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

摘要 近年来，尼古丁在青少年中的流行率飙升，但没有NIH资助的试验 已经开发或评估了vaping停止干预措施。理想的治疗必须直接针对已建立的 vaping风险因素.抑郁症状，这是常见的青少年vapers（36%），最近 已被确定为与电子烟相关的主要风险因素。抑郁症状与 电子烟是双向的，因此抑郁症状可以前瞻性地预测电子烟的开始和持续的电子烟。 吸烟会加重抑郁症。在有抑郁症状的吸烟者中， 戒烟必须同时针对抑郁症和烟草使用。因此，青少年的理想治疗方法 有抑郁症状的vapers可能也必须直接针对抑郁情绪。短暂行为激活 (BA)是一种成熟的，基于证据的抑郁症和戒烟治疗方法。适配版本 青少年停止吸烟的简短BA可以提供一种有希望的方法，同时针对抑郁症 症状在促进vaping停止服务。为了达到最大的人口影响， 干预措施必须通过现实世界的临床渠道和可传播的平台提供。初级保健提供者 处于青少年vaping治疗的第一线，但治疗资源有限。定制简报BA， 通过移动的应用程序停止和交付青少年vaping可以提供一个理想的策略来传播证据- 通过初级保健进行基于抑郁症的戒烟治疗。这种高风险高回报的目标 研究旨在开发、完善和评估青少年移动的电子烟戒烟的抑郁症专用简短BA app（"Goal2QuitVaping"）.通过MountainPass Technology LLC与 南卡罗来纳州医科大学，我们将开发Goal2QuitVaping与期间收集的反馈一致 与最终用户的焦点小组。软件开发将建立在我们以前和正在进行的研究开发 Brief BA的应用程序改编，用于初级保健抑郁症和戒烟治疗。Goal2QuitVaping将 随后通过迭代可用性测试进行改进。然后，我们将进行两组可行性随机化 对照试验1）Goal2QuitVaping vs. 2）在初级保健中照常治疗vaping停止。go/no 第二阶段的决策基准包括：1）Goal2QuitVaping的开发，2）演示 目标2戒烟治疗的可行性和可接受性，定义为随访期间应用程序保留率≥ 70%， 最终用户自我报告使用Goal2QuitVaping的益处，以及3）有效性数据表明Goal2QuitVaping 使用与抑郁症状和尼古丁vaping的减少有关。研究活动结合起来 强大的商业化机会，将共同推动我们的公司走向第二阶段及以后 以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.