ROSE Program for Postpartum Depression (ROSES-II Trial)
Palo Alto (17 mi)Overseen byJennifer E Johnson, PhD
Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Michigan State University
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 1 jurisdiction
Trial Summary
What is the purpose of this trial?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.
Is the ROSE Program a promising treatment for postpartum depression?Yes, the ROSE Program is a promising treatment for postpartum depression. It helps prevent postpartum depression in new mothers, especially those with low income, by providing group education during pregnancy. Studies show it reduces cases of postpartum depression in community settings.13456
What safety data exists for the ROSE Program for postpartum depression?The available research does not specifically address safety data for the ROSE Program. However, the studies focus on the effectiveness, cost-outcome, and scalability of the program in preventing postpartum depression, particularly in low-income and minority populations. The ROSE Program is a group educational intervention delivered during pregnancy and has been found to reduce cases of postpartum depression in community prenatal settings. No specific safety concerns are mentioned in the provided abstracts.12346
What data supports the idea that ROSE Program for Postpartum Depression is an effective treatment?The available research shows that the ROSE Program is effective in reducing cases of postpartum depression, especially in community prenatal settings serving low-income pregnant women. This suggests that the program is beneficial in preventing postpartum depression in these communities.13456
Do I need to stop my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial excludes those with a current major depressive episode or certain mental health disorders, it's possible that some medications related to these conditions might be relevant. Please consult with the trial coordinators for specific guidance.
Eligibility Criteria
This trial is for English-speaking women over 18, who are 12-32 weeks pregnant and receiving prenatal services at Henry Ford Health. They must have access to a phone and provide contact info for two people who can locate them. It excludes those currently experiencing major depression or with a history of bipolar or psychotic disorders.Treatment Details
The study tests the ROSE program's effectiveness in preventing postpartum depression among all new mothers, not just those at high risk. It compares ROSE to enhanced usual care across different levels of PPD risk, focusing on its prevention success rate, cost-effectiveness, equity, scalability, and underlying mechanisms.
2Treatment groups
Experimental Treatment
Active Control
Group I: ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns)Experimental Treatment1 Intervention
Evidence-based 5 session psychosocial intervention that has been found to prevent \~50% of postpartum depression among low-income, at risk women.
Group II: Enhanced Care as Usual (CAU)Active Control1 Intervention
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.
ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns) is already approved in United States for the following indications:
🇺🇸 Approved in United States as ROSE Program for:
- Prevention of postpartum depression
Find a clinic near you
Research locations nearbySelect from list below to view details:
Michigan State UniversityFlint, MI
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Who is running the clinical trial?
Michigan State UniversityLead Sponsor
Pacific Institute for Research and EvaluationCollaborator
Henry Ford Health SystemCollaborator
Butler HospitalCollaborator
References
Uncovering the Golden Veil: Applying the Evidence for Telephone Screening to Detect Early Postpartum Depression. [2020]Postpartum depression (PPD) is often detected later than symptom onset, or even undetected, because of lack of prompt or adequate screening. An evidence-based PPD screening protocol using a telephone-based format within a primary care practice was developed to identify symptoms and initiate treatment between 2 and 3 weeks postpartum. The Edinburgh Postnatal Depression Scale was used, with positive screens referred for provider and support services, and then tracked for follow-through. Fifty-two percent of women screened positive. Sixty-four percent accepted both provider and support referrals, with 89% follow-through with provider referrals and 78% follow-through with support referrals. Outcomes support early screening for PPD using a telephone-based format to effectively identify symptoms and acceptance of referrals by participants.
Effectiveness of Discharge Education on Postpartum Depression. [2018]To determine effectiveness of an educational intervention in reducing or preventing symptoms of postpartum depression (PPD).
Protocol for the ROSE sustainment (ROSES) study, a sequential multiple assignment randomized trial to determine the minimum necessary intervention to maintain a postpartum depression prevention program in prenatal clinics serving low-income women. [2023]More research on sustainment of interventions is needed, especially return on investment (ROI) studies to determine cost-benefit trade-offs for effort required to sustain and how much is gained when effective programs are sustained. The ROSE sustainment (ROSES) study uses a sequential multiple assignment randomized (SMART) design to evaluate the effectiveness and cost-effectiveness of a stepwise approach to sustainment of the ROSE postpartum depression prevention program in 90 outpatient clinics providing prenatal care to pregnant women on public assistance. Postpartum depression (PPD) is common and can have lasting consequences. Outpatient clinics offering prenatal care are an opportune place to provide PPD prevention because most women visit while pregnant. The ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns) program is a group educational intervention to prevent PPD, delivered during pregnancy. ROSE has been found to reduce cases of PPD in community prenatal settings serving low-income pregnant women.
Development and pilot testing of an adaptable protocol to address postpartum depression in pediatric practices serving lower-income and racial/ethnic minority families: contextual considerations. [2022]Postpartum depression (PPD) affects approximately 25% of women in lower-income and racial/ethnic minority populations in the USA. Evidence-based interventions for PPD screening and treatment exist, but many women with PPD are not identified or are inadequately treated. To address this gap, the American Academy of Pediatrics recommends screening for PPD at routine preventive visits in the first 6 months of postpartum, but less than half of pediatricians do so. Small PPD screening studies have been conducted in pediatric practices serving average-risk women, but less is known about practices serving families with lower-income and/or racial/ethnic minority status (safety-net practices). Study objectives were (1) to develop and pilot test an adaptable PPD screening protocol in safety-net practices and (2) to test strategies for implementing the protocol.
Multilingual Postpartum Depression Screening in Pediatric Community Health Clinics. [2022]This evidence-based practice project established postpartum depression (PPD) screening and followed maternal use of mental health services in a multilingual low socioeconomic status urban population.
Study protocol for the ROSE Scale-Up Study: Informing a decision about ROSE as universal postpartum depression prevention. [2023]To examine the effectiveness, cost-outcome, equity, scalability, and mechanisms of the Reach Out, Stay strong, Essentials for mothers of newborns (ROSE) postpartum depression prevention (PPD) program as universal versus selective or indicated prevention.