ChiCTR-TCS-14004601 版本V1.3 版本创建时间2016/06/02 22:21:40 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：

 ChiCTR-TCS-14004601 

最近更新日期：

Date of Last Refreshed on：

 2015-06-18 13:08:34 

注册时间：

Date of Registration：

 2014-05-05 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

行為激活對輕微抑鬱的療效研究

Public title：

The efficacy of group behavioural activation in the treatment of subthreshold depression in primary care in Hong Kong

注册题目简写：

English Acronym：

研究课题的正式科学名称：

行為激活對輕微抑鬱的療效研究

Scientific title：

The efficacy of group behavioural activation in the treatment of subthreshold depression in primary care in Hong Kong

研究课题代号(代码)：

Study subject ID：

 CRE-2012.583

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：

CUHK_CCT00410

申请注册联系人：

Yuying SUN 

研究负责人：

Prof. Samuel Yeung Shan WONG 

Applicant：

Yuying SUN 

Study leader：

Prof. Samuel Yeung Shan WONG 

申请注册联系人电话：

Applicant telephone：

 +852 2252 8797

研究负责人电话：

Study leader's
telephone：

+852 2252 8774

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：

 yuyingsun@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 yeungshanwong@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00410

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00410

申请注册联系人通讯地址：

4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T., HK

研究负责人通讯地址：

4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T., HK

Applicant address：

4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T., HK

Study leader's address：

4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T., HK

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：

School of Public Health, Prince of Wales Hospital

Applicant's institution：

School of Public Health, Prince of Wales Hospital

研究负责人所在单位：

Affiliation of the Leader：

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：

 N/A

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

School of Public Health, Prince of Wales Hospital

Name of the ethic committee：

School of Public Health, Prince of Wales Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2013-02-22 00:00:00

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：

School of Public Health, Prince of Wales Hospital

Primary sponsor：

School of Public Health, Prince of Wales Hospital

研究实施负责（组长）单位地址：

4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T., HK

Primary sponsor's address：

4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T., HK

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

HMRF

Source(s) of funding：

HMRF

研究疾病：

Subthreshold depression  

Target disease：

Subthreshold 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：

 IV期临床试验 

Study phase：

4

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

The BA intervention will be compared with care as usual (CAU) using a single blinded randomized design. Assessments with the outcome measures described below will take place at baseline, two, five months (3 months after intervention) and 1 year. The BA intervention will consist of weekly one and half hour session for 8 weeks. Participants assigned to the CAU will receive their medical care from the doctors who work in the general outpatient clinics. They are not referred to mental health intervention but receive active monitoring or regular minimal counselling from the primary care doctors.  

Objectives of Study：

The BA intervention will be compared with care as usual (CAU) using a single blinded randomized design. Assessments with the outcome measures described below will take place at baseline, two, five months (3 months after intervention) and 1 year. The BA intervention will consist of weekly one and half hour session for 8 weeks. Participants assigned to the CAU will receive their medical care from the doctors who work in the general outpatient clinics. They are not referred to mental health intervention but receive active monitoring or regular minimal counselling from the primary care doctors.

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) Aged 18 years or above;
2) Two to four symptoms of depression that are experienced for more than nearly every day or more than half the time for 2 or more weeks and which have affected work, home or social functioning (score 5-9 by Patient Health Questionnaire depression scale (PHQ-9)).

Inclusion criteria

1) Aged 18 years or above;
2) Two to four symptoms of depression that are experienced for more than nearly every day or more than half the time for 2 or more weeks and which have affected work, home or social functioning (score 5-9 by Patient Health Questionnaire depression scale (PHQ-9)).

排除标准：

1) major depression within the past 6 months;
2) lifetime history of other psychiatric disorders including generalized anxiety disorder, psychosis, schizophrenia and bipolar affective disorder, alcohol or substance abuse, presence of serious suicidal risk and medical illness with a prognosis of less than 6 months to live;
3) patients who are receiving current treatment (taking antidepressants or other psychotropic medications or enrolled in any form of psychological interventions) for any depressive disorders or symptoms.

