Randomized Trial of an Innovative Smartphone Intervention for Smoking Cessation

 描述（由申请人提供）：对戒烟干预技术的需求巨大，这些技术具有强大的潜在人群水平影响，成本尽可能低。这种潜力可以在戒烟干预的最新技术创新中找到：基于智能手机的戒烟软件应用程序（“应用程序”）。在2012年至2013年的两年期间，美国有400多个戒烟应用程序被下载了320万次。没有任何应用程序对一般成人戒烟有效性的试验已经公布，也没有NIH资助的戒烟干预试验正在进行中-尽管这是NIH资助的一个高优先级主题。戒烟应用程序的大量使用与其未知的有效性形成了严重的科学差距，可能会扼杀其人口水平的影响。 对美国临床实践指南（USCPG）应用程序的研究开始解决这一研究差距。但是，仅仅遵循USCPG在其他交付方式上有局限性。一种名为接受和承诺疗法（ACT）的方法通过创新的干预内容和六项已发表的试验的非常有希望的结果来解决这些限制。ACT的创新在于它的双重重点，即增加体验身体渴望、情感和暗示吸烟的想法的意愿，同时做出价值观引导的承诺行为改变。我们最近开发了第一个ACT戒烟应用程序，名为“SmartQuit”，并在一项试点随机对照试验（N 196）中进行了测试，将其与遵循USCPG（美国国家癌症研究所的“QuitGuide”）的应用程序进行了比较。结果显示，SmartQuit有：（1）参与者参与度和满意度高于QuitGuide，（3）接受渴望的程度高于QuitGuide，（3）在两个月的随访中，退出率明显高于QuitGuide（尽管不显著）。 基于这些有希望的结果，我们提出了一个完全有效的三臂随机对照试验（每组n = 811例），比较SmartQuit与QuitGuide以及每种应用程序与遵循USCPG的NCI的Clearing the Air小册子，以明确确定（1）USCPG应用程序是否比USCPG自助小册子更有效;（2）ACT应用程序是否比USCPG小册子更有效;（3）ACT应用程序比USCPG应用程序更有效。随着数百万人选择智能手机应用程序来帮助他们戒烟，这项创新研究显示了提高戒烟应用程序成功率的令人兴奋的前景，从而降低医疗成本并减少与烟草相关的过早死亡。

 DESCRIPTION (provided by applicant): There is tremendous need for smoking cessation intervention technologies with strong potential population-level impact at the lowest possible cost. That potential can be found in the newest technological innovation in quit smoking interventions: smartphone-based smoking cessation software applications ("apps"). There are over 400 smoking cessation apps, which were downloaded in the United States 3.2 million times during the two-year period 2012 to 2013. No trials of any app's effectiveness for general adult cessation have been published and no NIH-funded cessation intervention trials are in progress-despite the fact this is a high priority NIH funding topic. The enormous usage of smoking cessation apps contrasted with their unknown effectiveness creates a serious scientific gap that could stifle their population-level impact. Research on US Clinical Practice Guidelines (USCPG) apps begins to address that research gap. But only following the USCPG has had limitations in other modalities of delivery. An approach, called Acceptance & Commitment Therapy (ACT), addresses these limitations with both innovative intervention content and highly promising results from six published trials. ACT's innovation is its dual focus on increasing willingness to experience physical cravings, emotions, and thoughts that cue smoking while making values-guided committed behavior changes. We recently developed the first ACT app for smoking cessation, called "SmartQuit," and tested it in a pilot randomized controlled trial (N 196), comparing it with an app that follows USCPG (National Cancer Institute's "QuitGuide"). Results showed that SmartQuit had: (1) higher participant engagement and satisfaction than QuitGuide, (3) higher levels of acceptance of cravings than QuitGuide, and (3) descriptively higher quit rates (albeit non-significant) than QuitGuide at the two-month follow-up. Building on these promising results, we propose a fully-powered three-arm randomized controlled trial (n = 811 per arm) that compares SmartQuit to QuitGuide and each app to the NCI's Clearing the Air booklet, which follows the USCPG, to definitively determine whether (1) an USCPG app is more efficacious than a USCPG self-help booklet; (2) an ACT app is more efficacious than a USCPG booklet; (3) an ACT app is more efficacious than a USCPG app. As millions of people are choosing smartphone apps to help them quit smoking, this innovative study shows exciting promise for improving the success rates of quit smoking apps and thereby lowering healthcare costs and reducing premature tobacco-related deaths.