• Enric Aragonès, Antonia Caballero, Josep Ll Piñol, Germán López-Cortacans, Waleska Badia, Josep M Hernández, Pilar Casaus, Sílvia Folch, Josep Basora, Antonio Labad, and INDI research group.
• Tarragona-Reus Primary Care Area, Catalan Health Institute, Spain. earagones.tarte.ics@gencat.net
• Bmc Public Health. 2007 Sep 20; 7: 253.

BackgroundMost depressed patients are attended at primary care. However, there are significant shortcomings in the diagnosis, management and outcomes of these patients. The aim of this study is to determine whether the implementation of a structured programme for managing depression will provide better health outcomes than usual management.Methods/DesignDesignA cluster-randomized controlled trial involving two groups, one of which is the control group consisting of patients who are treated for depression in the usual way and the other is the intervention group consisting of patients on a structured programme for treating depression.Setting20 primary care centres in the province of Tarragona (Spain)Sample400 patients over 18 years of age who have experienced an episode of major depression (DSM-IV) and who need to initiate antidepressant treatmentInterventionA multi-component programme with clinical, educational and organisational procedures that includes training for the health care provider and evidence-based clinical guidelines. It also includes primary care nurses working as care-managers who provide educational and emotional support for the patients and who are responsible for active and systematic clinical monitoring. The programme aims to improve the primary care/specialized level interface.MeasurementsThe patients will be monitored by telephone interviews. The interviewer will not know which group the patient belongs to (blind trial). These interviews will be given at 0, 3, 6 and 12 months.Main VariablesSeverity of the depressive symptoms, response rate and remission rate.AnalysisOutcomes will be analyzed on an intent-to-treat basis and the unit of analysis will be the individual patient. This analysis will take into account the effect of study design on potential lack of independence between observations within the same cluster.DiscussionThe effectiveness of caring for depression in primary care can be improved by various strategies. The most effective models involve organisational changes and a greater role of nurses. However, these models are almost exclusively from the USA, and this randomized clinical trial will determine if this approach could be effective to improve the outcomes of depression in primary care in the Spanish health care system.Trial RegistrationISRCTN16384353.

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