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正念认知疗法治疗自杀幸存者预试验
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注册号：

Registration number：

 ChiCTR-OPC-17011190 

最近更新日期：

Date of Last Refreshed on：

 2017-04-20 17:22:36 

注册时间：

Date of Registration：

 2017-04-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

正念认知疗法治疗自杀幸存者预试验

Public title：

Mindfulness-based cognitive therapy for suicide survivors: a pilot study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

正念认知疗法治疗自杀幸存者预试验

Scientific title：

Mindfulness-based cognitive therapy for suicide survivors: 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 Yeung-shan WONG  

Applicant：

Tiffany 

Study leader：

Prof. Samuel Yeung-shan 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：

 +852-26063500

研究负责人传真：

Study leader's fax：

 +852-26063500

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：

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

Applicant's institution：

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

研究负责人所在单位：

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

Affiliation of the Leader：

JC School of Public Health and Primary Care, 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：

 068-17

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：

Survey and Behavioural Research Ethics Committee

Name of the ethic committee：

Survey and Behavioural 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：

School of Public Health and Primary Care, Prince of Wales Hospital, The Chinese University of Hong Kong

Primary sponsor：

School of Public Health and Primary Care, Prince of Wales Hospital, The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

School of Public Health and Primary Care, Prince of Wales Hospital, The Chinese University of Hong Kong

Primary sponsor's address：

School of Public Health and Primary Care, Prince of Wales Hospital, 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：

自杀幸存者  

Target disease：

Survivors of a family member or a significant other who committed suicide

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

单臂 

Study design：

Single arm 

研究目的：

(i) To examine the feasibility of an 8-week structured mindfulness based intervention group plus one-day retreat for suicide survivors; (ii) To examine the effects of the intervention on reducing grief related reactions and complications and psychological distress among suicide survivors; and (iii) To examine the acceptability of the intervention in terms of the participants perceived effectiveness of the programme and the extent of their participation in the intervention.  

Objectives of Study：

(i) To examine the feasibility of an 8-week structured mindfulness based intervention group plus one-day retreat for suicide survivors; (ii) To examine the effects of the intervention on reducing grief related reactions and complications and psychological distress among suicide survivors; and (iii) To examine the acceptability of the intervention in terms of the participants perceived effectiveness of the programme and the extent of their participation in the intervention.

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：

1) those who cannot read Chinese or understand Cantonese as the intervention will be conducted in group format in Cantonese;
2) unable to participate in the 8 week intervention;
3) the presence of severe physical or mental health conditions which hinder the participation of the 8 week intervention; and
4) having an score of 102 or above in the Inventory of Complicated Grief – Revised version (ICG-R). All participants will only join on voluntary basis and they can also withdraw anytime.

Exclusion criteria：

1) those who cannot read Chinese or understand Cantonese as the intervention will be conducted in group format in Cantonese;
2) unable to participate in the 8 week intervention;
3) the presence of severe physical or mental health conditions which hinder the participation of the 8 week intervention; and
4) having an score of 102 or above in the Inventory of Complicated Grief – Revised version (ICG-R). All participants will only join on voluntary basis and they can also withdraw anytime.

研究实施时间：

Study execute time：

从 From 2017-05-08 00:00:00至 To 2018-05-07 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2017-04-28 00:00:00 至 To 2017-05-08 00:00:00

干预措施：

Interventions：

组别：

Case series

样本量：

 15

Group：

MBCT

Sample size：

干预措施：

正念认知疗法

干预措施代码：

Intervention：

mindfulness based cognitive therapy

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)：

 Suicide Prevention Services 

单位级别：

 NGO 

Institution
hospital：

Suicide Prevention Services

Level of the institution：

NGO

测量指标：

Outcomes：

指标中文名：

Complicated Grief

指标类型：

主要指标

Outcome：

Complicated Grief

Type：

Primary indicator

测量时间点：

baseline before the intervention (T0), at 8 weeks from baseline (T1), 3 months post intervention (T2)

测量方法：

Self-administered postal questionnaires or face-to-face/telephone interview when necessary

Measure time point of outcome：

baseline before the intervention (T0), at 8 weeks from baseline (T1), 3 months post intervention (T2)

Measure method：

Self-administered postal questionnaires or face-to-face/telephone interview when necessary

指标中文名：

The Patient Health Questionnaire-9 (PHQ-9)

指标类型：

次要指标

Outcome：

The Patient Health Questionnaire-9 (PHQ-9)

Type：

Secondary indicator

测量时间点：

baseline before the intervention (T0), at 8 weeks from baseline (T1), 3 months post intervention (T2)

测量方法：

Self-administered postal questionnaires or face-to-face/telephone interview when necessary

Measure time point of outcome：

baseline before the intervention (T0), at 8 weeks from baseline (T1), 3 months post intervention (T2)

Measure method：

Self-administered postal questionnaires or face-to-face/telephone interview when necessary

指标中文名：

Generalised Anxiety Disorder Assessment (GAD-7)

指标类型：

次要指标

Outcome：

Generalised Anxiety Disorder Assessment (GAD-7)

Type：

Secondary indicator

测量时间点：

baseline before the intervention (T0), at 8 weeks from baseline (T1), 3 months post intervention (T2)

