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The feasibility and effects of mindfulness based relapse prevention (MBRP) on reducing craving and addictive behaviour in substance abuse disorders
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注册号：

Registration number：

 ChiCTR1900026247 

最近更新日期：

Date of Last Refreshed on：

 2019-09-28 13:32:46 

注册时间：

Date of Registration：

 2019-09-28 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

The feasibility and effects of mindfulness based relapse prevention (MBRP) on reducing craving and addictive behaviour in substance abuse disorders

Public title：

The feasibility and effects of mindfulness based relapse prevention (MBRP) on reducing craving and addictive behaviour in substance abuse disorders

注册题目简写：

English Acronym：

研究课题的正式科学名称：

The feasibility and effects of mindfulness based relapse prevention (MBRP) on reducing craving and addictive behaviour in substance abuse disorders

Scientific title：

The feasibility and effects of mindfulness based relapse prevention (MBRP) on reducing craving and addictive behaviour in local adults with substance abuse disorders

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：

Julia Chan 

研究负责人：

Samuel Yeung Shan Wong 

Applicant：

Julia Chan 

Study leader：

Samuel Yeung Shan Wong 

申请注册联系人电话：

Applicant telephone：

 +86 22528753

研究负责人电话：

Study leader's
telephone：

+86 22528753

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：

 juliachan19@gmail.com

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：

中國香港特別行政區新界沙田威爾士親王醫院公共衛生學院4樓

研究负责人通讯地址：

中國香港特別行政區新界沙田威爾士親王醫院公共衛生學院4樓409室

Applicant address：

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

Study leader's address：

R409, 4/F, School of Public Health, 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：

Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學

Affiliation of the Leader：

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：

 2019.230-T

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：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

Joint Chinese University Hong Kong-New Territories East Cluster Clinicial Research Ethics Commitee

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-09-10 00:00:00

伦理委员会联系人：

Envy Lee

Contact Name of the ethic committee：

Envy Lee

伦理委员会联系地址：

中國香港特別行政區新界沙田威爾士親王醫院呂志和臨床科學大樓8樓

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong, China

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：

Beat Drugs Fund Association

Primary sponsor：

Beat Drugs Fund Association

研究实施负责（组长）单位地址：

30/F, High Block, Queensway Government Offices, 66 Queensway Hong Kong

Primary sponsor's address：

30/F, High Block, Queensway Government Offices, 66 Queensway Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中國

省(直辖市)：

香港特別行政區

市(区县)：

Country：

China

Province：

Hong Kong Special Administrative Region

City：

Hong Kong

单位(医院)：

香港中文大學

具体地址：

香港中文大學威爾士親王醫院賽馬會公共衛生與基層醫療學院

Institution
hospital：

Chinese University, Hong Kong

Address：

4/F, Jockey Club School of Public Health, Prince of Wales Hospital

经费或物资来源：

Beat Drugs Fund Association

Source(s) of funding：

Beat Drugs Fund Association

研究疾病：

器物使用障礙  

Target disease：

Substance Use Disorder

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：

1. To evaluate the feasibility of using mindfulness- based relapse prevention (MBRP) programme among adults with substance abuse in Hong Kong; 2. To examine the changes of craving, substance use, mood symptoms, self-efficacy, acceptance, level of mindfulness and quality of life between those who have enrolled in the MBRP as compared to those in the usual care control group; 3. To evaluate the correlations between changes in substance use and craving and changes in mood symptoms, self-efficacy, acceptance, level of mindfulness, and quality of life; and 4. To study participants characteristics related to adherence and benefits associated with MBRP  

Objectives of Study：

1. To evaluate the feasibility of using mindfulness- based relapse prevention (MBRP) programme among adults with substance abuse in Hong Kong; 2. To examine the changes of craving, substance use, mood symptoms, self-efficacy, acceptance, level of mindfulness and quality of life between those who have enrolled in the MBRP as compared to those in the usual care control group; 3. To evaluate the correlations between changes in substance use and craving and changes in mood symptoms, self-efficacy, acceptance, level of mindfulness, and quality of life; and 4. To study participants characteristics related to adherence and benefits associated with MBRP

