ROSE Program for Preventing Postpartum Depression

(PPD-ACE Trial)

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Northwestern University

Disqualifiers: Major depressive episode, Substance use disorder, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate the impact of ROSE in individuals with adverse childhood experiences. The main question it aims to answer is, compared to enhanced treatment as usual, does the delivery of ROSE within a collaborative care model improve depressive symptom trajectories and prevent the development of perinatal depression. Participants will be randomized to either enhanced treatment as usual or the ROSE intervention, delivered by a care manager within a perinatal collaborative care program. They will complete self-reported surveys of their depression symptoms every 4 weeks to inform their symptom trajectories. They will also complete clinical interviews to establish any incident diagnoses of a major depressive episode.

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 data supports the effectiveness of the ROSE Program treatment for preventing postpartum depression?

The ROSE Program aims to prevent postpartum depression by using a collaborative care model, which has been shown to provide more timely and effective care for women with postpartum depression. Additionally, early screening and follow-up, as seen in similar programs, have been effective in identifying symptoms and ensuring treatment acceptance. ^{1 2 3 4 5}

Is the ROSE Program safe for preventing postpartum depression?

The available research does not specifically address safety concerns for the ROSE Program, but it is a group educational intervention, which generally suggests a low risk of harm. ^{1 2 3 5 6}

How is the ROSE Program treatment different from other treatments for postpartum depression?

The ROSE Program is unique because it is a group educational intervention delivered during pregnancy, specifically designed to prevent postpartum depression in low-income women by integrating into prenatal care settings, unlike other treatments that often require separate psychiatric evaluations or referrals. ^{1 3 4 6 7}

Research Team

Eligibility Criteria

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

I am 18 years old or older.

I speak English or Spanish.

Exclusion Criteria

Participation in a study with a competing intervention or outcome

Active substance use disorder

I am currently experiencing a major depressive episode.

Trial Timeline

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

Treatment Details

Interventions

• ROSE Program (Behavioral Intervention)

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.

Participant Groups

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+

Dr. Jeffrey Sherman

Northwestern University

Chief Medical Officer

MD from Northwestern University

Dr. Alicia Löffler

Northwestern University

Chief Executive Officer since 2010

PhD from the University of Massachusetts at Amherst, post-doctoral training at Caltech

Women and Infants Hospital of Rhode Island

Collaborator

Trials

119

Recruited

59,200+

Shannon Sullivan

Women and Infants Hospital of Rhode Island

Chief Executive Officer since 2020

Executive Master’s degree in Healthcare Leadership from Brown University, Master’s degree in Social Work from Boston College

Dr. Lisa Rameaka

Women and Infants Hospital of Rhode Island

Chief Medical Officer

MD from Robert Larner, M.D. College of Medicine at the University of Vermont, MBA from the University of Massachusetts

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Study protocol for the ROSE Scale-Up Study: Informing a decision about ROSE as universal postpartum depression prevention. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Multilingual Postpartum Depression Screening in Pediatric Community Health Clinics. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Postpartum Depression: Screening, Diagnosis, and Management Programs 2000 through 2010. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Uncovering the Golden Veil: Applying the Evidence for Telephone Screening to Detect Early Postpartum Depression. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Outcomes for collaborative care versus routine care in the management of postpartum depression. [2013]

6. England 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. [2023]

7. England pubmed.ncbi.nlm.nih.gov

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