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ROSE Program for Postpartum Depression (ROSES-II Trial)

Phase 3

Recruiting

Led By Jennifer E Johnson, PhD

Research Sponsored by Michigan State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (during pregnancy and 6 months after birth)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will determine the best way to get an evidence-based program to prevent postpartum depression to those who need it. Results will advise on whether the program should be universal.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since ROSE involves educational support rather than medication, it does not have typical drug side effects. However, participants may experience emotional discomfort discussing personal topics during the sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through 6 months after birth

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through 6 months after birth

This trial's timeline: 3 weeks for screening, Varies for treatment, and through 6 months after birth for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

SCID-5 Major Depressive Episode

Secondary study objectives

SF-12

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns)Experimental Treatment1 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 Control1 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.

Do I qualify?Apply below to find out