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

NCT05518162 | Completed FDA Device

• 2 other identifiers: RSRB00007456R44MH112216
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

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

  The MINI is a binary assessment of the diagnosis of postpartum depression. It yields a yes, no answer.

  3 months

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

  PHQ-9 is a 9 question tool that assesses depression symptoms. It ranges from 0-27 with higher scores indicating worse outcome.

  baseline

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

  PHQ-9 is a 9 question tool that assesses depression symptoms. It ranges from 0-27 with higher scores indicating worse outcome.

  1 month

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

  PHQ-9 is a 9 question tool that assesses depression symptoms. It ranges from 0-27 with higher scores indicating worse outcome.

  2 months

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

  PHQ-9 is a 9 question tool that assesses depression symptoms. It ranges from 0-27 with higher scores indicating worse outcome.

  3 months

Secondary Outcomes (1)

• Return on Investment (ROI)

  3 months

Study Arms (4)

women receiving InBloom app

EXPERIMENTAL

Device: InBloom

women receiving ROSE as usual

ACTIVE COMPARATOR

Behavioral: ROSE

historical controls- no treatment

NO 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).

electronic health record utilization data

NO 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.

Interventions

InBloom DEVICE

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.

women receiving InBloom app

ROSE BEHAVIORAL

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.

women receiving ROSE as usual

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 young age (18-21 years).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (1)

• Poleshuck E, Fox D, Abar B, Maeng D, Bilinski T, Beers L, Rosen J, Zlotnick C. Randomized clinical trial protocol of an app-based intervention to prevent postpartum depression. Contemp Clin Trials. 2025 Feb;149:107800. doi: 10.1016/j.cct.2024.107800. Epub 2024 Dec 30.

  PMID: 39743016 DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: August 26, 2022
• Study Start: July 17, 2023
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

US (1)