Integrated Smoking Cessation and Mood Management for Cardiac Patients

心脏病患者的综合戒烟和情绪管理

• 批准号: 8449738
• 负责人: Andrew M Busch
• 金额: $ 13.84万
• 依托单位: MIRIAM HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-04-15 至 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8449738
• 关键词: Abstinence; Address; Affect; Aftercare; Area; Award; Behavior; Behavioral; Cardiac; Cardiology; Cessation of life; Clinical Investigator; Clinical Research; Cognitive; Coronary heart disease; Counseling; Data; Depressed mood; Development; Educational workshop; Environment; Exercise; Funding; Future; General Population; Goals; Grant; Health behavior change; Hobbies; Hospitalization; Hospitals; Individual; Intervention; Interview; K-Series Research Career Programs; Knowledge; Length of Stay; Mails; Manuals; Manuscripts; Measures; Mediating; Mediator of activation protein; Medical; Mental Depression; Mentors; Mentorship; Moods; Myocardial Infarction; Outcome; Patient Self-Report; Patients; Perception; Population; Positive Reinforcements; Preparation; Prevalence; Printing; Procedures; Quality of life; Randomized Controlled Trials; Recording of previous events; Relapse; Research; Research Training; Risk; Sample Size; Schedule; Series; Smoke; Smoker; Smoking; Smoking Cessation Intervention; Smoking Status; Source; Structure; Testing; Time; Tobacco; Training; Treatment Efficacy; Unstable angina; Work; Writing; acute coronary syndrome; base; behavioral cardiology; career; depressive symptoms; design; efficacy testing; experience; follow-up; innovation; meetings; member; mortality; primary outcome; psychosocial; public health relevance; self help; skills; smoking cessation; social; standard care; statistics; success; symposium; theories

DESCRIPTION (provided by applicant): This K23 career development award will help the PI achieve his long-term career goal to become an independent clinical investigator developing innovative treatments to address health behavior change (including smoking cessation) and mood management in medical populations. As a first step into this research area, the proposed study will focus on cardiac patients who smoke. This award will build on the PI's emerging expertise in Behavioral Activation (BA), a well established, empirically supported treatment for depression that has recently shown promise for enhancing smoking cessation outcomes. Having developed a proficiency in BA for depression, the current K23 application will extend the PI's work to target smoking cessation in patients hospitalized for Acute Coronary Syndrome (ACS). Success in this new research area will require additional mentored training and research experiences. The highly structured training plan in the current application is ideally suited to allow the PI to conduct the proposed research plan (see below) and move towards his long-term career goals. The training plan will provide the PI with knowledge and skills regarding 1) development of theory-based, tailored treatments, 2) design and execution of Randomized Controlled Trials (RCT), 3) advanced statistics, 4) behavioral cardiology, and 5) manuscript preparation and grant writing. Training will be guided by an expert mentorship team with unique skill sets. Dr. Borrelli (primary mentor) is an expert in the design and testing of health behavior change interventions and has received multiple R01s focusing on smoking cessation among medical populations. Dr. Kahler (co-mentor) has particular statistical expertise in analyzing outcome data from smoking cessation trials and analyzing the relationship between smoking and mood. Dr Arrighi (co-mentor) is a cardiologist with a long history of clinical and research mentorship of cardiology fellows. Additional training will be provided by experts in adapting BA for use with medical patients (Dr. Pagoto, consultant) and smoking cessation in cardiac patients (Dr. Bock, collaborator). The PI will have regular meetings with all members of the mentorship team. In addition, the PI will attend relevant classes, seminars, workshops, and national conferences throughout the proposed award. The occurrence of Acute Coronary Syndrome (ACS; unstable angina, ST and non-ST elevation myocardial infarction) can be conceptualized as a "teachable moment," whereby patients may be more receptive to smoking cessation messages. Continued smoking following ACS is an independent predictor of mortality. Depressed mood post-ACS is also predictive of mortality, and smokers with depressed mood are less likely to abstain from smoking following an ACS hospitalization. Thus, a single, integrated treatment that targets both depressed mood and smoking could be highly effective in reducing post-ACS mortality. BA may be an ideal treatment or this population: it can easily integrate both mood and smoking cessation related goals and it focuses on addressing restriction of valued activities, which is common in the post-ACS population. Thus, the overall aims of the current study are to develop a BA treatment manual that integrates smoking cessation and mood management for post-ACS smokers (Behavioral Activation Treatment for cardiac patients who smoke; BAT-CS) and to gather preliminary data on the efficacy of this intervention compared to Standard Care. We will first develop the BAT-CS treatment manual through a series of individual qualitative interviews of both patients who quit and patients who failed to quit smoking following ACS. Next we will test feasibility and acceptability and refine the BAT-CS manual through test cases (N=10). Finally, we will conduct a pilot RCT (N=72) comparing BAT-CS (1 in-hospital session and 4-8 post-discharge sessions) to Standard Care (SC; 1 in-hospital session and 4 mailed packets of printed self-help materials). The primary outcome will be biochemically validated 7-day point prevalence abstinence. Differences in depressed mood, quality of life, and BA mediators will also be compared between conditions. Data produced by this research plan will provide pilot data for submission of an R01 to fund a large scale RCT testing the efficacy of BAT-CS. The proposed training and research plans provide substantial first steps towards the PI's ultimate goal of becoming an independent clinical investigator developing innovative treatments to address health behavior change and mood management in medical populations.

