ChiCTR2600117841 版本V1.0 版本创建时间2026/01/29 10:50:49 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：

 ChiCTR2600117841 

最近更新日期：

Date of Last Refreshed on：

 2026-01-29 10:50:39 

注册时间：

Date of Registration：

 2026-01-29 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

中华传统文化心理资源在青少年心理健康教育与心理干预中的应用研究

Public title：

A Study on the Application of Traditional Chinese Cultural Psychological Resources in Adolescent Mental Health Education and Psychological Intervention

注册题目简写：

English Acronym：

研究课题的正式科学名称：

中华传统文化心理资源在青少年心理健康教育与心理干预中的应用研究

Scientific title：

A Study on the Application of Traditional Chinese Cultural Psychological Resources in Adolescent Mental Health Education and Psychological Intervention

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：

程宏宇 

研究负责人：

程宏宇 

Applicant：

Cheng Hongyu 

Study leader：

Cheng Hongyu 

申请注册联系人电话：

Applicant telephone：

 +86 158 6810 7896

研究负责人电话：

Study leader's
telephone：

+86 158 6810 7896

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：

 chy688198@zju.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 chy688198@zju.edu.cn

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 https://www.zju.edu.cn/

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：

浙江省杭州市西湖区玉泉路1号

研究负责人通讯地址：

浙江省杭州市西湖区玉泉路1号

Applicant address：

No. 1, Yuquan Road, Xihu District, Hangzhou City, Zhejiang Province

Study leader's address：

No. 1, Yuquan Road, Xihu District, Hangzhou City, Zhejiang 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：

浙江大学

Applicant's institution：

Zhejiang University

研究负责人所在单位：

浙江大学

Affiliation of the Leader：

Zhejiang University

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 浙大心理申伦[2025]054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：

浙江大学心理与行为科学系医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee, Department of Psychology and Behavioral Sciences, Zhejiang University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-10-20 00:00:00

伦理委员会联系人：

王苑

Contact Name of the ethic committee：

Wang Yuan

伦理委员会联系地址：

浙江省杭州市西湖区玉泉路1号

Contact Address of the ethic committee：

No. 1, Yuquan Road, Xihu District, Hangzhou City, Zhejiang Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 571 8827 3186

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：

浙江大学

Primary sponsor：

Zhejiang University

研究实施负责（组长）单位地址：

浙江省杭州市西湖区玉泉路1号

Primary sponsor's address：

No. 1, Yuquan Road, Xihu District, Hangzhou City, Zhejiang 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)：

浙江

市(区县)：

杭州

Country：

China

Province：

Zhejiang

City：

Hangzhou

单位(医院)：

浙江大学

具体地址：

浙江省杭州市西湖区玉泉路1号

Institution
hospital：

Zhejiang University

Address：

No. 1, Yuquan Road, Xihu District, Hangzhou City, Zhejiang Province

经费或物资来源：

全国教育科学规划课题（计划申报），前期由自主经费或横向经费支出。

Source(s) of funding：

National Education Science Planning Project (planned application), with preliminary expenses covered by independent funds or horizontal funds.

研究疾病：

青少年普通群体情绪困扰及轻中度抑郁、焦虑等障碍  

Target disease：

Emotional distress in the general adolescent population and mild-to-moderate depression, anxiety and other disorders

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：

1. 系统梳理儒释道及中医典籍中的心理健康理论，结合现代心理学构建本土化文化心理资本框架，填补青少年心理干预本土化理论空白。 2. 借鉴和结合现代心理健康教育与干预理念，开发 “中庸思维训练”“六艺熏陶”“正念观想” 等基于传统文化的标准化心理干预课程，验证其在改善 12-24 岁青少年（含普通群体及轻中度情绪障碍者）情绪状态、提升心理健康水平中的有效性。 3. 明确传统文化心理干预对青少年脑电活动、情绪应激水平（唾液皮质醇）的影响，揭示其神经生理机制。 4. 形成可推广的校本心理健康教育与干预方案，为突破青少年心理干预技术本土化瓶颈、推动我国青少年心理健康教育发展提供实践支撑。  

