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

摘要 尽管在过去的30年里，美国的烟草使用率总体上有所下降， 3800万美国人仍然吸烟，对长期健康问题和死亡构成极高风险。那里 在过去的40年里， 年最近的评论指出，在临床和公众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， 吸烟者戒烟没有明显改善。个人、群体和公共卫生干预措施-两者都有 并且没有诸如尼古丁替代疗法的辅助治疗-通常使用以下的组合： 认知行为干预，但仍然需要新的，理论驱动的方法来提高 戒烟率和创新的干预措施，增加覆盖面和参与度，例如通过 计算机或移动的应用程序。我们建议调整并测试之前试点的认知应用程序的可行性 通过移动的应用程序提供戒烟的失调干预（CDI）。认知 失调干预已被证明是成功的治疗健康相关的问题，以及 物质使用，初步研究结果支持其用于戒烟。该计划将被评估 与60名成年每日吸烟者，并将成为唯一的认知失调移动的戒烟应用程序。我们 研发团队在开发和测试移动的应用程序以及开发 测试认知失调和戒烟干预。在第一阶段，我们将使用 迭代开发计划，用于设计和开发CDI原型应用程序前3个模块的功能。 研究团队将与在移动的开发方面拥有丰富经验的Twenty Ideas合作 智能手机的应用程序，其中许多已经商业化。我们将评估导航和可用性， 成人每日吸烟额外的试点测试将用于创建原型版本以供评估。的 评估研究将涉及60名成年人使用该应用程序并完成基线，1个月和3个月的随访。 还将分析可用性数据、程序使用的系统日志数据和参与者满意度数据。输入 将收集来自参与者的信息，以纳入第二阶段期间开发的其他功能。显著 戒烟尝试的变化、不吸烟天数（无烟日）和吸烟态度的变化 和行为将被用来确定第一阶段计划的有效性和证据， 第二阶段开发和评估。

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.