ChiCTR1800015151 版本V1.2 版本创建时间2019/04/09 20:46:39 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：

 ChiCTR1800015151 

最近更新日期：

Date of Last Refreshed on：

 2019-04-09 20:44:18 

注册时间：

Date of Registration：

 2018-03-09 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

行為激活加靜觀對抑鬱的療效研究

Public title：

The effectiveness of group behavioural activation with mindfulness (BAM) in the treatment of depression in primary care in Hong Kong: A randomised controlled trial

注册题目简写：

English Acronym：

BAM

研究课题的正式科学名称：

行為激活加靜觀對抑鬱的療效研究

Scientific title：

The effectiveness of group behavioural activation with mindfulness (BAM) in the treatment of depression in primary care in Hong Kong: A randomised 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：

CUHK_CCRB00595

申请注册联系人：

Aaroy CHAN 

研究负责人：

Prof. Samuel Yeung Shan WONG 

Applicant：

Aaroy CHAN 

Study leader：

Prof. Samuel Yeung Shan WONG 

申请注册联系人电话：

Applicant telephone：

 +852 2252-8463

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：

 aaroy@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)：

 https://www2.ccrb.cuhk.edu.hk/registry/public/456

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 https://www2.ccrb.cuhk.edu.hk/registry/public/456

申请注册联系人通讯地址：

4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T., Hong Kong, China

研究负责人通讯地址：

4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T., Hong Kong, China

Applicant address：

4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T., Hong Kong, China

Study leader's address：

4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T., Hong Kong, China

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：

The Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學

Affiliation of the Leader：

The 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：

 2017.486

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：

Joint CUHK-NTEC Clinical Research Ethics Committee

Name of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2018-01-19 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：

The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong

Primary sponsor：

The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong

Primary sponsor's address：

The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

N/A

Source(s) of funding：

N/A

研究疾病：

抑鬱  

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：

随机平行对照 

Study design：

Parallel 

研究目的：

行為激活加靜觀對抑鬱的療效研究  

Objectives of Study：

The objective of the BA intervention is to identify, promote, and reinforce activities and circumstances that are consistent with each participants long-term goals.

药物成份或治疗方案详述：

Group 1: The specific contents of the intervention for the group BA will include psychoeducation with respect to well-being, setting both short and long-term goals, self-monitoring of activity and mood using activity logs to recognize the association between specific activities and mood, scheduling daily activities, and identification of avoidance and its impact. The mindfulness component will be integrated with the BA components and will be used to increase the awareness of the relationship between activity and mood changes, including the awareness of avoidance behaviour, and its associated emotion and thoughts. The mindfulness component will also cultivate the development of non-judgmental acceptance of mood and thoughts, and self-compassion when difficult emotions arise owing to avoidance. The mindfulness component will be complementary to BA and only basic mindfulness skills will be taught to participants. These will include mindfulness of breath, sitting and walking meditation, and body scan. Group 2: Participants in the CAU group will be allowed unrestricted access to medical care provided by general outpatient clinics for their depression. In Hong Kong, general outpatient clinics provide primary care services at a low subsidized fee and the integrated mental health program (IMHP) is the current program used in primary care to provide mental health care for people with clinically significant depressive symptoms (PHQ-9 score > 10). Participants assigned to the CAU will receive their usual mental health care from healthcare workers and doctors in the IMHP. Data on participants’ health care utilization will be collected, including those about their visits and use of medications, which will be recorded using the electronic patient record systems. 

