please avoid describing your feelings or evaluations of the activities."

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

福建省 

市(区县):

 

Country:

China 

Province:

FUJIAN 

City:

 

单位(医院):

闽南师范大学 

单位级别:

大学 

Institution
hospital:

Minnan Normal University

Level of the institution:

University

测量指标:

Outcomes:

指标中文名:

社交焦虑症状总分

指标类型:

主要指标

Outcome:

Total Score of Social Anxiety Symptoms (LSAS)

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

认知重评策略使用频率

指标类型:

主要指标

Outcome:

Frequency of Cognitive Reappraisal Use (ERQ-CR)

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

自我同情水平总分

指标类型:

主要指标

Outcome:

Total Score of Self-Compassion (SCS)

Type:

Primary 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 18 years
最大 Max age 22 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):

随机序列将由一位不参与参与者招募、评估及干预执行的研究团队成员,使用 IBM SPSS Statistics 26.0 软件,通过计算机生成的区组随机化方法产生,区组大小设为6。分组结果(自我疏离写作组、表达性写作组、中性写作组)将按顺序放入不透光、密封、编号的信封中,以实现分配隐藏。在基线评估完成后,由另一名独立的研究助理按顺序拆开信封,告知参与者其分组。

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

The random sequence will be generated by a research team member who is not involved in participant recruitment, assessment, or intervention delivery. A computer-generated block randomization list (block size of 6) will be created using IBM SPSS Statistics software (version 26.0). The allocation results (to Self-Distancing Writing, Expressive Writing, or Neutral Writing groups) will be concealed in sequentially numbered, opaque, sealed envelopes. After the baseline assessment, an independent research assistant will open the envelopes in sequence to inform participants of their group assignment.

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:

本研究为评估者盲。负责收集主要结局指标(问卷)的研究人员对参与者的分组情况不知情。由于干预性质(写作指导语不同),参与者和干预执行者无法设盲。

Blinding:

This study is assessor-blinded. The research staff responsible for collecting the primary outcome measures (questionnaires) will be blinded to group assignment. Participants? and intervention facilitators? cannot be blinded due to the nature of the interventions (different writing instructions).

是否共享原始数据:

IPD sharing

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):

2030年12月31号 邮箱:yangshuoan1995@126.com

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

December 31, 2030 yangshuoan1995@126.com

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:

采用为本研究专门设计的纸质版基线、干预后、随访评估问卷(包含人口学、LSAS、ERQ、SCS等量表)以及纸质写作任务记录页,作为原始数据记录文件。 不涉及商业EDC系统。所有纸质问卷及写作材料在收集后将由研究人员进行匿名化处理(仅保留研究ID),并由双人独立录入至加密的Microsoft Excel文件。电子数据将存储于受密码保护的计算机,纸质材料将保存于上锁的文件柜。数据核对与清理将在SPSS软件中进行。

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

Case Report Forms: Study-specific paper-based baseline, post-intervention, and follow-up assessment questionnaires? (including demographics, LSAS, ERQ, SCS) and paper writing task sheets? will serve as the original source documents. Data Management System: A commercial EDC system will not be used. All paper-based materials will be anonymized (labeled with Study ID only) upon collection. Data will be independently double-entered into password-protected Microsoft Excel files by two researchers. Electronic data will be stored on a password-protected computer, and paper materials in a locked cabinet. Data checking and cleaning will be performed in 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:

 2026-05-30 17:34:57