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?

The Reach Out, Stand Strong, Essentials for New Mothers (ROSE) program is an evidence-based intervention that prevents half of cases of postpartum depression and was one of two interventions recommended by the US Preventive Services Task Force in 2019. All effectiveness trials of ROSE and of the other recommended PPD prevention intervention included only low-income women a single risk factor that doubles incidence of PPD. Thus, the existing evidence base for PPD prevention consists primarily of women at increased risk for PPD. Based on data from the PIs' current implementation study of ROSE, many healthcare and community agencies in this implementation trial (78%) find it is more feasible for them to provide or offer ROSE to every woman as part of their standard workflow, than it is to create a screening and referral process for at risk women. In addition to being more feasible for agencies, universal prevention may also be advantageous because the cost of a screening false negative (resulting in a preventable case of PPD; $32,000) far exceeds the cost of ROSE delivery ($50-$300/woman). Effectiveness of ROSE among low-income women at risk for PPD is known (ROSE prevents \~50% of PPD cases). To inform a recommendation about using ROSE as universal vs. selective or indicated prevention, we need to determine the effectiveness of ROSE among general populations of women, including women screening negative for PPD risk. Thus, this project will assess ROSE effectiveness across PPD risk levels and across prevention approaches in a sample of 2,320 women from a large regional health system (based in Detroit, MI). Each proposed aim gathers a piece of information missing that is needed to guide decision-making about ROSE as universal prevention. We will assess ROSE as universal, selective, and indicated prevention in terms of: (1) ROSE effectiveness relative to a control for each prevention approach in preventing PPD and improving functioning; (2) cost outcome, (3) equity and (4) scalability of each prevention approach; and (5) mechanisms of ROSE effects across PPD risk levels. 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 to those who need it in settings where they receive perinatal care by addressing a pragmatic and novel question (should ROSE be universal prevention?) and by examining equity and cost-outcome of universal vs. other prevention approaches.

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.

Is the ROSE Program for postpartum depression safe for humans?

The available research on the ROSE Program focuses on its effectiveness in preventing postpartum depression, particularly in low-income and minority populations, but does not provide specific safety data. However, as it is an educational intervention, it is generally considered safe for participants. ^{1 2 3 4 5}

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

The ROSE treatment is unique because it is a group educational program designed to prevent postpartum depression by providing support and essential information to mothers during pregnancy, especially targeting low-income women. Unlike other treatments that may focus on medication or therapy after symptoms appear, ROSE aims to prevent depression before it starts by integrating into prenatal care settings. ^{1 2 3 5 6}

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

The ROSE Program, which is a group educational intervention, has been shown to reduce cases of postpartum depression in community prenatal settings, especially among low-income pregnant women. Additionally, early screening for postpartum depression using a telephone-based format has been effective in identifying symptoms and ensuring follow-through with treatment referrals. ^{1 2 3 5 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

I am between 3 to 8 months pregnant.

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

Is willing and able to provide the name and contact information of at least two locator persons

Exclusion Criteria

I am currently experiencing a major depressive episode.

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

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

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]

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 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. 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

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

3. 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]

4. England 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. [2022]

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

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

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

Effectiveness of Discharge Education on Postpartum Depression. [2018]