van der Voort 2015.

Study characteristics
Methods	Allocation: 2‐armed pragmatic cluster‐randomised. Cluster‐randomisation performed at the level of outpatient teams. Teams that treated at least 20 patients with bipolar disorder were asked to participate. Clusters were matched into pairs by the number of nurses in each team willing to participate in the intervention. These were then randomly assigned to either the experimental or control group by use of an internet generator, performed blind by vdV. No characteristic matching was used due to similarities in quality of care. Design: multi‐site, cluster‐randomised controlled trial Duration: 12 months Date of study: February 2011 to August 2013 – but unclear date order (2011‐02‐01 2013‐08‐01) Country: The Netherlands Setting: 16 mental health outpatient clinics Recruitment method: all patients seen under participating teams were invited to participate Masking: patients and professionals could not be blinded due to the nature of the study. However, blinding was performed in the randomisation and statistical analysis, and researchers performing the interview for the Life Chart method were also masked.
Participants	Inclusion criteria: diagnosed with bipolar disorder type I, II or NOS, according to DSM‐IV‐TR. This is assessed through medical records and confirmed by the treating psychiatrist using the Dutch language version of the Questionnaire for Bipolar Illness (QBP‐NL), aged 18 to 65 years. Exclusion criteria: patients with severe or very severe mania or depression, with a score of 6 or 7 on the Clinical Global Impression ‐ Bipolar Disorder scale; patients with such a stable course of illness (during the last year) that low intensity of treatment suffices (2 to 4 poly clinical visits with a psychiatrist a year); patients without sufficient command of the Dutch language to be able to fill in the questionnaires; inability or unwillingness to give informed consent Number randomised to intervention and control: 18 teams were randomised, 9 to intervention, 9 to control; 138 participants were randomised, 56 intervention, 82 control Number completed study: 72 people (88%) from both groups completed the 12‐month assessment. Two teams had to drop out mid‐study, meaning 38 potential participants were unable to participate in the intervention, including 15 people who had consented. 71 patients consented, 56 actually initiated the intervention. 13 discontinued the intervention and 11 were lost to follow up. 45 people in the intervention (80%) completed the 12‐month assessment. Age: intervention mean 46.8 (9.8), control mean 44.7 (11.3) Sex: female: intervention 39 (70%), control 49 (60%) Diagnosis: bipolar type 1: intervention 39 (70%), control 49 (60%); bipolar type 2: intervention 11 (20%), control 28 (35%); bipolar NOS: intervention 2 (4%), control 4 (5%) Ethnicity: not reported Any significant differences between intervention and control groups? Significant differences between the following baseline characteristics: patients randomised to CC reported a higher number of months with depressive symptoms during the 6 months prior to baseline than patients in the control group. Patients in CC had higher severity of depressive symptoms in the week preceding baseline. Patients randomised to CC had a lower educational level compared to control. Patients in the CC experienced more functional impairments at baseline than patients in control. Patients in control condition reported at baseline a better quality of life concerning health‐related quality of life.
