Fred Hutchinson Cancer Research Center, Division of Public Health Sciences, Seattle, Washington.
Department of Psychology, University of Washington, Seattle.
JAMA Intern Med. 2020 Nov 1;180(11):1472-1480. doi: 10.1001/jamainternmed.2020.4055.
Smoking is a leading cause of premature death globally. Smartphone applications for smoking cessation are ubiquitous and address barriers to accessing traditional treatments, yet there is limited evidence for their efficacy.
To determine the efficacy of a smartphone application for smoking cessation based on acceptance and commitment therapy (ACT) vs a National Cancer Institute smoking cessation application based on US clinical practice guidelines (USCPG).
DESIGN, SETTING, AND PARTICIPANTS: A 2-group, stratified, double-blind, individually randomized clinical trial was conducted from May 27, 2017, to September 28, 2018, among 2415 adult cigarette smokers (n = 1214 for the ACT-based smoking cessation application group and n = 1201 for the USCPG-based smoking cessation application group) with 3-, 6-, and 12-month postrandomization follow-up. The study was prespecified in the trial protocol. Follow-up data collection started on August 26, 2017, and ended at the last randomized participant's 12-month follow-up survey on December 23, 2019. Data were analyzed from February 25 to April 3, 2020. The primary analysis was performed on a complete-case basis, with intent-to-treat missing as smoking and multiple imputation sensitivity analyses.
iCanQuit, an ACT-based smoking cessation application, which taught acceptance of smoking triggers, and the National Cancer Institute QuitGuide, a USCPG-based smoking cessation application, which taught avoidance of smoking triggers.
The primary outcome was self-reported 30-day point prevalence abstinence (PPA) at 12 months after randomization. Secondary outcomes were 7-day PPA at 12 months after randomization, prolonged abstinence, 30-day and 7-day PPA at 3 and 6 months after randomization, missing data imputed with multiple imputation or coded as smoking, and cessation of all tobacco products (including e-cigarettes) at 12 months after randomization.
Participants were 2415 adult cigarette smokers (1700 women [70.4%]; 1666 White individuals [69.0%] and 868 racial/ethnic minorities [35.9%]; mean [SD] age at enrollment, 38.2 [10.9] years) from all 50 US states. The 3-month follow-up data retention rate was 86.7% (2093), the 6-month retention rate was 88.4% (2136), and the 12-month retention rate was 87.2% (2107). For the primary outcome of 30-day PPA at the 12-month follow-up, iCanQuit participants had 1.49 times higher odds of quitting smoking compared with QuitGuide participants (28.2% [293 of 1040] vs 21.1% [225 of 1067]; odds ratio [OR], 1.49; 95% CI, 1.22-1.83; P < .001). Effect sizes were very similar and statistically significant for 7-day PPA at the 12-month follow-up (OR, 1.35; 95% CI, 1.12-1.63; P = .002), prolonged abstinence at the 12-month follow-up (OR, 2.00; 95% CI, 1.45-2.76; P < .001), abstinence from all tobacco products (including e-cigarettes) at the 12-month follow-up (OR, 1.60; 95% CI, 1.28-1.99; P < .001), 30-day PPA at 3-month follow-up (OR, 2.20; 95% CI, 1.68-2.89; P < .001), 30-day PPA at 6-month follow-up (OR, 2.03; 95% CI, 1.63-2.54; P < .001), 7-day PPA at 3-month follow-up (OR, 2.04; 95% CI, 1.64-2.54; P < .001), and 7-day PPA at 6-month follow-up (OR, 1.73; 95% CI, 1.42-2.10; P < .001).
This trial provides evidence that, compared with a USCPG-based smartphone application, an ACT-based smartphone application was more efficacious for quitting cigarette smoking and thus can be an impactful treatment option.
ClinicalTrials.gov Identifier: NCT02724462.
重要性:吸烟是导致全球过早死亡的主要原因。用于戒烟的智能手机应用程序无处不在,可以解决获取传统治疗方法的障碍,但它们的疗效证据有限。
目的:评估一种基于接受和承诺疗法(ACT)的智能手机应用程序(iCanQuit)与基于美国临床实践指南(USCPG)的国家癌症研究所戒烟应用程序(QuitGuide)相比,在戒烟方面的效果。
设计、地点和参与者:这是一项 2 组分层、双盲、个体随机临床试验,于 2017 年 5 月 27 日至 2018 年 9 月 28 日期间在全美 2415 名成年烟民中进行(ACT 戒烟应用组有 1214 名参与者,USCPG 戒烟应用组有 1201 名参与者),并在随机分组后进行 3、6 和 12 个月的随访。研究方案在试验方案中预先设定。随访数据收集于 2017 年 8 月 26 日开始,最后一次对最后一名随机参与者进行 12 个月随访调查的时间是 2019 年 12 月 23 日。数据分析时间是 2020 年 2 月 25 日至 4 月 3 日。主要分析采用完整病例分析,意向治疗缺失数据视为吸烟,并采用多重插补敏感性分析。
干预措施:iCanQuit,一种基于 ACT 的戒烟应用程序,它教授接受吸烟诱因;QuitGuide,一种基于 USCPG 的戒烟应用程序,它教授避免吸烟诱因。
主要结果和措施:主要结果是随机分组后 12 个月的 30 天点流行率戒烟率(PPA)。次要结果是随机分组后 12 个月的 7 天 PPA、长期戒烟率、随机分组后 3 个月和 6 个月的 30 天和 7 天 PPA、缺失数据的多重插补或编码为吸烟、以及随机分组后 12 个月所有烟草制品(包括电子烟)的戒烟率。
结果:参与者是来自全美 50 个州的 2415 名成年烟民(1700 名女性[70.4%];1666 名白人个体[69.0%]和 868 名少数民族[35.9%];平均[SD]年龄,38.2[10.9]岁)。3 个月随访数据保留率为 86.7%(2093 名),6 个月保留率为 88.4%(2136 名),12 个月保留率为 87.2%(2107 名)。对于主要结果,即第 12 个月随访时的 30 天 PPA,iCanQuit 组的戒烟率比 QuitGuide 组高 1.49 倍(28.2%[293 名/1040 名] vs 21.1%[225 名/1067 名];比值比[OR],1.49;95%置信区间[CI],1.22-1.83;P < .001)。次要结果非常相似,且具有统计学意义,即第 12 个月随访时的 7 天 PPA(OR,1.35;95%CI,1.12-1.63;P = .002)、第 12 个月随访时的长期戒烟率(OR,2.00;95%CI,1.45-2.76;P < .001)、第 12 个月随访时所有烟草制品(包括电子烟)的戒烟率(OR,1.60;95%CI,1.28-1.99;P < .001)、第 3 个月随访时的 30 天 PPA(OR,2.20;95%CI,1.68-2.89;P < .001)、第 6 个月随访时的 30 天 PPA(OR,2.03;95%CI,1.63-2.54;P < .001)、第 3 个月随访时的 7 天 PPA(OR,2.04;95%CI,1.64-2.54;P < .001)和第 6 个月随访时的 7 天 PPA(OR,1.73;95%CI,1.42-2.10;P < .001)。
结论和相关性:这项试验提供了证据,表明与基于 USCPG 的智能手机应用程序相比,基于 ACT 的智能手机应用程序在戒烟方面更有效,因此可以成为一种有效的治疗选择。
试验注册:ClinicalTrials.gov 标识符:NCT02724462。