The health consequences of bipolar disorder are reflected not only in psychiatric morbidity and mortality associated with recurrent mood episodes, but also in the profound medical burden suffered by these patients. Although collaborative care models for the treatment of depression in primary care have been developed and tested, bipolar disorder is primarily treated in psychiatric settings, meaning that very little attention has been devoted to medical comorbidity in bipolar disorder and no systematic interventions have been developed. This randomized clinical trial of 300 adults with bipolar disorder will compare integrated care treatment with guideline-based psychiatric care only. The integrated care treatment condition consists of three interlocking components: 1) psychopharmacologic management that takes into account specific medical diseases and risk factors common in individuals with bipolar disorder; 2) individualized medical and behavioral management of diseases and risk factors that takes into account each patient's specific psychiatric symptoms and treatment needs; and 3) a lifestyle modification intervention that focuses on risks common to all patients with bipolar I disorder. Our integrated care model will be contrasted to guideline-based psychiatric care only model that follows current evidence-based guidelines for the management of bipolar disorder. Our primary hypotheses are that, compared to guideline-based psychiatric care only, subjects assigned to integrated care treatment will experience: 1) fewer new affective episodes and more days in affective remission and 2) will have better functioning and quality of life. Our secondary hypotheses are that integrated care treatment will result in: 1) higher rates of outpatient medical care and psychiatric care; 2) lower rates of inpatient utilization (both medical and psychiatric) during the 21/2 years of the trial; 3) fewer affective episodes and more days well moderated by baseline medical burden; 4) better functioning and improved quality of life moderated by baseline medical burden; and 5) regular participation in and adherence to lifestyle interventions mediated by sustained remission of mood symptoms. Relevance: Bipolar disorder is a chronic, potentially lethal disease with poor psychiatric outcome that is associated with a high rate of suicide. Medical disease and medical risk factors are common in bipolar disorder and lead to even greater morbidity and mortality. This investigation is directed toward reducing the impact of medical burden on psychiatric outcomes as expressed in levels of functioning, extent of symptomatic remission, and degree of suicidality. ? ? ?
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