Today is 2019-10-22

Mechanisms involved in the effect of a brief mindfulness based intervention on personal recovery in people with bipolar disorder
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注册号:

Registration number:

ChiCTR1900024658 

最近更新日期:

Date of Last Refreshed on:

2019-07-20 

注册时间:

Date of Registration:

2019-07-20 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

Mechanisms involved in the effect of a brief mindfulness based intervention on personal recovery in people with bipolar disorder  

Public title:

Mechanisms involved in the effect of a brief mindfulness based intervention on personal recovery in people with bipolar disorder  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

Mechanisms involved in the effect of a brief mindfulness based intervention on personal recovery in people with bipolar disorder 

Scientific title:

Mechanisms involved in the effect of a brief mindfulness based intervention on personal recovery in people with bipolar disorder  

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:

Chan Ho Wan Sunny 

研究负责人:

Chan Ho Wan Sunny 

Applicant:

Chan Ho Wan Sunny 

Study leader:

Chan Ho Wan Sunny 

申请注册联系人电话:

Applicant telephone:

+852 27664676 

研究负责人电话:

Study leader's telephone:

+852 27664676 

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:

sunny.hw.chan@polyu.edu.hk 

研究负责人电子邮件:

Study leader's E-mail:

sunny.hw.chan@polyu.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:

Room ST502, The Hong Kong Polytechnic University, Hong Kong, China 

研究负责人通讯地址:

Room ST502, The Hong Kong Polytechnic University, Hong Kong, China 

Applicant address:

Room ST502, The Hong Kong Polytechnic University, Hong Kong, China 

Study leader's address:

Room ST502, The Hong Kong Polytechnic University, Hong Kong, China 

申请注册联系人邮政编码:

Applicant postcode:

0000 

研究负责人邮政编码:

Study leader's postcode:

0000 

申请人所在单位:

香港理工大學 

Applicant's institution:

The Hong Kong Polytechnic University 

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:

HSEARS20190327010 

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:

Human Subjects Ethics Sub-committee, Departmental Research Committee, The Hong Kong Polytechnic University 

Name of the ethic committee:

Human Subjects Ethics Sub-committee, Departmental Research Committee, The Hong Kong Polytechnic University 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

Prof. David Man Wai Kwong 

Contact Name of the ethic committee:

Prof. David Man Wai Kwong 

伦理委员会联系地址:

香港理工大學 

Contact Address of the ethic committee:

The Hong Kong Polytechnic University 

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:

Research Grants Council 

Primary sponsor:

Research Grants Council 

研究实施负责(组长)单位地址:

7/F., Shui On Centre, 6-8 Harbour Road, Wanchai, Hong Kong, China 

Primary sponsor's address:

7/F., Shui On Centre, 6-8 Harbour Road, Wanchai, Hong Kong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

General Research Fund and Early Career Scheme 

Source(s) of funding:

General Research Fund and Early Career Scheme 

研究疾病:

bipolar disease 

Target disease:

bipolar disease 

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:

研究目的:

1. To address extant research and intervention gaps by evaluating the efficacy and mechanisms of a psychosocial intervention to facilitate the process of personal recovery in adults living with BD; 2. To provide a novel insight into the landscape in which the brief MBI is applied to a new research area of personal recovery among people with BD; 3. To integrate the staging model of BD with the beneficial effects of the brief MBI along the process of personal recovery; 4. To better understand the lived experience of mindfulness during the personal recovery process among individuals living with BD; 5. To obtain important findings that will facilitate the development of our theoretical understanding of the change mechanisms important to the personal recovery process. 

Objectives of Study:

1. To address extant research and intervention gaps by evaluating the efficacy and mechanisms of a psychosocial intervention to facilitate the process of personal recovery in adults living with BD; 2. To provide a novel insight into the landscape in which the brief MBI is applied to a new research area of personal recovery among people with BD; 3. To integrate the staging model of BD with the beneficial effects of the brief MBI along the process of personal recovery; 4. To better understand the lived experience of mindfulness during the personal recovery process among individuals living with BD; 5. To obtain important findings that will facilitate the development of our theoretical understanding of the change mechanisms important to the personal recovery process. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

1. A diagnosis of Bipolar I or II disorder; 2. In a state of full remission for more than two months; 3. On regular medication; 4. Aged 18 years old or above; 5. A Structured Clinical Interview for DSM-IV Disorders (SCID; only the mood disorders sections) will be administered by trained clinicians to confirm the diagnosis and remission status of the participants. 

Inclusion criteria

1. A diagnosis of Bipolar I or II disorder; 2. In a state of full remission for more than two months; 3. On regular medication; 4. Aged 18 years old or above; 5. A Structured Clinical Interview for DSM-IV Disorders (SCID; only the mood disorders sections) will be administered by trained clinicians to confirm the diagnosis and remission status of the participants. 

排除标准:

With active suicidal ideation or self-harm behaviours; People with a comorbid diagnosis of schizophrenia, schizoaffective disorder, substance misuse, organic brain syndrome, or intellectual disability will be excluded. 

Exclusion criteria:

With active suicidal ideation or self-harm behaviours; People with a comorbid diagnosis of schizophrenia, schizoaffective disorder, substance misuse, organic brain syndrome, or intellectual disability will be excluded. 

研究实施时间:

Study execute time:

From2020-01-01To 2022-12-31 

干预措施:

Interventions:

组别:

Experimental group

样本量:

77

Group:

Experimental 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:

77

Group:

Control group

Sample size:

干预措施:

Waiting list

干预措施代码:

Intervention:

Waiting list

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):

Queen Mary Hospital 

单位级别:

 

Institution
hospital:

Queen Mary Hospital  

Level of the institution:

 

测量指标:

Outcomes:

指标中文名:

Bipolar Recovery Questionnaire

指标类型:

主要指标 

Outcome:

Bipolar Recovery Questionnaire

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

No

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 years
最大 Max age 65 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 PI will generate the random number sequence by a computer-generated randomization list.

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

The PI will generate the random number sequence by a computer-generated randomization list.

盲法:

Open label

Blinding:

Open label

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

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):

Available upon request

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

Available upon request

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:

Any information obtained in this study will remain very strictly confidential, will be known to no-one, and will be used for research purposes only. Codes, not names, are used on all test instruments to protect confidentiality. Data will be stored in encrypted file in the computer. To protect patient privacy, all research data and hard documents would be handled with significant care with regard to handling/storage/destruction of patients’ medical records. They would be locked in cabinets where the department or ward keeps patients’ confidential information.

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

Any information obtained in this study will remain very strictly confidential, will be known to no-one, and will be used for research purposes only. Codes, not names, are used on all test instruments to protect confidentiality. Data will be stored in encrypted file in the computer. To protect patient privacy, all research data and hard documents would be handled with significant care with regard to handling/storage/destruction of patients’ medical records. They would be locked in cabinets where the department or ward keeps patients’ confidential information.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-07-20
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