ChiCTR2500113703 版本V1.0 版本创建时间2025/12/02 11:12:28 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：

 ChiCTR2500113703 

最近更新日期：

Date of Last Refreshed on：

 2025-12-02 11:12:17 

注册时间：

Date of Registration：

 2025-12-02 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

1、请上传通过伦理审核的完整的最新版知情同意书（目前该处所传为方案），并完善纳入、排除标准，主次要指标等信息，与最新版研究方案一致（如有变更）； 2、确认征募起始时间，如未开始征募参试者，时间适当后延。 完成后回复邮件。 ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ? ??支持性正念自助干预（iMIED）对情绪困扰的成本效益与预防效果研究

Public title：

A Study on the Cost-Effectiveness and Preventive Efficacy of Supported Mindfulness-Based Self-Help Intervention (iMIED) for Emotional Distress

注册题目简写：

English Acronym：

研究课题的正式科学名称：

支持性正念自助干预（iMIED）对情绪困扰的成本效益与预防效果研究

Scientific title：

A Study on the Cost-Effectiveness and Preventive Efficacy of Supported Mindfulness-Based Self-Help Intervention (iMIED) for Emotional Distress

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：

张忆南 

研究负责人：

刘兴华 

Applicant：

Yinan Zhang 

Study leader：

Xinghua Liu 

申请注册联系人电话：

Applicant telephone：

 +86 158 2333 9524

研究负责人电话：

Study leader's
telephone：

+86 133 7166 9818

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：

 15823339524@163.com

研究负责人电子邮件：

Study leader's E-mail：

 xinghua_liu@pku.edu.cn

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 Peking University

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：

北京市颐和园路5号

研究负责人通讯地址：

北京市颐和园路5号

Applicant address：

Beijing, No.5 Summer Palace Road

Study leader's address：

Beijing, No.5 Summer Palace Road

申请注册联系人邮政编码：

Applicant postcode：

 100010

研究负责人邮政编码：

Study leader's postcode：

 100010

申请人所在单位：

北京大学

Applicant's institution：

Peking University

研究负责人所在单位：

北京大学

Affiliation of the Leader：

Peking 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：

 伦理批准书#2025-11-01

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：

北京大学心理与认知科学学院伦理及人体和动物保护委员会

Name of the ethic committee：

Committee for Protecting Human and Animal Subjects School of Psychological and Cognitive Sciences

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-11-21 00:00:00

伦理委员会联系人：

王垒

Contact Name of the ethic committee：

Lei Wang

伦理委员会联系地址：

北京市颐和园路5号

Contact Address of the ethic committee：

Beijing, No.5 Summer Palace Road

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 10 6275 7551

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 leiwang@pku.edu.cn

研究实施负责（组长）单位：

北京大学

Primary sponsor：

Peking University

研究实施负责（组长）单位地址：

北京市颐和园路5号

Primary sponsor's address：

Beijing, No.5 Summer Palace Road

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

北京大学

具体地址：

北京市颐和园路5号

Institution
hospital：

Peking University

Address：

Beijing, No.5 Summer Palace Road

经费或物资来源：

北京大学教育基金会

Source(s) of funding：

Peking University Education Foundation

研究疾病：

情绪困扰  

Target disease：

Emotional Distress

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：

本研究采用严谨的 2 年期随机对照试验设计，旨在从三个关键维度提供高水平证据支持。在临床价值层面，本研究将验证 “轻度支持 + 标准化内容” 的干预模式是否比常规干预更具优势，同时明确该干预模式对情绪障碍的预防作用。在经济价值层面，研究将首次针对情绪困扰人群开展正念干预的成本效益分析，为公共卫生决策提供关键的数据参考。在实施科学价值层面，研究将探索正念干预小程序在真实场景中的可持续使用模式，为数字心理健康干预措施的优化与落地应用提供实践依据。 本研究的立题依据紧密围绕数字心理健康领域的核心需求：在保障干预效果的前提下，通过 “支持性自助” 这一创新性设计，破解干预措施在可及性与有效性之间的固有矛盾；同时，借助长期随访数据与经济学分析，构建完整的证据链，为将低成本正念干预纳入公共卫生体系提供不可替代的科学支撑。  

