ChiCTR2500110038 版本V1.0 版本创建时间2025/09/29 10:43:44 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：

 ChiCTR2500110038 

最近更新日期：

Date of Last Refreshed on：

 2025-09-29 10:43:33 

注册时间：

Date of Registration：

 2025-09-29 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

基于线上平台的抑郁障碍患者“医-护-患”三元联动延续康复模式构建与效果评价

Public title：

Construction and Effect Evaluation of a "Doctor-Nurse-Patient" Ternary Linkage Continuous Rehabilitation Model for Patients with Depressive Disorders Based on Online Platforms

注册题目简写：

English Acronym：

研究课题的正式科学名称：

“互联网+”延续性康复训练模式构建及在抑郁障碍患者中的实证研究

Scientific title：

Construction of "Internet +" Continuous Rehabilitation Training Model and Empirical Study on Depression Patients

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：

杜炳毅 

研究负责人：

张艳萍 

Applicant：

Bingyi Du 

Study leader：

Yanping Zhang 

申请注册联系人电话：

Applicant telephone：

 +86 166 9094 6696

研究负责人电话：

Study leader's
telephone：

+86 373 337 3606

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：

 duby0930@163.com

研究负责人电子邮件：

Study leader's E-mail：

 13783731759@163.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：

河南省新乡市牧野区前进路207号河南省精神病医院

研究负责人通讯地址：

河南省新乡市牧野区前进路207号河南省精神病医院

Applicant address：

Henan Mental Hospital, No.207 Qianjin Road, Muye District, Xinxiang City, Henan Province, China

Study leader's address：

Henan Mental Hospital, No.207 Qianjin Road, Muye District, Xinxiang City, Henan Province, China

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：

新乡医学院第二附属医院(河南省精神病医院)

Applicant's institution：

The Second Affiliated Hospital of Xinxiang Medical University(Henan Mental Hospital)

研究负责人所在单位：

新乡医学院第二附属医院(河南省精神病医院)

Affiliation of the Leader：

The Second Affiliated Hospital of Xinxiang Medical University(Henan Mental Hospital)

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：

 XYEFYLL—(科研)-2025-04-2

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：

新乡医学院第二附属医院伦理委员会

Name of the ethic committee：

Ethics Committee of The Second Affiliated Hospital of Xinxiang Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-01-03 00:00:00

伦理委员会联系人：

赵明军

Contact Name of the ethic committee：

Mingjun Zhao

伦理委员会联系地址：

河南省新乡市牧野区前进路207号河南省精神病医院

Contact Address of the ethic committee：

Henan Mental Hospital, No.207 Qianjin Road, Muye District, Xinxiang City, Henan Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 159 3657 4545

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：

新乡医学院第二附属医院 （河南省精神病医院）

Primary sponsor：

The Second Affiliated Hospital of Xinxiang Medical University(Henan Mental Hospital)

研究实施负责（组长）单位地址：

河南省新乡市牧野区前进路207号河南省精神病医院

Primary sponsor's address：

Henan Mental Hospital, No.207 Qianjin Road, Muye District, Xinxiang City, Henan 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)：

河南省

市(区县)：

新乡市

Country：

China

Province：

Henan

City：

Xinxiang

单位(医院)：

新乡医学院第二附属医院

具体地址：

牧野区前进路207号河南省精神病医院

Institution
hospital：

The Second Affiliated Hospital of Xinxiang Medical University

Address：

Henan Mental Hospital, No.207 Qianjin Road, Muye District, Xinxiang City, Henan Province, China

经费或物资来源：

河南省科技攻关计划联合基金（行业）项目（235101610004）；中国河南省精神疾病防治协同创新中心开放课题（XTkf12）；河南省医学科技攻关项目（RKX202302024）；新乡医学院第二附属医院河南省心理学开放课题（XYEFYJSSJ-2023-01）。

Source(s) of funding：

Henan Province science and technology research and development plan joint fund (industry) project (235101610004); Open topic of Collaborative Innovation Center for Prevention and Treatment of mental illness in China Henan Province (XTkf12); Henan Province medical science and technology research project (RKX202302024); The open project of Henan Province psychology in the second Afffliated Hospital of Xinxiang Medical College (XYEFYJSSJ-2023–01).

研究疾病：

抑郁障碍  

Target disease：

Depressive disorder

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：

探讨基于线上平台的“医-护-患”三元联动延续性康复干预模式的构建对抑郁障碍患者的干预效果。  

Objectives of Study：

To explore the intervention effect of the construction of a "doctor-nurse-patient" three-way linkage continuous rehabilitation intervention model based on an online platform for patients with depressive disorders.