Objectives of Study：

1. Systematically sort out mental health theories in Confucian, Buddhist, Taoist and Traditional Chinese Medicine classics, and construct an indigenous cultural psychological capital framework combined with modern psychology, filling the gap in indigenous theories of adolescent psychological intervention. 2. Drawing on and integrating modern mental health education and intervention concepts, develop standardized traditional culture-based psychological intervention courses such as the Doctrine of the Mean thinking training, Six Arts edification and mindfulness meditation, and verify their effectiveness in improving emotional states and enhancing mental health among adolescents aged 12 to 24 (including general groups and those with mild-to-moderate emotional disorders). 3. Clarify the effects of traditional culture-based psychological intervention on adolescents' electroencephalogram (EEG) activities and emotional stress levels (salivary cortisol), and reveal its neurophysiological mechanisms. 4. Form a promotable school-based mental health education and intervention program, providing practical support for breaking the bottleneck of localization in adolescent psychological intervention technology and advancing the development of adolescent mental health education in China.

药物成份或治疗方案详述：

1. 总周期：12周为一个完整干预疗程，无延期或缩短情形，确因不良事件需暂停者，待问题解决后评估是否重启，重启后需补足干预时长。 2. 实施频次：每周开展2次干预，每次30分钟，间隔3-4天（如周二、周五）；采用团体干预模式，每组15-20人，人员固定，避免中途增减组员。 3. 时间安排：干预时段避开学业高峰（如课间、晚自习），中小学组安排在下午课后16:30-17:00，高校组安排在晚间19:00-19:30，确保参与度。 4、核心干预内容（标准化课程体系） 干预组采用“三维一体”传统文化心理干预课程，对照组采用常规心理健康教育课程（含情绪管理常识、压力应对技巧等通用内容），两组课程时长、频次完全一致，仅核心内容有差异。干预组具体课程包括但不限于以下模块：中庸思维训练（共8课时），六艺熏陶（共16课时）, 正念观想（共42课时）。 具体内容以中庸思维训练为例包括：1. 理论导入（2课时）：结合《论语》《中庸》经典名句，用青少年易懂的语言解读“执两用中”理念，结合学业压力、人际矛盾等场景案例，分析极端认知与负面情绪的关联；2. 情境模拟（4课时）：设置“考试失利后自我否定”“与同学冲突后报复心理”等典型场景，让组员分组演练中庸思维的应用的，学习“既不压抑情绪，也不盲目发泄”的应对方式，干预师现场点评指导；3. 日记反思（2课时）：引导组员记录每日极端认知事件，运用中庸思维改写认知逻辑，分享交流并优化思维模式。  

Description for medicine or protocol of treatment in detail：

1. Total Cycle: A full intervention course lasts 12 weeks, with no extension or shortening allowed. In case of suspension due to adverse events, eligibility for resumption will be reassessed after the issue is resolved, and the missed intervention duration must be supplemented upon resumption. 2. Implementation Frequency: The intervention is delivered twice a week, 30 minutes per session, with an interval of 3–4 days (e.g., Tuesday and Friday). A group intervention model is adopted, with 15–20 fixed participants per group; no addition or reduction of members is allowed midway. 3. Schedule Arrangement: Intervention sessions are arranged outside peak academic hours (e.g., between classes, evening self-study). The session for primary and secondary school students is scheduled from 16:30 to 17:00 after afternoon classes, and for college students from 19:00 to 19:30 in the evening to ensure participation rate. 4. Core Intervention Content (Standardized Curriculum System): The intervention group receives a "three-dimensional integrated" traditional culture-based psychological intervention curriculum, while the control group receives routine mental health education (including general content such as emotional management knowledge and stress coping skills). The two groups have identical curriculum duration and frequency, with differences only in core content. The intervention group’s specific curriculum includes but is not limited to the following modules: Doctrine of the Mean Thinking Training (8 class hours), Six Arts Edification (16 class hours), and Mindfulness Meditation (42 class hours). Taking the Doctrine of the Mean Thinking Training as an example, the detailed content is as follows: (1)Theoretical Introduction (2 class hours): Combining classic quotations from The Analects and The Doctrine of the Mean, the concept of "holding the mean between two extremes" is explained in adolescent-friendly language. Combined with scenario cases such as academic pressure and interpersonal conflicts, the correlation between extreme cognition and negative emotions is analyzed. (2)Scenario Simulation (4 class hours): Typical scenarios (e.g., self-denial after exam failure, retaliatory mentality after conflicts with peers) are designed. Group members practice applying the Doctrine of the Mean thinking in groups, learn to "neither suppress emotions nor vent blindly", with on-site comments and guidance from interventionists. (3)Diary Reflection (2 class hours): Participants are guided to record daily extreme cognition events, rewrite cognitive logic with the Doctrine of the Mean thinking, and share and exchange experiences to optimize their thinking patterns. 

