Randomized clinical trial protocol of an app-based intervention to prevent postpartum depression

Abstract

Purpose

To develop and evaluate the effectiveness of an asynchronously delivered app, InBloom, for postpartum depression (PPD) prevention relative to an evidence-based synchronously delivered in-person intervention, ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns) for depression and return on investment via a prospective randomized controlled trial and quasi-experimental cohort analyses.

Background

PPD affects 1 in 7 gestational parents in the US, causing emotional distress, consequences for infant development and child adjustment, disruptions in family relationships, and financial burden. ROSE is an evidence-based intervention administered as four in-person group sessions plus one postpartum booster session. Despite ROSE's demonstrated effectiveness, pragmatic barriers impact disseminating an in-vivo group intervention broadly to people at risk for PPD. If effective, an app may help overcome implementation barriers.

Design

We will develop an app based on the ROSE intervention, recruit 152 pregnant people ≥18 years, 17–32 weeks' gestation, and with risk factors for PPD, and randomize participants either to InBloom or ROSE. Primary outcomes are depression and return on investment (ROI). Hypothesized mechanisms are perceived access, engagement, and satisfaction with the intervention. Control groups include historical control subjects from the largest ROSE trial for depression outcomes and Electronic Health Record (EHR) data on concurrent patients from the same clinics not offered InBloom or ROSE for ROI outcomes.

Conclusion

At the end of the trial, we will know if InBloom is a viable alternative to ROSE, allowing further implementation studies of an easy, low-cost distribution app to reduce risk of PPD.

ClinicalTrials.gov Registration Identifier: NCT05518162