ChiCTR2200056204 版本V1.1 版本创建时间2022/09/26 14:09:43 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2200056204 

最近更新日期：

Date of Last Refreshed on：

 2022-09-26 11:40:32 

注册时间：

Date of Registration：

 2022-02-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

ONLINE MINDFULNESS THERAPY AS A SMOKING CESSATION AID IN MALAYSIA: A RANDOMIZED CONTROL TRIAL

Public title：

ONLINE MINDFULNESS THERAPY AS A SMOKING CESSATION AID IN MALAYSIA: A RANDOMIZED CONTROL TRIAL

注册题目简写：

English Acronym：

研究课题的正式科学名称：

ONLINE MINDFULNESS THERAPY AS A SMOKING CESSATION AID IN MALAYSIA: A RANDOMIZED CONTROL TRIAL

Scientific title：

ONLINE MINDFULNESS THERAPY AS A SMOKING CESSATION AID IN MALAYSIA: A 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：

Hemanath Sinnathamby 

研究负责人：

Associate Professor Dr. Fredie Robinson 

Applicant：

Hemanath Sinnathamby 

Study leader：

Associate Professor Dr. Fredie Robinson 

申请注册联系人电话：

Applicant telephone：

 +60 0183798815

研究负责人电话：

Study leader's
telephone：

+60 0168324477

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：

 hemanath@live.com

研究负责人电子邮件：

Study leader's E-mail：

 freddie@ums.edu.my

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：

308 Jalan Azalea 4/5, Taman Laman Azalea, Malaysia

研究负责人通讯地址：

Faculty of Medicine & Health Sciences (Fakulti Perubatan dan Sains Kesihatan (FPSK)), Jalan UMS, Kota Kinabalu Sabah, Malaysia

Applicant address：

308 Jalan Azalea 4/5, Taman Laman Azalea, Malaysia

Study leader's address：

Faculty of Medicine & Health Sciences (Fakulti Perubatan dan Sains Kesihatan (FPSK)), Jalan UMS, Kota Kinabalu Sabah, Malaysia

申请注册联系人邮政编码：

Applicant postcode：

 71800

研究负责人邮政编码：

Study leader's postcode：

 88400

申请人所在单位：

马来西亚沙巴大学

Applicant's institution：

University Malaysia Sabah

研究负责人所在单位：

马来西亚沙巴大学

Affiliation of the Leader：

University Malaysia Sabah,Malaysia

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：

 JKEtika 2/21 (9)

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：

Medical Research Ethics Commitee Faculty of Medicine and Health Sciences Universiti Malaysia Sabah

Name of the ethic committee：

Medical Research Ethics Commitee Faculty of Medicine and Health Sciences Universiti Malaysia Sabah

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-10-08 00:00:00

伦理委员会联系人：

Mr.Johan Alexander

Contact Name of the ethic committee：

Mr.Johan Alexander

伦理委员会联系地址：

Unversiti Malaysia Sabah, Jalan UMS, 88400, Kota Kinabalu, Sabah, Malaysia

Contact Address of the ethic committee：

Unversiti Malaysia Sabah, Jalan UMS, 88400, Kota Kinabalu, Sabah, Malaysia

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +60 0198991023

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 isaac@ums.edu.my

研究实施负责（组长）单位：

University Malaysia Sabah, Malaysia

Primary sponsor：

University Malaysia Sabah, Malaysia

研究实施负责（组长）单位地址：

Faculty of Medicine & Health Sciences (Fakulti Perubatan dan Sains Kesihatan (FPSK)), Jalan UMS, 88400, Kota Kinabalu Sabah, Malaysia

Primary sponsor's address：

Faculty of Medicine & Health Sciences (Fakulti Perubatan dan Sains Kesihatan (FPSK)), Jalan UMS, 88400, Kota Kinabalu Sabah, Malaysia