Interventions	Type of collaborative care: B Description of intervention: Intervention name: the Collaborative Care Programme Contains 3 elements of collaborative care: A multi‐professional approach to patient care: no collaboration with primary care A structured management plan: yes. The patient is an active member of the CC team. One important aim is to agree on the most important problems to be worked on, the related goals and which care is needed to achieve these goals. A contract is made, in which the problems, goals, content of treatment and care, and outcomes are elaborated; monitoring and relapse prevention, by using the Life Chart Method; pharmacotherapy and somatic care, with continuous monitoring of the effects; support for developing a healthy lifestyle. Scheduled patient follow‐ups: yes, psychoeducation 6 x 2‐hour sessions; problem‐solving treatment x 6 sessions; pharmacotherapy and somatic care continue as appropriate. Enhanced interprofessional communication: Collaborative Care Team consists at least of the patient (and preferably a family member or friend), the nurse and the psychiatrist. The team meets every 3 months. The primary nurse co‐ordinates care and is responsible for continuity of care. The patient has an active role in his/her own treatment. If the patient agrees, then family members, friends or caregivers are invited to participate in treatment. Other intervention components: Psychoeducation (based on the Dutch psychoeducation course, Hofman et al, 1992; Honig et al, 1997) adapted to the needs of patient and family Problem‐solving treatment (Schreuders et al, 2005/2007) Activity scheduling, if patients have prolonged depression Rehabilitation modules, if patients have low quality of life and minimal social participation Control group: Care as usual in outpatient clinics for bipolar disorder or mood disorders in general
Outcomes	Measures taken at: baseline, 6 and 12 months Primary outcome: fails to report which outcomes are considered primary or secondary, states “psychosocial functioning, course, prevalence, and severity of psychiatric symptoms and quality of life” Able to use: Functioning (Functioning Assessment Short Test ‐ FAST‐NL‐P) (baseline, 6 and 12 months) Depressive symptoms (Quick Inventory for Depressive Symptomology ‐ QIDS) (baseline, 6 and 12 months) Mania symptoms (Altman Self‐Rating Mania Scale ‐ ASRM) (baseline, 6 and 12 months) Average mood over last month (Life Chart Method ‐ LCM) (baseline, 6 and 12 months) Quality of Life (World Health Organization Quality of Life Questionnaire WHO‐QOL‐bref) (baseline, 6 and 12 months) Attitude towards medication, adherence (Drugs Attitude Inventory ‐ DAI‐10) (baseline, 6 and 12 months) Attrition (number lost to follow‐up) (6 months and 12 months) Unable to use: Current characteristics of bipolar disorder (the Questionnaire for Bipolar Illness ‐ QBP‐NL) (baseline) – not reported Current severity of bipolar disorder (Clinical Global Impression for Bipolar Disorder – CGI‐BP) (baseline, 6 and 12 months) – not reported Fidelity; nurses in the experimental group completed fidelity checklists to register collaborative care elements delivered – not of interest Symptoms (the Brief Symptom Inventory – BSI) (baseline, 6 and 12 months) ‐ not reported Assessment of needs (CANSAS‐P) (baseline, 6 and 12 months) ‐ not reported Mastery (Sense of Mastery Scale) (baseline, 6 and 12 months) ‐ not reported Satisfaction with care (visual analogue scale (VAS) and qualitative interview analysed using grounded theory); VAS not reported, qualitative study not used in this study Costs (direct and indirect) (Treatment Inventory Costs in Psychiatric patients – TIC‐P) (baseline, 6 and 12 months) ‐ not reported Perceived burden of caregivers (Involvement Evaluation Questionnaire – IEQ) (baseline, 6 and 12 months) ‐ not reported Caregiver satisfaction with care (VAS) (baseline, 6 and 12 months) ‐ not reported
Notes	Sources of monetary support GGZ Ingeest, VU University Medical Center, Dimence, AstraZeneca We "deflated" the sample sizes to account for clustering; n = 94 at 6 months and n = 91 at 12 months.

BD: bipolar disorder; BMI: body mass index; BP: blood pressure; BPD: bipolar disorder; BPRS: Brief Psychiatric Rating Scale; CC: collaborative care; CHW: community healthcare worker; CMHC: community mental health care clinic; CVD: cardiovascular disease; DSM‐IV: DSM: Diagnostic and Statistical Manual, version 4; FTE: full‐time equivalent; HDL: high‐density lipoprotein; ICD‐10 DCR: ICD‐10 Diagnostic Criteria for Research; ICD‐10: International Classification of Diseases, 10^th revision; IQR: interquartile range; LDL: low‐density lipoprotein; LGCC: Life Goals Collaborative Care; MCS: mental component score; NCC: nurse care co‐ordinator; NOS: not otherwise specified; PANSS: Positive and Negative Symptom Scale; PCS: mental component score; RCT: randomised controlled trial; SD: standard deviation; SF 36: Short form 36; VAMC: Veterans Administration Medical Centre; WHO‐DAS: World Health Organization Disability Assessment Scale