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

项目摘要/摘要 这份K23申请提出了有针对性的培训和研究，以促进申请者过渡到 独立科学家致力于开发创新、引人入胜和有效的数字健康干预措施 (DHIS)适用于高风险吸烟者--包括有社交焦虑症的人。背景：患有社交焦虑的个人- 那些完全符合社交焦虑症(SAD)诊断标准的人以及那些阈值以下的人 SAD症状)--这是一个研究不足、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。与普通民众相比，在社会上 焦虑的吸烟者的吸烟率是吸烟者的两倍(33%比17%)，而且不太可能继续吸烟 禁欲(29%对36%)。然而，没有针对这一高危群体的针对性干预措施。虽然是数字化的 健康干预(DHIS)为这些吸烟者提供了一种理想的治疗方式，与DHIS接触 低得惊人。因为更多地接触DHIS与更好的戒烟结果相关，完整的 DHIS用于吸烟的潜力远未实现，需要进行研究以优化与这些因素的接触 以改善结果的方式进行干预。增加参与度的单一方法不太可能是 对所有吸烟者都有效。适应性治疗策略(ATS)，允许灵活地进行何种干预 随着时间的推移，根据不同吸烟者的个性化需求，向他们提供组件 提高这些干预措施的有效参与度和有效性。研究策略： 建立在申请者的NIDA F32项目的基础上，在该项目中，她正在开发目标网站的核心内容 对社交焦虑症吸烟者的干预(MyWebQuit)，当前提案的目标是发展和 评估最终将按顺序排列的新接洽组件的可行性和可接受性 包括一个ATS，以提高与MyWebQuit的参与度和有效性。该项目包括 阶段：(1)开发新组件，以使用迭代的、以用户为中心的设计增强参与度 方法(Aim1)，以及(2)进行试点序贯多分配随机试验(SMART)，以评估： 进行全面智能控制的可行性、新组件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 可以实现更深入定制的AT(AIM2)的变量。训练计划：实现她的短期目标 为了实现长期的职业目标，这项建议将为申请人提供以下方面的高级培训：(1) 提高与DHIS接触的理论和科学，(2)指导构建的实验方法 高质量的抗精神病药物；(3)对涉及DHIS的临床试验进行、管理和分析 成群的吸烟者。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 和拨款建议书(即，全功率SMART的R01)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.