ROSE Program for Preventing Postpartum Depression

(PPD-ACE Trial)

Overseen By Sheehan Fisher, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Major depressive episode, Substance use disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Up to 6 months postpartum

76 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to prevent depression in new mothers, particularly those with difficult childhoods. Participants will either receive regular care with basic information or join the ROSE program, a collaborative care model. ROSE includes group sessions before birth and a follow-up session after. If participants show signs of depression, they will receive additional support. This trial suits those who are pregnant, less than 24 weeks along, and have experienced challenging childhoods. As an unphased trial, it offers a unique opportunity for participants to contribute to innovative research that could shape future care for new mothers.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications.

What prior data suggests that the ROSE Program is safe for preventing postpartum depression?

Research has shown that the ROSE Program is safe and easy for participants to manage. The U.S. Preventive Services Task Force recommends this proven program. Studies have found that it can reduce the risk of postpartum depression by up to 50% in some groups. Many health centers across the U.S., including Veterans Health Administration sites, have used the program without reporting any major safety issues. Overall, research supports ROSE as a safe choice for those seeking to prevent postpartum depression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ROSE Program for preventing postpartum depression because it offers a unique approach compared to standard treatments like medication or traditional therapy. Unlike these options, the ROSE Program provides a proactive, group-based intervention during pregnancy, which includes four prenatal sessions and a postpartum "booster" session. This method focuses on building support and resilience among new mothers before depression even starts, potentially reducing the incidence of postpartum depression. Additionally, the integration within a collaborative care model ensures ongoing support and timely treatment for those who develop depression symptoms.

What evidence suggests that the ROSE Program is effective for preventing postpartum depression?

Research has shown that the ROSE Program, which participants in this trial may receive, helps prevent postpartum depression. Studies have found that this program reduces depressive symptoms in new mothers by providing support and education. Specifically, new mothers who joined the ROSE Program reported fewer cases of postpartum depression than those who did not. The program includes group sessions that focus on mental health and coping strategies, which are linked to better emotional well-being. The ROSE Program is also recognized for improving mental health in mothers during and after pregnancy. These findings suggest that the ROSE Program could be especially helpful in preventing depression for those who had difficult childhood experiences. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for pregnant individuals over 18, with a history of adverse childhood experiences (ACE score ≥ 2), who are less than 24 weeks into a non-anomalous, single pregnancy. They must plan to deliver at Prentice Women's Hospital and not be currently experiencing major depression or substance use disorders.

Inclusion Criteria

Non-anomalous pregnancy

Less than 24 weeks gestation

Singleton gestation

Exclusion Criteria

Participation in a study with a competing intervention or outcome

Active substance use disorder

I am currently experiencing a major depressive episode.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either enhanced treatment as usual or the ROSE intervention, with monthly self-reported screens for depression

Up to 6 months postpartum

Monthly visits (virtual or in-person)

Follow-up

Participants are monitored for depressive symptoms and other psychological outcomes postpartum

6 months postpartum

3 visits (in-person) at 3rd trimester, 3 months postpartum, and 6 months postpartum

Open-label extension (optional)

Participants may continue to receive support and monitoring beyond the initial 6 months postpartum

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• ROSE Program

Trial Overview

The study tests the ROSE program against enhanced usual care in preventing perinatal depression among those with difficult childhoods. Participants will receive either standard care or the ROSE intervention and report their depressive symptoms every four weeks.

How Is the Trial Designed?

Group I: ROSE intervention Experimental Treatment 1 Intervention

Those randomized to the intervention will be offered 4 group-based prenatal sessions and one individual postpartum "booster" session guided by the Reach Out, Stand Strong, Essentials for New Mothers (ROSE) program embedded within the collaborative care model. Participants will be followed with monthly self-reported screens for depression, and those identified to have incident depression symptoms will receive treatment within the collaborative care model.