测量方法：

Self-administered postal questionnaires or face-to-face/telephone interview when necessary

Measure time point of outcome：

baseline before the intervention (T0), at 8 weeks from baseline (T1), 3 months post intervention (T2)

Measure method：

Self-administered postal questionnaires or face-to-face/telephone interview when necessary

指标中文名：

The WHO 5 Well-Being Index (WHO-5)

指标类型：

次要指标

Outcome：

The WHO 5 Well-Being Index (WHO-5)

Type：

Secondary indicator

测量时间点：

baseline before the intervention (T0), at 8 weeks from baseline (T1), 3 months post intervention (T2)

测量方法：

Self-administered postal questionnaires or face-to-face/telephone interview when necessary

Measure time point of outcome：

baseline before the intervention (T0), at 8 weeks from baseline (T1), 3 months post intervention (T2)

Measure method：

Self-administered postal questionnaires or face-to-face/telephone interview when necessary

指标中文名：

Work and Social Adjustment Scale (WSAS)

指标类型：

次要指标

Outcome：

Work and Social Adjustment Scale (WSAS)

Type：

Secondary indicator

测量时间点：

baseline before the intervention (T0), at 8 weeks from baseline (T1), 3 months post intervention (T2)

测量方法：

Self-administered postal questionnaires or face-to-face/telephone interview when necessary

Measure time point of outcome：

baseline before the intervention (T0), at 8 weeks from baseline (T1), 3 months post intervention (T2)

Measure method：

Self-administered postal questionnaires or face-to-face/telephone interview when necessary

指标中文名：

Brief COPE scale

指标类型：

次要指标

Outcome：

Brief COPE scale

Type：

Secondary indicator

测量时间点：

baseline before the intervention (T0), at 8 weeks from baseline (T1), 3 months post intervention (T2)

测量方法：

Self-administered postal questionnaires or face-to-face/telephone interview when necessary

Measure time point of outcome：

baseline before the intervention (T0), at 8 weeks from baseline (T1), 3 months post intervention (T2)

Measure method：

Self-administered postal questionnaires or face-to-face/telephone interview when necessary

指标中文名：

Five Facet Mindfulness Questionnaire (FFMQ)

指标类型：

次要指标

Outcome：

Five Facet Mindfulness Questionnaire (FFMQ)

Type：

Secondary indicator

测量时间点：

baseline before the intervention (T0), at 8 weeks from baseline (T1), 3 months post intervention (T2)

测量方法：

Self-administered postal questionnaires or face-to-face/telephone interview when necessary

Measure time point of outcome：

baseline before the intervention (T0), at 8 weeks from baseline (T1), 3 months post intervention (T2)

Measure method：

Self-administered postal questionnaires or face-to-face/telephone interview when necessary

指标中文名：

Mindfulness Attention Awareness Scale (MAAS)

指标类型：

次要指标

Outcome：

Mindfulness Attention Awareness Scale (MAAS)

Type：

Secondary indicator

测量时间点：

baseline before the intervention (T0), at 8 weeks from baseline (T1), 3 months post intervention (T2)

测量方法：

Self-administered postal questionnaires or face-to-face/telephone interview when necessary

Measure time point of outcome：

baseline before the intervention (T0), at 8 weeks from baseline (T1), 3 months post intervention (T2)

Measure method：

Self-administered postal questionnaires or face-to-face/telephone interview when necessary

指标中文名：

Experience in Close Relationship-Relationship Structures questionnaire (ECR-RS)

指标类型：

次要指标

Outcome：

Experience in Close Relationship-Relationship Structures questionnaire (ECR-RS)

Type：

Secondary indicator

测量时间点：

baseline before the intervention (T0), at 8 weeks from baseline (T1), 3 months post intervention (T2)

测量方法：

Self-administered postal questionnaires or face-to-face/telephone interview when necessary

Measure time point of outcome：

baseline before the intervention (T0), at 8 weeks from baseline (T1), 3 months post intervention (T2)

Measure method：

Self-administered postal questionnaires or face-to-face/telephone interview when necessary

指标中文名：

Integration of Stressful Life Experiences Scale (ISLES)

指标类型：

次要指标

Outcome：

Integration of Stressful Life Experiences Scale (ISLES)

Type：

Secondary indicator

测量时间点：

baseline before the intervention (T0), at 8 weeks from baseline (T1), 3 months post intervention (T2) Measure m

测量方法：

Self-administered postal questionnaires or face-to-face/telephone interview when necessary

Measure time point of outcome：

baseline before the intervention (T0), at 8 weeks from baseline (T1), 3 months post intervention (T2) Measure m

Measure method：

Self-administered postal questionnaires or face-to-face/telephone interview when necessary

指标中文名：

Satisfaction level and extent of participation in the support group

指标类型：

附加指标

Outcome：

Satisfaction level and extent of participation in the support group

Type：

Additional indicator

测量时间点：

post intervention

测量方法：

Self-administered postal questionnaires or face-to-face/telephone interview when necessary add a index below

Measure time point of outcome：

post intervention

Measure method：

Self-administered postal questionnaires or face-to-face/telephone interview when necessary add a index below

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 80 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）：

N/A

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

N/A

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：

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）：

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：

  2017-04-19 20:48:31
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