Development and Evaluation of a Brief Behavioral Activation Mobile Application for Nicotine Vaping Cessation Among Adolescent Primary Care Patients

摘要 近年来，蒸发尼古丁在青少年中的流行率急剧上升，但还没有NIH资助的试验 制定或评估了汽化戒断干预措施。理想的治疗方法必须直接针对已确立的目标 蒸发风险因素。抑郁症状在青少年尿布中很常见(36%)，最近 被确定为与蒸发有关的主要风险因素。抑郁症状与精神疾病的关系 电子烟是双向的，抑郁症状可预测电子烟的启动和持续时间。 吸烟会加剧抑郁。在有抑郁症状的吸烟者中，量身定制的干预措施 针对抑郁症和烟草使用都是戒烟所必需的。因此，对于青少年来说，一种理想的治疗方法 有抑郁症状的尿布也可能直接针对抑郁情绪。简明的行为激活 (BA)是一种行之有效的循证治疗抑郁症和戒烟的方法。改编后的版本 对青少年停止蒸发的短暂BA可以提供一种有希望的同时针对抑郁的方法 在促进汽化戒断服务中的症状。为了最大限度地发挥人口层面的影响，这 干预必须通过现实世界的临床渠道和可传播的平台进行。初级保健提供者 都在青少年蒸发治疗的第一线，但治疗资源有限。为以下客户量身定做简短的BA 青少年通过手机应用停止和分娩可以提供一个理想的策略来传播证据- 以抑郁症为基础，通过初级保健进行汽化戒烟治疗。这种高风险-高回报的目标 这项研究是为青少年戒烟活动开发、提炼和评估抑郁症特有的简明BA APP(“Goal2QuitVaping”)。通过Mountain Pass Technology LLC和 南卡罗来纳医科大学，我们将根据期间收集的反馈开发Goal2QuitVaping 与最终用户的焦点小组。软件开发将建立在我们先前和正在进行的研究开发的基础上 用于初级保健、抑郁和戒烟治疗的简明BA的APP改编。Goal2QuitVaping将 随后通过迭代可用性测试进行改进。然后我们将进行两组随机可行性研究 1)Goal2QuitVaping与2)在初级保健中停止蒸发的常规治疗的对照试验。去/不去 第二阶段的GO决策基准包括：1)开发Goal2QuitVaping，2)演示 Goal2QuitVaping治疗的可行性和可接受性，定义为在随访和 最终用户自行报告使用Goal2QuitVaping的好处，以及3)功效数据表明Goal2QuitVaping 使用与抑郁症状和尼古丁蒸发的减少有关。研究活动是相互关联的 拥有强大的商业化机会，这些商业化机会将共同推动我们的公司迈向第二阶段甚至更远 为了满足青少年对循证戒烟干预的公共卫生需求。

ABSTRACT The prevalence of vaping nicotine has skyrocketed among adolescents in recent years, yet no NIH-funded trials have developed or evaluated vaping cessation interventions. An ideal treatment must directly target established vaping risk factors. Depressive symptoms, which are common among adolescent vapers (36%), have recently been identified as a predominant vaping-related risk factor. The relationship between depressive symptoms and vaping is bidirectional such that depressive symptoms prospectively predict vaping initiation and sustained e- cigarette use exacerbates depression. Among smokers with depressive symptoms, tailored interventions that target both depression and tobacco use are necessary for cessation. Thus, an ideal treatment for adolescent vapers with depressive symptoms likely must also directly target depressed mood. Brief Behavioral Activation (BA) is a well-established, evidence-based treatment for depression and smoking cessation. An adapted version of Brief BA for adolescent vaping cessation could offer a promising approach to simultaneously target depressive symptoms in the service of promoting vaping cessation. To have maximum population-level impact, this intervention must be delivered via real-world clinical outlets and disseminable platforms. Primary care providers are on the front lines of adolescent vaping treatment but have limited treatment resources. Tailoring Brief BA for adolescent vaping cessation and delivery via a mobile app could offer an ideal strategy to disseminate evidence- based, depression-specific vaping cessation treatment via primary care. The goal of this high risk-high reward study is to develop, refine, and evaluate a depression-specific Brief BA for adolescent vaping cessation mobile app (“Goal2QuitVaping”). Via an established partnership between MountainPass Technology LLC and the Medical University of South Carolina, we will develop Goal2QuitVaping consistent with feedback gathered during focus groups with end-users. Software development will build upon our prior and ongoing research developing app adaptations of Brief BA for primary care depression and smoking cessation treatment. Goal2QuitVaping will subsequently be improved via iterative usability testing. We will then conduct a two-group feasibility randomized controlled trial of 1) Goal2QuitVaping vs. 2) treatment as usual for vaping cessation within primary care. Go/no go decision benchmarks for Phase II include: 1) development of Goal2QuitVaping, 2) demonstrated Goal2QuitVaping treatment feasibility and acceptability, defined as ³70% app retention across follow-up and end-user self-reported benefit of Goal2QuitVaping use, and 3) efficacy data suggesting that Goal2QuitVaping use is associated with decreases in depressive symptoms and nicotine vaping. Research activities are coupled with strong commercialization opportunities which together will propel our company toward Phase II and beyond to address the public health need for evidence-based vaping cessation interventions for adolescents.