Objectives of Study：

This study adopts a rigorous 2-year RCT design, aiming to generate high-level evidence in three key domains. Clinically, it will validate whether a "minimally supported + standardized content" intervention model yields superior efficacy compared to TAU and clarify its preventive effects on emotional disorders. Economically, this research will conduct the first cost-effectiveness analysis of mindfulness interventions targeting individuals with emotional distress, providing critical data to support public health decision-making. From an implementation science perspective, it will explore sustainable real-world usage patterns of a mindfulness intervention mini-program, thereby facilitating the optimized deployment of digital mental health interventions. The rationale for this study is grounded in unmet needs within the field of digital mental health: while ensuring intervention efficacy, the innovative "supported self-help" design addresses the inherent tension between accessibility and effectiveness. Through long-term follow-up and economic analysis, this research aims to establish an irreplaceable evidence base for integrating low-cost mindfulness interventions into public health systems.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

年龄在18～65岁之间。 伴有情绪困扰表现（如焦虑、抑郁等），且情绪困扰程度符合干预条件（PHQ-9得分≥5或GAD-7得分≥5）。 在研究期间愿意遵守正念自助课程训练和随访要求。

Inclusion criteria

Aged between 18 and 65 years. Presenting with emotional distress (e.g., anxiety, depression) with severity meeting the intervention requirements (PHQ-9 score >= 5 or GAD-7 score >= 5). Willing to comply with the requirements of mindfulness self-help courses and follow-up during the study period.

排除标准：

患有未受控的精神疾病（如重度抑郁症、精神分裂症等）或最近6个月内有自杀意念者. 之前参与过MIED相关课程或其他正念训练者。 无法参加规定的干预计划（因工作、生活等原因无法按时参加干预）。

Exclusion criteria：

Suffering from uncontrolled mental illnesses (e.g., major depressive disorder, schizophrenia) or having suicidal ideation within the past 6 months. Having previously participated in MIED-related courses or other mindfulness training programs. Unable to participate in the specified intervention plan (unable to attend the intervention on time due to work, life, or other reasons).

研究实施时间：

Study execute time：

从 From 2025-12-01 00:00:00至 To 2027-12-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-12-05 00:00:00 至 To 2026-01-01 00:00:00

干预措施：

Interventions：

组别：

iMIED组

样本量：

 500

Group：

iMIED Group

Sample size：

干预措施：

支持性正念自助干预（iMIED）基于刘兴华课题组开发的情绪困扰的正念干预（MIED），是针对情绪困扰人群的循证治疗方法。以微信小程序为工具，支持来访者以学练结合的形式完成49天打卡任务。其采用了生物-心理-社会系统观以及投入生活、调试痛苦容纳力、调试情绪性行为和提高认知灵活性心理病理菱形模型4个策略帮助来访改变。 iMIED具有较强的临床应用潜力，其干预周期相对较短（通常为49天），起效较快，且基于“生物-心理-社会”模型构建的四维病理机制（生活投入不足、痛苦容纳力偏低、情绪性行为过度、认知灵活性不足）与四大干预策略（提高生活投入、提升痛苦容纳力、调适过度情绪性行为、增强认知灵活性）逐一对应，使得干预目标明确、病因学与操作方法紧密衔接，有望实现精准干预并降低复发风险。

干预措施代码：

Intervention：

The supported mindfulness-based self-help intervention (iMIED) is based on the Mindfulness Intervention for Emotional Distress (MIED) developed by Xinghua Liu’s research team, an evidence-based treatment for individuals with emotional distress. Delivered via a WeChat Mini Program, it supports participants in completing a 49-day check-in task through a combination of learning and practice. Adopting a bio-psycho-social systems perspective, it employs four strategies derived from the psychopathological diamond model—engaging in life, regulating distress tolerance, adjusting emotional behavior, and enhancing cognitive flexibility—to facilitate behavioral change in participants. iMIED holds significant clinical application potential. With a relatively short intervention cycle (typically 49 days) and rapid onset of effects, its four-dimensional pathological mechanism (insufficient life engagement, low distress tolerance, excessive emotional behavior, and inadequate cognitive flexibility) based on the "bio-psycho-social" model is directly aligned with four core intervention strategies (improving life engagement, enhancing distress tolerance, regulating excessive emotional behavior, and boosting cognitive flexibility). This alignment ensures clear intervention targets, tight connection between etiology and operational methods, and is expected to achieve precise intervention and reduce relapse risk.