纳入标准：

1. 年龄在 12-24 岁之间，为在校中小学或高校学生； 2. 普通青少年需满足 PHQ-9（抑郁筛查量表）与 GAD-7（焦虑筛查量表）评分均＜10 分；轻中度情绪障碍者需满足 PHQ-9 评分 10-19 分、GAD-7 评分 10-14 分； 3. 未接受其他心理干预治疗（含药物干预、心理辅导等）； 4. 自愿参与本研究，18 岁以下受试者需经监护人知情同意并共同签署知情同意书； 5. 具备基本的理解与沟通能力，能够配合完成量表填写、干预课程参与及相关检测（EEG、唾液皮质醇检测等）。

Inclusion criteria

1. Aged 12-24 years old and currently enrolled as a primary/secondary school or college student. 2. For general adolescents: scores of both the Patient Health Questionnaire-9 (PHQ-9, depression screening scale) and Generalized Anxiety Disorder-7 (GAD-7, anxiety screening scale) are <10; for those with mild-to-moderate emotional disorders: PHQ-9 score ranges from 10 to 19 and GAD-7 score ranges from 10 to 14. 3. No history of other psychological interventions (including medication intervention, psychological counseling, etc.). 4. Voluntarily participate in this study; subjects under 18 years old must obtain guardians' informed consent and sign the informed consent form jointly with guardians. 5. Possess basic comprehension and communication abilities, and be able to cooperate in completing scale filling, intervention course participation and relevant tests (e.g., EEG, salivary cortisol test).

排除标准：

1. 存在重度情绪障碍（PHQ-9 评分≥20 分、GAD-7 评分≥15 分）或其他严重精神疾病； 2. 患有严重躯体疾病（如严重心脑血管疾病、神经系统疾病等）、认知障碍或智力发育迟缓； 3. 近 3 个月内参与过其他心理干预类研究或接受过专业心理治疗； 4. 存在药物滥用史、酒精依赖或其他可能影响研究结果的不良生活习惯； 5. 无法配合完成研究全程干预、数据收集及相关检测，或研究者判断存在其他不适宜参与本研究的情况。

Exclusion criteria：

1. Suffering from severe emotional disorders (PHQ-9 score ≥20, GAD-7 score ≥15) or other severe mental illnesses. 2. Having severe physical diseases (e.g., severe cardio-cerebrovascular diseases, nervous system diseases, etc.), cognitive impairment or intellectual developmental delay. 3. Having participated in other psychological intervention studies or received professional psychotherapy in the past 3 months. 4. Having a history of substance abuse, alcohol dependence, or other unhealthy living habits that may affect the research results. 5. Unable to cooperate with the full-course intervention, data collection and relevant tests of the study, or other circumstances deemed inappropriate for participation by researchers.

研究实施时间：

Study execute time：

从 From 2026-02-01 00:00:00至 To 2029-12-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-02-18 00:00:00 至 To 2026-08-31 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 150

Group：

Intervention Group

Sample size：

干预措施：

干预组：接受基于中华传统文化的心理干预课程，包括 “中庸思维训练”“六艺熏陶”“正念观想”“情志相胜法” 等核心模块，以团体工作坊、个体指导相结合的形式开展，每周 2 次，每次 30 分钟，持续 12 周。

干预措施代码：

Intervention：

Intervention group: Participants receive traditional Chinese culture-based psychological intervention courses covering core modules including Doctrine of the Mean Thinking Training, Six Arts Edification, Mindfulness Meditation, and Emotional Counteraction Therapy. The intervention is delivered through a combination of group workshops and individual guidance, twice a week, 30 minutes per session, for 12 consecutive weeks.

