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

Journal: Contemporary clinical trials

Volume: 149

Issue: 

Year of Publication: 

Affiliated Institutions:  Department of Psychiatry, University of Rochester Medical Center; Crittenden Blvd, Rochester, NY , United States of America; Department of Obstetrics and Gynecology, University of Rochester Medical Center, Elmwood Avenue, Rochester, NY , United States of America. Electronic address: Ellen_Poleshuck@urmc.rochester.edu. Fox Learning Systems, PO Box , Breckenridge, CO , United States of America. Electronic address: Debra@foxlearningsystems.com. Department of Emergency Medicine, University of Rochester Medical Center, Elmwood Avenue, Rochester, NY , United States of America. Electronic address: Beau_Abar@urmc.rochester.edu. Department of Psychiatry, University of Rochester Medical Center; Crittenden Blvd, Rochester, NY , United States of America. Electronic address: Daniel_Maeng@urmc.rochester.edu. Department of Psychiatry, University of Rochester Medical Center; Crittenden Blvd, Rochester, NY , United States of America. Electronic address: Tamara_Bilinski@urmc.rochester.edu. Department of Psychiatry, University of Rochester Medical Center; Crittenden Blvd, Rochester, NY , United States of America. Electronic address: Lauren_Beers@urmc.rochester.edu. Fox Learning Systems, PO Box , Breckenridge, CO , United States of America. Butler Hospital and the Department of Psychiatry & Human Behavior, Brown University, Blackstone Boulevard, Suite , Providence, RI , United States of America; Department of Psychiatry and Mental Health, University of Cape Town, South Africa. Electronic address: Caron_Zlotnick@brown.edu.

Abstract summary 

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.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.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.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.govRegistration Identifier:NCT05518162.

Authors & Co-authors:  Poleshuck Ellen E Fox Debra D Abar Beau B Maeng Daniel D Bilinski Tamara T Beers Lauren L Rosen Jules J Zlotnick Caron C

Study Outcome 

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Statistics
Citations : 
Authors :  8
Identifiers
Doi : 10.1016/j.cct.2024.107800
SSN : 1559-2030
Study Population
Female,Mothers
Mesh Terms
Other Terms
InBloom app;Mobile app;Perinatal depression;Postpartum depression;ROSE postpartum depression prevention intervention
Study Design
Cohort Study,Randomized Control Trial,Quasi Experimental Study
Study Approach
Country of Study
Publication Country
United States