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

适应性治疗策略的明智试点，以提高社交焦虑吸烟者对基于网络的吸烟干预的参与度

• 批准号: 9891751
• 负责人: Noreen Watson
• 金额: $ 17.51万
• 依托单位: FRED HUTCHINSON CANCER RESEARCH CENTER
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/9891751
• 关键词: Abstinence; Address; Adherence; Adult; Applications Grants; Applied Research; Area; Behavior Therapy; Biochemical; Characteristics; Communities; Data; Development; Diagnostic; Effectiveness; Effectiveness of Interventions; Electronic Mail; Empirical Research; Ensure; Feedback; General Population; Goals; Health; Individual; Integrative Therapy; Internet; Intervention; Knowledge; Manuscripts; Mental disorders; Mentorship; Methods; Modality; National Institute of Drug Abuse; Online Systems; Outcome; Patient Self-Report; Phase; Preparation; Prevalence; Procedures; Process; Randomized; Research; Research Priority; Research Training; Risk; Science; Scientist; Sequential Multiple Assignment Randomized Trial; Smoker; Smoking; Social Anxiety Disorder; Subgroup; Symptoms; Testing; Text Messaging; Time; Training; Training Support; United States; United States National Institutes of Health; Vulnerable Populations; alternative treatment; anxious; base; behavioral outcome; career; clinical trial analysis; design; digital; experience; flexibility; high risk; high risk population; improved; improved outcome; innovation; intervention effect; iterative design; meetings; pilot trial; programs; satisfaction; skills; smoking addiction; smoking intervention; social; social anxiety; social interventions; symposium; theories; treatment strategy; user centered design; web site

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.

项目概要/摘要 该 K23 申请提出了重点培训和研究，以促进申请人过渡到 独立科学家专注于开发创新、有吸引力和有影响力的数字健康干预措施 (DHI) 适用于高危吸烟者，包括患有社交焦虑的吸烟者。背景：有社交焦虑的人—— 符合社交焦虑症 (SAD) 完整诊断标准的人以及阈值以下的人 SAD 的症状）——这是一个未被充分研究和治疗的吸烟者群体。估计为 1,460 万 (36%) 美国成年吸烟者符合 SAD 的终生标准。与一般人群相比，社会 焦虑的吸烟者的吸烟率是吸烟者的两倍（33% vs. 17%），并且不太可能继续吸烟 禁欲（29% vs. 36%）。然而，目前尚无针对这一高危人群的针对性干预措施。虽然数字化 健康干预 (DHI) 为这些吸烟者提供了理想的治疗方式，参与 DHI 是 低得惊人。由于更多地参与 DHI 与更好的戒烟结果相关，因此全面 DHI 对吸烟的潜力远未实现，需要进行研究来优化与这些药物的接触 以改善结果的方式进行干预。单一方法不太可能提高参与度 对所有吸烟者均有效。适应性治疗策略 (ATS) 允许灵活地进行干预 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，这有望实现 提高这些干预措施的有效参与和有效性。研究策略： 以申请人的 NIDA F32 项目为基础，她正在该项目中开发目标网络的核心内容 针对社交焦虑吸烟者的干预措施（MyWebQuit），当前提案的目标是制定和 评估最终将排序的新参与组件的可行性和可接受性 包括一个 ATS，用于提高 MyWebQuit 的参与度和有效性。该项目包括 阶段：(1) 使用迭代、以用户为中心的设计开发新组件以增强参与度 方法（目标 1），以及 (2) 进行试点序贯多重分配随机试验 (SMART) 来评估： 进行全面SMART的可行性、新组件的可接受性和利用、 对流程（网站使用）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 ATS（目标 2）的变量。训练计划：实现她的短期和 长期职业目标，本提案将为申请人提供以下方面的高级培训：（1） 提高 DHI 参与度的理论和科学，(2) 为构建提供信息的实验方法 高质量 ATS，以及 (3) 开展、管理和分析涉及弱势群体 DHI 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情况、应用研究经验和手稿 和拨款提案（即用于全功能 SMART 的 R01）准备。