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Randomized Controlled Trial
Effectiveness of a multi-component programme for managing depression in primary care: a cluster randomized trial. The INDI project.
- Enric Aragonès, Josep Lluís Piñol, Antonia Caballero, Germán López-Cortacans, Pilar Casaus, Josep Maria Hernández, Waleska Badia, and Sílvia Folch.
- Tarragona-Reus Primary Care Area, Catalan Health Institute and IDIAP (Primary Care Research Institute) Jordi Gol, Barcelona, Spain. earagones.tarte.ics@gencat.cat
- J Affect Disord. 2012 Dec 15; 142 (1-3): 297-305.
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 RegistrationISRCTN16384353, 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.Copyright © 2012 Elsevier B.V. All rights reserved.
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