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

NCT ID: NCT05518162

Last Updated: 2026-02-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-17
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

women receiving InBloom app

Group Type: EXPERIMENTAL

InBloom

Intervention Type: 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 ROSE as usual

Group Type: ACTIVE_COMPARATOR

ROSE

Intervention Type: 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.

historical controls- no treatment

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

electronic health record utilization data

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 Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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 young age (18-21 years).

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Ellen Poleshuck

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39743016 (View on PubMed)

Other Identifiers

R44MH112216

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RSRB00007456

Identifier Type: -

Identifier Source: org_study_id