【ChiCTR2200056204】ONLINE MINDFULNESS THERAPY AS A SMOKING CESSATION AID IN MALAYSIA: A RANDOMIZED CONTROL TRIAL

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基本信息

登记号

ChiCTR2200056204

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2022-02-01

临床申请受理号

靶点

适应症

Non-communicable diseases

试验通俗题目

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

试验专业题目

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

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

71800

联系人通讯地址

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临床试验信息

试验目的

General Objective To determine whether counselling or mindfulness therapy is a better intervention as a quit smoking aid among smokers. Specific Objectives 1. 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. 2. To compare the difference of the scores on QSU-Brief before and after intervention in the two intervention groups using counselling and mindfulness therapy. 3. To compare the difference of the scores on DASS before and after intervention in the two intervention groups using counselling and mindfulness therapy. 4. 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. 5. To compare the difference of the scores on AAQ-2 before and after intervention in the two intervention groups using counselling and mindfulness therapy. 6. 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.

试验分类

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试验类型

随机抽样

试验分期

Ⅰ期

随机化

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.

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.

试验项目经费来源

University Malaysia Sabah, Malaysia

试验范围

目标入组人数

实际入组人数

第一例入组时间

2022-01-01

试验终止时间

2023-10-01

是否属于一致性

入选标准

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.；

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.；

研究者信息

研究负责人姓名

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试验机构

University Malaysia Sabah, Malaysia

研究负责人电话

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研究负责人邮箱

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研究负责人邮编

88400

联系人通讯地址