Pediatric bipolar disorderRationale, design, and methods of the systematic treatment enhancement program for bipolar disorder (STEP-BD)
Introduction
The Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD) is a national, longitudinal public health initiative designed to examine the effectiveness of treatments and their impact on the course of bipolar disorder. The initial proposal was made in response to a National Institute of Mental Health (NIMH) request (RFP 98-DS-0001) seeking a common intervention model for studies of treatment effectiveness. The request for proposal asked for a public health model Norquist and Hyman 1999, Norquist et al 1999 that enrolled patients with bipolar disorder of all subtypes, severity, and demographic groups. The NIMH funded STEP-BD as a contract to the Massachusetts General Hospital on October 1, 1998. The design and protocol were refined over the following year by committees convened by the STEP-BD Executive Committee and reviewed by an external advisory committee convened by the NIMH. STEP-BD commenced clinical operations in November 1999 and projects to enroll 5000 bipolar patients in treatment centers across the United States. The project is currently funded through 2005.
The purpose of this article is to provide an overview of the central purposes and methods of STEP-BD. Among large treatment studies, STEP-BD is notable for ensuring wide representation of the heterogeneity of presenting mood states and comorbidities that represent bipolar disorder. Moreover, STEP was designed with attention to the gap that can develop between well-controlled treatment trials and the ongoing treatment of patients in clinical settings. That is, do results in one generalize to the other? By combining a large naturalistic study with seamless entry of some participants into randomized trials, STEP-BD will be able to compare the results from methods that enhance internal validity with those that enhance external validity. In addition, the detailed study of a specific phase of the disorder will be complemented by detailed information on what came before and what came after the window on outcome offered by the typical randomized treatment trial.
Before discussing some of the strategies and innovations used in STEP-BD, it is helpful first to place bipolar disorder and its treatment in context.
Section snippets
Rationale: why a nationwide study of bipolar disorder?
Bipolar disorder is a major public health concern, recently ranked as the world’s eighth greatest cause of medical disability (Murray and Lopez 1996). Prevalence estimates range from 1.0% to 3% of the population of the United States (Kessler et al 1994, Regier et al 1990, Weissman et al 1988. Moreover, a substantial minority of people diagnosed with recurrent depressive episodes is found to have conditions within the broader spectrum of bipolar disorder Angst and Sellaro 2000, Goldberg 2001.
The design of STEP-BD
STEP-BD is not a single study but rather a platform or infrastructure designed to carry out a variety of clinical trials and other studies that require a cohort of well-characterized bipolar subjects. From the outset, STEP-BD was designed to be inclusive of the full spectrum of bipolar patients presenting for clinical care. Effort in the planning stage was devoted to capturing the heterogeneity of presentations (e.g., mood states and diagnostic specifiers) of the disorder itself, the rich
Conclusions
Bipolar mood disorder is a common, chronic, and often severe mental illness for which treatment effectiveness research is a high public health priority. The complexity of the condition, lack of a common intervention model, and the need for a large sample present daunting obstacles to researchers and provide compelling rationale for NIMH sponsorship of multisite collaborative research.
STEP-BD consists of a clinical coordinating center, data management center, and a network of collaborating sites
Acknowledgements
This project has been funded in whole or in part with Federal funds from the National Institute of Mental Health (NIMH), National Institutes of Health, under Contract N01MH80001. Any opinions, findings, and conclusions or recommendations expressed in this publication are those of the authors and do not necessarily reflect the views of the NIMH. This article was approved by the publication committee of the Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD). Core
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