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Efficacy Study of tDCS and Mindfulness on Cognitive Function of Affective Disorder
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注册号:

Registration number:

ChiCTR-INR-16008179 

最近更新日期:

Date of Last Refreshed on:

2016-03-29 

注册时间:

Date of Registration:

2016-03-29 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

 

Public title:

Efficacy Study of tDCS and Mindfulness on Cognitive Function of Affective Disorder  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

 

Scientific title:

Exploring the Effect of Transcranial Direct Current Stimulation and Mindfulness Training on Cognitive Modulation of Patients With Affective Disorders  

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:

 

研究负责人:

 

Applicant:

Chin-Lun Hung 

Study leader:

Chin-Lun Hung 

申请注册联系人电话:

Applicant telephone:

+886-979307893 

研究负责人电话:

Study leader's telephone:

+886-979307893 

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:

galenhung@tpech.gov.tw 

研究负责人电子邮件:

Study leader's E-mail:

galenhung@tpech.gov.tw 

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:

 

研究负责人通讯地址:

 

Applicant address:

309 Songde Road, Xinyi District, Taipei, Taiwan 

Study leader's address:

309 Songde Road, Xinyi District, Taipei, Taiwan 

申请注册联系人邮政编码:

Applicant postcode:

110 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

 

Applicant's institution:

Taipei City Hospital, Songde Branch 

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:

TCHIRB-10409114 

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:

 

Name of the ethic committee:

Taipei City Hospital Institutional Review Board 

伦理委员会批准日期:

Date of approved by ethic committee:

2015-12-14 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

 

Primary sponsor:

Department of Health, Taipei City Government 

研究实施负责(组长)单位地址:

 

Primary sponsor's address:

1 City Hall Road, Xinyi District, Taipei City 11008, Taiwan 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

 

Source(s) of funding:

Department of Health, Taipei City Government 

研究疾病:

 

Target disease:

Major Depressive Disorder and Bipolar 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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

 

Objectives of Study:

To examine the efficacy of combining tDCS and mindfulness training in modulating cognitive function of patients with major depression and bipolar disorder.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

 

Inclusion criteria

1. Aged 20 to 65; 2. Capable of understanding the study procedure and performing informed consent; 3. Fixed regimen of psychotropics for at least 4 weeks; 4. Received diagnosis of DSM-IV major depressive disorder or bipolar disorder; 5. Scoring 20 or above on ?Montgomery-Asberg Depression Rating Scale. 

排除标准:

 

Exclusion criteria:

1. Intellectual disability; 2. Received diagnosis of schizophrenia or substance use disorders; 3. Scoring over 12 on Young Mania Rating Scale; 4. Cerebrovascular or cardiovascular diseases; 5. Metal implants in the body, such as clips and pacemakers; 6. Previous depressive episode refractory to ECT; 7. Pregnant women; 8. Scalp allergic to helmet and electrodes of tDCS device; 9. Head trauma or infection; 10. Intracranial space-occupying lesions, meningitis or encephalitis, with brain surgeries; 11. Plan to receive brain surgery during the study period. 

研究实施时间:

Study execute time:

From2016-01-01To 2018-12-31 

干预措施:

Interventions:

组别:

样本量:

32

Group:

Combined treatment

Sample size:

干预措施:

干预措施代码:

Intervention:

tDCS 12 sessions (2mA, 20 minutes, F3 anodal, F4 cathodal) over 4 weeks+ simultaneous mindfulness practices

Intervention code:

组别:

样本量:

32

Group:

tDCS only

Sample size:

干预措施:

干预措施代码:

Intervention:

tDCS 12 sessions (2mA, 20 minutes, F3 anodal, F4 cathodal) over 6 weeks

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

 

省(直辖市):

 

市(区县):

 

Country:

China 

Province:

Taiwan 

City:

Taipei 

单位(医院):

 

单位级别:

 

Institution
hospital:

Taipei City Hospital, Songde Branch  

Level of the institution:

Tertiary Psychiatric Institution 

测量指标:

Outcomes:

指标中文名:

指标类型:

主要指标 

Outcome:

Cogstate computerized cognitive battery

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

次要指标 

Outcome:

Montgomery-Asberg Depression Rating Scale

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

次要指标 

Outcome:

Beck Depression Inventory (BDI)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

次要指标 

Outcome:

Beck Anxiety Inventory (BAI)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

次要指标 

Outcome:

Starkstein Apathy Scale

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

指标类型:

次要指标 

Outcome:

Physical Symptoms Inventory

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:

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 years
最大 Max age years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

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

A Research assistant blinded to all study procedures will carry out blocked randomization with randomly selected block sizes including 2, 4 and 6.

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

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

We will share the study protocol and metadata via this registry website ResMan

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:

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

An encrypted desktop will be used to store and manage and data, using SPSS as the analytic software.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-03-29
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