A SMART Pilot of Adaptive Treatment Strategies to Improve Engagement with a Web-based Smoking Intervention for Socially Anxious Smokers

项目总结/摘要 此K23申请提出了重点培训和研究，以促进申请人的过渡到一个 独立科学家专注于开发创新，参与和有影响力的数字健康干预措施 （DHIs）的高风险吸烟者，包括那些与社会焦虑。上一篇：社交焦虑症患者- 那些符合社交焦虑障碍（SAD）的完整诊断标准的人以及那些低于阈值的人 SAD的症状）-是一个研究不足和治疗不足的吸烟者群体。估计为1460万（36%） 美国成年吸烟者符合SAD的终生标准。与一般人群相比， 焦虑的吸烟者的吸烟率是吸烟率的两倍（33%对17%）， 禁欲（29%对36%）。然而，没有针对这一高危群体的干预措施。虽然数字 健康干预（DHIs）为这些吸烟者提供了理想的治疗方式， 惊人的低。因为更多地参与DHIs与更好的戒烟结果相关， DHIs对吸烟的潜力远未实现，需要进行研究以优化与这些人的接触。 以改善结果的方式进行干预。增加参与的单一方法不太可能 对所有吸烟者有效。适应性治疗策略（ATS），允许灵活选择干预措施 随着时间的推移，根据不同吸烟者的个性化需求， 改善这些干预措施的有效参与和效力。研究策略： 在申请人的NIDA F32项目的基础上，她正在开发目标网站的核心内容 针对社交焦虑型吸烟者的干预措施（MyWebQuit），目前提案的目标是制定和 评估新的交战组成部分的可行性和可接受性，这些组成部分最终将被排序， 包括ATS，用于提高MyWebQuit的参与度和有效性。该项目包括 阶段：（1）开发新组件，使用迭代的、以用户为中心的设计来增强参与度 方法（目标1），和（2）进行一项初步序贯多分配随机试验（SMART），以评估： 进行全面高级行政管理和资源培训的可行性、新组成部分的可接受性和使用情况、 对流程（网站利用率）和戒烟结果的潜在影响，并探索二次定制 这些变量可以实现更深入定制的ATS（Aim 2）。训练训练：为了实现她的短， 长期的职业目标，本计划将为申请人提供以下方面的高级培训：（1） 改善与DHI接触的理论和科学，（2）为建设提供信息的实验方法 高质量的ATS，以及（3）进行，管理和分析涉及DHIs的临床试验， 吸烟者群体。这些目标将通过这些领域专家的密切指导来实现， 精心挑选的教学活动和会议出席，应用研究经验，和手稿 和赠款提案（即R 01用于全功率SMART）准备。

PROJECT SUMMARY/ABSTRACT This K23 application proposes focused training and research to facilitate the applicant’s transition to an independent scientist focused on developing innovative, engaging, and impactful digital health interventions (DHIs) for high-risk smokers—including those with social anxiety. CONTEXT: Individuals with social anxiety— those who meet full diagnostic criteria for social anxiety disorder (SAD) as well as those with subthreshold symptoms of SAD)—are an understudied and undertreated group of smokers. An estimated 14.6 million (36%) adult smokers in the United States meet lifetime criteria for SAD. Compared to the general population, socially anxious smokers have double the prevalence rates of smoking (33% vs. 17%) and are less likely to remain abstinent (29% vs. 36%). However, there are no targeted interventions for this high-risk group. Although digital health interventions (DHIs) offer an ideal treatment modality for these smokers, engagement with DHIs is strikingly low. Because greater engagement with DHIs is associated with better cessation outcomes, the full potential of DHIs for smoking is far from realized and research is needed to optimize engagement with these interventions in ways that improve outcomes. A single approach to increasing engagement is unlikely to be efficacious for all smokers. Adaptive treatment strategies (ATSs) that allow flexibility in what intervention components are offered over time to different smokers based on their individualized needs hold promise for improving effective engagement with and effectiveness of these interventions. RESEARCH STRATEGY: Building upon the applicant’s NIDA F32 project in which she is developing the core content of a targeted web intervention for socially anxious smokers (MyWebQuit), the objective of the current proposal is to develop and assess the feasibility and acceptability of new engagement components that will be ultimately be sequenced to comprise an ATS for improving engagement with and effectiveness of MyWebQuit. The project includes phases to: (1) develop the new components to enhance engagement using an iterative, user-centered design approach (Aim1), and (2) conduct a pilot sequential multiple assignment randomized trial (SMART) to assess: the feasibility of conducting a full-scale SMART, the acceptability and utilization of the new components, the potential impact on process (website utilization) and cessation outcomes, and explore secondary tailoring variables that may enable a more deeply tailored ATS (Aim2). TRAINING PLAN: To achieve her short- and long-term career goals, this proposal will provide the applicant with advanced training in the following: (1) theory and science of improving engagement with DHIs, (2) experimental methods that inform the construction of high-quality ATSs, and (3) conduct, management, and analysis of clinical trials involving DHIs for vulnerable groups of smokers. These goals will be accomplished through close mentorship from experts in these areas, carefully selected didactic activities and conference attendance, applied research experiences, and manuscript and grant proposal (i.e. an R01 for a fully-powered SMART) preparation.