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 (eROSE)

InBloom App vs ROSE Outcomes and Mechanisms

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).

Study Overview

• Status: Recruiting
• Conditions: Post-partum Depression
• Intervention / Treatment: Behavioral: ROSE; Device: InBloom

• Study Type: Interventional
• Enrollment (Estimated): 152
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tamara Bilinski; Phone Number: 585-275-3138; Email: tamara_bilinski@urmc.rochester.edu

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Recruiting
      • University of Rochester Medical Center
      • Contact: Tamara Bilinski; Phone Number: 585-275-3138; Email: tamara_bilinski@urmc.rochester.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: women receiving InBloom app	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.
Active Comparator: women receiving ROSE as usual	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.
No Intervention: 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).
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Return on Investment (ROI)	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.	3 months

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: National Institute of Mental Health (NIMH)

Study record dates

Study Major Dates

• Study Start (Actual): July 17, 2023
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: August 24, 2022
• First Submitted That Met QC Criteria: August 24, 2022
• First Posted (Actual): August 26, 2022

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 26, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: RSRB00007456; R44MH112216 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes