Effect of a collaborative multidimensional approach versus usual care on the resolution of adult depression in primary care in Chile: study protocol for a single blinded cluster randomized controlled trial

Abstract

Background: Major depression (MD) is a prevalent and disabling condition in Chile. Most MD cases are treated at the primary care level. In Chilean primary care, the authors have gathered evidence of a prevalent complex depression subtype associated with a worse prognosis and characterized by interpersonal difficulties, suicidality and trauma history. This MD presentation suggests the need for a multidimensional, trauma-informed and interprofessional approach. The present study protocol describes the context, hypotheses and methods for a cluster randomized control trial (RCT) comparing a collaborative multidimensional approach and usual care in treatment outcomes of MD in primary care in Chile. Methods: This is a two-arm, single-blinded, cluster RCT to compare the efficacy of a collaborative multidimensional approach for depression (CMAD) versus usual care to treat MD in primary care clinics in Chile. In total, 394 depressed adults from 18 to 65 years of age in twelve clinics located in Chile’s Maule Region will be consented to participate in the study. Patients and care teams from each clinic will be randomized to the intervention or to the control arm. Interprofessional teams in the intervention arm will attend 27 hours of didactic and active learning sessions focused on clinical competences to effectively engage, treat and follow up patients with complex presentation of MD. Team in the control arm will receive 27 didactic sessions on current clinical guidelines for MD, professionals in both arms will receive 27 hours of continued education. Discussion: To improve treatment outcomes of MD in Chile, primary care teams should develop clinical competencies relevant to complex, difficult-to-treat types of MD within collaborative and trauma-informed approaches.