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

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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.