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A group-based compassionate mind training on depression in Hong Kong: a pilot randomized control trial
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注册号：

Registration number：

 ChiCTR2400091460 

最近更新日期：

Date of Last Refreshed on：

 2024-10-29 11:05:22 

注册时间：

Date of Registration：

 2024-10-29 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

A group-based compassionate mind training on depression in Hong Kong: a pilot randomized control trial

Public title：

A group-based compassionate mind training on depression in Hong Kong: a pilot randomized control trial

注册题目简写：

Compassionate mind training, CMT, depression, Hong Kong

English Acronym：

Compassionate mind training, CMT, depression, Hong Kong

研究课题的正式科学名称：

A group-based compassionate mind training on depression in Hong Kong: a pilot randomized control trial

Scientific title：

A group-based compassionate mind training on depression in Hong Kong: a pilot randomized control 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：

Sum To Dorothy SHU 

研究负责人：

Sum To Dorothy SHU 

Applicant：

Sum To Dorothy SHU 

Study leader：

Sum To Dorothy SHU 

申请注册联系人电话：

Applicant telephone：

 +852 9629 1516

研究负责人电话：

Study leader's
telephone：

+852 9629 1516

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：

 1009041620@link.cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 1009041620@link.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 Psychology The Chinese University of Hong Kong Room 328 3rd Floor, Sino Building Shatin, New Territories Hong Kong SAR

研究负责人通讯地址：

Department of Psychology The Chinese University of Hong Kong Room 328 3rd Floor, Sino Building Shatin, New Territories Hong Kong SAR

Applicant address：

Department of Psychology The Chinese University of Hong Kong Room 328 3rd Floor, Sino Building Shatin, New Territories Hong Kong SAR

Study leader's address：

Department of Psychology The Chinese University of Hong Kong Room 328 3rd Floor, Sino Building Shatin, New Territories Hong Kong SAR

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：

Hospital Authority Hong Kong SAR

Applicant's institution：

Hospital Authority Hong Kong SAR

研究负责人所在单位：

Hospital Authority Hong Kong SAR

Affiliation of the Leader：

Hospital Authority Hong Kong SAR

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：

 CIRB-2024-384-1

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：

Hospital Authority Central Institutional Review Board (Central IRB)

Name of the ethic committee：

Hospital Authority Central Institutional Review Board (Central IRB)

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-10-09 00:00:00

伦理委员会联系人：

Ms Mandy Luk

Contact Name of the ethic committee：

Ms Mandy Luk

伦理委员会联系地址：

Room 503, 5/F, Block A, HA Central Coordinating Office, Centre for Health Protection, 147C Argyle Street, Kowloon, Hong Kong

Contact Address of the ethic committee：

Room 503, 5/F, Block A, HA Central Coordinating Office, Centre for Health Protection, 147C Argyle Street, Kowloon, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 2300 8472

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 hacco@ha.org.hk

研究实施负责（组长）单位：

Department of Psychology, The Chinese University of Hong Kong

Primary sponsor：

Department of Psychology, The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

Department of Psychology The Chinese University of Hong Kong Room 328 3rd Floor, Sino Building Shatin, New Territories Hong Kong SAR

Primary sponsor's address：

Department of Psychology The Chinese University of Hong Kong Room 328 3rd Floor, Sino Building Shatin, New Territories Hong Kong SAR

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)：

Hospital Authority

具体地址：

Department of Clinical Psychology, 1/F, East Block, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR

Institution
hospital：

Hospital Authority

Address：

Department of Clinical Psychology, 1/F, East Block, Pamela Youde Nethersole Eastern Hospital, Hong Kong SAR

经费或物资来源：

Self-finance

Source(s) of funding：

Self-finance

研究疾病：

 

Target disease：

Depressive disorders

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：

The study is to evaluate the effectiveness of the group-based compassionate mind training (CMT) protocol on patients' psychopathology conditions, fears of compassion and self-compassion. The study would also consider participants' homework compliance in the evaluation of treatment outcomes.  

Objectives of Study：

The study is to evaluate the effectiveness of the group-based compassionate mind training (CMT) protocol on patients' psychopathology conditions, fears of compassion and self-compassion. The study would also consider participants' homework compliance in the evaluation of treatment outcomes.

