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Randomized clinical trial protocol of an app-based intervention to prevent postpartum depression
Ellen Poleshuck1, Debra Fox2, Beau Abar3
1Department of Psychiatry, University of Rochester Medical Center; 300 Crittenden Blvd, Rochester, NY 14642, United States of America; Department of Obstetrics and Gynecology, University of Rochester Medical Center, 601 Elmwood Avenue, Rochester, NY 14642, United States of America.
This study compares a new app, InBloom, for postpartum depression (PPD) prevention against an in-person program, ROSE. The goal is to determine if the app is an effective and accessible alternative for PPD prevention.
Area of Science:
- Reproductive Health
- Mental Health Technology
- Clinical Psychology
Background:
- Postpartum depression (PPD) affects 1 in 7 US parents, impacting maternal mental health, infant development, and family dynamics.
- The evidence-based ROSE intervention, involving in-person sessions, faces dissemination challenges due to practical barriers.
- Digital health interventions may offer a scalable solution to overcome these barriers in PPD prevention.
Purpose of the Study:
- To develop and evaluate the effectiveness of the InBloom app for PPD prevention.
- To compare the asynchronous InBloom app with the synchronous, in-person ROSE intervention.
- To assess the return on investment (ROI) for both interventions.
Main Methods:
- A prospective randomized controlled trial will recruit 152 pregnant individuals at risk for PPD.
- Participants will be randomized to either the InBloom app or the ROSE intervention.
- Quasi-experimental cohort analyses using historical and EHR data will be employed for ROI assessment.
Main Results:
- Primary outcomes include depression levels and ROI.
- Secondary outcomes will examine perceived access, engagement, and satisfaction with interventions.
- Clinical trial registration: NCT05518162.
Conclusions:
- The study aims to determine if InBloom is a viable, low-cost alternative to the ROSE intervention for PPD prevention.
- Findings will inform further implementation studies of digital tools for PPD risk reduction.
- Successful validation of InBloom could enhance accessibility to PPD prevention strategies.
