Management of depression during pregnancy in primary care in Brazil: a cluster ransomised trial

Abstract Background Depression during pregnancy is common but it is often unrecognised and left untreated despite the adverse consequences for mother and baby. We assess the acceptability and feasibility of the Program for the Management of Depression during Pregnancy (PROGRAVIDA), which aims to overcome these barriers in primary care in Brazil. Methods We did this cluster randomised trial at 12 Family Health Centres in in Sao Paulo, Brazil. We enrolled adult pregnant women with a Patient Health Questionnaire-9 (PHQ-9) score of more than 4. Centres were randomly assigned (1:1) to either PROGRAVIDA or usual prenatal care. PROGRAVIDA consists of eight sessions of home-based psychosocial intervention (psychoeducation and problem solving) and improved case-management led by nurse assistants. Patients were not masked to allocation, but researcher assistants were at baseline and follow-up assessments. The primary outcome was at least 50% decrease in depressive symptoms at 4 months in the intention-to-treat population. Here, we assess the acceptability and feasibility of PROGRAVIDA. The study is registered with ClinicalTrials.gov, NCT01719289. Findings We screened 3796 women, of whom 943 (25%) had a PHQ-9 score of more than 4. Mean PHQ-9 score at baseline was 13·6 (SD 5·1) for the intervention group and 13·4 (5·2) for the control group. Only 23 (1%) of 3796 women were receiving treatment for depression at baseline. 680 (72%) women participated in the trial (333 in the intervention group, 347 in the control group). 264 did not participate: 100 refused and 164 met exclusion criteria. Primary outcome data were collected for 602 (88%) of participants. Interpretation PROGRAVIDA is feasible and well accepted by patients. The programme overcame the main barriers to care for pregnant women with depression. The cost-effectiveness of PROGRAVIDA needs to be proven before the programme can be widely introduced in Brazil. Funding CNPq-Brazil.