RESUMEN
TRIAL DESIGN: This was a multicenter cluster-randomized controlled trial. PARTICIPANTS: A total of 227 patients ≥18 years old with a new onset of depressive symptoms who screened positive on the first two items of the Patient Health Questionnaire-9 (PHQ-9) were recruited by primary care physicians (PCPs) of eight health districts of three Italian regions from September 2009 to June 2011. INTERVENTION: PCPs of the intervention group received a specific collaborative care program including 2 days of intensive training, implementation of a stepped care protocol, depression management toolkit and scheduled meetings with a dedicated consultant psychiatrist. OBJECTIVE: The objective was to determine whether a collaborative care program for depression management in primary care leads to higher remission rate than usual PCP care. OUTCOMES: Outcome was clinical remission as expressed on PHQ-9 <5 at 3 months. RANDOMIZATION: An independent researcher used computer-generated randomization to assign involved primary care groups to the two alternative arms. BLINDING: PCPs and research personnel were not blinded. RESULTS: The 223 PCPs enrolled recruited 227 patients (128 in collaborative care arm, 99 in the usual care arm). At 3 months (n=210), the proportion of patients who achieved remission was higher, though the difference was not statistically significant, in the collaborative care group. The effect size was of 0.11. When considering only patients with minor/major depression, collaborative care appeared to be more effective than usual care (P=.015). CONCLUSIONS: The present intervention for managing depression in primary care, designed to be applicable to the Italian context, appears to be effective and feasible.