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

项目概要/摘要 吸烟仍然是公共卫生的优先事项，在抑郁症患者中非常普遍。 症状针对抑郁症的戒烟干预措施是必要的，但目前缺乏，特别是 可以在初级保健中容易地传播的治疗。做一个简单明了的证据- 基于抑郁症的特定戒烟干预，例如行为激活（BA），用于通过移动的 应用程序有可能克服现有的治疗障碍，并达到许多抑郁的吸烟者谁不是 目前正在接受必要的治疗。这种应用程序与药物治疗的整合， 类似的翻译潜力，如尼古丁替代疗法（NRT）采样，提供了一个双管齐下的 针对复发的心理和身体依赖风险因素的方法。本研究 该项目将开发、系统评估和临床测试一种综合戒烟干预措施，包括 抑郁症专用BA智能手机移动的应用程序（Goal 2 Quit）和NRT采样，将满足未满足的需求 一种易于传播的、基于证据的、针对抑郁症的戒烟干预措施， 在乎具体目标包括：1）Goal 2 Quit的可用性测试（N=5）和可行性测试前的改进，2） 通过初级保健进行的Goal 2 Quit + NRT采样综合干预的单臂可行性试验（N=12） 以及随后的干预改进，以及3）初级保健中的小规模RCT（N=180）， Goal 2 Quit + NRT采样与TAU，以提供更大RCT的效应量估计值。研究环境， MUSC的设施和资源非常适合成瘾研究的指导职业发展。K23 培训目标是：1）扩大戒烟干预开发的培训，重点是 烟草使用和抑郁症的共病，2）获得大规模的基本知识和经验， 戒烟的有效性临床试验，3）通过获得移动的应用程序开发经验 在以患者为中心，以用户为中心的移动健康干预开发方面的专业知识，4）发展初级 护理-心理健康一体化，侧重于实施科学和传播心理和 通过初级保健进行行为健康干预，5）扩大科学领域的基本职业技能 沟通，包括赠款写作，会议演示文稿和手稿准备。结构化 马修·卡彭特博士、布赖恩·希茨曼博士、肯尼思·鲁杰罗博士、瓦妮莎·迪亚兹博士和伊丽莎白博士的指导 Garrett-Mayer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 组合：1）开发新的戒烟干预措施，同时针对心理健康， 成瘾，2）在真实的世界中递送这些新颖的干预（例如，初级保健），以及3）利用技术， 克服治疗障碍。本文提出的培训旨在发展所有三个方面的专门知识 在这些领域，代表了从以前的培训明显的进步，没有这个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.