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注册号: Registration number: |
ChiCTR2500106543 |
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最近更新日期: Date of Last Refreshed on: |
2025-07-25 10:20:18 |
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注册时间: Date of Registration: |
2025-07-25 00:00:00 |
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注册号状态: |
补注册 |
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Registration Status: |
Retrospective registration |
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注册题目: |
接纳承诺疗法对老年人退休适应的干预 |
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Public title: |
Intervention of acceptance and commitment therapy on retirement adaptation of the elderly |
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注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
老年人社会参与与退休适应的研究:心理灵活性的中介效应及干预 |
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Scientific title: |
Research on Social Participation and Retirement Adaptation of the Elderly: The Mediating Effect and Intervention of Psychological Flexibility |
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研究课题代号(代码): Study subject ID: |
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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: |
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申请注册联系人: |
杨芳 |
研究负责人: |
刘健 |
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Applicant: |
Fang Yang |
Study leader: |
Jian Liu |
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申请注册联系人电话: Applicant telephone: |
+86 195 5815 8230 |
研究负责人电话:
Study leader's |
+86 159 6812 9892 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
1061621843@qq.com |
研究负责人电子邮件: Study leader's E-mail: |
lj7037@126.com |
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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): |
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申请注册联系人通讯地址: |
杭州市西湖区天目山路305号 |
研究负责人通讯地址: |
杭州市西湖区天目山路305号 |
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Applicant address: |
No. 305, Tianmushan Road, Xihu District, Hangzhou |
Study leader's address: |
No. 305, Tianmushan Road, Xihu District, Hangzhou |
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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: |
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申请人所在单位: |
杭州市第七人民医院 |
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Applicant's institution: |
Affiliated Mental Health Center & Hangzhou Seventh People's Hospital |
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研究负责人所在单位: |
杭州市第七人民医院 |
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Affiliation of the Leader: |
Affiliated Mental Health Center & Hangzhou Seventh People's Hospital |
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是否获伦理委员会批准: |
是 |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
研(2024年)伦审第(047)号 |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
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批准本研究的伦理委员会名称: |
杭州市第七人民医院伦理审查委员会 |
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Name of the ethic committee: |
Hangzhou Seventh People's Hospital Ethics Committee |
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伦理委员会批准日期: Date of approved by ethic committee: |
2024-07-02 00:00:00 | ||
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伦理委员会联系人: |
张雨桐 |
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Contact Name of the ethic committee: |
Yutong Zhang |
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伦理委员会联系地址: |
杭州市西湖区天目山路305号 |
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Contact Address of the ethic committee: |
No. 305, Tianmushan Road, Xihu District, Hangzhou |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 571 8512 3265 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
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研究实施负责(组长)单位: |
州市第七人民医院 |
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Primary sponsor: |
Affiliated Mental Health Center & Hangzhou Seventh People's Hospital |
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研究实施负责(组长)单位地址: |
杭州市西湖区天目山路305号杭 |
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Primary sponsor's address: |
No. 305, Tianmushan Road, Xihu District, Hangzhou |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
自筹 |
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Source(s) of funding: |
Self-raised funds |
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研究疾病: |
无 |
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Target disease: |
None |
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研究疾病代码: |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
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Study phase: |
N/A |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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研究目的: |
本研究通过探究心理灵活性在社会参与与退休适应中起到的中介作用以及探究通过接纳承诺疗法(ACT)对心理灵活性干预后,老年人退休适应的变化。 |
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Objectives of Study: |
This study explores the mediating role of psychological flexibility in social participation and retirement adaptation, and investigates the changes in retirement adaptation of the elderly after the intervention of psychological flexibility through Acceptance Commitment Therapy (ACT). |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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纳入标准: |
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Inclusion criteria |
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排除标准: |
1.有认知障碍或精神疾病,MMSE量表排除; 2.严重身体疾病,瘫痪、卧床不起等; 3.退休返聘人士 |
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Exclusion criteria: |
1. Cognitive impairment or mental illness is excluded by the MMSE scale. 2. Severe physical illness, paralysis, bedridden conditions, etc. 3. Retired rehired individuals. |
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研究实施时间: Study execute time: |
从 From 2024-07-03 00:00:00至 To 2025-07-03 00:00:00 |
征募观察对象时间: Recruiting time: |
从 From 2024-07-29 00:00:00 至 To 2024-10-19 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
结束 /Completed |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
随机序列由课题组的独立方法学家(非干预实施者)通过计算机随机数生成法产生,采用区组随机法。分配方案保存在加密电子文件中,由未参与招募的研究助理管理。当合格受试者签署知情同意书后,研究助理通过系统获取分配结果。 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
The random sequence was generated by the independent methodologists of the research group (non-intervention implementered) through the computer random number generation method, using the block randomization method. The allocation plan is saved in an encrypted electronic file and managed by research assistants who did not participate in the recruitment. When the qualified subjects signed the informed consent form, the research assistant obtained the allocation results through the system. |
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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 |
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盲法: |
无 |
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Blinding: |
NA |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
是Yes |
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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): |
公开部分数据,2025年12月后公开完整数据。https://lcnkum71ley3.feishu.cn/wiki/KJeXwU4j6i2x2ikpT8PcIHlKnrc?from=from_copylink |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
Contact the author by email after July 2025,https://lcnkum71ley3.feishu.cn/wiki/KJeXwU4j6i2x2ikpT8PcIHlKnrc?from=from_copylink |
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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: |
一、纸质数据采集流程 : 使用预印制的带有连续编号的纸质调查问卷进行数据采集,每份问卷包含:受试者唯一编号ID,模块页:基线评估(黄页)/干预记录(蓝页)/不良事件(红页) 和签名栏:评估员+受试者双签名 。 二、Excel数据管理方案 :由双人独立录入,后锁定数据库,启用跟踪更改功能+另存为带日期版本,严格设置权限。 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
1. Paper-based data collection process: Data collection is conducted using pre-printed paper questionnaires with consecutive serial numbers. Each questionnaire includes: the unique ID of the subject, module pages: baseline assessment (yellow page)/Intervention record (blue page)/adverse events (red page), and signature column: dual signatures of the assessor and the subject. 2. Excel Data Management Solution: Two people enter data independently, then lock the database, enable the tracking change function + save as a date version, and strictly set permissions. |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |