NCT05700760 The ROSE Scale-up Study: Informing a Decision About ROSE as Universal PPD Prevention
| NCT ID | NCT05700760 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Michigan State University |
| Condition | Postpartum Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,320 participants |
| Start Date | 2023-06-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,320 participants in total. It began in 2023-06-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 (4) scalability of each prevention approach; and (5) mechanisms of ROSE effects across PPD risk levels. We will integrate results to advise about ROSE as universal prevention. This definitive PPD prevention trial will show how best to get an evidence-based program to those who need it in settings where they receive perinatal care by addressing a pragmatic and novel question (should ROSE be universal prevention?) and by examining equity and cost-outcome of universal vs. other prevention approaches.
Eligibility Criteria
Inclusion Criteria: 1. Is aged 18 or older 2. Is receiving prenatal services within the U.S 3. Is between 12-32 weeks pregnant 4. Speaks and understand English well enough to understand questionnaires when they are read aloud 5. Has access to a telephone through owning one, a relative/friend, or an agency 6. Is willing and able to provide the name and contact information of at least two locator persons Exclusion Criteria: 1. Has a current major depressive episode 2. Has current or past diagnosis of a bipolar disorder or a psychotic disorder
Contact & Investigator
Jennifer E Johnson, PhD
PRINCIPAL INVESTIGATOR
Michigan State University
Frequently Asked Questions
Who can join the NCT05700760 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Postpartum Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05700760 currently recruiting?
Yes, NCT05700760 is actively recruiting participants. Contact the research team at jjohns@msu.edu for enrollment information.
Where is the NCT05700760 trial being conducted?
This trial is being conducted at Flint, United States.
Who is sponsoring the NCT05700760 clinical trial?
NCT05700760 is sponsored by Michigan State University. The principal investigator is Jennifer E Johnson, PhD at Michigan State University. The trial plans to enroll 2,320 participants.
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