Description for medicine or protocol of treatment in detail：

Group 1: The specific contents of the intervention for the group BA will include psychoeducation with respect to well-being, setting both short and long-term goals, self-monitoring of activity and mood using activity logs to recognize the association between specific activities and mood, scheduling daily activities, and identification of avoidance and its impact. The mindfulness component will be integrated with the BA components and will be used to increase the awareness of the relationship between activity and mood changes, including the awareness of avoidance behaviour, and its associated emotion and thoughts. The mindfulness component will also cultivate the development of non-judgmental acceptance of mood and thoughts, and self-compassion when difficult emotions arise owing to avoidance. The mindfulness component will be complementary to BA and only basic mindfulness skills will be taught to participants. These will include mindfulness of breath, sitting and walking meditation, and body scan. Group 2: Participants in the CAU group will be allowed unrestricted access to medical care provided by general outpatient clinics for their depression. In Hong Kong, general outpatient clinics provide primary care services at a low subsidized fee and the integrated mental health program (IMHP) is the current program used in primary care to provide mental health care for people with clinically significant depressive symptoms (PHQ-9 score > 10). Participants assigned to the CAU will receive their usual mental health care from healthcare workers and doctors in the IMHP. Data on participants health care utilization will be collected, including those about their visits and use of medications, which will be recorded using the electronic patient record systems. 

纳入标准：

1) Aged 18 years or above;
2) Screened by the Patient Health Questionnaire (PHQ-9) with a score of 10 or above;
3) Screened positive for major depression using the Structured Clinical Interview for DSM-V (SCID).

Inclusion criteria

1) Aged 18 years or above;
2) Screened by the Patient Health Questionnaire (PHQ-9) with a score of 10 or above;
3) Screened positive for major depression using the Structured Clinical Interview for DSM-V (SCID).

排除标准：

1) Having a lifetime history of psychosis, schizophrenia and bipolar affective disorder, alcohol or substance abuse, the presence of serious suicidal risk or medical illness with a prognosis of less than 6 months to live;
2) Currently receiving any psychotherapy including being enrolled in the integrated mental health program (IMHP) or was enrolled in the IMHP within the past 6 months;
3) Having received any psychotherapy in the past 6 months; and
4) currently practising or has practiced meditation or enrolled in mindfulness based interventions during the past one year.

Exclusion criteria：

1) Having a lifetime history of psychosis, schizophrenia and bipolar affective disorder, alcohol or substance abuse, the presence of serious suicidal risk or medical illness with a prognosis of less than 6 months to live;
2) Currently receiving any psychotherapy including being enrolled in the integrated mental health program (IMHP) or was enrolled in the IMHP within the past 6 months;
3) Having received any psychotherapy in the past 6 months; and
4) currently practising or has practiced meditation or enrolled in mindfulness based interventions during the past one year.

研究实施时间：

Study execute time：

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

征募观察对象时间：

Recruiting time：

从 From 2018-03-19 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：

Two groups

样本量：

 158

Group：

Two groups

Sample size：

干预措施：

psychoeducation with respect to well-being, setting both short and long-term goals, self-monitoring of activity and mood using activity logs to recognize the association between specific activities and mood, scheduling daily activities, and identification of avoidance and its impact versus receive their usual mental health

干预措施代码：

Intervention：

psychoeducation with respect to well-being, setting both short and long-term goals, self-monitoring of activity and mood using activity logs to recognize the association between specific activities and mood, scheduling daily activities, and identification of avoidance and its impact versus receive their usual mental health

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)：

 The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong 

单位级别：

 The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong 

Institution
hospital：

The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong

Level of the institution：

The Jockey Club School of Public Health and Primary Care, The Chinese University of Hong Kong

测量指标：

Outcomes：

指标中文名：

Patient Health Questionnaire (PHQ-9)

指标类型：

主要指标

Outcome：

Patient Health Questionnaire (PHQ-9)

Type：

Primary indicator

测量时间点：

At 6 months (T2) post-randomisation

测量方法：

Depression levels will be assessed by PHQ-9.

Measure time point of outcome：

At 6 months (T2) post-randomisation

Measure method：

Depression levels will be assessed by PHQ-9.

指标中文名：

Patient Health Questionnaire (PHQ-9)

指标类型：

次要指标

Outcome：

Patient Health Questionnaire (PHQ-9)

Type：

Secondary indicator

测量时间点：

At 2 months (T1) and 12 months (T3) post randomisation.

测量方法：

Depression levels will be assessed by PHQ-9

Measure time point of outcome：

At 2 months (T1) and 12 months (T3) post randomisation.

