ChiCTR2500107106 版本V1.0 版本创建时间2025/08/04 16:14:44 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：

ChiCTR2500107106 

最近更新日期：

Date of Last Refreshed on：

2025-08-04 16:14:12 

注册时间：

Date of Registration：

2025-08-04 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

数字化认知行为治疗对腹腔镜袖状胃切除术“抑郁-超重/肥胖”共病的中青年患者的影响

Public title：

Effect of digital cognitive behavioral therapy on young and middle-aged patients with depression-overweight / obesity comorbidity in laparoscopic sleeve gastrectomy

注册题目简写：

English Acronym：

研究课题的正式科学名称：

数字化认知行为治疗对腹腔镜袖状胃切除术“抑郁-超重/肥胖”共病的中青年患者的影响

Scientific title：

Effect of digital cognitive behavioral therapy on young and middle-aged patients with depression-overweight / obesity comorbidity in laparoscopic sleeve gastrectomy

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：

田贺峰 

研究负责人：

田贺峰 

Applicant：

Tian Hefeng 

Study leader：

Tian Hefeng 

申请注册联系人电话：

Applicant telephone：

+86 138 4320 6337

研究负责人电话：

Study leader's telephone：

+86 138 4320 6337

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：

2461881634@qq.com

研究负责人电子邮件：

Study leader's E-mail：

2461881634@qq.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：

浙江省杭州市上城区庆春东路3号浙江大学医学院附属邵逸夫医院

研究负责人通讯地址：

浙江省杭州市上城区庆春东路3号浙江大学医学院附属邵逸夫医院

Applicant address：

Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine, No.3, East Qingchun Road, Shangcheng District, Hangzhou, Zhejiang Province

Study leader's address：

Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine, No.3, East Qingchun Road, Shangcheng District, Hangzhou, 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：

浙江大学医学院附属邵逸夫医院

Applicant's institution：

Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine

研究负责人所在单位：

浙江大学医学院附属邵逸夫医院

Affiliation of the Leader：

Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine

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：

邵逸夫医院伦审2025研第0514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：

浙江大学医学院附属邵逸夫医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2025-07-02 00:00:00

伦理委员会联系人：

隋伟静

Contact Name of the ethic committee：

Sui Weijing

伦理委员会联系地址：

浙江大学医学院附属邵逸夫医院医学伦理委员会

Contact Address of the ethic committee：

Medical Ethics Committee of Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 571 8600 6811

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：

浙江大学医学院附属邵逸夫医院

Primary sponsor：

Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine

研究实施负责（组长）单位地址：

浙江省杭州市上城区庆春东路3号浙江大学医学院附属邵逸夫医院

Primary sponsor's address：

Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine, No.3, East Qingchun Road, Shangcheng District, Hangzhou, 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)：

Country：

China

Province：

Zhejiang

City：

单位(医院)：

浙江大学医学院附属邵逸夫医院

具体地址：

浙江省杭州市上城区庆春东路3号浙江大学医学院附属邵逸夫医院

Institution
hospital：

Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine

Address：

Run Run Shaw Hospital Affiliated to Zhejiang University School of Medicine, No.3, East Qingchun Road, Shangcheng District, Hangzhou, Zhejiang Province

经费或物资来源：

无

Source(s) of funding：

no

Target disease：

Depression-overweight/obesity

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：

本研究拟探讨dCBT对LSG抑郁-超重/肥胖共病的中青年患者心理状态和生活质量的影响。  

Objectives of Study：

This study intends to investigate the effect of dcbt on the psychological status and quality of life in young and middle-aged patients with lsg depression-overweight / obesity comorbidity.

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）BMI≥24kg/m2为超重，BMI≥28kg/m2为肥胖,接受腹腔镜胃袖状切除术治疗的患者且抑郁自评量表（SDS）≥63； 2）年龄 18～50 岁； 3）神志清楚，具有交流沟通表达能力； 4）知情同意并自愿参与本研究。

Inclusion criteria

1. bmi 24 kg/m^2 is overweight, bmi 28 kg/m^2 is obese patients undergoing laparoscopic sleeve resection and depression self-rating scale (sds) 63; 2. age 18 to 50 years; 3. conscious, communication skills; 4. informed consent and voluntary participation in the study

排除标准：

1）术后出现相对比较严重的并发症； 2）存在认知交流沟通障碍者 ； 3）合并有严重疾病，如心、肝、脑、肾等器官功能障碍的患者； 4）服用过精神类药物、睡眠药物的患者； 5）接受其他临床干预试验者。

Exclusion criteria：

1. relatively serious postoperative complications; 2. patients with cognitive communication disorders; 3. patients with serious diseases, such as heart, liver, brain, kidney and other organ dysfunction; 4. patients who have taken psychotropic drugs and sleep drugs; 5. patients with other clinical intervention trials.

