(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.
