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NCT05700760 · ClinicalTrials.gov registry record · NA

The ROSE Scale-up Study: Informing a Decision About ROSE as Universal PPD Prevention

A NA study of Postpartum Depression, sponsored by Michigan State University.

Recruiting
Registry status
NA
Development phase
2,320
Enrollment target
1
Study location

NCT05700760: Recruiting NA study of Postpartum Depression, sponsored by Michigan State University.

NCT05700760 is a NA study of Postpartum Depression that is actively recruiting participants, run by Michigan State University. The registered enrollment target is 2,320 participants, above the 426-participant average among 47 other Postpartum Depression trials with a reported enrollment target (445% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05700760, a NA study of Postpartum Depression, is actively recruiting participants, sponsored by Michigan State University.

RECRUITING
Registry status
NA
Development phase
2,320 participants
Enrollment target
1
Study location

Study Summary

The Reach Out, Stand Strong, Essentials for New Mothers (ROSE) program is an evidence-based intervention that prevents half of cases of postpartum depression and was one of two interventions recommended by the US Preventive Services Task Force in 2019. All effectiveness trials of ROSE and of the other recommended PPD prevention intervention included only low-income women a single risk factor that doubles incidence of PPD. Thus, the existing evidence base for PPD prevention consists primarily of women at increased risk for PPD. Based on data from the PIs' current implementation study of ROSE, many healthcare and community agencies in this implementation trial (78%) find it is more feasible for them to provide or offer ROSE to every woman as part of their standard workflow, than it is to create a screening and referral process for at risk women. In addition to being more feasible for agencies, universal prevention may also be advantageous because the cost of a screening false negative (resulting in a preventable case of PPD; $32,000) far exceeds the cost of ROSE delivery ($50-$300/woman). Effectiveness of ROSE among low-income women at risk for PPD is known (ROSE prevents \~50% of PPD cases). To inform a recommendation about using ROSE as universal vs. selective or indicated prevention, we need to determine the effectiveness of ROSE among general populations of women, including women screening negative for PPD risk. Thus, this project will assess ROSE effectiveness across PPD risk levels and across prevention approaches in a sample of 2,320 women from a large regional health system (based in Detroit, MI). Each proposed aim gathers a piece of information missing that is needed to guide decision-making about ROSE as universal prevention. We will assess ROSE as universal, selective, and indicated prevention in terms of: (1) ROSE effectiveness relative to a control for each prevention approach in preventing PPD and improving functioning; (2) cost outcome, (3) equity and (

Primary Outcome

The SCID is the gold standard diagnostic assessment of major depressive episode.

Conditions Studied

Postpartum Depression

Interventions

  • BEHAVIORAL ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns)
  • BEHAVIORAL Enhanced Care as Usual (CAU)

Study Locations (1)

Michigan

  • Michigan State University - Flint

Trial Details

FieldValue
Enrollment Target 2,320 participants
Start Date 2023-06-01
Est. Completion 2027-12-31
Phase NA
Michigan State University

120 total trials

What NCT05700760 shows while recruiting

NCT05700760 is an interventional study that assigns participants to a tested intervention. Its 2,320 participants enrollment target places it among the larger protocols in the corpus, above the 426-participant average among 47 other Postpartum Depression trials with a reported enrollment target (445% higher).

The record links to 1 condition, with Postpartum Depression appearing as the primary indexed condition, and to 2 interventions - of which ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns) is the first listed.

NCT05700760 reports a single indexed study location in Michigan.

Frequently Asked Questions

What is clinical trial NCT05700760 about?

NCT05700760 is a clinical study titled "The ROSE Scale-up Study: Informing a Decision About ROSE as Universal PPD Prevention". The Reach Out, Stand Strong, Essentials for New Mothers (ROSE) program is an evidence-based intervention that prevents half of cases of postpartum depression and was one of two interventions recommended by the US Preventive Services Task Force in 2019. All effectiveness trials of ROSE and of the oth...

What is the current status of trial NCT05700760?

This trial is currently recruiting. It is a NA study. The enrollment target is 2,320 participants. The study started on 2023-06-01. Estimated completion is 2027-12-31.

What conditions does trial NCT05700760 study?

This clinical trial studies the following conditions: Postpartum Depression.

What interventions are being tested in trial NCT05700760?

The interventions under investigation include: ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns) (BEHAVIORAL), Enhanced Care as Usual (CAU) (BEHAVIORAL).

Who is sponsoring clinical trial NCT05700760?

This trial is sponsored by Michigan State University, which has 120 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05700760 being conducted?

This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Postpartum Depression

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05700760's enrollment target sits among peer trials

2,320 2nd of 47 the highest of 47 other Postpartum Depression trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Postpartum Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05700760

Source: ClinicalTrials.gov NCT05700760, the US trial registry maintained by the National Library of Medicine. NCT05700760 (large enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.