Integrated Smoking Cessation and Mood Management for Cardiac Patients

描述（由申请人提供）：这个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，以解决医疗人群的健康行为改变（包括戒烟）和情绪管理。作为进入这一研究领域的第一步，拟议中的研究将集中在吸烟的心脏病患者身上。该奖项将基于PI在行为激活（BA）方面的新兴专业知识，这是一种成熟的，经验支持的抑郁症治疗方法，最近显示出提高戒烟效果的希望。目前K23的应用将把PI的工作扩展到针对急性冠状动脉综合征（ACS）住院患者的戒烟。在这个新的研究领域取得成功将需要额外的指导培训和研究经验。当前应用程序中高度结构化的培训计划非常适合PI进行拟议的研究计划（见下文），并朝着他的长期职业目标迈进。培训计划将为PI提供以下方面的知识和技能：1)发展基于理论的、量身定制的治疗方法，2)随机对照试验（RCT）的设计和执行，3)高级统计学，4)行为心脏病学，以及5)手稿准备和拨款撰写。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）是健康行为改变干预措施设计和测试方面的专家，并在医疗人群中接受了多项关注戒烟的r01。Kahler博士（共同导师）在分析戒烟试验的结果数据和分析吸烟与情绪之间的关系方面具有特殊的统计专长。Arrighi博士（共同导师）是一位心脏病专家，在心脏病学研究员的临床和研究指导方面有着悠久的历史。专家将提供额外的培训，使BA适用于内科患者（Pagoto博士，顾问）和心脏病患者戒烟（Bock博士，合作者）。PI将与导师团队的所有成员举行定期会议。此外，在整个拟议的奖项期间，PI将参加相关课程，研讨会，讲习班和国家会议。急性冠脉综合征（ACS，不稳定型心绞痛，ST段抬高和非ST段抬高型心肌梗死）的发生可以被定义为一个“教育时刻”，患者可能更容易接受戒烟信息。ACS后继续吸烟是死亡率的独立预测因子。ACS后的抑郁情绪也预示着死亡率，并且患有抑郁情绪的吸烟者在ACS住院后戒烟的可能性更小。因此，针对抑郁情绪和吸烟的单一综合治疗可以非常有效地降低acs后死亡率。对于这一人群来说，BA可能是一种理想的治疗方法：它可以很容易地将情绪和戒烟相关的目标结合起来，并侧重于解决有价值活动的限制，这在acs后人群中很常见。因此，本研究的总体目标是为acs后吸烟者制定一份综合戒烟和情绪管理的BA治疗手册（针对吸烟的心脏病患者的行为激活治疗；BAT-CS），并收集与标准治疗相比该干预措施有效性的初步数据。我们将首先通过对ACS后戒烟患者和未能戒烟患者的一系列个体定性访谈来制定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（N=10）完善BAT-CS手册。最后，我们将进行一项试验性随机对照试验（N=72），比较BAT-CS（1次住院治疗和4-8次出院后治疗）与标准治疗（SC； 1次住院治疗和4包印刷自助材料的邮寄）。主要结果将是生化验证的7天点流行禁欲。抑郁情绪、生活质量和BA介质的差异也将在条件之间进行比较。该研究计划产生的数据将为提交R01提供试点数据，以资助大规模的随机对照试验测试BAT-CS的疗效。拟议的培训和研究计划为PI的最终目标迈出了实质性的第一步，即成为一名独立的临床研究者，开发创新的治疗方法，以解决医疗人群的健康行为改变和情绪管理问题。

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.