PROJECT SUMMARY/ABSTRACT Cigarette smoking remains a public health priority and is highly prevalent among those with depressive symptoms. Depression-specific cessation interventions are necessary but currently lacking, particularly treatments that can be readily disseminated within primary care. Tailoring a simple, straightforward evidence- based, depression-specific cessation intervention, such as Behavioral Activation (BA), for delivery via a mobile app holds the potential to overcome existing treatment barriers and reach many depressed smokers who are not currently receiving necessary treatment. The integration of such an app with pharmacological treatment that has similar translational potential, such as nicotine replacement therapy (NRT) sampling, offers a dual-pronged approach targeting both psychological and physical dependence risk factors for relapse. The present research project will develop, systematically evaluate, and clinically test an integrated cessation intervention comprised of a depression-specific BA smartphone mobile app (Goal2Quit) and NRT sampling that will meet the unmet need for an easily disseminable, evidence-based, depression-specific cessation intervention for delivery via primary care. Specific aims include: 1) usability testing of Goal2Quit (N=5) and refinements prior to feasibility testing, 2) a single-arm feasibility test (N=12) of the integrated Goal2Quit + NRT Sampling intervention via primary care and subsequent refinements of the intervention, and 3) a small-scale RCT (N=180) within primary care of Goal2Quit + NRT Sampling vs. TAU to provide effect size estimates for a larger RCT. The research environment, facilities, and resources at MUSC are ideally suited for mentored career development in addiction research. K23 training objectives are to: 1) broaden training in smoking cessation intervention development, focused on the comorbidity of tobacco use and depression, 2) acquire essential knowledge and experience in large-scale, effectiveness clinical trials for smoking cessation, 3) cultivate mobile app development experience by gaining expertise in patient-focused, user-centered mHealth intervention development, 4) develop expertise in Primary Care-Mental Health Integration, focused on implementation science and dissemination of psychological and behavioral health interventions via primary care, and 5) expand essential career skills in scientific communication, including grant writing, conference presentations, and manuscript preparation. Structured mentorship from Drs. Matthew Carpenter, Brian Hitsman, Kenneth Ruggiero, Vanessa Diaz, and Elizabeth Garrett-Mayer will ensure training goals are met. The candidate’s long-term career goal is to direct a research portfolio that: 1) develops novel smoking cessation interventions simultaneously targeting mental health and addiction, 2) delivers these novel interventions in the real world (e.g., primary care), and 3) utilizes technology, to overcome treatment barriers. The training proposed herein is designed to develop expertise across all three of these areas, represents a clear progression from prior training, and would not be possible without this K23.

PROJECT NARRATIVE Cigarette smoking remains a public health priority and is highly prevalent among those with depressive symptoms. Depression-specific psychological cessation interventions are necessary but currently lacking, particularly disseminable treatments that can be delivered within primary care. The present research project will develop, systematically evaluate, and clinically test an integrated cessation intervention comprised of a depression-specific Behavioral Activation (BA) for cessation smartphone mobile application (Goal2Quit) and nicotine replacement therapy (NRT) sampling (i.e., provision of a two-week combination NRT starter kit) that will meet the unmet need for an easily disseminable, evidence-based, depression-specific cessation intervention for delivery via primary care.