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

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.

Conditions

• Postpartum Depression

Interventions

BEHAVIORAL

ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns)

Evidence-based 5 session psychosocial intervention that has been found to prevent \~50% of postpartum depression among low-income, at risk women.

BEHAVIORAL

Enhanced Care as Usual (CAU)

Usual care at the study site does not include postpartum depression prevention. Instead, HFHS clinics try to screen for PPD that has already occurred and refer women for mental health care. Screening for existing PPD at these clinics primarily relies on the EPDS (10+), Perinatal women who score 10+ on the EPDS are referred for mental health services. Services received depends on follow-up, severity, and the mental health wait list. Our study will exclude women meeting criteria for likely current major depressive episode at baseline and assist them in obtaining mental health care. Enhanced CAU consists of usual care + monitoring and emergency referral, as is required to fulfill ethical obligations to trial participants.

Sponsors & Collaborators

• Pacific Institute for Research and Evaluation

  collaborator OTHER

• Henry Ford Health System

  collaborator OTHER

• Butler Hospital

  collaborator OTHER

• Michigan State University

  lead OTHER

Principal Investigators

• Jennifer E Johnson, PhD · Michigan State University

• Caron Zlotnick, PhD · Butler Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-06-01

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• United States

Study Locations