Randomized Trial of an Innovative Smartphone Intervention for Smoking Cessation

 描述(由申请人提供)：非常需要戒烟干预技术，以尽可能低的成本在人群水平上产生强烈的潜在影响。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(APP)。有超过400款戒烟应用程序，在2012年至2013年的两年时间里，这些应用程序在美国被下载了320万次。目前还没有关于任何APP对一般成人戒烟有效性的试验发表，也没有由NIH资助的戒烟干预试验正在进行--尽管这是NIH资助的一个高度优先的话题。戒烟应用程序的大量使用与它们未知的有效性形成了一个严重的科学鸿沟，可能会扼杀它们在人口层面的影响。对美国临床实践指南(USCPG)应用程序的研究开始填补这一研究空白。但是，只有遵循USCPG在其他交付方式方面才有限制。一种名为接受与承诺疗法(ACT)的方法，通过创新的干预内容和来自六个已发表试验的非常有希望的结果来解决这些限制。ACT的创新是其双重关注，即在做出以价值观为导向的承诺行为改变的同时，增加体验身体渴望、情绪和暗示吸烟的想法的意愿。我们最近开发了第一个用于戒烟的ACT应用程序，名为“SmartQuit”，并在试点随机对照试验(N 196)中进行了测试，将其与遵循USCPG(国家癌症研究所的“QuitGuide”)的应用程序进行了比较。结果表明，在两个月的跟踪调查中，SmartQuit的参与者参与度和满意度高于QuitGuide，(3)对渴望的接受程度高于QuitGuide，以及(3)描述性地高于QuitGuide的戒烟率(尽管不显著)。在这些令人振奋的结果的基础上，我们提出了一项完全有效的三臂随机对照试验(n=811)，将SmartQuit与QuitGuide进行比较，并将每个应用程序与NCI遵循USCPG的《净化空气》小册子进行比较，以最终确定(1)USCPG应用程序比USCPG自助小册子更有效；(2)ACT应用程序比USCPG应用程序更有效；(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，这项创新的研究显示出令人兴奋的前景，可以提高戒烟应用程序的成功率，从而降低医疗成本，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.