Effectiveness of a multi-component programme for managing depression in primary care: A cluster randomized trial. The INDI project

BackgroundThere are significant shortcomings in the management and clinical outcomes of depressed patients. The objective is to assess the effectiveness of a multi-component programme to improve the management of depression in primary care.MethodsThis is a cluster-randomized controlled trial, conducted between June 2007 and June 2010. Twenty primary care centres were allocated to intervention group or usual care group. The intervention consisted of a multi-component programme with clinical, educational and organizational procedures including primary care nurses working as case-managers. Outcomes were monitored by a blinded interviewer at 0, 3, 6 and 12 months. Trial registration: ISRCTN16384353, at http://isrctn.org.ResultsIn total, 338 adult patients with major depression (DSM-IV) were assessed at baseline. At 12 months, 302 patients were assessed, 172 in the intervention group and 130 in the control group. The severity of depression (mean Patient Health Questionnaire-9 score) was 1.76 points lower in the intervention group [7.15 vs. 8.78, 95% CI=−3.53 to 0.02, p=0.053]. The treatment response rate was 15.4% higher in the intervention group than in the controls [66.9% vs. 51.5%, odds ratio 1.9, 95% CI=1.2 to 3.1, p=0.011)], and the remission rate was 13.4% higher [48.8% vs. 35.4%, odds ratio 1.8, 95% CI=1.1 to 2.9, p=0.026)].LimitationsUnblinded physicians diagnosed depression in their patients and decided whether to include them in the study, so we cannot discount a hidden selection bias.ConclusionsThe programme for managing depression leads to better clinical outcomes in patients with major depression in primary care settings.