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

省(直辖市)：

市(区县)：

Country：

Province：

City：

单位(医院)：

具体地址：

Institution
hospital：

Address：

经费或物资来源：

University Malaysia Sabah, Malaysia

Source(s) of funding：

University Malaysia Sabah, Malaysia

研究疾病：

Non-communicable diseases  

Target disease：

Non-communicable diseases

研究疾病代码：

Target disease code：

研究类型：

预防性研究

Study type：

Prevention

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

随机抽样 

Study design：

Randomly Sampling 

研究目的：

General Objective To determine whether counselling or mindfulness therapy is a better intervention as a quit smoking aid among smokers. Specific Objectives a)To compare the difference of the scores on Fagerstrom Test for Nicotine Dependence before and after intervention in the two intervention groups using counselling and mindfulness therapy. b)To compare the difference of the scores on QSU-Brief before and after intervention in the two intervention groups using counselling and mindfulness therapy. c)To compare difference of the scores on DASS before and after intervention in the two intervention groups using counselling and mindfulness therapy. d)To compare the difference of the scores on the mindfulness, attention, and awareness scale (MAAS) before and after intervention in the two intervention groups using counselling and mindfulness therapy. e)To compare the difference of the scores on AAQ-2 before and after intervention in the two intervention groups using counselling and mindfulness therapy. f)The compare difference and linear relationship of the number of average cigarettes smoked per day in the two intervention groups using counselling and mindfulness therapy.  

Objectives of Study：

General Objective To determine whether counselling or mindfulness therapy is a better intervention as a quit smoking aid among smokers. Specific Objectives a)To compare the difference of the scores on Fagerstrom Test for Nicotine Dependence before and after intervention in the two intervention groups using counselling and mindfulness therapy. b)To compare the difference of the scores on QSU-Brief before and after intervention in the two intervention groups using counselling and mindfulness therapy. c)To compare difference of the scores on DASS before and after intervention in the two intervention groups using counselling and mindfulness therapy. d)To compare the difference of the scores on the mindfulness, attention, and awareness scale (MAAS) before and after intervention in the two intervention groups using counselling and mindfulness therapy. e)To compare the difference of the scores on AAQ-2 before and after intervention in the two intervention groups using counselling and mindfulness therapy. f)The compare difference and linear relationship of the number of average cigarettes smoked per day in the two intervention groups using counselling and mindfulness therapy.

药物成份或治疗方案详述：

Intervention: Mindfulness Therapy according to treatment protocol from a previous study(Mak et al, 2015)(https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-015-1485-z). Control: Counseling therapy Based on clinical practice guidelines (CPG) on Treatment of Tobacco Use Disorder 2016, published by the Ministry of Health Malaysia (CPG , 2016) Procedure Each participant, before the intervention start will be required to answer a set of questionnaires administered by the researcher to acquire the baseline score of smoking status, nicotine dependence, mental status, mindfulness state and smoking urges. The participant will be screened for their eligibility status according to the baseline information. Furthermore, people with a severe DASS score will be contacted through phone to advise them to seek medical attention at the nearest health clinic for further assessment. A total of three sections of therapy will be conducted which is including the first initial section and 2 follow-up sections with 2 weeks gap in between each section. All three sections will be conducted completely via the online platform Google Meet by five mindfulness therapies and five counseling therapies. Meanwhile, the whole process of the workflow will be organized and supervised by the main researcher. One week after the third section is completed, again the participants will be required to answer a set of questionnaires to observe the improvement in regard to quitting smoking and mental status and the set of questionnaires again will be repeated after 5 weeks. 

Description for medicine or protocol of treatment in detail：

Intervention: Mindfulness Therapy according to treatment protocol from a previous study(Mak et al, 2015)(https://bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-015-1485-z). Control: Counseling therapy Based on clinical practice guidelines (CPG) on Treatment of Tobacco Use Disorder 2016, published by the Ministry of Health Malaysia (CPG , 2016) Procedure Each participant, before the intervention start will be required to answer a set of questionnaires administered by the researcher to acquire the baseline score of smoking status, nicotine dependence, mental status, mindfulness state and smoking urges. The participant will be screened for their eligibility status according to the baseline information. Furthermore, people with a severe DASS score will be contacted through phone to advise them to seek medical attention at the nearest health clinic for further assessment. A total of three sections of therapy will be conducted which is including the first initial section and 2 follow-up sections with 2 weeks gap in between each section. All three sections will be conducted completely via the online platform Google Meet by five mindfulness therapies and five counseling therapies. Meanwhile, the whole process of the workflow will be organized and supervised by the main researcher. One week after the third section is completed, again the participants will be required to answer a set of questionnaires to observe the improvement in regard to quitting smoking and mental status and the set of questionnaires again will be repeated after 5 weeks. 