药物成份或治疗方案详述：

Mindfulness based relapse prevention (MBRP) is an integration of traditional cognitive behavioural relapse prevention with mindfulness techniques and practices adapted from mindfulness based stress reduction (MBSR). This is a feasibility study and is a single-blinded, randomized controlled trial with two study arms: the MBRP programme is led by trained mindfulness instructors and a usual care control group (UCCG). The MBRP will last for 8 weeks and outcome measures will be collected at similar time points in both the MBRP and UCCG groups (baseline, immediately post intervention, at 3 months post intervention, 6 months post intervention, 9 months post intervention and 12 months post intervention) (Figure 1). Qualitative focus group discussions or individual interviews will be conducted to obtain feedback of the MBRP programme from participants after the MBRP course. 

Description for medicine or protocol of treatment in detail：

Mindfulness based relapse prevention (MBRP) is an integration of traditional cognitive behavioural relapse prevention with mindfulness techniques and practices adapted from mindfulness based stress reduction (MBSR). This is a feasibility study and is a single-blinded, randomized controlled trial with two study arms: the MBRP programme is led by trained mindfulness instructors and a usual care control group (UCCG). The MBRP will last for 8 weeks and outcome measures will be collected at similar time points in both the MBRP and UCCG groups (baseline, immediately post intervention, at 3 months post intervention, 6 months post intervention, 9 months post intervention and 12 months post intervention) (Figure 1). Qualitative focus group discussions or individual interviews will be conducted to obtain feedback of the MBRP programme from participants after the MBRP course. 

纳入标准：

Inclusion criteria

排除标准：

1. Inability to provide valid consent;
2. Current or lifetime psychotic disorder diagnosed by the Structured Clinical interview for DSM-IV or DSM-5 - Imminent suicidal risk;
3. Dementia.

Exclusion criteria：

1. Inability to provide valid consent;
2. Current or lifetime psychotic disorder diagnosed by the Structured Clinical interview for DSM-IV or DSM-5 - Imminent suicidal risk;
3. Dementia.

研究实施时间：

Study execute time：

从 From 2019-09-10 00:00:00至 To 2021-09-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2019-10-10 00:00:00 至 To 2021-06-09 00:00:00

干预措施：

Interventions：

组别：

Experimental group

样本量：

 40

Group：

Experimental group

Sample size：

干预措施：

MBRP intervention

干预措施代码：

Intervention：

MBRP intervention

Intervention code：

组别：

Control group

样本量：

 40

Group：

Control Group

Sample size：

干预措施：

Usual Care

干预措施代码：

Intervention：

Usual Care

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：

Hong Kong SAR

单位(医院)：

 香港中文大學 

单位级别：

 大學 

Institution
hospital：

Chinese University of Hong Kong

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Substance Use Calender (self-report)

指标类型：

主要指标

Outcome：

Substance Use Calender (self-report)

Type：

Primary indicator

测量时间点：

baseline, post intervention, 3 months post intervention, 6 months post intervention, 9 months post intervention, 12 months post intervention

测量方法：

Questionnaire

Measure time point of outcome：

baseline, post intervention, 3 months post intervention, 6 months post intervention, 9 months post intervention, 12 months post intervention

Measure method：

Questionnaire

指标中文名：

Drug Craving (Penn Alcohol Craving Scale)

指标类型：

次要指标

Outcome：

Drug Craving (Penn Alcohol Craving Scale)

Type：

Secondary indicator

测量时间点：

baseline, post intervention, 3 months post intervention, 6 months post intervention, 9 months post intervention, 12 months post intervention

测量方法：

Questionnaire

Measure time point of outcome：

baseline, post intervention, 3 months post intervention, 6 months post intervention, 9 months post intervention, 12 months post intervention