Intervention code：

组别：

对照组

样本量：

 150

Group：

Control group

Sample size：

干预措施：

对照组：接受常规心理健康教育课程（如情绪管理基础、压力应对常识、人际交往技巧等通用内容），干预时长、频率及实施形式与干预组保持一致，确保基线干预条件均衡。

干预措施代码：

Intervention：

Control group: Participants receive routine mental health education courses (including general content such as basic emotional management, common stress coping knowledge, and interpersonal skills). The intervention duration, frequency and delivery format are consistent with the intervention group to ensure balanced baseline intervention conditions.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 浙江 

市(区县)：

 杭州 

Country：

China

Province：

Zhejiang

City：

Hangzhou

单位(医院)：

 浙江大学 

单位级别：

 大学 

Institution
hospital：

Zhejiang University

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

抑郁症状改善程度（PHQ-9评分）

指标类型：

主要指标

Outcome：

Degree of improvement in depressive symptoms (PHQ-9 score)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

焦虑症状改善程度（GAD-7评分）

指标类型：

次要指标

Outcome：

Degree of improvement in anxiety symptoms (GAD-7 score)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

情绪调节能力

指标类型：

次要指标

Outcome：

Emotional regulation ability

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

脑电活动指标（α波、β波功率等）

指标类型：

次要指标

Outcome：

Electroencephalogram (EEG) activity indicators (such as alpha wave, beta wave power, etc.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

情绪应激水平（唾液皮质醇浓度）

指标类型：

次要指标

Outcome：

Emotional stress level (salivary cortisol concentration)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

行为表现与干预依从性

指标类型：

次要指标

Outcome：

Behavioral performance and intervention compliance

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

安全性指标（包括不良事件（如情绪波动加剧、躯体不适等）、不良反应）

指标类型：

副作用指标

Outcome：

Safety indicators (including adverse events (such as increased mood swings, physical discomfort, etc.), adverse reactions)

Type：

Adverse events

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：

唾液

组织：

Sample Name：

Saliva

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

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 12 岁 years
最大 Max age 24 岁 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）：

本研究采用计算机软件生成随机数字序列，由不参与受试者纳入与筛查的独立统计人员负责，通过 SPSS 软件的 “随机数生成器” 功能，按年龄分层（确保各年龄层随机序列独立）生成 1:1 分配的随机序列，对应干预组与对照组。

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

In this study, a random number sequence was generated by computer software, which was undertaken by an independent statistician not involved in subject recruitment and screening. Using the "Random Number Generator" function in SPSS software, a 1:1 allocation random sequence corresponding to the intervention group and the control group was generated with age stratification (ensuring independent random sequences for each age group).

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：

由于干预内容具有明确的文化特色，无法对受试者及干预实施者进行完全盲法，但对结局评估者（量表评分审核者、脑电数据分析师、唾液皮质醇检测人员）采用单盲设计，即结局评估者不了解受试者的分组情况，以减少评估偏倚。

Blinding：

Due to the distinct cultural characteristics of the intervention content, it is impossible to completely blind the subjects and the intervention implementer. However, a single-blind design is adopted for the outcome evaluators (scale score reviewers, electroencephalogram data analysts, and salivary cortisol testers), meaning that the outcome evaluators do not know the grouping of the subjects to reduce assessment bias.

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）：

通过国家科技资源共享服务平台（如国家人口与健康科学数据中心）或国际公认的科研数据共享平台（如 Figshare）进行共享。

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

Data sharing will be conducted via national science and technology resource sharing service platforms (e.g., National Population and Health Science Data Center) or internationally recognized scientific research data sharing platforms (e.g., Figshare).

