Mindfulness-based mHealth intervention for pregnant black and Latina women at high risk of postpartum depression—the Healthy Mama and Baby study: protocol and data overview for a randomised controlled trial in an integrated healthcare delivery system

Postpartum depression (PPD) is a debilitating condition affecting over 20% of postpartum women, with disproportionately higher rates among black and Latina women compared with their white counterparts. Current recommendations for PPD prevention demand significant healthcare system resources, highlighting the need for alternative, evidence-based interventions that minimise strain on these systems. Mindfulness has been shown to effectively reduce depressive symptoms and prevent relapse across various populations. However, no studies to date have evaluated the efficacy of a digitally delivered mindfulness intervention specifically for black and Latina women at increased risk of PPD.This article presents the protocol for the Healthy Mama and Baby study, a randomised controlled trial (RCT). This trial evaluates whether a mobile-based (mHealth) mindfulness intervention tailored for pregnant women reduces depressive symptoms among pregnant black and Latina women at high risk for PPD. We are conducting a fully remote RCT, recruiting 600 pregnant black and/or Latina women at risk of PPD from Kaiser Permanente Northern California (KPNC), an integrated healthcare delivery system. Participants are enrolled before 30 weeks' gestation. They are randomised into either an mHealth mindfulness intervention arm, which receives access to a mindfulness app tailored specifically for pregnant and postpartum women, or a time-matched and attention-matched active control arm, which receives access to an online program of calming nature sounds. Both arms are instructed to engage in their assigned program for 5-20 min per day for 6 weeks. Outcome assessments are conducted online at baseline, post intervention and post partum (~7 weeks post partum) using validated questionnaires. Outcomes include depressive symptoms (primary) and anxiety, sleep and perceived stress (secondary). All study procedures have been approved by the KPNC Institutional Review Board. The findings will be disseminated widely through peer-reviewed publications and conference presentations. NCT05186272.