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Mindfulness-based Self-compassion Program for Caregivers of People with Mental Disorders: a Pilot Study
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注册号：

Registration number：

 ChiCTR-IPR-17012125 

最近更新日期：

Date of Last Refreshed on：

 2017-07-25 15:55:35 

注册时间：

Date of Registration：

 2017-07-25 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Mindfulness-based Self-compassion Program for Caregivers of People with Mental Disorders: a Pilot Study

Public title：

Mindfulness-based Self-compassion Program for Caregivers of People with Mental Disorders: a Pilot Study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Mindfulness-based Self-compassion Program for Caregivers of People with Mental Disorders: a Pilot Study

Scientific title：

Mindfulness-based Self-compassion Program for Caregivers of People with Mental Disorders: a Pilot Study

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：

Tiffany 

研究负责人：

Prof. Samuel Wong 

Applicant：

Tiffany 

Study leader：

Prof. Samuel Wong 

申请注册联系人电话：

Applicant telephone：

 +852 22528758

研究负责人电话：

Study leader's
telephone：

+852 22528774

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：

 tiffanyding@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)：

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：

4/F, JC School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, N.T., Hong Kong

研究负责人通讯地址：

4/F, JC School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, N.T., Hong Kong

Applicant address：

4/F, JC School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, N.T., Hong Kong

Study leader's address：

4/F, JC School of Public Health and Primary Care, Prince of Wales Hospital, Shatin, N.T., 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：

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：

 2017.306

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：

The Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee

Name of the ethic committee：

The 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：

 1990-01-01 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：

香港中文大學

Primary sponsor：

The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

Prince of Wales Hospital, Shatin, N.T., Hong Kong

Primary sponsor's address：

Prince of Wales Hospital, Shatin, N.T., 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：

NA

Source(s) of funding：

NA

研究疾病：

精神障礙患者的照顧者  

Target disease：

caregivers of people with mental 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：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

The objective of this pilot study is to examine the feasibility and acceptability of a mindfulness-based self-compassion interventional program specifically developed for caregivers of people with mental disorders in Hong Kong, using wait list control and a pre-post design plus qualitative components.  

Objectives of Study：

The objective of this pilot study is to examine the feasibility and acceptability of a mindfulness-based self-compassion interventional program specifically developed for caregivers of people with mental disorders in Hong Kong, using wait list control and a pre-post design plus qualitative components.

药物成份或治疗方案详述：

Mindfulness based intervention The intervention will be modified based on protocol used in previous studies using mindfulness based stress reduction, (Kabat-Zinn, 1990) mindfulness based cognitive therapy(Morgan, 2003) and mindful parenting.(van de Weijer-Bergsma, Formsma, de Bruin, & Bogels, 2012; van der Oord, Bogels, & Peijnenburg, 2012) The intervention will include 8 sessions for caregivers. The treatment will consist of 8 weekly 120-mininute group sessions with one-day retreat. Before the 8-week intervention, one brief session will be provided to participants to let them know about the concept and arrangement of the group-based intervention. Participants will receive session handouts describing the session theme, instructions for practice, and homework completion forms. There will be 12 to 15 participants in each group.  

Description for medicine or protocol of treatment in detail：

Mindfulness based intervention The intervention will be modified based on protocol used in previous studies using mindfulness based stress reduction, (Kabat-Zinn, 1990) mindfulness based cognitive therapy(Morgan, 2003) and mindful parenting.(van de Weijer-Bergsma, Formsma, de Bruin, & Bogels, 2012; van der Oord, Bogels, & Peijnenburg, 2012) The intervention will include 8 sessions for caregivers. The treatment will consist of 8 weekly 120-mininute group sessions with one-day retreat. Before the 8-week intervention, one brief session will be provided to participants to let them know about the concept and arrangement of the group-based intervention. Participants will receive session handouts describing the session theme, instructions for practice, and homework completion forms. There will be 12 to 15 participants in each group.  

纳入标准：

Inclusion criteria

排除标准：

The exclusion criteria will be: 1) being unable to communicate and understand Chinese language as the intervention will be conducted in Chinese, 2) have a medical condition rendering him/her to be incapable to participate in the study, 3) unwilling or unable to give consent, or 4) participating in another ongoing psychological intervention or having previous experiences in regular mindfulness or yoga practices.

Exclusion criteria：

The exclusion criteria will be: 1) being unable to communicate and understand Chinese language as the intervention will be conducted in Chinese, 2) have a medical condition rendering him/her to be incapable to participate in the study, 3) unwilling or unable to give consent, or 4) participating in another ongoing psychological intervention or having previous experiences in regular mindfulness or yoga practices.

