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.

项目总结