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

Last updated: October 8, 2024
Sponsor: University of Rochester
Overall Status: Active - Recruiting

Phase

N/A

Condition

Depression

Post-partum Depression

Treatment

InBloom

ROSE

eROSE

Clinical Study ID

NCT05518162
RSRB00007456
R44MH112216
  • Ages > 18
  • Female

Study Summary

A randomized trial of pregnant people at risk for postpartum depression comparing the InBloom app (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 17 weeks pregnant through 3 months postpartum).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 17-32 weeks pregnant

  • enrolled for prenatal care in one of the five identified practices

  • English speaking

  • able to use an app (audio/visual/dexterity)

  • have one or more of the following PPD risk factors: Medicaid eligible; anxiety (GAD-7 > 10) during pregnancy; mild to moderate depressive symptoms (PHQ-9 = 10-19);self-reported history of depression treatment; gestational diabetes; and/or youngage (18-21 years).

Exclusion

Exclusion Criteria:

  • patients with acute mental health needs

  • cannot communicate in English

  • demonstrate significant cognitive impairment

  • are planning to place the child for adoption

  • PHQ-9 depression score > 19

  • younger than age 18

Study Design

Total Participants: 152
Treatment Group(s): 3
Primary Treatment: InBloom
Phase:
Study Start date:
July 17, 2023
Estimated Completion Date:
July 01, 2025

Connect with a study center

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Active - Recruiting

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