Virtual versus in-person ROSE program (La Luz) as universal prevention for perinatal depression: Protocol for a randomized controlled trial in a safety net hospital

Abstract

Perinatal depression disproportionally affects underserved communities, who need effective and accessible prevention programs. Reach Out, Stay strong, Essentials for new mothers (ROSE) has demonstrated effectiveness in preventing postpartum depression in underserved populations when delivered in person. This ongoing randomized controlled trial (RCT) tests the novel virtual implementation of ROSE as universal prevention in a Federally Qualified Health Center setting. We adopted the name, La Luz, for ROSE to be culturally relevant to our population. Pregnant individuals <30 gestational weeks (target N = 900) are randomized to either the virtual or in-person La Luz program, which consists of four 90-min group sessions. Groups are offered in English and Spanish, based on participants' preference. Participants complete surveys at seven timepoints: before program, 28 gestational weeks, 35 gestational weeks, and 6-weeks, 3-months, 6-months, and 12-months postpartum. Primary outcomes are postpartum depression severity measured by the 20-item Symptom Checklist (SCL-20) and 10-item Center of Epidemiologic Studies Depression Scale (CESD-10). We will perform intent-to-treat analysis to test whether virtual La Luz is non-inferior to in-person La Luz. This study also evaluates implementation process and outcomes of both modalities of La Luz to inform the development of an implementation toolkit. This RCT contributes to our knowledge of perinatal depression prevention and addresses access barriers for underserved populations. If effectiveness of virtual La Luz is demonstrated, the new evidence for a scalable low-cost prevention can be used to reduce perinatal depression and offer accessible treatment options for people who face significant barriers to care. Clinicaltrials.gov registration identifier: NCT05766475.