Bipolar Disorder Center for Pennsylvanians: Implementing an Effectiveness Trial to Improve Treatment for At-Risk Patients

Abstract

Objective Adolescents, elderly persons, African Americans, and rural residents with bipolar disorder are less likely than their middle-aged, white, urban counterparts to be diagnosed, receive adequate treatment, remain in treatment once identified, and have positive outcomes. The Bipolar Disorder Center for Pennsylvanians (BDCP) study was designed to address these disparities. This report highlights the methods used to recruit, screen, and enroll a cohort of difficult-to-recruit individuals with bipolar disorder. Methods Study sites included three specialty clinics for bipolar disorder in a university setting and a rural behavioral health clinic. Study operations were standardized, and all study personnel were trained in study procedures. Several strategies were used for recruitment. Results It was possible to introduce the identical assessment and screening protocol in settings regardless of whether they had a history of implementing research protocols. This protocol was also able to be used across the age spectrum, in urban and rural areas, and in a racially diverse cohort of participants. Across the four sites 515 individuals with bipolar disorder were enrolled as a result of these methods (69 African Americans and 446 non–African Americans). Although clinical characteristics at study entry did not differ appreciably between African Americans and non–African Americans, the pathways into treatment differed significantly. Conclusions Rigorous recruitment and assessment procedures can be successfully introduced in different settings and with different patient cohorts, thus facilitating access to high-quality treatment for individuals who frequently do not receive appropriate care for bipolar disorder.

An approach to revealing clinically relevant subgroups across the mood spectrum

“…All participants were in a DSM-defined major depressive episode at the time of the MOODS and at screening for study entry, and were selected from one of three parent randomized clinical trials: 1) Bipolar Disorder Center for Pennsylvanians Study (Fagiolini et al, 2009; Kupfer et al, 2009), 2) Bipolar 2 Study (MH84831, PI: Swartz), and 3) Depression Phenotypes Study (Frank et al, 2011). All three of these studies were based out of the same clinic with largely overlapping staff.…”

“…The BDCP study (Fagiolini et al, 2009; Kupfer et al, 2009) followed 463 individuals aged ≥ 12 with bipolar disorder (BP1, BP2, bipolar disorder not otherwise specified, or schizoaffective disorder, bipolar type) longitudinally for between 1 – 3 years. The study was conducted at sites in Pittsburgh, PA and DuBois, PA.…”

“…When participants met DSM-IV criteria for a mood episode or experienced a clinical worsening they were randomized to either specialized care for bipolar disorder (SCBD) or SCBD plus an enhanced clinical intervention (SCBD+ECI), and remained in this treatment arm for the remainder of their time in the study. Full study details are provided elsewhere (Fagiolini et al, 2009; Kupfer et al, 2009). …”

“…The BDCP study used the Bipolar Disorder Visit Form (BDVF; Kupfer et al, 2009) to capture current (hypo)manic and depressive symptoms. Although these depressive and (hypo)manic symptom data collection instruments are different, they capture many highly overlapping symptoms (see Supplement).…”

Season of Birth Is Associated With Adult Body Mass Index in Patients With Bipolar Disorder

“…For detailed descriptions of all the study procedures, refer to Kupfer et al (2009) and Frank et al (2011). As part of the inclusion criteria for the parent study (ME02385, Bipolar Disorder Center for Pennsylvanians), participants were required to have a Diagnostic and Statistical Manual of Mental Disorders , Fourth Edition (DSM-IV) diagnosis for Bipolar I, Bipolar II, Bipolar Not Otherwise Specified (NOS) or Schizoaffective Bipolar subtype.…”