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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

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.
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.
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.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
Return on Investment (ROI)

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).

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,869 Previous Clinical Trials
2,777,384 Total Patients Enrolled
24 Trials studying Postpartum Depression
7,996 Patients Enrolled for Postpartum Depression
University of RochesterLead Sponsor
859 Previous Clinical Trials
538,551 Total Patients Enrolled
4 Trials studying Postpartum Depression
595 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
~59 spots leftby Jul 2025
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