Measure method：

Questionnaire

指标中文名：

Depression (PHQ-9)

指标类型：

次要指标

Outcome：

Depression (PHQ-9)

Type：

Secondary indicator

测量时间点：

baseline, post intervention, 3 months post intervention, 6 months post intervention, 9 months post intervention, 12 months post intervention

测量方法：

Questionnaire

Measure time point of outcome：

baseline, post intervention, 3 months post intervention, 6 months post intervention, 9 months post intervention, 12 months post intervention

Measure method：

Questionnaire

指标中文名：

Anxiety (GAD-7)

指标类型：

次要指标

Outcome：

Anxiety (GAD-7)

Type：

Secondary indicator

测量时间点：

baseline, post intervention, 3 months post intervention, 6 months post intervention, 9 months post intervention, 12 months post intervention

测量方法：

Questionnaire

Measure time point of outcome：

baseline, post intervention, 3 months post intervention, 6 months post intervention, 9 months post intervention, 12 months post intervention

Measure method：

Questionnaire

指标中文名：

Addiction Severity (Addiction Severity Index - Lite Version）

指标类型：

次要指标

Outcome：

Addiction Severity (Addiction Severity Index - Lite Version)

Type：

Secondary indicator

测量时间点：

baseline, post intervention, 3 months post intervention, 6 months post intervention, 9 months post intervention, 12 months post intervention

测量方法：

Questionnaire

Measure time point of outcome：

baseline, post intervention, 3 months post intervention, 6 months post intervention, 9 months post intervention, 12 months post intervention

Measure method：

Questionnaire

指标中文名：

Drug Avoidance Self-Efficacy (Drug Avoidance Self-Efficacy Scale)

指标类型：

次要指标

Outcome：

Drug Avoidance Self-Efficacy (Drug Avoidance Self-Efficacy Scale)

Type：

Secondary indicator

测量时间点：

baseline, post intervention, 3 months post intervention, 6 months post intervention, 9 months post intervention, 12 months post intervention

测量方法：

Questionnaire

Measure time point of outcome：

baseline, post intervention, 3 months post intervention, 6 months post intervention, 9 months post intervention, 12 months post intervention

Measure method：

Questionnaire

指标中文名：

Level of Acceptance (Acceptance and Action Questionnaire)

指标类型：

次要指标

Outcome：

Level of Acceptance (Acceptance and Action Questionnaire)

Type：

Secondary indicator

测量时间点：

baseline, post intervention, 3 months post intervention, 6 months post intervention, 9 months post intervention, 12 months post intervention

测量方法：

Questionnaire

Measure time point of outcome：

baseline, post intervention, 3 months post intervention, 6 months post intervention, 9 months post intervention, 12 months post intervention

Measure method：

Questionnaire

指标中文名：

Level of Mindfulness (Five Facet Mindfulness Questionnaire)

指标类型：

次要指标

Outcome：

Level of Mindfulness (Five Facet Mindfulness Questionnaire)

Type：

Secondary indicator

测量时间点：

baseline, post intervention, 3 months post intervention, 6 months post intervention, 9 months post intervention, 12 months post intervention

测量方法：

Questionnaire

Measure time point of outcome：

baseline, post intervention, 3 months post intervention, 6 months post intervention, 9 months post intervention, 12 months post intervention

Measure method：

Questionnaire

指标中文名：

Meditation Practice (worksheet reporting type and duration of mindfulness practice)

指标类型：

次要指标

Outcome：

Meditation Practice (worksheet reporting type and duration of mindfulness practice)

Type：

Secondary indicator

测量时间点：

baseline, post intervention, 3 months post intervention, 6 months post intervention, 9 months post intervention, 12 months post intervention

测量方法：

Questionnaire

Measure time point of outcome：

baseline, post intervention, 3 months post intervention, 6 months post intervention, 9 months post intervention, 12 months post intervention

Measure method：

Questionnaire

指标中文名：

Health Related Quality of Life (EuroQol Eq-5D-5L)

