women receiving eROSE for Postpartum Depression

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Rochester Medical Center, Rochester, NY
Postpartum Depression+3 More
eROSE - Device
Eligibility
18+
Female
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Study Summary

A randomized trial of pregnant people at risk for post- partum depression comparing e-ROSE (n = 76) to ROSE (n = 76; weekly scheduled group), and two control groups. We will assess Depression at baseline and 1, 2 and 3 months, ROI at 3 months, Satisfaction at 1 and 3 months and Perceived Access at 1 and 3 months. Subject participation will last up to 8 months (minimum 20 weeks pregnant through 3 months postpartum).

Eligible Conditions

  • Postpartum Depression

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Postpartum Depression

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: 3 months

3 months
Return on Investment (ROI)
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)

Trial Safety

Safety Progress

1 of 3

Other trials for Postpartum Depression

Trial Design

4 Treatment Groups

women receiving ROSE
1 of 4
historical controls- no treatment
1 of 4
electronic health record utilization data
1 of 4
women receiving eROSE
1 of 4
Active Control
Experimental Treatment

152 Total Participants · 4 Treatment Groups

Primary Treatment: women receiving eROSE · No Placebo Group · N/A

women receiving eROSE
Device
Experimental Group · 1 Intervention: eROSE · Intervention Types: Device
women receiving ROSE
Behavioral
ActiveComparator Group · 1 Intervention: ROSE · Intervention Types: Behavioral
historical controls- no treatmentNoIntervention Group · 1 Intervention: historical controls- no treatment · Intervention Types:
electronic health record utilization dataNoIntervention Group · 1 Intervention: electronic health record utilization data · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months

Trial Background

Prof. Ellen Poleshuck, Professor
Principal Investigator
University of Rochester
Closest Location: University of Rochester Medical Center · Rochester, NY
Photo of Rochester  1Photo of Rochester  2Photo of Rochester  3
2018First Recorded Clinical Trial
1 TrialsResearching Postpartum Depression
408 CompletedClinical Trials

Eligibility Criteria

Age 18+ · Female Participants · 4 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.