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：

Patients with neurodevelopmental disorders, schizophrenia spectrum and other psychotic disorders, bipolar disorders, obsessive-compulsive disorders, comorbid substance use disorder, personality disorders, potential risks to self and/or others, neurocognitive disorders, intellectual disabilities, physical disabilities, severe medical illnesses (such as newly diagnosis at acute phase, potential to undergo intensive treatment), who could not read Chinese and speak in Cantonese, who did not read and write, as well as those who had previously received compassion-based or mindfulness-based interventions.

Exclusion criteria：

Patients with neurodevelopmental disorders, schizophrenia spectrum and other psychotic disorders, bipolar disorders, obsessive-compulsive disorders, comorbid substance use disorder, personality disorders, potential risks to self and/or others, neurocognitive disorders, intellectual disabilities, physical disabilities, severe medical illnesses (such as newly diagnosis at acute phase, potential to undergo intensive treatment), who could not read Chinese and speak in Cantonese, who did not read and write, as well as those who had previously received compassion-based or mindfulness-based interventions.

研究实施时间：

Study execute time：

从 From 2024-10-30 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-10-30 00:00:00 至 To 2025-12-26 00:00:00

干预措施：

Interventions：

组别：

Intervention group (CMT + TAU)

样本量：

 64

Group：

Intervention group (CMT + TAU)

Sample size：

干预措施：

4-week compassionate mind training group

干预措施代码：

Intervention：

4-week compassionate mind training group

Intervention code：

组别：

Control group

样本量：

 64

Group：

Control group

Sample size：

干预措施：

TAU

干预措施代码：

Intervention：

TAU

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)：

 Pamela Youde Nethersole Eastern Hospital 

单位级别：

  

Institution
hospital：

Pamela Youde Nethersole Eastern Hospital

Level of the institution：

Hospital

测量指标：

Outcomes：

指标中文名：

The Chinese Version of Patient Health Questionnaire-9 (C-PHQ-9)

指标类型：

主要指标

Outcome：

The Chinese Version of Patient Health Questionnaire-9 (C-PHQ-9)

Type：

Primary indicator

测量时间点：

测量方法：

Self-report

Measure time point of outcome：

Measure method：

Self-report

指标中文名：

The Chinese Version of Generalized Anxiety Disorder (C-GAD-7)

指标类型：

主要指标

Outcome：

The Chinese Version of Generalized Anxiety Disorder (C-GAD-7)

Type：

Primary indicator

测量时间点：

测量方法：

Self-report

Measure time point of outcome：

Measure method：

Self-report

指标中文名：

The Chinese Version of Self-Compassion Scale (C-SCS)

指标类型：

次要指标

Outcome：

The Chinese Version of Self-Compassion Scale (C-SCS)

Type：

Secondary indicator

测量时间点：

测量方法：

Self-report

Measure time point of outcome：

Measure method：

Self-report

指标中文名：

The Chinese Version of Fears of Compassion Scale (C-FCS)

指标类型：

次要指标

Outcome：

The Chinese Version of Fears of Compassion Scale (C-FCS)

Type：

Secondary indicator

测量时间点：

测量方法：

Self-report

Measure time point of outcome：

Measure method：

Self-report

指标中文名：

Practice Record (Homework Compliance)

指标类型：

次要指标

Outcome：

Practice Record (Homework Compliance)

Type：

Secondary indicator

测量时间点：

测量方法：

Self-report

Measure time point of outcome：

Measure method：

Self-report

指标中文名：

Satisfaction Survey

指标类型：

附加指标

Outcome：

Satisfaction Survey

Type：

Additional indicator

测量时间点：

测量方法：

Self-report

Measure time point of outcome：

Measure method：

Self-report

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

None

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

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 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）：

Participants will be allocated to the intervention group or control group (1:1 ratio) randomly. A research assistant who is not involved in the intervention would generate the random numbers by computer.

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

Participants will be allocated to the intervention group or control group (1:1 ratio) randomly. A research assistant who is not involved in the intervention would generate the random numbers by computer.

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：

Blinding：

None

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）：

Article

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

Article

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：

Collect data through questionnaire and enter it into Excel for management.

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

Collect data through questionnaire and enter it into Excel for management.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2024-10-29 11:04:49
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