Adjunctive Behavior Therapy for Bipolar I Depression

描述（由候选人提供）：这个以指导患者为导向的研究职业发展奖（K23）的目标是为劳伦·温斯托克博士准备一个独立的临床研究生涯，专注于主要情感障碍的现象学和治疗。在她之前的临床和研究经验的基础上，Weinstock博士在双相抑郁症的研究中寻求额外的指导研究培训。尽管研究结果表明抑郁症占双相情感障碍相关发病率和死亡率的很大一部分，并且与显著的功能障碍和对药物治疗的普遍不良反应有关，但对心理社会干预的研究还不够充分。为了满足这一临床需求，拟议的研究计划旨在开发一种专门用于治疗双相I型抑郁症的辅助行为疗法。在本研究的背景下，Weinstock博士的培训目标是：1)增加双相抑郁症现象学和治疗的知识；2)开发联合治疗试验结果数据的设计、执行和分析方面的专业知识；3)了解与临床研究中使用精神科药物相关的临床和研究问题，为未来在多学科环境下的合作做好准备；4)在与严重精神病患者的工作中增加伦理和多元文化问题的知识；5)拓展基金写作和稿件准备技能。本次培训将由：1)博士的专家指导。伊万·米勒、马克·鲍尔、迈克尔·阿迪斯、雪莉·约翰逊和大卫·斯特朗；2)课程、研讨会和临床指导经验；3)布朗医学院可利用的各种资源；4)项目实施。Weinstock博士将实施一项为期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社会心理干预的初步效果。这种干预被称为改良行为激活疗法（M-BAT），将作为药物治疗的辅助手段，并将依赖于适用于双相抑郁症的行为激活原理。作为一种治疗单极抑郁症的有效干预措施，行为激活通过增加自然强化行为的频率，促进常规调节和替代性应对，针对维持抑郁的回避和退缩。拟议拨款的前18个月将致力于开发M-BAT并在公开试验中进行试点。随后，Weinstock博士将进行一项小型随机试验，比较M-BAT +半结构化药物治疗与单独半结构化药物治疗。关于M-BAT的可行性和可接受性以及结果的临床意义的数据，结合统计分析的结果，将用于通知R01申请进行全面的临床试验。

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.