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Structured frontal lobe based cognitive stimulation to older adults with depressive symptoms but without dementia or mild cognitive impairment
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注册号：

Registration number：

 ChiCTR1900027029 

最近更新日期：

Date of Last Refreshed on：

 2019-10-29 17:26:30 

注册时间：

Date of Registration：

 2019-10-29 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Structured frontal lobe based cognitive stimulation to older adults with depressive symptoms but without dementia or mild cognitive impairment

Public title：

Structured frontal lobe based cognitive stimulation to older adults with depressive symptoms but without dementia or mild cognitive impairment

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Structured frontal lobe based cognitive stimulation to older adults with depressive symptoms but without dementia or mild cognitive impairment

Scientific title：

Structured frontal lobe based cognitive stimulation to older adults with depressive symptoms but without dementia or mild cognitive impairment

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 

Applicant：

Allen Ting Chun LEE 

Study leader：

Allen Ting Chun LEE 

申请注册联系人电话：

Applicant telephone：

 +852 26076026

研究负责人电话：

Study leader's
telephone：

+852 26076026

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：

香港中文大學

Applicant's institution：

Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學

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：

 2019.497

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：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

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：

 2019-10-23 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：

中國香港特別行政區新界沙田威爾士親王醫院呂志和臨床科學大樓8/F

Contact Address of the ethic committee：

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

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 35053824

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 crec2@cuhk.edu.hk

研究实施负责（组长）单位：

Faculty of Medicine, Chinese University of Hong Kong

Primary sponsor：

Faculty of Medicine, Chinese University of Hong Kong

研究实施负责（组长）单位地址：

Faculty of Medicine, Chinese University of Hong Kong, Hong Kong SAR, China

Primary sponsor's address：

Faculty of Medicine, Chinese University of Hong Kong, Hong Kong SAR, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Direct Grant for Research 2018/2019

Source(s) of funding：

Direct Grant for Research 2018/2019

研究疾病：

depressive symptoms  

Target disease：

depressive symptoms

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：

 II期临床试验 

Study phase：

2

研究设计：

随机抽样 

Study design：

Randomly Sampling 

研究目的：

1. to test whether cognitive stimulation can improve depressive symptoms in older adults who are still cognitively relatively normal; 2. to test whether the improvement in depressive symptoms can be explained by changes in cognitive performance, inflammatory response, and BDNF level  

Objectives of Study：

1. to test whether cognitive stimulation can improve depressive symptoms in older adults who are still cognitively relatively normal; 2. to test whether the improvement in depressive symptoms can be explained by changes in cognitive performance, inflammatory response, and BDNF level

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

non-Chinese ethnicity; living in care homes; having history of stroke, traumatic brain injury, Parkinson’s disease, MCI, or clinical dementia; scoring Hong Kong Chinese version of Montreal Cognitive Assessment (HK-MoCA) ≤25 (i.e. the cutoff score for MCI in young old with high educational level); taking drugs that affect cognition (e.g. benzodiazepines, anti-dementia medication, etc.); having history of bipolar affective disorder, psychosis, or substance abuse; already attending other cognitive or psychological intervention programs; and having significant impairments in vision, hearing or communication

Exclusion criteria：

non-Chinese ethnicity; living in care homes; having history of stroke, traumatic brain injury, Parkinsons disease, MCI, or clinical dementia; scoring Hong Kong Chinese version of Montreal Cognitive Assessment (HK-MoCA) ≤25 (i.e. the cutoff score for MCI in young old with high educational level); taking drugs that affect cognition (e.g. benzodiazepines, anti-dementia medication, etc.); having history of bipolar affective disorder, psychosis, or substance abuse; already attending other cognitive or psychological intervention programs; and having significant impairments in vision, hearing or communication

研究实施时间：

Study execute time：

从 From 2019-11-01 00:00:00至 To 2020-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2019-11-01 00:00:00 至 To 2020-06-29 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 30

Group：

Control group

Sample size：

干预措施：

watch health videos

干预措施代码：

Intervention：

watch health videos

Intervention code：

组别：

试验组

样本量：

 30

Group：

Experimental group

Sample size：

干预措施：

computerized cognitive training

干预措施代码：

Intervention：

computerized cognitive training

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 香港中文大學 

单位级别：

 大學 

Institution
hospital：

Chinese University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

severity of depressive symptoms

指标类型：

主要指标

Outcome：

severity of depressive 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：

Cognitive performance

指标类型：

次要指标

Outcome：

Cognitive performance

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Blood inflammatory markers

指标类型：

次要指标

Outcome：

Blood inflammatory markers

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：

血液

组织：

靜脈

Sample Name：

Blood

Tissue：

vein

人体标本去向

 使用后销毁  

说明

分析後銷毀

Fate of sample：

Destruction after use  

Note：

disposed after analysis

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 55 岁 years
最大 Max age 75 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）：

In the randomization procedure, each participant will be assigned a special code generated by a computer. The statistician of the department will perform all the randomization and will not be involved in enrollment or outcome assessment.

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

In the randomization procedure, each participant will be assigned a special code generated by a computer. The statistician of the department will perform all the randomization and will not be involved in enrollment or outcome assessment.

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：

Open label

Blinding：

Open label

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）：

to be announced

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

to be announced

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：

to be announced

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

to be announced

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：

  2019-10-29 17:26:30
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