Exclusion criteria：

1) major depression within the past 6 months;
2) lifetime history of other psychiatric disorders including generalized anxiety disorder, psychosis, schizophrenia and bipolar affective disorder, alcohol or substance abuse, presence of serious suicidal risk and medical illness with a prognosis of less than 6 months to live;
3) patients who are receiving current treatment (taking antidepressants or other psychotropic medications or enrolled in any form of psychological interventions) for any depressive disorders or symptoms.

研究实施时间：

Study execute time：

从 From 2014-06-01 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2014-06-01 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：

Behavioral Activation

样本量：

 115

Group：

Behavioral Activation

Sample size：

干预措施：

Behavioural activation: The Martell and Colleagues 2010 protocol will be used for the content of group BA intervention due to its established efficacy. The objective of the BA intervention is to identify, promote and reinforce activities and circumstances that are consistent with each participant’s long term goals.

干预措施代码：

Intervention：

Behavioural activation: The Martell and Colleagues 2010 protocol will be used for the content of group BA intervention due to its established efficacy. The objective of the BA intervention is to identify, promote and reinforce activities and circumstances that are consistent with each participant’s long term goals.

Intervention code：

组别：

Behavioral Activation (to be continued)

样本量：

 0

Group：

Behavioral Activation (to be continued)

Sample size：

干预措施：

Specific content of the group BA will include psychoeducation with respect to well-being, setting both short and long term goals, the self-monitoring of activity and mood using activity logs to recognize the association between specific activities and mood,

干预措施代码：

Intervention：

Specific content of the group BA will include psychoeducation with respect to well-being, setting both short and long term goals, the self-monitoring of activity and mood using activity logs to recognize the association between specific activities and mood,

Intervention code：

组别：

Behavioral Activation (to be continued)

样本量：

 0

Group：

Behavioral Activation (to be continued)

Sample size：

干预措施：

scheduling daily activities and the identification of avoidance and its impact using the Trigger Response Avoidance Pattern model to allow participants to be more aware of their decision making with respect to their behaviors and to explore alternative behaviors with the aim to achieve goals. Weekly two hour/se

干预措施代码：

Intervention：

scheduling daily activities and the identification of avoidance and its impact using the Trigger Response Avoidance Pattern model to allow participants to be more aware of their decision making with respect to their behaviors and to explore alternative behaviors with the aim to achieve goals. Weekly two hour/se

Intervention code：

组别：

Care As Usual

样本量：

 115

Group：

Care As Usual

Sample size：

干预措施：

Participants assigned to the CAU will receive their medical care from the doctors who work in the general outpatient clinics. They are not referred to mental health intervention but receive active monitoring or regular minimal counselling from the primary care doctors.

干预措施代码：

Intervention：

Participants assigned to the CAU will receive their medical care from the doctors who work in the general outpatient clinics. They are not referred to mental health intervention but receive active monitoring or regular minimal counselling from the primary care doctors.

Intervention code：

组别：

Care As Usual (to be continued)

样本量：

 0

Group：

Care As Usual (to be continued)

Sample size：

干预措施：

All participants will be informed that their health care utilization, including their visits and use of medications will be recorded using the electronic patient record systems.

干预措施代码：

Intervention：

All participants will be informed that their health care utilization, including their visits and use of medications will be recorded using the electronic patient record systems.

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)：

 Prince of Wales Hospital 

单位级别：

 Prince of Wales Hospital 

Institution
hospital：

Prince of Wales Hospital

Level of the institution：

Prince of Wales Hospital

测量指标：

Outcomes：

指标中文名：

Reduction of self-reported depressive symptoms

指标类型：

主要指标

Outcome：

Reduction of self-reported depressive symptoms

Type：

Primary indicator

测量时间点：

Assessments with the outcome measures will take place at baseline, two, five months (3 months after intervention) and 1 year.

测量方法：

measured by the validated Chinese version Beck Depression Inventory-II (BDI-II).

Measure time point of outcome：

Assessments with the outcome measures will take place at baseline, two, five months (3 months after intervention) and 1 year.

Measure method：

measured by the validated Chinese version Beck Depression Inventory-II (BDI-II).