Intervention code：

组别：

等待组

样本量：

 500

Group：

Waiting Listing Group

Sample size：

干预措施：

常规治疗加安慰剂。

干预措施代码：

Intervention：

TAU plus placebo.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 Beijing 

市(区县)：

 Beijing 

Country：

China

Province：

Beijing

City：

Beijing

单位(医院)：

 北京大学 

单位级别：

 大学 

Institution
hospital：

Peking University

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

焦虑症状

指标类型：

主要指标

Outcome：

Anxiety Symptom

Type：

Primary indicator

测量时间点：

分别在干预第3周（T1），干第5周（T2），干预第8周（T3），干预后3个月（T4），干预结束后6个月（T5），干预结束后12个月（T6），干预结束后第24个月（T7）使用标准化的量表测量所有被试的情绪状态等指标进行测量。

测量方法：

OASIS、GAD-7

Measure time point of outcome：

At the 3rd week (T1), 5th week (T2), and 8th week (T3) of the intervention, as well as at 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention, standardized scales were used to measure all participants' emotional states and other indicators.

Measure method：

OASIS & GAD-7

指标中文名：

抑郁症状

指标类型：

主要指标

Outcome：

Depression Symptom

Type：

Primary indicator

测量时间点：

分别在干预第3周（T1），干第5周（T2），干预第8周（T3），干预后3个月（T4），干预结束后6个月（T5），干预结束后12个月（T6），干预结束后第24个月（T7）使用标准化的量表测量所有被试的情绪状态等指标进行测量。

测量方法：

ODSIS、PHQ-9

Measure time point of outcome：

At the 3rd week (T1), 5th week (T2), and 8th week (T3) of the intervention, as well as at 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention, standardized scales were used to measure all participants' emotional states and other indicators.

Measure method：

ODSIS & PHQ-9

指标中文名：

过度的情绪性行为

指标类型：

主要指标

Outcome：

Excessive emotional behavior

Type：

Primary indicator

测量时间点：

分别在干预第3周（T1），干第5周（T2），干预第8周（T3），干预后3个月（T4），干预结束后6个月（T5），干预结束后12个月（T6），干预结束后第24个月（T7）使用标准化的量表测量所有被试的情绪状态等指标进行测量。

测量方法：

Excessive Emotional Behavior Inventory、AAQ-II、BEAQ

Measure time point of outcome：

At the 3rd week (T1), 5th week (T2), and 8th week (T3) of the intervention, as well as at 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention, standardized scales were used to measure all participants' emotional states and other indicators.

Measure method：

Excessive Emotional Behavior Inventory & AAQ-II & BEAQ

指标中文名：

痛苦容纳

指标类型：

次要指标

Outcome：

Distress Tolerance

Type：

Secondary indicator

测量时间点：

分别在干预第3周（T1），干第5周（T2），干预第8周（T3），干预后3个月（T4），干预结束后6个月（T5），干预结束后12个月（T6），干预结束后第24个月（T7）使用标准化的量表测量所有被试的情绪状态等指标进行测量。

测量方法：

DIS、DTS

Measure time point of outcome：

At the 3rd week (T1), 5th week (T2), and 8th week (T3) of the intervention, as well as at 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention, standardized scales were used to measure all participants' emotional states and other indicators.

Measure method：

DIS & DTS

指标中文名：

生活投入度

指标类型：

次要指标

Outcome：

Engaging in Life Scale

Type：

Secondary indicator

测量时间点：

分别在干预第3周（T1），干第5周（T2），干预第8周（T3），干预后3个月（T4），干预结束后6个月（T5），干预结束后12个月（T6），干预结束后第24个月（T7）使用标准化的量表测量所有被试的情绪状态等指标进行测量。

测量方法：

Engaging in Life Scale

Measure time point of outcome：

At the 3rd week (T1), 5th week (T2), and 8th week (T3) of the intervention, as well as at 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention, standardized scales were used to measure all participants' emotional states and other indicators.

Measure method：

Engaging in Life Scale

指标中文名：

认知灵活性

指标类型：

次要指标

Outcome：

Cognitive Flexibility

Type：

Secondary indicator

测量时间点：

分别在干预第3周（T1），干第5周（T2），干预第8周（T3），干预后3个月（T4），干预结束后6个月（T5），干预结束后12个月（T6），干预结束后第24个月（T7）使用标准化的量表测量所有被试的情绪状态等指标进行测量。

测量方法：

Treating Thought as Thought Scale (TTT) 、认知灵活性问卷

Measure time point of outcome：

At the 3rd week (T1), 5th week (T2), and 8th week (T3) of the intervention, as well as at 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention, standardized scales were used to measure all participants' emotional states and other indicators.