Measure method：

Depression levels will be assessed by PHQ-9

指标中文名：

The Structured Clinical Interview for DSM-IV (SCID)

指标类型：

次要指标

Outcome：

The Structured Clinical Interview for DSM-IV (SCID)

Type：

Secondary indicator

测量时间点：

Assessed at baseline (T0), and 2 (T1), 6 (T2), and 12 months (T3) post randomisation.

测量方法：

Semi-structured interview in clinical settings for detecting major DSM-IV Axis I diagnoses

Measure time point of outcome：

Assessed at baseline (T0), and 2 (T1), 6 (T2), and 12 months (T3) post randomisation.

Measure method：

Semi-structured interview in clinical settings for detecting major DSM-IV Axis I diagnoses

指标中文名：

Generalized Anxiety Disorder 7 item scale (GAD-7)

指标类型：

次要指标

Outcome：

Generalized Anxiety Disorder 7 item scale (GAD-7)

Type：

Secondary indicator

测量时间点：

Assessed at baseline (T0), and 2 (T1), 6 (T2), and 12 months (T3) post randomisation.

测量方法：

Anxiety level will be assessed by GAD-7.

Measure time point of outcome：

Assessed at baseline (T0), and 2 (T1), 6 (T2), and 12 months (T3) post randomisation.

Measure method：

Anxiety level will be assessed by GAD-7.

指标中文名：

Quality-adjusted life-year (QALY)

指标类型：

次要指标

Outcome：

Quality-adjusted life-year (QALY)

Type：

Secondary indicator

测量时间点：

Assessed at baseline (T0), and 2 (T1), 6 (T2), and 12 months (T3) post randomisation.

测量方法：

To measure the generic quality of life of participants in studies.

Measure time point of outcome：

Assessed at baseline (T0), and 2 (T1), 6 (T2), and 12 months (T3) post randomisation.

Measure method：

To measure the generic quality of life of participants in studies.

指标中文名：

Cost effectiveness analysis

指标类型：

次要指标

Outcome：

Cost effectiveness analysis

Type：

Secondary indicator

测量时间点：

Assessed at baseline (T0), and 2 (T1), 6 (T2), and 12 months (T3) post randomisation.

测量方法：

Cost of the intervention will be estimated from the societal perspective.

Measure time point of outcome：

Assessed at baseline (T0), and 2 (T1), 6 (T2), and 12 months (T3) post randomisation.

Measure method：

Cost of the intervention will be estimated from the societal perspective.

指标中文名：

Activity and Circumstantial Change

指标类型：

次要指标

Outcome：

Activity and Circumstantial Change

Type：

Secondary indicator

测量时间点：

Assessed at baseline (T0), and 2 (T1), 6 (T2), and 12 months (T3) post randomisation.

测量方法：

Assess the extent to which participants experience both activity change and circumstantial change.

Measure time point of outcome：

Assessed at baseline (T0), and 2 (T1), 6 (T2), and 12 months (T3) post randomisation.

Measure method：

Assess the extent to which participants experience both activity change and circumstantial change.

指标中文名：

Health service utilization and medication use

指标类型：

次要指标

Outcome：

Health service utilization and medication use

Type：

Secondary indicator

测量时间点：

Assessed at baseline (T0), and 2 (T1), 6 (T2), and 12 months (T3) post randomisation.

测量方法：

Utilization of health services including visits to doctors or accident and emergency units, visits to any specialist outpatient clinics, use of other allied health services and hospitalizations, medications, and days of absence from work

Measure time point of outcome：

Assessed at baseline (T0), and 2 (T1), 6 (T2), and 12 months (T3) post randomisation.

Measure method：

Utilization of health services including visits to doctors or accident and emergency units, visits to any specialist outpatient clinics, use of other allied health services and hospitalizations, medications, and days of absence from work

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

Recruiting status：

结束

/Completed

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）：

Randomized two-armed intervention study

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

Randomized two-armed intervention study

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：

Single-blind

Blinding：

Single-blind

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

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）：

Not stated

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

Not stated

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：

Not stated

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

Not stated

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2018-03-11 00:08:33