Biomedical subjects

Cooperative Studies Program 430 Study Team

Publications and source records attributed to Cooperative Studies Program 430 Study Team.

3 recordsLinked to original sources

PubMed2006

Collaborative care for bipolar disorder: part I. Intervention and implementation in a randomized effectiveness trial.

Outcome for bipolar disorder remains suboptimal despite the availability of efficacious treatments. To improve treatment effectiveness in clinical practice, a Veterans Affairs study team created a care model conceptually similar to the lithium clinics of the 1970s but augmented by principles of more recent collaborative care models for chronic medical illnesses. This intervention consists of improving patients' self-management skills through psychoeducation; supporting providers' decision making through simplified practice guidelines; and enhancing access to care, continuity of care, and information flow through the use of a nurse care coordinator. In this article, which is part I of a two-part report, the authors summarize the conceptual background and development of the intervention, describe the design of a three-year, 11-site randomized effectiveness trial, and report data describing its successful implementation. Trial design emphasized aspects of effectiveness to support generalizability of the findings and eventual dissemination of the intervention. Part II (see companion article, this issue) reports clinical, functional, and overall cost outcomes of the trial.

Adult↗

PubMed2006

Collaborative care for bipolar disorder: Part II. Impact on clinical outcome, function, and costs.

OBJECTIVE: The study addressed whether a collaborative model for chronic care, described in part I (this issue), improves outcome for bipolar disorder. METHODS: The intervention was designed to improve outcome by enhancing patient self-management skills with group psychoeducation; providing clinician decision support with simplified practice guidelines; and improving access to care, continuity of care, and information flow via nurse care coordinators. In an effectiveness design veterans with bipolar disorder at 11 Veterans Affairs hospitals were randomly assigned to three years of care in the intervention or continued usual care. Blinded clinical and functional measures were obtained every eight weeks. Intention-to-treat analysis (N=306) with mixed-effects models addressed the hypothesis that improvements would accrue over three years, consistent with social learning theory. RESULTS: The intervention significantly reduced weeks in affective episode, primarily mania. Broad-based improvements were demonstrated in social role function, mental quality of life, and treatment satisfaction. Reductions in mean manic and depressive symptoms were not significant. The intervention was cost-neutral while achieving a net reduction of 6.2 weeks in affective episode. CONCLUSIONS: Collaborative chronic care models can improve some long-term clinical outcomes for bipolar disorder. Functional and quality-of-life benefits also were demonstrated, with most benefits accruing in years 2 and 3.

Adult↗

PubMed2005

Impact of childhood abuse on the course of bipolar disorder: a replication study in U.S. veterans.

BACKGROUND: The association between early childhood abuse and the course of illness, including psychiatric comorbidities, in adults with bipolar disorder has not been examined in a predominantly male or veteran population. METHODS: As part of the VA Cooperative Study 430, "Reducing the Efficacy-Effectiveness Gap in Bipolar Disorder," 330 veterans (91% male) with bipolar I or II disorder who were enrolled in a 3-year prospective study were examined for baseline data obtained at study entry. Diagnoses were determined by the use of the SCID. A semistructured interview designed to elicit data about exposure to childhood physical, sexual, or combined abuse was conducted as part of baseline demographic and clinical information. Other reports from this data set have not addressed the issues of childhood adversity. RESULTS: Childhood abuse was reported by 48.3% of the subjects (47.3% of men). Any abuse (AA) was reported by 48.3%; sexual abuse without physical abuse (SA) was reported by 8%, physical abuse without sexual abuse (PA) by 20.7%, and both types of abuse (combined abuse, CA) by 18.7% of the male subjects. Female veterans reported more SA (27%) and less PA (6.7%). AA subjects were more likely to have current PTSD and lifetime diagnoses of panic disorder and alcohol use disorders. CA was associated with lower SF-36 Mental scores, higher likelihood of current PTSD and lifetime diagnoses of alcohol use disorders, as well as more lifetime episodes of major depression and higher likelihood of at least one suicide attempt. Younger age at study entry was associated with AA and PA. LIMITATIONS: Potential limitations include generalizability beyond the male, veteran population of patients with bipolar disorder and the methodology used to elicit abuse histories. CONCLUSIONS: Similar to studies of predominantly female nonveteran samples, this study extends the finding that a history of childhood abuse acts as a disease course modifier in male veterans with bipolar disorder. Clinicians should routinely seek information regarding abuse and be aware that these patients may be more difficult to treat than bipolar patients who have no abuse histories.

Adult↗