Measure method：

Treating Thought as Thought Scale (TTT) & CFI

指标中文名：

成本

指标类型：

主要指标

Outcome：

Cost

Type：

Primary indicator

测量时间点：

分别在干预第3周（T1），干第5周（T2），干预第8周（T3），干预后3个月（T4），干预结束后6个月（T5），干预结束后12个月（T6），干预结束后第24个月（T7）使用标准化的量表测量所有被试的情绪状态等指标进行测量。

测量方法：

TIC-P、HEQ、中国疾病相关成本评估问卷

Measure time point of outcome：

At the 3rd week (T1), 5th week (T2), and 8th week (T3) of the intervention, as well as at 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention, standardized scales were used to measure all participants' emotional states and other indicators.

Measure method：

TIC-P & HEQ & Chinese Questionnaire for Disease-Related Cost Assessment

指标中文名：

收益

指标类型：

主要指标

Outcome：

Benefit

Type：

Primary indicator

测量时间点：

分别在干预第3周（T1），干第5周（T2），干预第8周（T3），干预后3个月（T4），干预结束后6个月（T5），干预结束后12个月（T6），干预结束后第24个月（T7）使用标准化的量表测量所有被试的情绪状态等指标进行测量。

测量方法：

EQ-5D-5L

Measure time point of outcome：

At the 3rd week (T1), 5th week (T2), and 8th week (T3) of the intervention, as well as at 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention, standardized scales were used to measure all participants' emotional states and other indicators.

Measure method：

EQ-5D-5L

指标中文名：

人口统计学信息

指标类型：

附加指标

Outcome：

Demographic Information

Type：

Additional indicator

测量时间点：

分别在干预第3周（T1），干第5周（T2），干预第8周（T3），干预后3个月（T4），干预结束后6个月（T5），干预结束后12个月（T6），干预结束后第24个月（T7）使用标准化的量表测量所有被试的情绪状态等指标进行测量。

测量方法：

Demographic Questionnaire

Measure time point of outcome：

At the 3rd week (T1), 5th week (T2), and 8th week (T3) of the intervention, as well as at 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention, standardized scales were used to measure all participants' emotional states and other indicators.

Measure method：

Demographic Questionnaire

指标中文名：

正念水平

指标类型：

附加指标

Outcome：

Mindfulness

Type：

Additional indicator

测量时间点：

分别在干预第3周（T1），干第5周（T2），干预第8周（T3），干预后3个月（T4），干预结束后6个月（T5），干预结束后12个月（T6），干预结束后第24个月（T7）使用标准化的量表测量所有被试的情绪状态等指标进行测量。

测量方法：

FFMQ-SF

Measure time point of outcome：

At the 3rd week (T1), 5th week (T2), and 8th week (T3) of the intervention, as well as at 3 months (T4), 6 months (T5), 12 months (T6), and 24 months (T7) post-intervention, standardized scales were used to measure all participants' emotional states and other indicators.

Measure method：

FFMQ-SF

指标中文名：

不良事件

指标类型：

附加指标

Outcome：

Adverse Event

Type：

Additional indicator

测量时间点：

测量方法：

不良事件记录表

Measure time point of outcome：

Measure method：

Adverse Event Record Form

指标中文名：

使用者满意度和意见反馈

指标类型：

附加指标

Outcome：

User Satisfaction and Feedback

Type：

Additional indicator

测量时间点：

测量方法：

User Satisfaction and Feedback Form

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

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 岁 years
最大 Max age 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）：

随机化方法：?? 本研究采用基于计算机的简单随机分配法。 ??实施步骤：?? 使用R软件（4.3.1版本）生成随机序列。 首先创建一个包含1000个连续唯一ID的研究对象列表。 设置随机种子（seed = 123）以确保结果可重现。 为每个ID生成一个服从均匀分布（0-1区间）的随机数。 根据随机数的大小对所有ID进行重新排序，实现样本序列的完全随机打乱。 将打乱后序列的前500个ID分配至A组（干预组），后500个ID分配至B组（对照组）。 ??隐蔽机制：?? 随机分配序列由独立统计师在数据库锁定后生成，分组结果直接导入研究数据库，研究招募人员在入组前无法预知分配序列。

