Randomized clinical trial to test the efficacy of a smartphone app for smoking cessation for nondaily smokers

随机临床试验，测试智能手机应用程序对非日常吸烟者戒烟的功效

• 批准号: 10715401
• 负责人: Bettina B. Hoeppner
• 金额: $ 70.68万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-03 至 2028-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10715401
• 关键词: Abstinence; Acceleration; Address; Adult; Affect; Barrier Contraception; Behavior Therapy; Behavioral; Black Populations; Cigarette; Clinical Practice Guideline; Collaborations; Control Groups; Data Collection; Effectiveness; Enrollment; Exercise; Failure; Goals; Health; Health behavior; Intervention; Latinx population; Mental Health; Methods; Modeling; Motivation; National Cancer Institute; Outcome; Outcome Measure; Participant; Pattern; Persons; Pharmacological Treatment; Prevalence; Process; Psychology; Public Health; Race; Readiness; Reporting; Research; Self Efficacy; Series; Single-Blind Study; Smiling; Smoke; Smoker; Smoking; Smoking Cessation Intervention; Surveys; Testing; Therapeutic; United States; Withdrawal; Work; behavior test; comparison control; craving; effectiveness testing; efficacious treatment; efficacy testing; health disparity; improved; meetings; novel; pharmacologic; preference; primary endpoint; primary outcome; public health priorities; randomized trial; randomized, clinical trials; smartphone application; smoking abstinence; smoking cessation; theories; therapy resistant; treatment duration; treatment guidelines; trial comparing

Project Summary Nondaily smoking is an increasingly prevalent pattern of smoking with substantial health detriments. Currently, 25% of all U.S. adult smokers are nondaily smokers, and this prevalence has increased by 27% in the last decade. Formerly believed to be a transient pattern of smoking, research has established that nondaily smoking is often a persistent pattern. Nondaily smoking is more prevalent among Black and Latinx persons in the United States and is increasingly prevalent among people with serious mental health issues. Despite substantial harms associated with nondaily smoking, the U.S. Clinical Practice Guidelines for smoking cessation offer no guidance on how to support nondaily smokers in smoking cessation due to a lack of evidence for efficacious approaches. A continued failure to address nondaily smoking widens existing health disparities at an increasingly accelerated rate. Empirically supported interventions are critically needed. Only two trials to date have targeted nondaily smoking cessation. Both focused on pharmacological options, and both failed to show efficacy in achieving smoking abstinence. Our team has developed a behavioral treatment for nondaily smokers: the Smiling Instead of Smoking (SiS) smartphone app. This app utilizes positive psychology exercises to enhance engagement of nondaily smokers and to maintain positive affect while they undergo a quit attempt. This approach is based on nondaily smokers' preference to focus on positive self- identity and wellness, and evidence that shows that greater positive affect is associated with increased self- efficacy to quit smoking, decreased desire to smoke and greater readiness to process self-relevant health information, all of which are constructs highlighted in dominant health behavior theories as causal agents in successful behavioral change. In collaboration with nondaily smokers, we have rigorously and iteratively developed and tested this app in a series of small-scale studies. This work has demonstrated the app's ability to engage nondaily smokers, and has shown proof-of-concept efficacy in a small, randomized trial, where participants using the SiS app had significantly higher self-efficacy, lower craving and higher positive affect at the end of treatment, compared to controls. We now propose to test the efficacy of this app to improve 6-month abstinence in a large-scale, single-blind, remote, parallel, randomized clinical trial comparing the SiS app to the NCI's app “QuitGuide”. All participants will be asked to set a quit date and to use the provided app for 7 weeks, 1 week prior to and 6 weeks after their quit date. Online surveys will be conducted at enrollment and 2, 6, 12, 24 and 52 weeks after the initially chosen quit date. The primary outcome measure will be 30-day point prevalence abstinence 6 months post quit. If found to be efficacious, this study would provide the first evidence of an efficacious treatment for nondaily smokers, for whom currently no treatment guidelines exist.

项目摘要 通过确定健康的健康，非每日吸烟是一种越来越普遍的吸烟模式。现在， 美国所有美国成年吸烟者中有25％是非每日吸烟者，而这种流行率在最后一个吸烟者增加了27％ 十年。研究以前被认为是吸烟的短暂模式，研究确定 吸烟通常是一种持续的模式。在黑人和拉丁裔人中，非每日吸烟更为普遍 在患有严重心理健康问题的人们中，美国越来越普遍。尽管 美国临床实践指南与非每日吸烟有关的重大危害 戒烟没有提供有关如何支持非每日吸烟者在戒烟中的指导 有效方法的证据。持续未能解决无限吸烟的现有健康状况 差距越来越加速。需要非常需要支持的干预措施。仅有的 迄今为止的两项试验已针对非每日戒烟。两者都专注于药物选择，并且 两者都没有表现出在戒烟中的效率。我们的团队已经开发了行为待遇 对于非每日吸烟者：微笑而不是吸烟（SIS）智能手机应用程序。该应用程序利用正面 心理学练习以增强非每日吸烟者的参与并在他们的同时保持积极影响 进行退出尝试。这种方法基于非每日吸烟者偏爱专注于积极的自我 身份和健康，以及证明更大积极影响与自我增加有关的证据 戒烟的疗效，减少吸烟的欲望以及更大的准备工作的准备就绪 信息，所有这些都是主要的健康行为理论中突出显示的构造 成功的行为改变。与非每日吸烟者合作，我们经过严格且迭代的方式 在一系列小规模研究中开发并测试了该应用程序。这项工作证明了该应用的能力 吸烟者吸烟者，并在一项小型的随机试验中显示出概念验证效率，在这里 使用SIS应用程序的参与者具有更高的自我效能感，较低的渴望和更高的积极影响 与对照组相比，治疗的结束。现在，我们建议测试该应用程序的效率以改善6个月 比较SIS应用程序的大规模，单盲，遥远，平行的临床试验中的禁欲 NCI的应用程序“戒烟”。所有参与者将被要求设置戒烟日期并使用提供的应用程序7周， 戒烟日期前和6周前1周。在线调查将在注册和2、6、12进行 最初选择退出日期后的24和52周。主要结果度量将为30天 戒烟后6个月戒酒。如果发现有效，这项研究将提供第一个证据 对于目前尚无治疗指南的非每日吸烟者的有效治疗。