指标中文名：

Incidence of DSM-IV major depression

指标类型：

次要指标

Outcome：

Incidence of DSM-IV major depression

Type：

Secondary indicator

测量时间点：

1 year

测量方法：

SCID (Structured Clinical Interview for DSM-IV)

Measure time point of outcome：

1 year

Measure method：

SCID (Structured Clinical Interview for DSM-IV)

指标中文名：

Improvement in quality of life

指标类型：

次要指标

Outcome：

Improvement in quality of life

Type：

Secondary indicator

测量时间点：

measured at baseline, two, five months (3 months after intervention) and 1 year.

测量方法：

measured by the validated Chinese version Medical Outcomes Study Short-Form Health Survey (SF-12).

Measure time point of outcome：

measured at baseline, two, five months (3 months after intervention) and 1 year.

Measure method：

measured by the validated Chinese version Medical Outcomes Study Short-Form Health Survey (SF-12).

指标中文名：

Utilization of health services including visits to primary care doctors

指标类型：

次要指标

Outcome：

Utilization of health services including visits to primary care doctors

Type：

Secondary indicator

测量时间点：

measured at baseline, two, five months (3 months after intervention) and 1 year.

测量方法：

including visits to primary care doctors (both private and public) or accident and emergency units, visits to any specialist outpatient clinics, use of other psychiatric services such as psychologists, social workers or occupational therapists, and hospitalizations and the number of days of absence from work will b

Measure time point of outcome：

measured at baseline, two, five months (3 months after intervention) and 1 year.

Measure method：

including visits to primary care doctors (both private and public) or accident and emergency units, visits to any specialist outpatient clinics, use of other psychiatric services such as psychologists, social workers or occupational therapists, and hospitalizations and the number of days of absence from work will b

指标中文名：

activity change and circumstantial change

指标类型：

次要指标

Outcome：

activity change and circumstantial change

Type：

Secondary indicator

测量时间点：

measured at baseline, two, five months (3 months after intervention) and 1 year.

测量方法：

The 8-item Activity and Circumstances Change Questionnaire

Measure time point of outcome：

measured at baseline, two, five months (3 months after intervention) and 1 year.

Measure method：

The 8-item Activity and Circumstances Change Questionnaire

指标中文名：

patients to rate their impairment in 3 life domains including work, social and family/home management

指标类型：

次要指标

Outcome：

patients to rate their impairment in 3 life domains including work, social and family/home management

Type：

Secondary indicator

测量时间点：

measured at baseline, two, five months (3 months after intervention) and 1 year.

测量方法：

The Sheehan Disability Scale

Measure time point of outcome：

measured at baseline, two, five months (3 months after intervention) and 1 year.

Measure method：

The Sheehan Disability Scale

指标中文名：

Anxiety symptoms

指标类型：

次要指标

Outcome：

Anxiety symptoms

Type：

Secondary indicator

测量时间点：

measured at baseline, two, five months (3 months after intervention) and 1 year

测量方法：

State Trait Anxiety Inventory

Measure time point of outcome：

measured at baseline, two, five months (3 months after intervention) and 1 year

Measure method：

State Trait Anxiety Inventory

指标中文名：

Satisfaction with delivered care

指标类型：

次要指标

Outcome：

Satisfaction with delivered care

Type：

Secondary indicator

测量时间点：

measured at baseline, two, five months (3 months after intervention) and 1 year

测量方法：

a question adopted from CAHPS 2.0 Adult Questionnaire.

Measure time point of outcome：

measured at baseline, two, five months (3 months after intervention) and 1 year

Measure method：

a question adopted from CAHPS 2.0 Adult Questionnaire.

指标中文名：

Quality-adjusted life years

指标类型：

次要指标

Outcome：

Quality-adjusted life years

Type：

Secondary indicator

测量时间点：

measured at baseline, two, five months (3 months after intervention) and 1 year

测量方法：

EuroQol-five dimension-five level (EQ-5D-5L)

Measure time point of outcome：

measured at baseline, two, five months (3 months after intervention) and 1 year

Measure method：

EuroQol-five dimension-five level (EQ-5D-5L)

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 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）：

RCT

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

RCT

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：

Blinding：

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

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)：

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：

数据与安全监察委员会：

Data and Safety Monitoring Committee：

注册人：

Name of Registration：

  2015-06-18 13:08:34