Randomized clinical trial to test the efficacy of a smartphone app for smoking cessation for nondaily smokers

项目摘要 非日常吸烟是一种日益普遍的吸烟方式，对健康有很大的危害。目前， 25%的美国成年吸烟者不是每天吸烟，这一比例在过去的几年里增加了27% 十年。以前被认为是一种短暂的吸烟模式，研究已经确定了非每日吸烟 吸烟通常是一种持久的习惯。非每日吸烟在#年黑人和拉丁裔人群中更为普遍 在美国，并且在有严重精神健康问题的人中越来越普遍。尽管 与非日常吸烟相关的实质性危害，美国吸烟临床实践指南 戒烟没有提供如何支持非每日吸烟者戒烟的指导，因为缺乏 有效方法的证据。持续未能解决非日常吸烟问题扩大了现有的健康 差距正在以越来越快的速度增长。迫切需要有经验支持的干预措施。仅限 到目前为止，有两项试验的目标是非每日戒烟。两者都专注于药理选择，以及 两者都未能显示出在实现戒烟方面的有效性。我们的团队已经开发出一种行为疗法 对于非日常吸烟者：微笑代替吸烟(SIS)智能手机应用程序。这个应用程序利用了积极的 心理练习，以提高非日常吸烟者的参与度，并在吸烟时保持积极情绪 经历一次戒烟尝试。这种方法是基于非每日吸烟者更倾向于关注积极的自我 认同感和健康，以及证据表明更大的积极情绪与更多的自我相关 戒烟的效果，减少吸烟的欲望，并更愿意处理自我相关的健康 信息，所有这些都是在主导的健康行为理论中强调的作为因果因素的结构 成功的行为改变。在与非日常吸烟者的合作中，我们严格和反复地 在一系列小规模研究中开发和测试了这款应用程序。这项工作展示了这款应用程序的能力 让非日常吸烟者参与，并在一项小型随机试验中显示出概念验证效果，其中 使用SIS应用程序的参与者在以下方面具有显著更高的自我效能感、更低的渴望和更高的积极情绪 治疗结束，与对照组相比。我们现在建议测试这款应用的有效性，以提高6个月的性能 一项大规模、单盲、远程、平行、随机的临床试验，比较了SIS APP和 NCI的应用程序“QuitGuide”。所有参与者将被要求设定戒烟日期，并使用提供的应用程序7周。 戒烟日期前1周和戒烟后6周。在线调查将在招生时和2日、6日、12日、 在最初选择的戒烟日期后24周和52周。主要的结果衡量标准将是30天点 戒烟6个月后普遍戒烟。如果被发现是有效的，这项研究将提供第一个证据 对非每日吸烟者的有效治疗，目前还没有针对他们的治疗指南。

Project Summary Nondaily smoking is an increasingly prevalent pattern of smoking with substantial health detriments. Currently, 25% of all U.S. adult smokers are nondaily smokers, and this prevalence has increased by 27% in the last decade. Formerly believed to be a transient pattern of smoking, research has established that nondaily smoking is often a persistent pattern. Nondaily smoking is more prevalent among Black and Latinx persons in the United States and is increasingly prevalent among people with serious mental health issues. Despite substantial harms associated with nondaily smoking, the U.S. Clinical Practice Guidelines for smoking cessation offer no guidance on how to support nondaily smokers in smoking cessation due to a lack of evidence for efficacious approaches. A continued failure to address nondaily smoking widens existing health disparities at an increasingly accelerated rate. Empirically supported interventions are critically needed. Only two trials to date have targeted nondaily smoking cessation. Both focused on pharmacological options, and both failed to show efficacy in achieving smoking abstinence. Our team has developed a behavioral treatment for nondaily smokers: the Smiling Instead of Smoking (SiS) smartphone app. This app utilizes positive psychology exercises to enhance engagement of nondaily smokers and to maintain positive affect while they undergo a quit attempt. This approach is based on nondaily smokers' preference to focus on positive self- identity and wellness, and evidence that shows that greater positive affect is associated with increased self- efficacy to quit smoking, decreased desire to smoke and greater readiness to process self-relevant health information, all of which are constructs highlighted in dominant health behavior theories as causal agents in successful behavioral change. In collaboration with nondaily smokers, we have rigorously and iteratively developed and tested this app in a series of small-scale studies. This work has demonstrated the app's ability to engage nondaily smokers, and has shown proof-of-concept efficacy in a small, randomized trial, where participants using the SiS app had significantly higher self-efficacy, lower craving and higher positive affect at the end of treatment, compared to controls. We now propose to test the efficacy of this app to improve 6-month abstinence in a large-scale, single-blind, remote, parallel, randomized clinical trial comparing the SiS app to the NCI's app “QuitGuide”. All participants will be asked to set a quit date and to use the provided app for 7 weeks, 1 week prior to and 6 weeks after their quit date. Online surveys will be conducted at enrollment and 2, 6, 12, 24 and 52 weeks after the initially chosen quit date. The primary outcome measure will be 30-day point prevalence abstinence 6 months post quit. If found to be efficacious, this study would provide the first evidence of an efficacious treatment for nondaily smokers, for whom currently no treatment guidelines exist.