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

Randomization Method:?? A computer-based simple randomization procedure was employed. ??Procedures:?? The random sequence was generated using R software (version 4.3.1). A list of 1000 consecutive unique participant IDs was created. A random seed (seed = 123) was set to ensure reproducibility. A unique random number, following a uniform distribution (interval 0-1), was generated for each ID. All IDs were then completely re-ordered by sorting based on the assigned random numbers. The first 500 IDs in the scrambled sequence were allocated to Group A (intervention), and the remaining 500 IDs were allocated to Group B (control). ??Allocation Concealment:?? The random allocation sequence was generated by an independent statistician after database lock. The assignment results were directly imported into the research database, ensuring that recruiters could not foresee the allocation sequence before enrollment.

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：

一、参与者盲法设计? 为避免参与者因知晓分组信息产生期望偏差，采用 “模糊分组标识 + 合理理由解释” 的盲法策略：? 向所有参与者仅告知其所属 “学员批次编号”（如 “2025 组学员”“2027 组学员”），不透露任何与 “实验组 / 对照组” 相关的分组信息；同时以 “项目资源有限，需按批次分阶段开展” 为合理理由，解释不同批次学员接收内容的时间差异，减少参与者对分组的猜测，确保其始终处于盲态。? 二、干预者（辅助打卡助教）盲法设计? 为避免助教因知晓分组信息产生操作偏差（如对实验组学员额外提示），采用 “标准化操作 + 内容盲态” 的实施方式：? 操作标准化：所有辅助打卡的助教需严格遵循统一流程，在每日规定时间向对应批次学员发送学习内容链接，且发送时间、话术（如 “今日学习链接已送达，请注意查收”）均提前固定，不允许自主调整；? 内容盲态控制：助教仅负责按预设名单发送链接，不被告知各链接对应的分组属性（即无法区分所发链接属于实验组还是对照组），从信息源头确保其对分组情况处于盲态；? 对照组内容设定：为进一步强化盲法效果，对照组链接仅包含与研究主题无关的通用阅读材料（如科普短文、生活常识等），与实验组干预内容在形式上保持 “链接推送” 的一致性，避免助教或参与者通过内容差异推断分组。

Blinding：

??(1) Participant Blinding Design?? To prevent expectation bias resulting from participants' awareness of their group assignments, a blinding strategy of "ambiguous group labeling + plausible rationale explanation" was adopted: All participants were only informed of their "participant batch number" (e.g., "2025 Batch," "2027 Batch") without any disclosure of "experimental/control group" information. Simultaneously, a plausible rationale—"project resources are limited and need to be allocated in batches and phases"—was provided to explain the timing differences in content delivery across batches. This approach minimized participants’ speculation about group assignments and ensured they remained blinded throughout the study. ??(2) Interventionist (Support Assistant) Blinding Design?? To prevent operational bias (e.g., additional prompts to the experimental group) arising from assistants’ awareness of group assignments, an implementation method of "standardized procedures + content blinding" was employed: ??Standardized Procedures??: All support assistants strictly followed a unified workflow, sending learning content links to participants in their assigned batches at predetermined times each day. The timing and messaging (e.g., "Today’s learning link has been delivered. Please complete the learning task and check in") were fixed in advance, with no autonomous adjustments permitted. ??Content Blinding??: Assistants were only responsible for distributing links based on a pre-set list and were not informed of the group affiliation of each link (i.e., they could not distinguish whether the links belonged to the experimental or control group). This ensured blinding at the source of information. ??Control Group Content Setup??: To further reinforce blinding, the control group links contained only general reading materials unrelated to the study topic (e.g., popular science articles, life tips). These materials maintained consistency with the experimental group in the form of "link delivery," preventing assistants or participants from inferring group assignments based on content differences.

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

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）：

因为考虑到患者隐私的保密，我们不共享原始数据，如有需要，可以联系本研究的通讯作者。

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

The sharing of raw data is restricted to protect participant confidentiality, as underscored by our ethical approvals. Researchers may submit a methodologically sound proposal to the corresponding author to request data under a formal data use agreement.

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：

所有问卷通过问卷星在线收集并存储于其加密服务器。电子知情同意在线完成，仅授权研究成员可访问。

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

The questionnaires were administered online via Wenjuanxing and the collected data were stored on its encrypted servers. Electronic informed consent was obtained online, with access restricted to authorized research members.

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：

  2025-12-02 11:12:17