ROSE Program for Postpartum Depression

Overseen By Juliana Zeller

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Not female, Under 18, others

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

Compensation: Varies

Number of Visits: 6

117 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the ROSE Program, a collaborative care model, to determine its effectiveness in preventing and reducing postpartum depression in pregnant women by decreasing stress and increasing social support. Participants will attend six weekly group sessions, either online or at a clinic, plus one individual session after delivery. The trial seeks pregnant women in their second trimester, receiving prenatal care at the Sunset Park Family Health Center, who have experienced some level of stress or trauma, as identified by specific questionnaires. As an unphased trial, this study offers an opportunity to contribute to important research that could enhance postpartum care for future mothers.

Will I have to stop taking my current medications?

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

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

Research has shown that the ROSE Program, designed to prevent postpartum depression, is generally well-received. It includes sessions aimed at reducing stress and increasing support for new mothers. While specific safety details are not provided, the program focuses on mental health support rather than medication. This focus reduces the likelihood of side effects, as no drugs are involved. The program's supportive and educational approach makes it likely safe for most participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for postpartum depression involve medication or traditional therapy, but the ROSE Program is unique because it offers a structured, supportive group intervention that can be accessed virtually. This program consists of six weekly group sessions and one individual session post-delivery, providing flexibility for new mothers who may have difficulty attending in-person therapy. Researchers are excited about the ROSE Program because it not only addresses mental health but also incorporates elements of stress management and social support, which are crucial during the postpartum period. This holistic approach has the potential to provide more comprehensive and accessible support for new mothers compared to standard treatments.

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

Research has shown that the ROSE Program, which participants in this trial may receive, effectively reduces postpartum depression. Studies have found that it can halve the rates of postpartum depression in new mothers. This is crucial because postpartum depression affects many women after childbirth, impacting their well-being and ability to care for their babies. The program includes group sessions focusing on mental health support, which helps lower stress and increase social connections for pregnant women. By offering this support, the ROSE Program helps mothers build stronger support networks and improve their mental health, making it a promising option for those at risk of postpartum depression. ^{1 3 6 7 8}

Who Is on the Research Team?

Bonnie Kerker, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for pregnant women at least 18 years old in their second trimester receiving care at the Sunset Park Family Health Center. Participants must understand English or Spanish, be able to consent, and have mild depressive symptoms as indicated by a score of 4-12 on the Edinburgh Postnatal Depression Scale or record two or more ACEs.

Inclusion Criteria

I can understand and agree to the study's details.

Is pregnant

Receive prenatal care at the Sunset Park Family Health Center for Women's Health and Pediatrics (SPWHP)

Exclusion Criteria

Positive score to #10 on the Edinburgh Postnatal Depression Scale

Is not in the second trimester of her pregnancy

I am not female.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Feasibility Phase (Pilot, Phase 1)

Tests the acceptability and feasibility of a postpartum depression prevention intervention among pregnant women

7 weeks

6 weekly group sessions (virtual or in-person), 1 individual session post-delivery

Outcomes Evaluation Phase (Phase 2)

Evaluates the effectiveness of the intervention to decrease maternal stress and depressive symptoms, and increase perceived social support and self-efficacy

4-5 weeks post-birth

Post-birth visit

Follow-up

Participants are monitored for changes in postpartum depression, stress, social support, and self-efficacy

4-5 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ROSE Program

Trial Overview The ROSE Program is being tested for its effectiveness in preventing and reducing postpartum depression symptoms, decreasing stress levels, and increasing social support among pregnant women during their prenatal period.

How Is the Trial Designed?

Group I: Rose Program Group Experimental Treatment 1 Intervention

ROSE is a 7-session intervention. Participants will attend 6 weekly group sessions virtually, through a program on the computer called WebEx or at the clinic, and then one individual session after delivery. Participants will complete a few questionnaires at three different timepoints, including demographics, stress, social support, physical and mental health, and trauma.

Group II: Comparison Group Active Control 1 Intervention

Participants will complete three sets of questionnaires including demographics, stress, social support, physical and mental health, and trauma.

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

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]

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]

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]

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 redesigned follow-up care program significantly reduced postpartum depression scores at six weeks, three months, six months, and twelve months postpartum, indicating its effectiveness in early identification and treatment.

Training public health nurses to recognize and support mothers with postpartum depression can lead to better mental health outcomes and lower parenting stress, suggesting a cost-effective approach to improving maternal care in the community.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Redesigned community postpartum care to prevent and treat postpartum depression in women--a one-year follow-up study. Glavin, K., Smith, L., Sørum, R., et al.[2011]

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 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]

Citations

1. samhsa.gov samhsa.gov/

Home | SAMHSA - Substance Abuse and Mental Health ... SAMHSA leads efforts to advance behavioral health across the U.S., offering resources for mental health, substance use, and community well-being.

2. implementationscience.biomedcentral.com implementationscience.biomedcentral.com/articles/10.1186/s13012-025-01420-z

Outcomes of the ROSE Sustainment (ROSES) Study, a ... This Sequential Multiple Assignment Randomized Trial (SMART) was conducted to determine minimum implementation support needed for agencies serving pregnant ...

3. publichealth.msu.edu publichealth.msu.edu/news-items/research/646-rose-program-cuts-rates-of-postpartum-depression-in-half-while-saving-money

ROSE Program Cuts Rates of Postpartum Depression in Half ... Imagine you're a new mom, sleep-deprived and home alone with your baby. It's been over a month since you gave birth and you thought you would ...

4. womenandinfants.org womenandinfants.org/rose-program-postpartum-depression

Rose Program | Postpartum Depression Care Maternal mental health is a critical component of perinatal care and maternal safety. The ROSE Program (Reach Out, Stay Strong, Essentials for mothers of ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10528027/

Informing a decision about ROSE as universal postpartum ... To assess ROSE as universal prevention, we need to determine the effectiveness of ROSE among all pregnant people, including those screening negative for PPD ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11812186/

Outcomes of the ROSE Sustainment (ROSES) Study, a ... This Sequential Multiple Assignment Randomized Trial (SMART) was conducted to determine minimum implementation support needed for agencies serving pregnant ...

7. aha.org aha.org/role-hospitals-women-infants-hospital-rhode-island-rose-program-prevent-postpartum-depression

ROSE program aims to prevent postpartum depression Postpartum depression occurs in around one to seven women. Commonly occurring within six weeks after childbirth, PPD can affect the mother and her ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT05700760

The ROSE Scale-up Study: Informing a Decision About ... 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 ...