ChiCTR2500095764 版本V1.1 版本创建时间2025/01/13 16:58:15 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：

 ChiCTR2500095764 

最近更新日期：

Date of Last Refreshed on：

 2025-01-13 14:43:52 

注册时间：

Date of Registration：

 2025-01-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Computer Use for Seniors on Mood Improvement and Logic Enhancement: A randomized waitlist-controlled trial

Public title：

Computer Use for Seniors on Mood Improvement and Logic Enhancement: A randomized waitlist-controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Computer Use for Seniors on Mood Improvement and Logic Enhancement: A randomized waitlist-controlled trial

Scientific title：

Computer Use for Seniors on Mood Improvement and Logic Enhancement: A randomized waitlist-controlled trial

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：

Allen Ting Chun Lee 

研究负责人：

Allen Ting Chun Lee; Linda LAM 

Applicant：

Allen Ting Chun Lee 

Study leader：

Allen Ting Chun Lee 

申请注册联系人电话：

Applicant telephone：

 +852 2607 6031

研究负责人电话：

Study leader's
telephone：

+852 2607 6031

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：

 allenlee@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 allenlee@cuhk.edu.hk

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：

Department of Psychiatry, Chinese University of Hong Kong

研究负责人通讯地址：

Department of Psychiatry, Chinese University of Hong Kong

Applicant address：

Department of Psychiatry, Chinese University of Hong Kong

Study leader's address：

Department of Psychiatry, Chinese University of Hong Kong

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：

Chinese University of Hong Kong

Applicant's institution：

Chinese University of Hong Kong

研究负责人所在单位：

Chinese University of Hong Kong

Affiliation of the Leader：

Chinese University of Hong Kong

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：

 2024.603-T

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：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

Name of the ethic committee：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-12-30 00:00:00

伦理委员会联系人：

Envy Lee

Contact Name of the ethic committee：

Envy Lee

伦理委员会联系地址：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3505 3935

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 crer2@cuhk.edu.hk

研究实施负责（组长）单位：

Chinese University of Hong Kong

Primary sponsor：

Chinese University of Hong Kong

研究实施负责（组长）单位地址：

Sha Tin District, New Territories, Hong Kong Special Administrative Region of China

Primary sponsor's address：

Sha Tin District, New Territories, Hong Kong Special Administrative Region of China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong SAR

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

Chinese University of Hong Kong

具体地址：

Sha Tin District, New Territories, Hong Kong Special Administrative Region of China

Institution
hospital：

Chinese University of Hong Kong

Address：

Sha Tin District, New Territories, Hong Kong Special Administrative Region of China

经费或物资来源：

Knowledge Transfer Project Fund (KPF) of the Chinese University of Hong Kong, and Social Innovation and Entrepreneurship Development Fund (SIE Fund) of the Government of HKSAR

Source(s) of funding：

Knowledge Transfer Project Fund (KPF) of the Chinese University of Hong Kong, and Social Innovation and Entrepreneurship Development Fund (SIE Fund) of the Government of HKSAR

研究疾病：

Depression  

Target disease：

Depression

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：

随机交叉对照 

Study design：

Cross-over 

研究目的：

The primary objective is to ascertain the treatment effect of CCT on mood in community-living older adults with depression. The secondary objective is to examine the retention effect of CCT on mood 6 weeks after cessation of CCT.  

Objectives of Study：

The primary objective is to ascertain the treatment effect of CCT on mood in community-living older adults with depression. The secondary objective is to examine the retention effect of CCT on mood 6 weeks after cessation of CCT.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

community-living Chinese individuals aged 60 years and older and having a primary diagnosis of major depressive disorder (single or recurrent episodes without psychotic features) based on the DSM-5 criteria, with moderate-to-severe depression (HAM-D total score >=17) and cognitive symptoms [Item 8 (slowness of thought and speech, impaired ability to concentrate) score >=2 in HAM-D], but without MCI or dementia (based on the age- and education-specific cutoff of HK-MoCA).

