Integrated Smoking Cessation and Mood Management for Cardiac Patients

描述(由申请者提供)：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调查员，开发创新的治疗方法，以解决医疗人群的健康行为变化(包括戒烟)和情绪管理。作为进入这一研究领域的第一步，拟议的研究将侧重于吸烟的心脏病患者。该奖项将建立在PI在行为激活(BA)方面的新兴专业知识的基础上，BA是一种成熟的、有经验支持的抑郁症治疗方法，最近显示出提高戒烟效果的前景。在精通BA治疗抑郁症后，目前的K23应用程序将扩大PI的工作范围，使其针对因急性冠脉综合征(ACS)住院的患者戒烟。在这一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。当前申请中高度结构化的培训计划非常适合让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)基于理论的定制治疗的开发；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；5)手稿准备和拨款撰写。培训将由一支拥有独特技能的专家指导团队进行。Borrelli博士(首席导师)是设计和测试健康行为改变干预措施的专家，并获得了多个R01，重点是在医疗人群中戒烟。Kahler博士(共同导师)在分析戒烟试验的结果数据以及分析吸烟和情绪之间的关系方面拥有特殊的统计学专业知识。Arrighi博士(共同导师)是一位心脏病专家，在心脏病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)和心脏病患者的戒烟(Bock博士，合作者)。PI将定期与指导小组的所有成员举行会议。此外，在整个拟议的奖项过程中，PI将参加相关的课程、研讨会、研讨会和全国会议。急性冠脉综合征(ACS；不稳定型心绞痛、ST段抬高和非ST段抬高的心肌梗死)的发生可以被概念化为“可教的时刻”，患者可能更容易接受戒烟信息。急性冠脉综合征后持续吸烟是死亡率的独立预测因素。急性冠脉综合征后的抑郁情绪也预示着死亡率，情绪抑郁的吸烟者在急性冠脉综合征住院后戒烟的可能性较小。因此，同时针对抑郁情绪和吸烟的单一综合治疗在降低急性冠脉综合征后死亡率方面可能非常有效。BA可能是一种理想的治疗方法或这一人群：它可以很容易地整合情绪和戒烟相关目标，并专注于解决有价值的活动限制，这在急性冠脉综合征后人群中很常见。因此，当前研究的总体目标是制定一份BA治疗手册，将戒烟和对ACS后吸烟者的情绪管理结合在一起(吸烟心脏病患者的行为激活治疗；BAT-CS)，并收集这种干预与标准护理相比较的效果的初步数据。我们将首先开发BAT-CS治疗手册，通过对戒烟患者和ACS后未能戒烟的患者进行一系列个人定性访谈。接下来，我们将通过测试用例(N=10)来测试可行性和可接受性，并对BAT-CS手册进行细化。最后，我们将进行一项试验性随机对照试验(N=72)，将BAT-CS(1次住院治疗和4至8次出院后治疗)与标准护理(SC；1次住院治疗和4包邮寄的打印自助材料)进行比较。主要结果将是生化验证的7天点流行戒酒。在抑郁情绪、生活质量和BA中介方面的差异也将在不同条件下进行比较。这项研究计划产生的数据将为提交R01提供试点数据，以资助一项大规模的随机对照试验，测试BAT-CS的效力。拟议的培训和研究计划向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调查员，开发创新的治疗方法，以解决医疗人群的健康行为变化和情绪管理问题。 公共卫生相关性：项目叙述吸烟和抑郁情绪都可以预测急性冠脉综合征后的死亡率。然而，到目前为止，还没有针对戒烟和管理情绪的咨询治疗被设计在这一人群中。这项拟议的工作旨在开发一种基于行为激活的治疗方法，这种方法已经显示出在其他人群中作为吸烟和情绪管理的综合治疗方法的前景。

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. PUBLIC HEALTH RELEVANCE: Project Narrative Smoking and depressed mood are both predictive of mortality following Acute Coronary Syndrome. However, to date, no counseling treatment has been designed to target smoking cessation and manage mood in this population. The proposed work aims to develop such a treatment based on Behavioral Activation, an approach that has shown promise as an integrated treatment for smoking and mood management in other populations.