Efficacy of Cognitive Behavioral Therapy-based Smartphone App for Smoking Cessation in China: a Study Protocol of a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,289
- 试验地点
- 1
- 主要终点
- Biologically verified continuously smoking abstinence at week 26
研究概览
简要总结
This study aims to evaluate the efficacy of cognitive behavioral therapy (CBT)-based cigarette smoking cessation smartphone app for treatment seeking smokers in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cigarette smokers (smoked more than 100 cigarettes in their lifetime, and currently smoke five or more cigarettes a day)
- •25 years of age or older
- •Being able to read and write in Chinese
- •Owning a smartphone
- •Have experience of using apps
- •Expressing an interest in quitting smoking within the next month
- •Willing to provide informed consent to participate in the study
排除标准
- •Only use electronic cigarettes
- •Smokers without attempts to quit smoking
- •Participants with severe mental illness
- •Participants who had already started their quit attempt or using any smoking cessation treatment at the time of registration
- •Unable to use smartphone and apps
- •Unable to read and write in Chinese
结局指标
主要结局
Biologically verified continuously smoking abstinence at week 26
时间窗: 26 weeks
Participants in this study will be considered to be biologically verified continuously smoking abstinence if they report smoking no more than 5 cigarettes since the quit date and have an expired carbon monoxide concentration of less than 10 ppm (for local participants who will be able to go to the PI affiliated hospital) or a urine cotinine cutoff point of 200 ng/ml (cotinine urine dipsticks will be mailed to each participant's address, and test will be confirmed by video call and by family members) at week 26 (6 months) after quit date. This abstinence has been applied by the Society for Research on Nicotine and Tobacco (SRNT) (Hughes, Keely et al. 2003) and the 'Russell Standard' (West, Hajek et al. 2005).
次要结局
- Self-reported continuous smoking abstinence(26 weeks)
- Reductions in number of cigarettes smoked per day(26 weeks)
- 7-day point prevalence smoking abstinence(26 weeks)
研究者
Yanhui Liao
Principal Investigator
Sir Run Run Shaw Hospital