NCT05518162

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

InBloom App vs ROSE Outcomes and Mechanisms

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Post-partum Depression

Interventions

Type	Name	Description
DEVICE	InBloom	The Rose Program (RPv2) application will be built for iOS and Android devices (including tablets) and will feature a video-based Learning Management System (LMS) which provides resources for people with postpartum depression to improve their wellbeing. Each InBloom session will contain 4-5 video modules with specific themes contained in each ROSE session which are 3-5 minutes each.
BEHAVIORAL	ROSE	ROSE will be offered as a psychoeducational course on adjusting to parenthood by a health professional embedded in the obstetric clinics. There are five 90-minute group sessions which provide interpersonal rationale for the program, a review of the course outline, ground rules for the group, and the signs and symptoms of "baby blues" and postpartum depression, stress management skills. managing role transitions with an emphasis on transition to motherhood and the development of a support system, identifying types of interpersonal conflicts common around childbirth and techniques for resolving them, skills for resolving interpersonal conflicts and an opportunity to review and reinforce the content of the previous sessions.

Timeline

• Start date: 2023-07-17
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2022-08-26
• Last updated: 2026-02-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study