Department of Psychiatry, Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University, Hangzhou, China
Key Laboratory of Medical Neurobiology of Zhejiang Province, Hangzhou, China.
BMJ Open. 2021 Jan 13;11(1):e041985. doi: 10.1136/bmjopen-2020-041985.
A number of smartphone apps have been proved to be effective in assisting smoking cessation in many countries, but little is known about the effectiveness of smartphone apps that assist in smoking cessation in China. This study aims to evaluate the efficacy of cognitive behavioural therapy (CBT)-based cigarette smoking cessation smartphone app for treatment-seeking smokers in China.
In this remote control, randomised controlled trial, the participants will be randomised and allocated in 1:1 ratio to smoking cessation app intervention group or to control group. Participants will receive a 12-week intervention (treatment group will receive CBT-based cigarette smoking cessation smartphone app intervention and control group will receive text messaging-based control intervention) with follow-up at week 26. The primary outcome includes biologically verified continuous smoking abstinence at week 26 after the quit date. The main secondary outcomes include 7-hour point prevalence smoking abstinence at weeks 1, 2, 3, 4, 8, 12, 16, 20 and 26, self-reported continuous smoking abstinence at weeks 4, 8, 12, 16, 20 and 26 after the quit date. About 1200 smokers with willingness to make a quit attempt within a month from January 2021 to August 2021 or until the recruitment process is complete will be recruited. The final 26-week follow-up will be completed in August 2022. The trial results will be available by the end of 2022. All analyses will be done on an intention-to-treat basis. Based on the previous studies, we hypothesised that this CBT-based app will be an effective, feasible and accessible smoking cessation app in China.
Ethical approval was obtained from the ethics committee of Sir Run Run Shaw Hospital, an affiliate of Zhejiang University, Medical College (number: 20200129-33). Study results will be disseminated via research conference presentations and peer-reviewed publications.
NCT04421170.
许多国家的研究已经证实，一些智能手机应用程序在帮助戒烟方面非常有效，但在中国，帮助戒烟的智能手机应用程序的有效性知之甚少。本研究旨在评估基于认知行为疗法（CBT）的戒烟智能手机应用程序对中国有戒烟意愿的吸烟者的疗效。
在这项远程控制、随机对照试验中，参与者将以 1:1 的比例随机分配到戒烟应用程序干预组或对照组。参与者将接受为期 12 周的干预（治疗组将接受基于 CBT 的戒烟智能手机应用程序干预，对照组将接受基于短信的对照干预），并在第 26 周进行随访。主要结局包括在戒烟日期后的第 26 周通过生物验证的连续吸烟 abstinence。主要次要结局包括第 1、2、3、4、8、12、16、20 和 26 周的 7 小时点患病率吸烟 abstinence、戒烟日期后第 4、8、12、16、20 和 26 周的自我报告连续吸烟 abstinence。从 2021 年 1 月至 2021 年 8 月或直到招募过程完成期间，有意愿在一个月内戒烟的约 1200 名吸烟者将被招募。最终的 26 周随访将于 2022 年 8 月完成。试验结果将于 2022 年底公布。所有分析均基于意向治疗原则进行。基于先前的研究，我们假设这种基于 CBT 的应用程序将是一种在中国有效、可行且易于获得的戒烟应用程序。
本研究已获得浙江大学医学院附属邵逸夫医院伦理委员会的批准（编号：20200129-33）。研究结果将通过研究会议报告和同行评议出版物进行传播。
NCT04421170。
