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Behavioral Intervention App for Postpartum Depression (eROSE Trial)

N/A

Recruiting

Research Sponsored by University of Rochester

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 3 months

Awards & highlights

eROSE Trial Summary

This trial is testing whether e-ROSE, a weekly scheduled group chat, is effective in reducing post-partum depression compared to ROSE, a weekly in-person group, and two control groups.

Who is the study for?

This trial is for pregnant individuals between 20-35 weeks along, who are at risk for postpartum depression. They must be English-speaking and receiving prenatal care at certain practices. Eligible participants may have a low income, anxiety or mild to moderate depressive symptoms during pregnancy, a history of depression treatment, gestational diabetes, or be aged 18-21.Check my eligibility

What is being tested?

The study compares the effectiveness of two apps: InBloom and ROSE in preventing postpartum depression among pregnant people at risk. Participants will be randomly assigned to one of these interventions or control groups and followed from mid-pregnancy through three months after birth.See study design

What are the potential side effects?

Since this trial involves behavioral interventions delivered via electronic apps rather than medications, traditional side effects are not expected. However, users might experience discomfort if sensitive topics are discussed.

eROSE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months

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

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

mean depression severity measured using Patient Health Questionnaire (PHQ-9)

proportion of participants with post-partum depression assessed using the Mini International Neuropsychiatric Interview (MINI)

Secondary outcome measures

Return on Investment (ROI)

eROSE Trial Design

4Treatment groups

Experimental Treatment

Active Control

Group I: women receiving InBloom appExperimental Treatment1 Intervention

Group II: electronic health record utilization dataActive Control1 Intervention

We will leverage EHR utilization data by retrospectively identifying 152 people from the same clinics who did not receive ROSE or InBloom and matched for eligibility criteria, demographics and PPD risk factors using propensity scores, and comparing their utilization to those in the ROSE and InBloom groups.

Group III: women receiving ROSE as usualActive Control1 Intervention

Group IV: historical controls- no treatmentActive Control1 Intervention

We will capitalize on data from a large ROSE trial which consists of a demographically similar sample by comparing depression diagnosis outcomes for Inbloom and ROSE to the 96 participants in the care as usual group (an educational pamphlet on PPD).

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH

2,785 Previous Clinical Trials

2,689,604 Total Patients Enrolled

24 Trials studying Postpartum Depression

7,991 Patients Enrolled for Postpartum Depression

University of RochesterLead Sponsor

838 Previous Clinical Trials

518,415 Total Patients Enrolled

4 Trials studying Postpartum Depression

975 Patients Enrolled for Postpartum Depression

Media Library

eROSE Clinical Trial Eligibility Overview. Trial Name: NCT05518162 — N/A

Postpartum Depression Research Study Groups: electronic health record utilization data, women receiving InBloom app, women receiving ROSE as usual, historical controls- no treatment

Postpartum Depression Clinical Trial 2023: eROSE Highlights & Side Effects. Trial Name: NCT05518162 — N/A

eROSE 2023 Treatment Timeline for Medical Study. Trial Name: NCT05518162 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals able to enroll in this clinical investigation presently?

"As per the record on clinicaltrials.gov, this study is no longer accepting applicants; it was posted in July and last updated in August of 2022. Despite its conclusion, there are still 1,301 additional trials actively recruiting participants right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treatment of Post-partum Depression Using an Behavioral Intervention Called ROSE (Reach Out, Stay Strong, Essentials for Mothers of Newborns) Delivered Using an Electronic App

Ellen Poleshuck 2023. "Treatment of Post-partum Depression Using an Behavioral Intervention Called ROSE (Reach Out, Stay Strong, Essentials for Mothers of Newborns) Delivered Using an Electronic App". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05518162.