Kilbourne 2012.

Study characteristics
Methods	Allocation: randomised in blocks of 16 to 20 stratified by age, race and diabetes diagnosis to ensure balance of characteristics Design: RCT, multicentre Duration: 12‐month follow‐up Date of study: October 2010 to August 2012 Country: USA Setting: 2 community‐based mental health outpatient programmes in Southeastern Michigan Recruitment method: not specified Masking: single‐blind (outcomes assessor blind to intervention)
Participants	Inclusion criteria: adult patients with an active diagnosis or treatment plan for bipolar disorder I, II or NOS with at least one cardiometabolic risk factor (diagnosis or indication of hypertension, hyperlipidaemia, diabetes or BMI > 25) who received care in one of 2 participating community mental health outpatient programmes. Other criteria included community‐dwelling and English‐speaking. Exclusion criteria: severely cognitively impaired or unable to give informed consent Number randomised to intervention and control: 68 participants enrolled and 32 randomised to the Life Goals Collaborative Care group (LGCC), 33 to enhanced treatment as usual (ETU) Number completed study: 65 completed both 6‐ and 12‐month measures Age: intervention 47.2 ± 11.8; control 43.4 ± 13.6 Sex: intervention 15 (56%); control 21 (66%) female Diagnosis: breakdown by diagnosis not provided Ethnicity: intervention 7 (22%); control 5 (16%) African American Any significant differences between intervention and control groups? no statistically significant baseline demographic or clinical differences between groups
Interventions	Type of collaborative care: B Description of intervention: Intervention name: Life Goals Collaborative Care Contains 3 elements of collaborative care: A multi‐professional approach to patient care: no involvement with primary care A structured management plan: yes, interventionist provided four 2‐hour weekly group self‐management sessions, followed by brief care management contact with patients randomised to LGCC for up to 6 months. Each group session included approximately 8 to 10 participants, and sessions were based on social cognitive theory. The sessions included active discussions by patients that were focused on their personal goals, and alignment of those goals with healthy behaviour changes and action planning to cope with current symptoms. Specific focus points covered throughout the 4 sessions included bipolar disorder and cardiovascular disease risk, stigma issues, wellness habits including diet and exercise within the context of symptom coping strategies and collaborative care management. Scheduled patient follow‐ups: yes, brief (20‐minute) care management contact with patients in LGCC for up to 6 months. These were used to track symptoms and progress towards wellness goals using motivational techniques. Enhanced interprofessional communication: yes, a nurse care manager served as a liaison between patients and providers regarding ongoing care and, through regular phone calls, the care manager referred urgent matters to medical and mental health providers and was involved in documenting patient progress over time, and outreach/crisis management after critical service encounters or missed appointments. Other intervention components: Life Goals Collaborative Care (LGCC) is designed to reduce the risk factors for CVD, through improved control of psychiatric symptoms, increased positive health behaviours, as well as improved co‐ordination of physical and mental health care. Description of control: Enhanced usual care. Patients receive care as usual, in addition to mailings on wellness topics over the 6‐month intervention period and referral to primary care services off site.
Outcomes	Measures taken at: baseline, 6 months and 12 months Primary outcomes: cardiometabolic risk factors; waist circumference, blood pressure, BMI Able to use: Quality of life (Short Form 12 ‐ SF‐12) (baseline, 6 months and 12 months) Manic and depressive symptoms (Internal State Scale ‐ ISS) (baseline, 6 months and 12 months) Blood pressure (diastolic and systolic BP mmHg) (baseline, 6 months and 12 months) Body mass index (BMI kg/m2) (baseline, 6 months and 12 months) Waist circumference (inches) (baseline, 6 months and 12 months) Functioning (WHO‐DAS) (baseline, 6 months and 12 months) Attrition (number lost to follow up) (12 months) Unable to use: None
Notes	Study conducted in 2009