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：

本研究数据采集与管理严格遵循学术规范及数据溯源要求，采用病例记录表（Case Record Form, CRF）与电子数据采集和管理系统（Electronic Data Capture, EDC）相结合的方式开展，确保数据的完整性、准确性与安全性。 1、病例记录表（CRF）管理 a. 表单设计：定制化编制CRF，内容涵盖受试者基线信息（年龄、性别、学段等人口学特征）、筛查指标（PHQ-9、GAD-7量表评分）、干预过程记录（课程参与情况、依从性、不良事件）、结局评估数据（各时间点量表评分、EEG指标、唾液皮质醇浓度）及随访信息，确保每一项研究数据均有对应记录项，无遗漏核心指标。 b. 填写规范：由经过培训的研究助理负责填写，填写时严格对照原始检测报告、干预记录，做到及时、准确、清晰，无涂改、无缺项；若需修正数据，需标注修改日期、修改人及修改原因，保留原始数据痕迹，确保可溯源。 c. 归档保管：CRF填写完成后，由专人核对无误后签字确认，按受试者编号顺序整理归档，存放于加密文件柜，建立借阅登记制度，仅授权研究人员可查阅，杜绝数据泄露或丢失。 2、电子数据采集和管理系统（EDC）应用 本研究采用基于互联网的EDC系统ResMan开展电子数据采集与管理，实现数据的数字化管控与高效溯源。 a. 数据录入：研究助理在CRF填写完成24小时内，将数据同步录入ResMan系统，录入过程中严格遵循“一人一账号”原则，账号设置专属密码并定期更换，录入数据后由双人交叉核对，确保电子数据与CRF原始数据完全一致。 b. 系统管控：ResMan系统具备数据校验、权限分级、操作日志追溯功能。数据校验可自动识别异常值（如量表评分超出合理范围）并提示，需研究人员核实后手动确认；权限分级明确，统计人员、干预人员、研究助理分别对应不同操作权限，避免数据篡改；操作日志实时记录所有数据录入、修改、查阅行为，全程可追溯。 c. 数据备份与安全：系统自动每日进行数据云端备份，同时定期导出数据至加密服务器，采用双重备份策略防止数据丢失；数据传输及存储过程采用加密协议，严格遵守数据隐私保护规定，隐匿受试者个人身份信息，仅以唯一编号关联数据。

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

Data collection and management in this study strictly adhere to academic norms and data traceability requirements. A combined approach of Case Record Form (CRF) and Electronic Data Capture (EDC) system is adopted to ensure the completeness, accuracy and security of data. I. Management of Case Record Form (CRF) a) Form Design: A customized CRF is developed, covering subjects' baseline information (demographic characteristics such as age, gender and educational stage), screening indicators (PHQ-9 and GAD-7 scale scores), intervention process records (course participation, compliance, adverse events), outcome assessment data (scale scores at each time point, EEG indicators, salivary cortisol concentrations) and follow-up information. Each piece of research data is assigned a corresponding record item to ensure no core indicators are omitted. b) Completion Specifications: The CRF is filled out by trained research assistants, who strictly cross-reference original test reports and intervention records to ensure timeliness, accuracy and clarity, with no alterations or missing items. If data revision is required, the revision date, reviser and revision reason must be indicated, and original data traces shall be retained to ensure traceability. c) Filing and Storage: After completion, the CRF is verified by designated personnel, signed upon confirmation of accuracy, sorted and filed by unique subject number, and stored in an encrypted file cabinet. A borrowing registration system is established, allowing access only for authorized researchers to prevent data leakage or loss. II. Application of Electronic Data Capture (EDC) System This study adopts ResMan, an internet-based EDC system, for electronic data collection and management to realize digital data control and efficient traceability. a) Data Entry: Research assistants enter data into the ResMan system within 24 hours after CRF completion, strictly following the "one person, one account" principle. Exclusive passwords are set for accounts and updated regularly. After entry, data is cross-checked by two independent staff to ensure full consistency between electronic data and original CRF data. b) System Control: The ResMan system is equipped with data verification, hierarchical permission management and operation log traceability functions. Data verification can automatically identify and prompt outliers (e.g., scale scores beyond reasonable ranges), which require manual confirmation by researchers after verification. Hierarchical permissions are clearly defined, with distinct operation rights assigned to statisticians, interventionists and research assistants to prevent data tampering. Operation logs record all data entry, revision and inquiry behaviors in real time, enabling full-process traceability. c) Data Backup and Security: The system performs automatic daily cloud backup of data and regularly exports data to an encrypted server, adopting a dual backup strategy to prevent data loss. Encryption protocols are applied during data transmission and storage, and data privacy protection regulations are strictly followed. Subjects' personal identification information is anonymized, and data is linked only via unique subject numbers.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

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  2026-01-29 10:50:39