药物成份或治疗方案详述：

成立延续性康复训练团队，团体命名为“MindEase云端疗愈圈”。精神科医生和精神科护士要求中级及以上职称，工作满10年以上，精神科医生需要同时取得国家级心理治疗师，精神科护士需取得我院精神康复训练治疗师资格。团队包括组长1名，负责协调训练排班。秘书1名，负责发布训练通知，指导患者云平台使用和进行身份号码确认。精神科医师7名，负责疾病诊断、研究对象选择、线上团体认知行为治疗和药物指导。康复训练治疗师7名，负责线上正念技能训练和社交技能训练。精神科护士7名，协助训练时实时指导患者、总结线上训练时患者发布问题，结束后及时解答问题、进行电话随访和指导患者进行量表评估。共分7组，每组10名患者。精神康复治疗师负责线上康复训练，精神科护士负责电话随访和指导患者量表评定。患者每天需要进行服药打卡，心情打卡和睡眠打卡，在13周之内完成全部训练。每周训练2次，一次50～60分钟，训练内容是团体认知行为治疗、正念技能训练和社交技能训。平台以集体视频形式开展，课程开始前5 min给于短信提醒，采用预约制，点击链接或进入平台康复训练界面即可开始训练。 

Description for medicine or protocol of treatment in detail：

A continuous rehabilitation training team was established and named the "MindEase Cloud Healing Circle". Psychiatrists and psychiatric nurses are required to have an intermediate-level or higher professional title and at least 10 years of work experience. Psychiatrists need to obtain the national-level psychotherapist qualification, and psychiatric nurses need to obtain the qualification of a psychiatric rehabilitation training therapist in our hospital. The team consists of 1 team leader, responsible for coordinating the training schedule; 1 secretary, responsible for issuing training notices, guiding patients on the use of the cloud platform and confirming their identity numbers; 7 psychiatrists, responsible for disease diagnosis, selection of research subjects, online group cognitive - behavioral therapy and medication guidance; 7 rehabilitation training therapists, responsible for online mindfulness skills training and social skills training; and 7 psychiatric nurses, assisting in real - time guidance of patients during training, summarizing the problems posted by patients during online training, answering questions promptly after the training, conducting telephone follow - ups and guiding patients in scale assessment. A total of 7 groups were formed, with 10 patients in each group. Psychiatric rehabilitation therapists are responsible for online rehabilitation training, and psychiatric nurses are responsible for telephone follow-ups and guiding patients in scale assessment. Patients need to clock in for taking medication, mood, and sleep every day, and complete all the training within 13 weeks. Training is conducted twice a week, each session lasting 50 - 60 minutes. The training content includes group cognitive-behavioral therapy, mindfulness skills training, and social skills training. The platform conducts training in the form of group videos. A text message reminder is sent 5 minutes before the course starts. It adopts an appointment system. Training can be started by clicking the link or entering the rehabilitation training interface of the platform. 

纳入标准：

1）符合国际疾病分类第10次修订版（International Classification of Diseases 10th Revision，ICD-10)诊断标准，包括抑郁发作、复发性抑郁障碍患者，由两名主治及以上职称医师共同诊断；（2）按照Davis JM的划分线，24项版本汉密顿抑郁量表(Hamilton Depression Scale,HAMD)≤34分，中度或轻度的抑郁障碍患者；（3）年龄18～60周岁；（4）小学以上文化程度，理解力正常，能正常沟通和交流；（5）会使用精神康复智能云平台系统；（6）患者及家属知情同意，自愿参加本研究。

Inclusion criteria

1.Patients meet the diagnostic criteria of the 10th Revision of the International Classification of Diseases (ICD - 10), including those with depressive episodes and recurrent depressive disorders, and are diagnosed jointly by two physicians with the title of attending physician or above; 2.According to the cut - off line of Davis JM, patients with moderate or mild depressive disorders have a score of <=34 on the 24 - item version of the Hamilton Depression Scale (HAMD); 3. Aged between 18 and 60 years old; 4. Having an educational level above primary school, normal comprehension ability, and being able to communicate normally; 5. Being able to use the intelligent cloud platform system for mental rehabilitation; 6. Patients and their families give informed consent and voluntarily participate in this study.

