Adjunctive Behavior Therapy for Bipolar I Depression

描述(由候选人提供)：这个以患者为导向的指导研究职业发展奖(K23)的目标是让Lauren Weinstock博士为专注于主要情感障碍的现象学和治疗的独立临床研究生涯做好准备。基于她之前治疗单相重度抑郁症的临床和研究经验，温斯托克博士寻求在双相抑郁症研究方面进行额外的指导性研究培训。尽管发现抑郁症占了双相情感障碍相关发病率和死亡率的很大一部分，而且它与严重的功能障碍和对药物治疗的反应普遍较差有关，但心理社会干预一直没有得到充分的研究。为了解决这一临床需求，拟议的研究计划试图开发一种为治疗双相I型抑郁症量身定做的辅助行为疗法。在这项研究的背景下，Weinstock博士的培训目标是：1)增加双相抑郁症现象学和治疗方面的知识；2)在联合治疗试验中开发设计、执行和分析结果数据的专业知识；3)了解与临床研究中使用精神药物有关的临床和研究问题，以便为未来在多学科环境下的合作做准备；4)增加与严重精神病患者合作中的伦理和跨文化问题的知识；5)扩大拨款撰写和手稿准备技能。这项培训将由以下方面推动：1)来自Ivan Miller、Mark Bauer、Michael亚的斯亚贝巴、Sheri Johnson和David Strong博士的专家指导；2)课程、研讨会和指导临床经验；3)布朗医学院提供的各种资源；以及4)拟议项目的实施。温斯托克博士将实施一个为期5年的研究项目，在此期间，她将开发和评估针对双相I型抑郁症的量身定制的心理社会干预的初步疗效。这项名为改进的行为激活疗法(M-BAT)的干预措施将作为药物治疗的辅助手段提供，并将依赖于适应双相抑郁的行为激活原则。行为激活作为一种对单相抑郁具有既定疗效的干预措施，通过增加自然强化行为的频率，促进常规调节和替代应对，针对维持抑郁的回避和撤退。拟议奖励的前18个月将专门用于开发M-BAT并在公开审判中进行试点。随后，温斯托克博士将进行一项小型随机试验，将M-BAT加半结构化药物疗法与单独使用半结构化药物疗法进行比较。有关M-BAT的可行性和可接受性以及研究结果的临床意义的数据，将与统计分析的结果相结合，用于R01申请进行全面临床试验。

DESCRIPTION (provided by candidate): The goal of this Mentored Patient-Oriented Research Career Development Award (K23) is to prepare Dr. Lauren Weinstock for an independent clinical research career focused on the phenomenology and treatment of major affective disorders. Building upon her prior clinical and research experiences with unipolar major depression, Dr. Weinstock seeks additional mentored research training in the study of bipolar depression. Despite findings that depression accounts for a substantial portion of the morbidity and mortality associated with bipolar disorder, and that it is associated with significant functional impairment and generally poor response to pharmacotherapy, psychosocial interventions have been understudied. To address this clinical need, the proposed research plan seeks to develop an adjunctive behavioral therapy tailored for the treatment of bipolar I depression. Within the context of this research, Dr. Weinstock's training goals are: 1) to increase knowledge of the phenomenology and treatment of bipolar depression; 2) to develop expertise in the design, execution, and analysis of outcome data in combined treatment trials; 3) to understand clinical and research issues related to the use of psychiatric medications in clinical research, so as to prepare for future collaborations in a multidisciplinary setting; 4) to increase knowledge of ethical and multicultural issues in work with severely mentally ill patients; and 5) to expand grant writing and manuscript preparation skills. This training will be facilitated by: 1) expert mentorship from Drs. Ivan Miller, Mark Bauer, Michael Addis, Sheri Johnson, and David Strong; 2) coursework, seminars, and supervised clinical experiences; 3) the diverse resources available at Brown Medical School; and 4) implementation of the proposed project. Dr. Weinstock will implement a 5-year research project, during which she will develop and evaluate the preliminary efficacy of a tailored psychosocial intervention for bipolar I depression. The intervention, called Modified Behavioral Activation Therapy (M-BAT), will be provided as an adjunct to pharmacotherapy, and will rely upon behavioral activation principles adapted for bipolar depression. As an intervention with established efficacy for treatment of unipolar depression, behavioral activation targets the avoidance and withdrawal that maintain depression by increasing the frequency of naturally-reinforcing behaviors and promoting routine regulation and alternative coping. The first 18 months of the proposed award will be devoted to developing M-BAT and piloting it in an open trial. Subsequently, Dr. Weinstock will conduct a small randomized trial, comparing M-BAT plus semi-structured pharmacotherapy to semi-structured pharmacotherapy alone. Data concerning the feasibility and acceptability of M-BAT and clinical significance of findings, combined with results from statistical analyses, will be used to inform an R01 application for a full-scale clinical trial.