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The STEP-BD study has three main regional sites: Massachusetts General Hospital in Boston, MA, University of Pittsburgh, Pittsburgh, PA and University of Colorado, Boulder and Denver, CO. Each of these regional sites has its own particular responsibilities in study management and conduct.

The Clinical Coordinating Center (CCC) is located at Massachusetts General Hospital (MGH). The CCC is responsible for overseeing all study activities including regulatory submissions (FDA and NIMH), site selection, study personnel training, rater certification, managing and conducting study monitoring visits. The CCC manages and negotiates all internal and external contracts and budgets for the trial. The study drug distribution for the trial is managed and maintained by the MGH Research Pharmacy. Additionally, MGH is lead site for Cognitive Behavioral Therapy training and implementation.

The University of Pittsburgh is home to the Data Coordinating Center (DCC) which will be housed in the Epidemiology Data Center. The DCC will be responsible for the management of the data collected in the STEP-BD study using an Internet/Web-based data system. In addition, the DCC will be conducting statistical analyses of the data for the reporting of the results of the study. The University of Pittsburgh is also the lead site for training and implementation of Interpersonal and Social Rhythm Therapy.

The University of Colorado is responsible for leading the Psychosocial Intervention portion of this trial. This study is designed to look not only at pharmacologic treatments of bipolar disorder but also to investigate psychosocial treatment in this disorder. We are investigating three forms of intensive treatment: Family-Focused Therapy, Interpersonal and Social Rhythm Therapy, and Cognitive Behavioral Therapy. We will be comparing these intensive therapies to the Collaborative Care Plus, in which patients will be given a workbook and have up to 3 therapy sessions with a clinical specialist to educate the patient on signs, symptoms and management of bipolar disorder. The University of Colorado heads up the Family-Focused Therapy training and implementation.

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