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Completed

NCT Number: 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

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).

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Key information

Conditions

Post-partum Depression Depression, Postpartum Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Pregnancy Complications Puerperal Disorders Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 3 months

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

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

    Time frame: baseline

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

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

    Time frame: 1 month

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

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

    Time frame: 2 months

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

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

    Time frame: 3 months

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

Secondary outcomes

  1. Return on Investment (ROI)

    Time frame: 3 months

    To calculate the return portion of ROI, all-cause healthcare utilization data of each patient will be obtained from the EHR. For each type of healthcare utilization, the corresponding per-unit reimbursement rate, obtained from New York State Medicaid fee schedule (https://omh.ny.gov/omhweb/medicaid_reimbursement/), which will then be multiplied by the utilization frequency to obtain the total reimbursement and thus total cost of care on a per-patient basis for each of the 3 groups. To calculate the investment portion of ROI, both the fixed costs (i.e., investment cost that does not vary by the number of patients treated) and the variable costs (i.e., investment cost that does vary by the number of patients treated) will be considered of the eROSE/ROSE intervention. Total utilization cost minus the intervention investment.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

InBloom App vs ROSE Outcomes and Mechanisms

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 26, 2022
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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