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

Trial Summary

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

The research suggests that effective postpartum depression programs often include integrated care within primary care settings, specific follow-up, and management procedures, which are characteristics of the ROSE Program. Programs with these features have shown success in improving outcomes for postpartum depression. ^{1 2 3 4 5}

Is the ROSE Program for Postpartum Depression safe for humans?

The available research does not specifically address safety concerns for the ROSE Program, but it is a group educational intervention aimed at preventing postpartum depression, which suggests it is generally safe as it involves education rather than medication or invasive procedures. ^{1 3 6 7 8}

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

The ROSE Program is unique because it is a group educational intervention designed to prevent postpartum depression by being delivered during pregnancy, specifically targeting low-income women in prenatal clinics. Unlike other treatments that may focus on screening and treating postpartum depression after it occurs, ROSE aims to prevent it from developing in the first place. ^{1 3 4 6 8}

What is the purpose of this trial?

This trial aims to evaluate the ROSE program, which supports new mothers by reducing stress and depression through education and social support. The study focuses on pregnant women in Sunset Park, Brooklyn. The program helps by offering useful information and emotional support to make motherhood easier. The ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns) program is a series of classes taught during pregnancy to prevent depression.

Research Team

Bonnie Kerker, PhD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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]

References

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

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

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

Implementation of Routine Postpartum Depression Screening and Care Initiation Across a Multispecialty Health Care Organization: An 18-Month Retrospective Analysis. [2018]

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

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

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

Redesigned community postpartum care to prevent and treat postpartum depression in women--a one-year follow-up study. [2011]

6. 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]

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

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

8. 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]