指标类型：

次要指标

Outcome：

Health Related Quality of Life (EuroQol Eq-5D-5L)

Type：

Secondary indicator

测量时间点：

baseline, post intervention, 3 months post intervention, 6 months post intervention, 9 months post intervention, 12 months post intervention

测量方法：

Questionnaire

Measure time point of outcome：

baseline, post intervention, 3 months post intervention, 6 months post intervention, 9 months post intervention, 12 months post intervention

Measure method：

Questionnaire

指标中文名：

Interview (one hour, open ended questions on perceived practice of mindfulness course)

指标类型：

次要指标

Outcome：

Interview (one hour, open ended questions on perceived practice of mindfulness course)

Type：

Secondary indicator

测量时间点：

baseline, post intervention, 3 months post intervention, 6 months post intervention, 9 months post intervention, 12 months post intervention

测量方法：

Questionnaire

Measure time point of outcome：

baseline, post intervention, 3 months post intervention, 6 months post intervention, 9 months post intervention, 12 months post intervention

Measure method：

Questionnaire

指标中文名：

Urine test

指标类型：

主要指标

Outcome：

Urine test

Type：

Primary indicator

测量时间点：

baseline, post intervention, 3 months post intervention, 6 months post intervention, 9 months post intervention, 12 months post intervention

测量方法：

Measure time point of outcome：

baseline, post intervention, 3 months post intervention, 6 months post intervention, 9 months post intervention, 12 months post intervention

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

Urine

组织：

Urine

Sample Name：

Urine

Tissue：

Urine

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 70 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）：

Randomization will be conducted by an independent statistician in a 1:1 ratio to allocate patients into two groups, using computer-generated random numbers.

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

Randomization will be conducted by an independent statistician in a 1:1 ratio to allocate patients into two groups, using computer-generated random numbers.

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：

In this open-label study, blinding of therapists and participants will not be possible. However, all data collection will be performed by a trained research assistant blinded to the allocation status of the participants. The research assistant will receive rigorous training in standardized data collection procedures. Data entry will be prepared so that the person can conduct the statistical analyses without referring to allocation information, thus ensuring blinding during data analysis.

Blinding：

In this open-label study, blinding of therapists and participants will not be possible. However, all data collection will be performed by a trained research assistant blinded to the allocation status of the participants. The research assistant will receive rigorous training in standardized data collection procedures. Data entry will be prepared so that the person can conduct the statistical analyses without referring to allocation information, thus ensuring blinding during data analysis.

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

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）：

Data will be available by request to the Principle Investigator after the end of the trial

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

Data will be available by request to the Principle Investigator after the end of the trial

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：

The study purpose and procedures will be explained in details to study participants. Consent form will be signed before data collection. Assessments will be conducted at baseline, post intervention, 3, 6, 9 and 12 months post intervention. A qualitative interview with study participants will also be held at post intervention. Participants will complete assessments by pen and paper. Urine samples will be collected in person. Regarding post intervention data collection, questionnaires and urine samples will also be collected in person. Urine samples will be destructed following collection of results. For the qualitative discussions, they will be anonymized. The typed transcripts and collected data will be kept in the password-protected computer and any printed copies will be kept in a locked file cabinet. Only the research personnel who are responsible for this project will have access to the information.

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

The study purpose and procedures will be explained in details to study participants. Consent form will be signed before data collection. Assessments will be conducted at baseline, post intervention, 3, 6, 9 and 12 months post intervention. A qualitative interview with study participants will also be held at post intervention. Participants will complete assessments by pen and paper. Urine samples will be collected in person. Regarding post intervention data collection, questionnaires and urine samples will also be collected in person. Urine samples will be destructed following collection of results. For the qualitative discussions, they will be anonymized. The typed transcripts and collected data will be kept in the password-protected computer and any printed copies will be kept in a locked file cabinet. Only the research personnel who are responsible for this project will have access to the information.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2019-09-28 13:32:46
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