Development and Testing of a Depression-Specific Behavioral Activation Mobile App Paired with Nicotine Replacement Therapy Sampling for Smoking Cessation Treatment Via Primary Care

项目摘要/摘要 吸烟仍然是公共健康的优先事项，在抑郁症患者中非常普遍。 症状。针对抑郁症的戒烟干预是必要的，但目前缺乏，特别是 可以很容易地在初级保健中传播的治疗。定制一个简单、直接的证据-- 基于抑郁症的特定戒烟干预，如行为激活(BA)，通过移动设备提供 APP有可能克服现有的治疗障碍，接触到许多不是抑郁症的吸烟者 目前正在接受必要的治疗。将这样的APP与药物治疗相结合 类似的翻译潜力，如尼古丁替代疗法(NRT)样本，提供了双管齐下的 针对复发的心理和身体依赖风险因素的方法。目前的研究 该项目将开发、系统评估和临床测试综合戒烟干预措施，包括 针对抑郁症的BA智能手机应用程序(Goal2Quit)和NRT采样将满足未得到满足的需求 一种易于传播的、基于证据的、特定于抑郁症的戒烟干预措施，通过初级治疗提供 关心。具体目标包括：1)Goal2Quit的可用性测试(N=5)和可行性测试前的改进，2) 综合Goal2Quit NRT抽样干预通过初级保健的单臂可行性测试(N=12) 以及3)初级保健范围内的小规模随机对照试验(N=180) Goal2Quit NRT抽样与TAU对比，为较大的随机对照试验提供效果大小估计。研究环境， 墨尔本南加州大学的设施和资源非常适合在成瘾研究中指导职业发展。K23 培训目标是：1)扩大戒烟干预发展培训，重点放在 烟草使用和抑郁的共病，2)获得大规模的基本知识和经验， 戒烟有效性临床试验，3)通过获取移动应用开发经验 以患者为中心、以用户为中心的mHealth干预开发方面的专业知识，4)发展初级专业知识 关怀-心理健康一体化，重点是实施科学和传播心理和 通过初级保健进行行为健康干预，以及5)扩展科学领域的基本职业技能 沟通，包括拨款撰写、会议报告和手稿准备。结构化 马修·卡彭特博士、布莱恩·希斯曼博士、肯尼斯·鲁杰罗博士、凡妮莎·迪亚兹博士和伊丽莎白博士的指导 加勒特-梅耶尔将确保实现培训目标。候选人的长期职业目标是指导一项研究 产品组合：1)开发新的戒烟干预措施同时针对心理健康和 成瘾，2)在现实世界中提供这些新的干预措施(例如，初级保健)，以及3)利用技术， 克服治疗障碍。这里提出的培训旨在培养这三个领域的专业知识。 在这些领域中，代表着与以前的培训相比有了明显的进步，没有K23是不可能的。

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.