PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Gra

摘要 尽管美国的烟草使用率在过去30年里总体下降，但近 3800万美国人仍然吸烟，这对长期健康问题和死亡构成了极高的风险。那里 在过去的40年里，一直在进行广泛的研究，评估各种戒烟方法 好几年了。最近的综述指出，在临床和公共应用方面都取得了重大进展 帮助吸烟者戒烟的健康干预措施；然而，他们也得出结论， 吸烟者戒烟的情况并没有明显改善。个人、团体和公共卫生干预--两者都有 在没有尼古丁替代疗法等辅助手段的情况下--通常使用某种组合 认知-行为干预，但仍然需要新的、理论驱动的方法来加强 戒烟率和提高覆盖面和参与度的创新干预措施，例如通过 电脑或移动应用程序。我们建议调整和测试以前试行的认知 不和谐干预(CDI)戒烟将通过手机应用程序提供。认知 不和谐干预已被证明在治疗与健康有关的问题以及 物质使用，初步研究结果支持其在戒烟中的使用。将对该计划进行评估 与60名成年人每天吸烟，并将成为唯一的认知失调戒烟移动应用程序。我们的 研发团队在开发和测试移动应用程序以及开发 并测试认知失调和戒烟干预。在第一阶段中，我们将使用 迭代开发计划，设计和开发CDI原型应用程序的前3个模块的功能。 研究团队将与在移动开发方面拥有丰富经验的20个Ideas合作 智能手机应用程序，其中许多已经商业化。我们将使用以下工具评估导航和可用性 成人每日吸烟者。将使用额外的试点测试来创建用于评估的原型版本。这个 评估研究将包括让60名成年人使用该应用程序，并完成基线、1个月和3个月的跟踪调查。 可用性数据、程序使用的系统日志数据和参与者满意度数据也将被分析。输入 将从参与者那里收集，以纳入将在第二阶段开发的其他功能。重要 戒烟尝试、不吸烟天数(无烟天数)和吸烟态度的变化 并将使用行为来确定第一阶段计划的有效性和继续进行的证据 第二阶段的发展和评估。

Abstract Despite overall declines in the rate of tobacco use in the United States over the past 30 years, nearly 38 million Americans still smoke, posing extremely high risk for long-term health problems and death. There has been extensive research evaluating a wide range of smoking cessation approaches over the past 40 years. Recent reviews note that there has been significant progress in the application of both clinical and public health interventions to help smokers quit; however, they have also concluded that the overall success rate of smokers quitting has not significantly improved. Individual, group and public health interventions – both with and without adjunctive aids such as nicotine replacement therapy – have generally used some combination of cognitive-behavioral interventions, but there remains a need for novel, theory-driven approaches to enhance quit rates and innovative interventions that increase reach and engagement, such as those offered via computer or mobile app. We propose to adapt and test the feasibility of a previously piloted cognitive dissonance intervention (CDI) for smoking cessation that will be delivered via a mobile app. Cognitive dissonance interventions have been shown to be successful in treating health-related problems, as well as substance use, and preliminary findings support its use in smoking cessation. The program will be evaluated with 60 adult daily smokers and will be the only cognitive dissonance mobile app for smoking cessation. Our research and development team has extensive experience developing and testing mobile apps and developing and testing cognitive dissonance and smoking cessation interventions. In the first phase, we will use an iterative development plan to design and develop functionality of the first 3 modules of the CDI prototype app. The research team will partner with Twenty Ideas who have extensive experience in the development of mobile apps for smartphones, many of which have been commercialized. We will assess navigation and usability with adult daily smokers. Additional pilot testing will be used to create a prototype version for evaluation. The evaluation study will involve having 60 adults use the app and complete baseline, 1- and 3-month follow-up. Usability data, system log data on program use, and participant satisfaction data will also be analyzed. Input from participants will be gathered to incorporate additional features to be developed during Phase II. Significant changes in quit attempts, number of days without smoking (smokefree days) and changes in smoking attitudes and behavior will be used to determine the efficacy of the Phase I program and evidence for proceeding to Phase II development and evaluation.