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【ChiCTR2200065390】Effect of additional mindfulness training to smoking cessation treatment on relapse prevention of Chinese smokers: a pragmatic randomized-controlled trial

基本信息
登记号

ChiCTR2200065390

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

2022-11-03

临床申请受理号

/

靶点

/

适应症

Substance abuse

试验通俗题目

Effect of additional mindfulness training to smoking cessation treatment on relapse prevention of Chinese smokers: a pragmatic randomized-controlled trial

试验专业题目

Effect of additional mindfulness training to smoking cessation treatment on relapse prevention of Chinese smokers: a pragmatic randomized-controlled trial

申办单位信息
申请人联系人
申请人名称
联系人邮箱
联系人邮编

联系人通讯地址
临床试验信息
试验目的

To evaluate the effectiveness of a brief individual mindfulness training when added to smoking cessation treatment (i.e. nicotine replacement therapy + counseling) for preventing relapse in smoking compared to smoking cessation treatment only. Previous meta-analyses suggested having a more vigorous design in research on mindfulness training for smoking cessation (Maglione et al., 2017; Oikonomou et al., 2017). This study will be reported following the Consolidated Standards of Reporting Trials (CONSORT) standards (Schulz et al., 2010).

试验分类
试验类型

随机平行对照

试验分期

Ⅰ期

随机化

The randomization table of each strata will be generated by an independent researcher via an online software.

盲法

none

试验项目经费来源

未说明

试验范围

/

目标入组人数

45

实际入组人数

/

第一例入组时间

2022-10-03

试验终止时间

2024-10-03

是否属于一致性

/

入选标准

1. Self-report daily smokers; 2. Receive nicotine patch treatment; 3. Motivated to quit within the next 30 days; 4. Aged >= 18 years; 5. Able to speak and read Chinese; 6. Not being pregnant.；

排除标准

1. Contraindication of nicotine patch use; 2. With significant physical illness or severe cognitive impairment that create obstacle for communication, such as blindness or severe hearing loss; 3. Actively psychotic or manic; 4. With active illicit drug use; 5. Alcohol dependence with Alcohol Use Disorders Identification Test (AUDIT) score 20 or above (World-Health-Organization, 2001); 6. Participation in mindfulness course or having daily mindfulness practice in the previous 12 months; 7. Participation in smoking cessation treatment in the previous 12 months.；

研究者信息
研究负责人姓名
试验机构

Prince of Wales Hospital

研究负责人电话
研究负责人邮箱
研究负责人邮编

/

联系人通讯地址

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