描述（由申请人提供）：这项K23职业发展奖将帮助PI实现他的长期职业目标，成为一名独立的临床研究者，开发创新的治疗方法来解决健康行为改变（包括戒烟）和医疗人群中的情绪管理。作为该研究领域的第一步，拟议的研究将集中于吸烟的心脏病患者。该奖项将基于PI的行为激活（BA）的新兴专业知识，这是一种良好的，经验支持的抑郁症治疗方法，最近显示出有望增强戒烟结果的希望。当前的K23应用程序熟练掌握了抑郁症，将扩大PI的工作，以针对住院治疗急性冠状动脉综合征（ACS）的患者的戒烟。在这个新的研究领域的成功将需要额外的指导培训和研究经验。 当前申请中高度结构化的培训计划非常适合允许PI执行拟议的研究计划（见下文），并朝着他的长期职业目标迈进。培训计划将为PI提供有关1）基于理论的，量身定制的治疗的知识和技能，2）随机对照试验的设计和执行（RCT），3）高级统计，4）行为心脏病学和5）手稿准备和赠款写作。培训将由具有独特技能的专家指导团队指导。 Borrelli博士（主要导师）是对健康行为变化干预措施的设计和测试专家，并收到了多个R01，重点是医疗人群中的戒烟。卡勒（Kahler）博士（Co-Incertor）在分析戒烟试验的结果数据并分析吸烟与情绪之间的关系方面具有特殊的统计专业知识。 Arrighi博士（Co-Centor）是一名心脏病专家，具有悠久的心脏病学临床和研究指导历史。专家将提供额外的培训，以适应BA的专家（Pagoto博士，顾问）和心脏病患者的戒烟（合作者Bock博士）。 PI将与指导团队的所有成员定期开会。此外，PI将在拟议的奖项中参加相关课程，研讨会，研讨会和民族会议。 急性冠状动脉综合征的发生（ACS；不稳定的心绞痛，ST和非ST升高心肌梗死）可以概念化为“可教的时刻”，因此患者可能会更接受戒烟信息。 ACS之后继续吸烟是死亡率的独立预测指标。 ACS后情绪低落也可以预测死亡率，心情抑郁的吸烟者不太可能在ACS住院后戒烟。因此，一种针对情绪低落和吸烟的单一综合治疗方法可能在降低ACS后死亡率方面非常有效。 BA可能是理想的治疗方法或这种人群：它可以轻松地整合情绪和戒烟相关的目标，并且重点是解决对价值活动的限制，这在后ACS人群中很常见。 因此，当前研究的总体目的是制定一份BA治疗手册，该手册将吸烟和情绪管理整合到ACS吸烟者（对吸烟的心脏患者的行为激活治疗； BAT-CS），并收集有关此干预措施与标准护理相比的初步数据。我们将通过一系列戒烟患者和未能在AC后戒烟的患者进行一系列个人定性访谈，首先开发BAT-CS治疗手册。接下来，我们将测试可行性和可接受性，并通过测试用例完善BAT-CS手册（n = 10）。最后，我们将进行一项试点RCT（n = 72），以比较BAT-CS（1个院内会议和4-8个入院后会议）与标准护理（SC; 1个院内会话和4封邮寄的印刷自助材料）。主要结果将是生物化学验证的7天点场禁欲。情绪抑郁，生活质量和BA调解人的差异也将在条件之间进行比较。该研究计划生产的数据将提供试点数据以提交R01，以资助大规模的RCT测试BAT-CS的功效。 拟议的培训和研究计划为PI的最终目标提供了重要的第一步，即成为一名独立的临床研究者，开发创新的治疗方法，以解决医疗人群中的健康行为变化和情绪管理。