研究实施时间：

Study execute time：

从 From 2026-01-01 00:00:00至 To 2028-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-01-01 00:00:00 至 To 2027-01-01 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

38

Group：

experimental group

Sample size：

干预措施：

干预组是在对照组的基础上增加dCBT。术后3个月强化期：每周干预2次，干预12周，在每周末进行，每次干预时间在 30分钟左右。干预内容共包括认知行为治疗、认知行为治疗巩固、行为放松治疗三大模块。认知行为治疗：使用动画联合文字以及音频方式来详细讲解视频，使患者相对更加容易接受。生动有趣的向患者讲述有关饮食营养、负性情绪和疼痛控制等方面的知识，主要包括消解手术所产生的恐惧、改善睡眠情况、加强术后活动观念、强化积极思维等具体内容，使患者能够有效识别和修正不良认知，同时还可以增强和改变患者不良行为动机。认知行为治疗巩固：通过真人出境视频如术后量化活动等规范患者的适应性行为，使患者更好掌握具体的行为方式，在行为上实现一定的改变，进而加强和强化患者的认知改变。所使用的闯关练习题主要是通过使患者回顾前几个阶段的重点内容，实施自我检测。行为放松治疗：放松治疗主要是通过音乐的节奏使患者进行身体及呼吸的放松训练，同时也为患者提供了一个练习和审查的机会，使其学会控制自己的情绪。

干预措施代码：

Intervention：

The intervention group added dcbt to the control group.3-month intensive period: intervention twice a week, 12 weeks, at each weekend, each intervention time is about 30 minutes. The intervention includes three modules: cognitive behavioral therapy, cognitive behavioral therapy consolidation, and behavioral relaxation therapy.The intervention group added dcbt to the control group.3-month intensive period: intervention twice a week, 12 weeks, at each weekend, each intervention time is about 30 minutes. The intervention includes three modules: cognitive behavioral therapy, cognitive behavioral therapy consolidation, and behavioral relaxation therapy.The intervention group added dcbt to the control group.3-month intensive period: intervention twice a week, 12 weeks, at each weekend, each intervention time is about 30 minutes. The intervention includes three modules: cognitive behavioral therapy, cognitive behavioral therapy consolidation, and behavioral relaxation therapy.The intervention group added dcbt to the control group.3-month intensive period: intervention twice a week, 12 weeks, at each weekend, each intervention time is about 30 minutes. The intervention includes three modules: cognitive behavioral therapy, cognitive behavioral therapy consolidation, and behavioral relaxation therapy.Cognitive behavioral therapy: Use animation combined with text and audio to explain the video in detail, making it relatively more acceptable to patients. Vivid and interesting to patients about diet nutrition, negative emotions and pain control knowledge, mainly including fear of surgery, improve sleep situation, strengthen postoperative activity concept, strengthen the positive thinking specific content, make patients can effectively identify and correct bad cognition, at the same time also can enhance and change patients with bad behavior motivation.Consolidation of Cognitive behavioral therapy: Standardize the adaptive behavior of patients through live exit videos, such as postoperative quantitative activities, so that patients can better master the specific behavior mode and achieve certain changes in behavior, and then strengthen and strengthen the cognitive change of patients. The exercises used are mainly self-testing by allowing the patient to review the focus of the previous stages.Behavioral relaxation therapy: relaxation therapy mainly involves the relaxation of the body and breathing through the rhythm of music, and also provides an opportunity for patients to practice and review to learn to control their emotions.

Intervention code：

组别：

对照组

样本量：

38

Group：

control group

Sample size：

干预措施：

对照组腹腔镜袖状胃切除术抑郁-超重/肥胖共病的中青年患者实施常规术后护理，包括患者在出院前所进行的面对面健康宣教，包括为患者提供运动、营养膳食、心理护理等在内的健康指导，同时也为患者提供纸质版健康教育资料。术后还需要定期对患者进行电话随访。

干预措施代码：

Intervention：

Control group laparoscopic sleeve gastrectomy depression-overweight-obesity young patients with routine postoperative care, including patients before discharge face to face health education, including health guidance including exercise, nutritional diet, psychological care, but also provide patients with paper health education materials. Regular telephone follow-up of the patients is also required after surgery.

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)：

  

Country：

China 

Province：

Zhejiang 

City：

 

单位(医院)：

浙江大学医学院附属邵逸夫医院 

单位级别：

三甲 

Institution
hospital：

Run Run Shaw Hospital affiliated to Zhejiang University School of Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

抑郁程度

指标类型：

主要指标

Outcome：

Depressive degree

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

体力活动能力

指标类型：

次要指标

Outcome：

physical work capacity

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

饮食行为

指标类型：

次要指标

Outcome：

Eating behavior

Type：

Secondary 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：

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 50 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）：

招募患者作为研究对象，将研究对象按照入院时间进行编号为1-76，然后利用 SPSS28.0 生成随机数，将与患者编号相对应的随机数按照从小到大的进行排序后再依次编号 1～76；编号为 1～38 的患者作为干预组，编号为39～76 患者作为对照组。对照组对腹腔镜袖状胃切除术抑郁-超重/肥胖共病的中青年患者实施常规护理，干预组在对照组的基础上增加dCBT。

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

Patients were recruited as the study subjects, and the study subjects were numbered 1-76 according to the admission time, and then the random numbers were generated by spss28.0, and the random numbers corresponding to the patient numbers were sorted from small to large and then numbered 1-76;Patients numbered 1 to 38 were used as intervention group and patients numbered 39 to 76 as control group. The control group administered usual care for young and middle-aged patients with laparoscopic sleeve gastrectomy depression-overweight / obesity comorbidity, and the intervention group added dcbt to the control 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：

对术后评估人员设盲

Blinding：

The postoperative evaluator was blinded

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

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）：

研究公开发表后半年，邮件联系研究负责人合理获取。

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

Six months after the publication of the research, contact the research leader via email to obtain reasonable information.

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：

电子采集和管理系统

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

Electronic acquisition and management system

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：

  2025-08-04 16:14:12