Inclusion criteria

community-living Chinese individuals aged 60 years and older and having a primary diagnosis of major depressive disorder (single or recurrent episodes without psychotic features) based on the DSM-5 criteria, with moderate-to-severe depression (HAM-D total score >=17) and cognitive symptoms [Item 8 (slowness of thought and speech, impaired ability to concentrate) score >=2 in HAM-D], but without MCI or dementia (based on the age- and education-specific cutoff of HK-MoCA).

排除标准：

Individuals found to have active suicidal idea, psychotic symptoms, or treatment-resistant [history of electroconvulsive therapy, transcranial magnetic stimulation, or no clinical response to >=2 different classes of antidepressants] will be excluded and referred to the psychiatric services of the Hospital Authority. Other exclusion criteria are non-Chinese; living in care homes; having history or ongoing substance abuse (including alcohol), mania, bipolar or psychotic disorder, posttraumatic stress disorder, anxiety disorder, personality disorder, or mental disorder due to organic cause; having history of traumatic brain injury, Parkinson’s disease, stroke, dementia, or scoring below HK-MoCA cutoff; or having language barrier or impairment in communication (poor vision or hearing despite correction).

Exclusion criteria：

Individuals found to have active suicidal idea, psychotic symptoms, or treatment-resistant [history of electroconvulsive therapy, transcranial magnetic stimulation, or no clinical response to >=2 different classes of antidepressants] will be excluded and referred to the psychiatric services of the Hospital Authority. Other exclusion criteria are non-Chinese; living in care homes; having history or ongoing substance abuse (including alcohol), mania, bipolar or psychotic disorder, posttraumatic stress disorder, anxiety disorder, personality disorder, or mental disorder due to organic cause; having history of traumatic brain injury, Parkinson’s disease, stroke, dementia, or scoring below HK-MoCA cutoff; or having language barrier or impairment in communication (poor vision or hearing despite correction).

研究实施时间：

Study execute time：

从 From 2025-01-01 00:00:00至 To 2026-09-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-02-01 00:00:00 至 To 2026-03-31 00:00:00

干预措施：

Interventions：

组别：

Intervention

样本量：

 26

Group：

Intervention

Sample size：

干预措施：

CCT for the first 6 weeks (one hour per session, twice a week), followed by a 6-week observation period

干预措施代码：

Intervention：

CCT for the first 6 weeks (one hour per session, twice a week), followed by a 6-week observation period

Intervention code：

组别：

Waitlist Control

样本量：

 26

Group：

Waitlist Control

Sample size：

干预措施：

a 6-week waitlist observation before starting CCT in the subsequent 6 weeks

干预措施代码：

Intervention：

a 6-week waitlist observation before starting CCT in the subsequent 6 weeks

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong SAR 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 Chinese University of Hong Kong 

单位级别：

 University 

Institution
hospital：

Chinese University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Mood symptoms

指标类型：

主要指标

Outcome：

Mood symptoms

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

PHQ-9

指标类型：

次要指标

Outcome：

PHQ-9

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Global cognitive function

指标类型：

次要指标

Outcome：

Global cognitive function

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：

none

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 60 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）：

Participants will be randomly allocated into either the intervention group (CCT) or the waitlist control group in a 1:1 ratio. The randomization will be done using a computer, and participants will be assigned their allocation codes according to the order of their entry into the study.

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

Participants will be randomly allocated into either the intervention group (CCT) or the waitlist control group in a 1:1 ratio. The randomization will be done using a computer, and participants will be assigned their allocation codes according to the order of their entry into the study.

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：

Although participants will know which group they are allocated to, they will be advised not to discuss with other participants or the outcome assessor. The research assistant who facilitates the CCT will not be involved in the outcome assessment. The outcome assessor will be blinded to the allocation status and will not participate in delivering the intervention.

Blinding：

Although participants will know which group they are allocated to, they will be advised not to discuss with other participants or the outcome assessor. The research assistant who facilitates the CCT will not be involved in the outcome assessment. The outcome assessor will be blinded to the allocation status and will not participate in delivering the intervention.

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）：

None

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

None

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：

None

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

None

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：

  2025-01-13 14:42:49