Effectiveness of Brief Psychological Intervention for Depression in Pregnancy (BIND-P): A multi-centric randomized controlled trial (RCT).

Background: Depression is the most prevalent psychiatric disorder among women during pregnancy but often goes undetected and untreated. Aim: This study aimed to assess whether a brief psychological intervention for depression in pregnancy (BIND-P) delivered by nurses is efficacious in the treatment of depression as compared to Treatment as Usual (TAU). Methods: A multi-centric, hospital-based open-label parallel group, randomized controlled trial was conducted at four sites across India (one each in Northern and Central India, and two in Southern India) from 2018 to 2022. A total of 1,352 participants were randomly allocated (1:1) to BIND-P and TAU groups. The primary outcome assessment was a reduction in PHQ-9 scores (from baseline to 8 weeks post recruitment). The secondary outcome was the outcome of pregnancy and infant development at 6/10/14 weeks post pregnancy. Results: Both groups demonstrated a reduction in PHQ-9 scores from baseline to follow-up. However, the between-group difference was not statistically significant (adjusted mean difference [BIND-P vs TAU]: 0.03; Conclusion: The BIND-P intervention was not inferior to TAU in reducing depressive symptoms but demonstrated lower discontinuation rates. As a low-intensity psychosocial intervention (LIPI), BIND-P may be a feasible and acceptable option for integration into routine maternal healthcare services, with potential to help reduce the treatment gap in perinatal mental health.