Group II: Enhanced treatment as usual Active Control 1 Intervention

Those randomized to enhanced treatment as usual will receive brief psychoeducation about perinatal depression and the associations between ACEs and perinatal depression. Information about the collaborative care program will be provided. Individuals will be followed with monthly self-reported screens for depression, without any prevention programming for perinatal depression. Those identified to have incident depression symptoms will receive recommendations for treatment within the collaborative care model.

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Women and Infants Hospital of Rhode Island

Collaborator

Trials

119

Recruited

59,200+

Published Research Related to This Trial

A study involving 701 women at high risk for postpartum depression found that those receiving telephone-based peer support reported high satisfaction levels (80.5%) and positive relationship qualities such as trust and acceptance.

The peer support provided emotional, informational, and appraisal support, indicating that this approach can be an effective preventive strategy against postpartum depression, especially when tailored to the needs of the mothers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum depression peer support: maternal perceptions from a randomized controlled trial. Dennis, CL.[2022]

In a 6-month project involving 273 mothers, a screening protocol for postpartum depression (PPD) was successfully implemented, achieving an 83.5% screening rate during well-child visits.

Of the mothers who screened positive for PPD, 73.1% were referred to mental health services, and 63.2% attended their referral, demonstrating effective follow-up and support for those in need.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multilingual Postpartum Depression Screening in Pediatric Community Health Clinics. Cohen, M., Stephens, CTD., Zaheer, A., et al.[2022]

A telephone-based screening protocol for postpartum depression (PPD) was developed and implemented, successfully identifying symptoms in 52% of women screened between 2 and 3 weeks postpartum.

The protocol led to high acceptance rates for referrals, with 64% of women accepting both provider and support services, and follow-through rates of 89% for provider referrals and 78% for support referrals, highlighting the efficacy of early screening and intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Uncovering the Golden Veil: Applying the Evidence for Telephone Screening to Detect Early Postpartum Depression. BenDavid, DN., Hunker, DF., Spadaro, KC.[2020]

The ROSE postpartum depression prevention program will be tested on 2320 pregnant individuals to evaluate its effectiveness as a universal prevention strategy, compared to selective or indicated prevention methods.

This study aims to provide insights into the cost-effectiveness, equity, and scalability of the ROSE program, making it the largest trial of its kind to date, which could influence future guidelines on postpartum depression prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study protocol for the ROSE Scale-Up Study: Informing a decision about ROSE as universal postpartum depression prevention. Johnson, JE., Loree, AM., Sikorskii, A., et al.[2023]

Women with postpartum depression managed through a collaborative care management (CCM) approach had significantly fewer days to their first follow-up appointment (6.1 days) compared to those receiving routine primary care (31.4 days), indicating faster access to care.

The CCM model resulted in a much higher remission rate at 6 months (46.7%) compared to routine care (6.3%), demonstrating its effectiveness in improving outcomes for women diagnosed with postpartum depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes for collaborative care versus routine care in the management of postpartum depression. Truitt, FE., Pina, BJ., Person-Rennell, NH., et al.[2013]

Universal postpartum depression (PPD) screening in the U.S. is still debated, with only a few programs evaluated for their effectiveness, and only two studies showing improved maternal outcomes at 6 to 12 months postpartum.

Successful PPD screening programs are those that are integrated into primary care, providing follow-up and management within the same setting, which minimizes the need for external referrals and enhances treatment accessibility.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postpartum Depression: Screening, Diagnosis, and Management Programs 2000 through 2010. Yawn, BP., Olson, AL., Bertram, S., et al.[2023]

The ROSE sustainment (ROSES) study is evaluating the effectiveness and cost-effectiveness of a stepwise approach to sustaining a postpartum depression prevention program in 90 outpatient clinics, aiming to reduce postpartum depression rates among low-income pregnant women.

This study is the first randomized trial to assess the return on investment (ROI) of sustainment strategies in implementation science, which will provide valuable insights into maintaining effective interventions in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Johnson, JE., Wiltsey-Stirman, S., Sikorskii, A., et al.[2023]

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