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

开发和测试抑郁症特异性行为激活移动应用程序，并结合尼古丁替代疗法采样，通过初级保健进行戒烟治疗

• 批准号: 10112873
• 负责人: Jennifer Renee Dahne
• 金额: $ 20.08万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-04-01 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10112873
• 关键词: Address; Adherence; Adult; Area; Behavioral; Cellular Phone; Clinical; Clinical Practice Guideline; Clinical Research; Communication; Depressed mood; Development; Development Plans; Ensure; Environment; Evidence based treatment; Funding; General Population; Goals; Grant; Group Psychotherapy; Health Technology; Individual; Intervention; Interview; Knowledge; Leadership; Light; Manuscripts; Mental Depression; Mental Health; Mentors; Mentorship; Motivation; National Institute of Drug Abuse; Nicotine; Outcome; Participant; Patients; Persons; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacotherapy; Physical Dependence; Physicians; Physiological; Positioning Attribute; Preparation; Primary Care Physician; Primary Health Care; Procedures; Professional Competence; Psychological Dependence; Public Health; Publications; Randomized; Relapse; Research; Research Personnel; Research Project Grants; Resources; Risk Factors; Sampling; Smoker; Smoking; Smoking Cessation Intervention; Structure; Technology; Testing; Time; Tobacco use; Training; Visit; Withdrawal; Work; Writing; addiction; arm; base; behavioral health intervention; career; career development; catalyst; cigarette smoking; comorbidity; depressive symptoms; design; effectiveness clinical trial; evidence base; experience; feasibility testing; implementation science; innovation; intervention refinement; laboratory experience; mHealth; mobile application; mobile computing; nicotine replacement; novel; patient oriented research; post-doctoral training; psychologic; public health priorities; recruit; screening; secondary outcome; smartphone Application; smoking cessation; smoking prevalence; symposium; therapy development; treatment as usual; usability; Address; Adherence; Adult; Area; Behavioral; Cellular Phone; Clinical; Clinical Practice Guideline; Clinical Research; Communication; Depressed mood; Development; Development Plans; Ensure; Environment; Evidence based treatment; Funding; General Population; Goals; Grant; Group Psychotherapy; Health Technology; Individual; Intervention; Interview; Knowledge; Leadership; Light; Manuscripts; Mental Depression; Mental Health; Mentors; Mentorship; Motivation; National Institute of Drug Abuse; Nicotine; Outcome; Participant; Patients; Persons; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacotherapy; Physical Dependence; Physicians; Physiological; Positioning Attribute; Preparation; Primary Care Physician; Primary Health Care; Procedures; Professional Competence; Psychological Dependence; Public Health; Publications; Randomized; Relapse; Research; Research Personnel; Research Project Grants; Resources; Risk Factors; Sampling; Smoker; Smoking; Smoking Cessation Intervention; Structure; Technology; Testing; Time; Tobacco use; Training; Visit; Withdrawal; Work; Writing; addiction; arm; base; behavioral health intervention; career; career development; catalyst; cigarette smoking; comorbidity; depressive symptoms; design; effectiveness clinical trial; evidence base; experience; feasibility testing; implementation science; innovation; intervention refinement; laboratory experience; mHealth; mobile application; mobile computing; nicotine replacement; novel; patient oriented research; post-doctoral training; psychologic; public health priorities; recruit; screening; secondary outcome; smartphone Application; smoking cessation; smoking prevalence; symposium; therapy development; treatment as usual; usability

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.

项目摘要/摘要 吸烟仍然是公共卫生的重中之重，在患有抑郁症的人中非常普遍 症状。需要采取特定于抑郁症的戒烟干预措施，但目前缺乏，尤其是 可以在初级保健中很容易传播的治疗方法。调整简单，直接的证据 - 基于抑郁症特异性戒烟干预，例如行为激活（BA），用于通过移动 App具有克服现有的治疗障碍并吸引许多不受欢迎的吸烟者的潜力 目前正在接受必要的治疗。这种应用程序与具有药物治疗的集成 类似的翻译潜力，例如尼古丁替代疗法（NRT）采样，提供双管 针对心理和身体依赖风险因素的方法。本研究 项目将开发，系统地评估并在临床上测试完成的综合戒烟干预措施完成 抑郁症特定的BA智能手机移动应用程序（goal2Quit）和NRT抽样将满足未满足需求的 用于易于发射的，基于循证的，抑郁的抑郁特异性戒烟干预措施，以通过初级交付 关心。具体目的包括：1）目标2Quit（n = 5）的可用性测试和可行性测试之前的改进，2） 通过初级保健的集成目标 + NRT采样干预的单臂可行性测试（n = 12） 以及随后的干预措施，以及3）初级保健中的小规模RCT（n = 180） GOAL2QUIT + NRT采样与TAU可为较大的RCT提供效果尺寸估计。研究环境， MUSC的设施和资源非常适合成瘾研究中的职业发展。 K23 培训目标是：1）扩大戒烟干预开发的培训，重点是 烟草使用和抑郁的合并症，2）在大规模的大规模上获得基本知识和经验， 戒烟的有效性临床试验，3）通过获得移动应用程序开发经验 以患者为中心，以用户为中心的MHealth干预开发的专业知识，4）发展主要知识 护理健康融合，侧重于实施科学和心理学的传播 通过初级保健行为健康干预措施，5）扩大科学的基本职业技能 沟通，包括赠款写作，会议演讲和手稿准备。结构 博士的遗产。 Matthew Carpenter，Brian Hitsman，Kenneth Ruggiero，Vanessa Diaz和Elizabeth Garrett-Mayer将确保实现培训目标。候选人的长期职业目标是指导研究 投资组合：1）开发新型的戒烟干预措施，只是针对心理健康和 成瘾，2）在现实世界中提供这些新颖的干预措施（例如，初级保健），3）利用技术， 克服治疗障碍。本文提出的培训旨在在这三个方面发展专业知识 在这些领域中，这是从先前培训中明确的进步，没有这个K23是不可能的。