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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
ROSES-II 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.Check my eligibility
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.See study design
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.
ROSES-II Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
SCID-5 Major Depressive Episode
Secondary outcome measures
SF-12
ROSES-II 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.
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Who is running the clinical trial?
Michigan State UniversityLead Sponsor
185 Previous Clinical Trials
599,707 Total Patients Enrolled
Pacific Institute for Research and EvaluationOTHER
26 Previous Clinical Trials
31,894 Total Patients Enrolled
1 Trials studying Postpartum Depression
250 Patients Enrolled for Postpartum Depression
Henry Ford Health SystemOTHER
300 Previous Clinical Trials
2,097,562 Total Patients Enrolled
2 Trials studying Postpartum Depression
151 Patients Enrolled for Postpartum Depression
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently experiencing a major depressive episode.I am between 3 to 8 months pregnant.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns)
- Group 2: Enhanced Care as Usual (CAU)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there any documented risk associated with the ROSE program for mothers of newborns?
"According to our internal assessment, ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns) was assigned a score of 3 as there has been multiple rounds of data confirming its safety and efficacy."
Answered by AI
Are there any available slots for enrolment in this clinical trial?
"According to clinicaltrials.gov, this medical study is no longer accepting participants as of January 17th 2023; the trial was initially posted on June 1st 2023. However, there are 1,301 other trials actively recruiting at present time."
Answered by AI
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