ROSE Program for Postpartum Depression

(ROSES-II Trial)

Overseen By Caron Zlotnick, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Michigan State University

Disqualifiers: Major depressive episode, Bipolar, Psychotic, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

2320 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of the ROSE program, a series of five sessions aimed at preventing postpartum depression, particularly among new mothers. The goal is to determine if offering ROSE to all pregnant women, regardless of risk level, is more beneficial than the usual care, which treats depression after it begins. Women between 12 and 32 weeks pregnant, receiving prenatal services in the U.S., and without major depression, may be suitable for this trial. Participation will help researchers determine if universal access to ROSE can better prevent postpartum depression and improve mental health support for all new mothers. As an unphased trial, this study provides a unique opportunity for participants to contribute to groundbreaking research that could enhance mental health support for new 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. It's best to discuss this with the trial coordinators or your healthcare provider.

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

Research shows that participants receive the ROSE program well. This psychosocial intervention focuses on talking and learning skills instead of medication, usually posing fewer risks than drug treatments.

Studies have found that the ROSE program can reduce the risk of postpartum depression by about half in women more likely to develop it, demonstrating its effectiveness and safety. Participants have reported no serious side effects or negative reactions.

The US Preventive Services Task Force also recommends the ROSE program, further supporting its safety and effectiveness. As researchers explore its use for more women, they ensure it remains a safe and effective choice for everyone, regardless of their initial risk of postpartum depression. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The ROSE Program is unique because it offers a preventive approach to postpartum depression, unlike standard care options, which typically focus on treating depression after it has already developed. This program consists of a five-session psychosocial intervention designed to empower at-risk, low-income mothers right after childbirth. Researchers are excited about ROSE because it has the potential to cut postpartum depression rates by half among participants, providing proactive support rather than reactive treatment.

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, effectively prevents postpartum depression. Past studies found it prevents about 50% of cases in low-income women at risk. The program includes five sessions that offer emotional support and help new mothers develop skills to reduce their depression risk. In 2019, the U.S. Preventive Services Task Force recommended it as one of the best ways to address this issue. Although most evidence comes from studies on at-risk women, the program's success suggests it could also benefit a broader range of new mothers. ^{1 2 3 4 6}

Who Is on the Research Team?

Jennifer E Johnson, PhD

Principal Investigator

Michigan State University

Caron Zlotnick, PhD

Principal Investigator

Butler Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Speaks and understands English well enough to understand questionnaires when they are read aloud

Is receiving prenatal services at Henry Ford Health

Has access to a telephone through owning one, a relative/friend, or an agency

Exclusion Criteria

Has a current or past diagnosis of a bipolar disorder or a psychotic 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

Intervention

Participants receive the ROSE program, a 5-session psychosocial intervention aimed at preventing postpartum depression.

5 weeks

5 sessions (in-person or virtual)

Enhanced Care as Usual (CAU)

Participants receive usual care, which includes screening for existing PPD and referral for mental health services if needed.

6 months

Follow-up

Participants are monitored for safety and effectiveness after the intervention, with assessments of major depressive episodes and functioning.

6 months

Regular follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• Enhanced Care as Usual (CAU)
• ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns)

Trial Overview 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.

How Is the Trial Designed?

Group I: ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns) Experimental Treatment 1 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 Control 1 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

Who Is Running the Clinical Trial?

Michigan State University

Lead Sponsor

Trials

202

Recruited

687,000+

Pacific Institute for Research and Evaluation

Collaborator

Trials

28

Recruited

34,200+

Henry Ford Health System

Collaborator

Trials

334

Recruited

2,197,000+

Butler Hospital

Collaborator

Trials

133

Recruited

16,700+

Published Research Related to This Trial

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]

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 pilot study developed and tested a postpartum depression (PPD) screening protocol in safety-net pediatric practices, resulting in an increase in screening rates from 75% to 85% and follow-up documentation from 66% to 87% over three months.

Despite the successful implementation of the protocol, only 6.5% of women screened positive for PPD, indicating a need for further adaptations to improve the effectiveness of screening in diverse populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Goff, SL., Moran, MJ., Szegda, K., et al.[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]

An educational intervention aimed at preventing postpartum depression (PPD) did not significantly reduce depression symptoms in women up to 6 months after childbirth, based on a study involving 240 participants.

Key risk factors for PPD included low socioeconomic status and a history of depression or anxiety, suggesting that targeted education and support may need to be provided earlier, possibly during pregnancy, to effectively address these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Discharge Education on Postpartum Depression. McCarter-Spaulding, D., Shea, S.[2018]

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. publichealth.msu.edu publichealth.msu.edu/flint-research/flint-public-health-research/jennifer-johnson-phd/the-rose-sustainment-study

The ROSE Sustainment Study This program provides pregnant people with the skills and information they need to lower their risk of postpartum depression.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714423002203

Informing a decision about ROSE as universal postpartum ... ... postpartum depression (PPD; see Table 1) through counseling interventions. The Reach Out, Stay strong, Essentials for mothers of newborns (ROSE) program was ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37473848/

Informing a decision about ROSE as universal postpartum ... Affiliations. 1 Charles Stewart Mott Department of Public Health, Michigan State University College of Human Medicine, 200 East 1(st) St ...

5. 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 ...

6. 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 ...