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Design and rationale of a randomized controlled trial to reduce cardiovascular disease risk for patients with bipolar disorder.

Goodrich DE, Kilbourne AM, Lai Z, Post EP, Bowersox NW, Mezuk B, Schumacher K, Bramlet M, Welsh DE, Bauer MS. Design and rationale of a randomized controlled trial to reduce cardiovascular disease risk for patients with bipolar disorder. Contemporary clinical trials. 2012 Jul 1; 33(4):666-78.

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BACKGROUND: Persons with bipolar disorder (BD) experience a disproportionate burden of medical comorbidity, notably cardiovascular disease (CVD), contributing to decreased function and premature mortality. We describe the design, rationale, and baseline findings for the Self-Management Addressing Heart Risk Trial (SMAHRT), a randomized controlled effectiveness trial of an intervention (Life Goals Collaborative Care; LGCC) designed to reduce CVD risk factors and improve physical and mental health outcomes in patients with BD. METHODS: Patients with BD and at least one CVD risk factor were recruited from a VA healthcare system and randomized to either LGCC or usual care (UC). LGCC participants attended four weekly, group-based self-management sessions followed by monthly individual contacts supportive of health behavior change and ongoing medical care management. In contrast, UC participants received monthly wellness newsletters. Physiological and questionnaire assessments measured changes in CVD outcomes and quality of life (QOL) over 24 months. RESULTS: Out of the 180 eligible patients, 134 patients were enrolled (74%) and 118 started the study protocols. At baseline (mean age = 54, 17% female, 5% African American) participants had a high burden of clinical risk with nearly 70% reporting at least three CVD risk factors including, smoking (41%) and physical inactivity (57%). Mean mental and physical HRQOL scores were 1.5 SD below SF-12 population averages. CONCLUSION: SMAHRT participants experienced substantial CVD morbidity and risk factors, poor symptom control, and decreased QOL. LGCC is the first integrated intervention for BD designed to mitigate suboptimal health outcomes by combining behavioral medicine and care management strategies.

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