Actify! An mHealth mood management tool to improve population-level smoking cessation - PROJECT SUMMARY Cigarette smoking is responsible for over 480,000 deaths annually in the US—nearly double the number of drug overdose and alcohol-related deaths combined—making cigarettes the most deadly drug of abuse. Although smoking rates have declined over the past 50 years, tobacco use remains a critical public health problem, and more effective cessation interventions are needed. Depressive symptoms are a key barrier to cessation for many and reduce the odds of cessation by as much as 50-60%. Despite this, standard cessation treatments do not focus on reducing depressive symptoms as a means of supporting cessation. Doing so, however, could increase treatment effectiveness. Behavioral activation (BA) is a proven intervention for depression. Research suggests combining BA and standard cessation treatment may increase quit rates. Delivering this intervention through a mobile health application (mHealth app) would also make the treatment more accessible (smoking cessation apps are downloaded over 1 million times per year in the US alone), thereby increasing its impact. To test this hypothesis, we developed Actify!, the first app-based cessation intervention to combine BA with standard cessation support. In a rigorous, pilot randomized trial (n = 242), Actify! had descriptively higher user satisfaction and quit rates than the National Cancer Institute’s (NCI) QuitGuide app (e.g., 18.5% vs. 12.2% abstinence at 6 months). We now propose to conduct a fully-powered, randomized controlled trial to evaluate the efficacy of Actify! relative to QuitGuide at 6 months post- randomization (Aim 1), examine the moderating effects of pre-quit depression on 6-month cessation outcomes (Aim 2), and evaluate the extent to which changes in behavioral activation and depressive symptoms mediate these outcomes (Aim 3). This work is highly significant and innovative: (1) Actify! is the first standalone mHealth intervention of any kind to actively target reducing depression and promoting smoking cessation simultaneously; (2) strong preliminary evidence supports Actify!’s acceptability and efficacy relative to an active standard care comparator, the NCI QuitGuide app; and, (3) mHealth apps offer a promising and cost-effective modality for disseminating the intervention, if it is found to be effective. This project will also provide a definitive test of whether Actify! is superior to QuitGuide and, therefore, warrants future dissemination. It will also provide critical insights into our premise that addressing depressive symptoms with app-based BA can enhance cessation for people with and without a history of depressive symptoms at treatment initiation.