ACT on Vaping: Digital Therapeutic for Young Adult Vaping Cessation

ACT on Vaping：针对年轻人戒烟的数字疗法

• 批准号: 10533937
• 负责人: Jaimee Heffner
• 金额: $ 79.47万
• 依托单位: FRED HUTCHINSON CANCER CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10533937
• 关键词: Abstinence; Address; Benchmarking; Biochemical; Birth; Cigarette Smoker; Clinical; Combined Modality Therapy; Cotinine; Cyprus; Development; Education; Enrollment; Ethnic Origin; Exposure to; Feedback; Geography; Guidelines; Health; Hour; Inhalation; Intervention; Mediating; Mediator of activation protein; Modality; Multimedia; Nicotine; Nicotine Dependence; Outcome; Patient Self-Report; Phase; Population; Positioning Attribute; Prevalence; Race; Randomized; Randomized Controlled Trials; Readiness; Regulatory Pathway; Reporting; Risk; Sampling; Self Efficacy; Severities; Sexual and Gender Minorities; Text Messaging; Therapeutic; Time; Tobacco; Tobacco Use Cessation; Tobacco use; Treatment Efficacy; Waiting Lists; Work; aged; arm; base; brief advice; cigarette smoke; consumer demand; design; digital; digital treatment; effective therapy; effectiveness evaluation; efficacy outcomes; electronic cigarette use; electronic cigarette user; evidence base; experience; flexibility; improved; individualized medicine; innovation; member; nicotine exposure; novel; novel strategies; phase 2 study; pilot trial; preference; programs; psychologic; recruit; satisfaction; sex; smartphone Application; smoking cessation; standard care; theories; tobacco abstinence; tobacco cessation intervention; tobacco products; toxicant; treatment effect; trial design; vaping; young adult

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.

项目摘要 近十分之一的年轻人报告目前使用电子烟，使他们面临发展尼古丁的风险 成瘾和长期暴露于吸入有毒物质的健康影响。尽管需要有效的 治疗，以帮助这些年轻人戒烟，很少有治疗针对任何类型的烟草使用的年轻人 已经对成年人进行了评估，特别是对于使用vape并有独特治疗需求的年轻人。到 为了满足这些需求，我们建议开发和评估一个以化身为主导的数字化接受和承诺 治疗（ACT）计划称为ACT对Vaping的年轻成人电子烟用户在所有阶段的准备， 不干了该方案建立在以前试点工作中成功采用的干预框架之上， 使用者满意度高，经生物化学证实的戒烟率很有希望。在UG 3中- 在本研究的第一阶段，我们将进行一项初步的随机对照试验，以初步评估可接受性， 干预的初步效果相对于一个简短的建议和教育控制的条件。Go/no-go UG 3阶段的标准包括：（a）已完成应用程序开发。(b)完成FDA Q-提交。（c）第（1）款 已完成的试点试验（n=60）显示对电子烟ACT的满意度平均至少为3.5（满分5）;和（d） 相对于对照组，3个疗效终点中至少1个终点的结局更好的证据： 戒烟（沉思阶梯变化评分的平均差异≥ 1），24小时戒烟尝试（差异≥ 5%）， 和3个月时所有尼古丁/烟草产品经可替宁证实的30天点戒烟率（≥ 5%的差异）。如果这些基准得到满足，我们将进入UH 3阶段-一个完全动力的，随机的 两种干预措施的对照试验（n=1178），主要疗效结局为可替宁证实的30天 随机化后6个月时的点患病率禁欲。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谁vape， (2)电子烟使用者有发展尼古丁依赖的风险，并暴露于有毒物质， 对健康产生负面影响;（3）标准的烟草护理干预措施不能满足以下人群的独特治疗需求： 年轻的成年人谁vape，（4）ACT已被证明比标准的烟草护理方法更好的疗效 治疗，以及（5）年轻人对电子烟戒烟计划的消费需求很高， 有241，000名年轻人参加了真相倡议的“这就是退出”短信计划 2019年1月至2021年11月。它也是创新的：（1）它是第一个基于ACT的程序的任何 一种年轻人的电子烟，（2）一个数字戒烟计划，使用化身，互动游戏，和其他 多媒体体验作为参与策略与现有治疗方法有很大不同，（3） 没有针对年轻成人vaping的基于证据的智能手机应用程序，尽管对此有强烈的偏好 模态;和，（4）没有任何类型的数字程序与证明年轻的成年人e- 吸烟者在不同程度上准备戒烟。