纳入标准：

1. Adult aged 18 to 60 years;
2. Smokers who are moderately dependent or highly dependent according to the Fagerstrom test;
3. Able to understand Malay and English moderately;
4. Have excess to the internet connection;
5. Currently residing in Malaysia.

Inclusion criteria

1. Adult aged 18 to 60 years;
2. Smokers who are moderately dependent or highly dependent according to the Fagerstrom test;
3. Able to understand Malay and English moderately;
4. Have excess to the internet connection;
5. Currently residing in Malaysia.

排除标准：

1. Currently undergoing any other smoking cessation program which is conducted under private or government healthcare center (Quit smoking clinics);
2. On any kind of nicotine replacement therapy;
3. Currently using any kind of psychoactive medications;
4. Has a serious or unstable medical/mental condition.

Exclusion criteria：

1. Currently undergoing any other smoking cessation program which is conducted under private or government healthcare center (Quit smoking clinics);
2. On any kind of nicotine replacement therapy;
3. Currently using any kind of psychoactive medications;
4. Has a serious or unstable medical/mental condition.

研究实施时间：

Study execute time：

从 From 2022-01-01 00:00:00至 To 2023-10-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-03-01 00:00:00 至 To 2022-07-01 00:00:00

干预措施：

Interventions：

组别：

A

样本量：

 79

Group：

A

Sample size：

干预措施：

Mindfulness therapy

干预措施代码：

Intervention：

Mindfulness therapy

Intervention code：

组别：

B

样本量：

 79

Group：

B

Sample size：

干预措施：

Counselling Therapy

干预措施代码：

Intervention：

Counselling Therapy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 马来西亚

省(直辖市)：

 沙巴 

市(区县)：

 哥打基纳巴鲁 

Country：

Malaysia

Province：

Sabah

City：

Kota Kinabalu

单位(医院)：

 马亚西亚沙巴大学 

单位级别：

 大學 

Institution
hospital：

University Malaysia Sabah

Level of the institution：

Education

测量指标：

Outcomes：

指标中文名：

Quit smoking

指标类型：

主要指标

Outcome：

Quit smoking

Type：

Primary indicator

测量时间点：

Day 65

测量方法：

questionnaire

Measure time point of outcome：

Day 65

Measure method：

questionnaire

指标中文名：

Reduce smoking

指标类型：

主要指标

Outcome：

Reduce smoking

Type：

Primary indicator

测量时间点：

Day 65

测量方法：

questionnaire

Measure time point of outcome：

Day 65

Measure method：

questionnaire

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

N/A

组织：

Sample Name：

N/A

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 60 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）：

All the eligible participants who were included into the study after the screening process will be randomized to either mindfulness therapy group or counselling group. The randomization process will completely be done by using computer generated randomization Excel software to excluded bias.

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

All the eligible participants who were included into the study after the screening process will be randomized to either mindfulness therapy group or counselling group. The randomization process will completely be done by using computer generated randomization Excel software to excluded bias.

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：

The intervention group will be labelled Group A for mindfulness therapy and Group B for counselling therapy, hence the participate only will be told which group they are assigned to without informing what kind of therapy they are subjected to undergo.

Blinding：

The intervention group will be labelled Group A for mindfulness therapy and Group B for counselling therapy, hence the participate only will be told which group they are assigned to without informing what kind of therapy they are subjected to undergo.

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

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）：

Manual data sharing if required

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

Manual data sharing if required

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：

Google Form

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

Google Form

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2022-02-01 13:50:10