研究实施时间：

Study execute time：

从 From 2017-08-19 00:00:00至 To 2018-08-18 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2017-08-01 00:00:00 至 To 2017-09-02 00:00:00

干预措施：

Interventions：

组别：

intervention group

样本量：

 15

Group：

intervention group

Sample size：

干预措施：

Mindfulness based intervention

干预措施代码：

Intervention：

Mindfulness based intervention

Intervention code：

组别：

control group

样本量：

 15

Group：

control group

Sample size：

干预措施：

waitlist control

干预措施代码：

Intervention：

waitlist control

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)：

 香港特別行政區 

Country：

China

Province：

Hong Kong SAR

City：

Hong Kong

单位(医院)：

 香港中文大學 

单位级别：

 香港中文大學 

Institution
hospital：

Chinese University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

feasibility and acceptability of the intervention

指标类型：

主要指标

Outcome：

feasibility and acceptability of the intervention

Type：

Primary indicator

测量时间点：

baseline and post intervention

测量方法：

1) adherence (2) perceived level of easiness and satisfaction of the intervention (3) perceived facilitators and barriers in receiving mindfulness based intervention, through the qualitative interviews/focused groups.

Measure time point of outcome：

baseline and post intervention

Measure method：

1) adherence (2) perceived level of easiness and satisfaction of the intervention (3) perceived facilitators and barriers in receiving mindfulness based intervention, through the qualitative interviews/focused groups.

指标中文名：

Zarit Burden Interview (ZBI)

指标类型：

次要指标

Outcome：

Zarit Burden Interview (ZBI)

Type：

Secondary indicator

测量时间点：

baseline and post intervention

测量方法：

survey

Measure time point of outcome：

baseline and post intervention

Measure method：

survey

指标中文名：

Depression, Anxiety, Stress Scales (DASS)

指标类型：

次要指标

Outcome：

Depression, Anxiety, Stress Scales (DASS)

Type：

Secondary indicator

测量时间点：

baseline and post intervention

测量方法：

survey

Measure time point of outcome：

baseline and post intervention

Measure method：

survey

指标中文名：

The Self-Compassion Scale - Short Form (SCS-SF)

指标类型：

次要指标

Outcome：

The Self-Compassion Scale - Short Form (SCS-SF)

Type：

Secondary indicator

测量时间点：

baseline and post intervention

测量方法：

survey

Measure time point of outcome：

baseline and post intervention

Measure method：

survey

指标中文名：

The 13-item Sense of Coherence Scale (SOC-13)

指标类型：

次要指标

Outcome：

The 13-item Sense of Coherence Scale (SOC-13)

Type：

Secondary indicator

测量时间点：

baseline and post intervention

测量方法：

survey

Measure time point of outcome：

baseline and post intervention

Measure method：

survey

指标中文名：

Mindfulness (FFMQ and MAAS)

指标类型：

次要指标

Outcome：

Mindfulness (FFMQ and MAAS)

Type：

Secondary indicator

测量时间点：

baseline and post intervention

测量方法：

survey

Measure time point of outcome：

baseline and post intervention

Measure method：

survey

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 18 岁 years
最大 Max age 65 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）：

The participants will be randomized to either intervention or control group on a 1:1 ratio with the use of random numbers in computer which will be generated by a statistician who is independent of this study. The randomization results will be sealed in opaque envelops which will be only opened afte

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

The participants will be randomized to either intervention or control group on a 1:1 ratio with the use of random numbers in computer which will be generated by a statistician who is independent of this study. The randomization results will be sealed in opaque envelops which will be only opened afte

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：

The participants and instructors by nature will be informed of the randomisation allocation results, however, the trained research assistant/associate who conducts the assessments and the statistician who conducts the data analysis will be kept blinded of the grouping.

Blinding：

The participants and instructors by nature will be informed of the randomisation allocation results, however, the trained research assistant/associate who conducts the assessments and the statistician who conducts the data analysis will be kept blinded of the grouping.

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）：

The data will be available upon request after the study has been conducted.

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

The data will be available upon request after the study has been conducted.

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 will be filled in questionnaires in paper. The data will be entered and saved in statistical softwares, Word and/or Excels files. The records will be locked in cabinets or saved in pass-word protected computers.

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

Data will be filled in questionnaires in paper. The data will be entered and saved in statistical softwares, Word and/or Excels files. The records will be locked in cabinets or saved in pass-word protected computers.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

注册人：

Name of Registration：

  2017-07-25 15:55:35
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