排除标准：

（1）有精神症状或精神发育迟缓的患者；（2）合并有其他严重躯体疾病的患者；（3）不会使用电脑或手机信息系统的患者；（4）线上训练网络中断或延迟超过15分钟者按照1次脱落计算，≥3次不参与训练按照自动脱落计算。（5）学习过心理学知识的患者。

Exclusion criteria：

1. Patients with mental symptoms or mental retardation; 2. Patients complicated with other serious physical diseases; 3. Patients who cannot use computer or mobile phone information systems; 4. If the online training network is interrupted or delayed for more than 15 minutes, it is counted as one dropout. If a patient fails to participate in training for >=3 times, it is counted as an automatic dropout. 5. Patients who have learned psychology knowledge.

研究实施时间：

Study execute time：

从 From 2024-09-02 00:00:00至 To 2025-08-06 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-01-06 00:00:00 至 To 2025-03-04 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 66

Group：

Experimental group

Sample size：

干预措施：

精神康复治疗师负责线上康复训练，精神科护士负责电话随访和指导患者量表评定。患者每天需要进行服药打卡，心情打卡和睡眠打卡，在13周之内完成全部训练。每周训练2次，一次50～60分钟，训练内容是团体认知行为治疗、正念技能训练和社交技能训练。平台以集体视频形式开展，课程开始前5 min给于短信提醒，采用预约制，点击链接或进入平台康复训练界面即可开始训练。

干预措施代码：

Intervention：

Psychiatric rehabilitation therapists are responsible for online rehabilitation training, and psychiatric nurses are responsible for telephone follow-ups and guiding patients in scale assessment. Patients need to clock in for taking medication, mood, and sleep every day, and complete all the training within 13 weeks. Training is conducted twice a week, each session lasting 50 - 60 minutes. The training content includes group cognitive-behavioral therapy, mindfulness skills training, and social skills training. The platform conducts training in the form of group videos. A text message reminder is sent 5 minutes before the course starts. It adopts an appointment system. Training can be started by clicking the link or entering the rehabilitation training interface of the platform.

Intervention code：

组别：

等待对照组

样本量：

 66

Group：

Waiting control group

Sample size：

干预措施：

常规药物治疗、精神科护士每月一次电话随访和定期复诊。

干预措施代码：

Intervention：

Conventional drug therapy, monthly telephone follow-ups by psychiatric nurses, and regular follow-up visits.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 河南省 

市(区县)：

 新乡市 

Country：

China

Province：

Henan

City：

Xinxiang

单位(医院)：

 新乡医学院第二附属医院 

单位级别：

 三甲 

Institution
hospital：

The Second Affiliated Hospital of Xinxiang Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

抑郁症状

指标类型：

主要指标

Outcome：

Depressive symptom

Type：

Primary indicator

测量时间点：

干预前，干预13周末，干预17周末

测量方法：

汉密顿抑郁量表

Measure time point of outcome：

Pre-intervention,end of week 13 post-intervention,end of week 17 post-intervention

Measure method：

Hamilton Depression Scale

指标中文名：

抑郁状态

指标类型：

主要指标

Outcome：

Depressive state

Type：

Primary indicator

测量时间点：

干预前，干预13周末，干预17周末

测量方法：

抑郁自评量表

Measure time point of outcome：

Pre-intervention,end of week 13 post-intervention,end of week 17 post-intervention

Measure method：

Self-Rating Depression Scale

指标中文名：

社交功能

指标类型：

主要指标

Outcome：

Social features

Type：

Primary indicator

测量时间点：

干预前，干预13周末，干预17周末

测量方法：

社交技能评定目录

Measure time point of outcome：

Pre-intervention,end of week 13 post-intervention,end of week 17 post-intervention

Measure method：

Social Skills Checklist

指标中文名：

社会适应能力

指标类型：

主要指标

Outcome：

Social adaptation ability

Type：

Primary indicator

测量时间点：

干预前，干预13周末，干预17周末

测量方法：

社会适应功能评估量表

Measure time point of outcome：

Pre-intervention,end of week 13 post-intervention,end of week 17 post-intervention

Measure method：

Social Adaptive Functioning Evaluation

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

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 60 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）：

由课题组成员周悦抛硬币决定受试对象进入试验组或等待对照组。

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

A coin was flipped by subject member Yue Zhou to decide whether the subject would enter the Experimental group or Waiting control group.

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：

无

Blinding：

None

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）：

ResMan,论文发表后一年内， http://www.medresman.org.cn/login.aspx。

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

ResMan, within one year of publication, http://www.medresman.org.cn/login.aspx.

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：

患者住院期间的资料采集通过病历记录表记录，患者出院后依托医院随访移动系统(http://39.98.91.186:8090/index.action)进行记录。

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

Data collection during hospitalization was recorded by a medical record sheet, and recorded by the hospital follow-up mobile system after discharge.

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：

  2025-09-29 10:43:33