ACT on Vaping: Digital Therapeutic for Young Adult Vaping Cessation

项目总结 近十分之一的年轻人报告说，他们目前使用电子烟，这使他们面临产生尼古丁的风险 吸入性毒物的成瘾和长期健康影响。尽管需要有效的 帮助这些年轻吸烟者戒烟的治疗方法，针对年轻人中任何类型的烟草使用的治疗很少 对成年人进行了评估，特别是对吸食电子烟和有独特治疗需求的年轻人。至 为了满足这些需求，我们建议开发和评估以虚拟化身为主导的数字接受和承诺 治疗(ACT)计划名为ACT on Vaping，适用于处于所有准备阶段的年轻成年电子烟使用者 不干了。该方案建立在先前试点工作中成功采用的干预框架的基础上， 很高的用户满意度和非常有希望的生化证实的烟草戒断率。在UG3中- 在本研究阶段，我们将进行试点随机对照试验，初步评估可接受性和 初步对干预效果进行了简要建议和教育控制情况。去/不去-去 UG3阶段的标准包括：(A)已完成应用程序开发。(B)完成了食品和药物管理局的Q-提交。(C) 已完成的试点试验(n=60)对Vaping的ACT表示满意，平均至少为3.5分(满分5分)；和(D) 相对于对照，至少3个疗效终点中的1个有更好结果的证据：准备就绪的变化 戒烟(冥想阶梯改变得分的平均差异≥1)，24小时戒烟尝试(≥5%的差异)， 和可替宁确认在3个月内戒除所有尼古丁/烟草产品的30天点流行率(≥ 5%的差异)。如果达到这些基准，我们将进入UH3阶段--一个完全有动力的、随机的 两种干预措施的对照试验(n=1178)，主要疗效结果为可替宁确认的30天 随机化后6个月的时点戒断率。我们还将评估主持人和调解人 治疗效果。这个项目意义重大：(1)它关注的是越来越多的年轻人吸食电子烟， (2)电子烟使用者有患上尼古丁依赖的风险，并接触到下列毒物 对健康产生负面影响；(3)标准护理烟草干预措施不能满足患者独特的治疗需求 年轻人使用VAPE，(4)ACT已显示出比标准治疗方法更好的烟草疗效 治疗，以及，(5)年轻人对汽化戒烟计划的消费需求很高，因为 有241,000名年轻人注册了Truth Initiative，这就是退出短信计划的证据 2019年1月至2021年11月。它还具有创新性：(1)它是第一个基于ACT的计划 Kind for Young成人Vaping，(2)使用化身、互动游戏和其他方式的数字戒烟程序 作为参与策略的多媒体体验与现有的治疗方法有很大不同，(3) 没有针对年轻人使用电子烟的基于证据的智能手机应用程序，尽管人们强烈倾向于这样做 模式；以及，(4)没有任何类型的数字节目显示出对年轻人电子邮件的有效性。 吸烟者准备戒烟的程度各不相同。

PROJECT SUMMARY Almost one in ten young adults report current e-cigarette use, putting them at risk of developing nicotine addiction and long-term health effects of exposure to inhaled toxicants. Despite the need for effective treatments to help these young users quit, very few treatments targeting any type of tobacco use among young adults have been evaluated, particularly for young adults who vape and have unique treatment needs. To address these needs, we propose to develop and evaluate an avatar-led, digital Acceptance and Commitment Therapy (ACT) program called ACT on Vaping for young adult e-cigarette users at all stages of readiness to quit. This program builds upon an intervention framework employed successfully in previous pilot work, with high user satisfaction and very promising rates of biochemically confirmed tobacco abstinence. In the UG3- phase of this study, we will conduct a pilot randomized controlled trial to preliminarily evaluate acceptability and preliminary efficacy of the intervention relative to a brief advice and education control condition. Go/no-go criteria for the UG3 phase include: (a) Completed app development. (b) Completed FDA Q-submission. (c) Completed pilot trial (n=60) showing satisfaction with ACT on Vaping averaging at least 3.5 out of 5; and (d) relative to control, evidence of better outcomes on at least 1 of 3 efficacy endpoints: change in readiness to quit (mean difference in Contemplation Ladder change scores ≥ 1), 24-hour quit attempts (≥ 5% difference), and cotinine-confirmed 30-day point prevalence abstinence from all nicotine/tobacco products at 3 months (≥ 5% difference). If these benchmarks are met, we will proceed to the UH3 phase—a fully-powered, randomized controlled trial (n=1178) of the two interventions, with a primary efficacy outcome of cotinine-confirmed 30-day point prevalence abstinence at 6 months post-randomization. We will also evaluate moderators and mediators of treatment effects. This project is significant: (1) it focuses on a growing population of young adults who vape, (2) e-cigarette users are at risk for developing nicotine dependence and are exposed to toxicants that negatively impact health; (3) standard care tobacco interventions don’t address the unique treatment needs of young adults who vape, (4) ACT has demonstrated better efficacy than standard care approaches for tobacco treatment, and, (5) there is high consumer demand for vaping cessation programs among young adults, as evidenced by 241,000 young adult enrollments to Truth Initiative’s This is Quitting text messaging program between January 2019 and November 2021. It is also innovative: (1) it is the first ACT-based program of any kind for young adult vaping, (2) a digital cessation program using avatars, interactive games, and other multimedia experiences as engagement strategies is substantially different than existing treatments, (3) there are no evidence-based smartphone apps targeting young adult vaping, despite a strong preference for this modality; and, (4) there are no digital programs of any type with demonstrated efficacy for young adult e- cigarette users at varying levels of readiness to quit.