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

Not Applicable

Recruiting

• Conditions: Post-partum Depression
• Interventions: Device: InBloom; Behavioral: ROSE

• Registration Number: NCT05518162
• Lead Sponsor: University of Rochester

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-24
• Study First Submitted QC: 2022-08-24
• Study First Posted: 2022-08-26
• Study Start: 2023-07-17
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-11
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 152

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
women receiving InBloom app	InBloom	-
women receiving ROSE as usual	ROSE	-

Primary Outcome Measures

Name	Time	Method
mean depression severity measured using Patient Health Questionnaire (PHQ-9)	3 months	PHQ-9 is a 9 question tool that assesses depression symptoms. It ranges from 0-27 with higher scores indicating worse outcome.
proportion of participants with post-partum depression assessed using the Mini International Neuropsychiatric Interview (MINI)	3 months	The MINI is a binary assessment of the diagnosis of postpartum depression. It yields a yes, no answer.

Secondary Outcome Measures

Name	Time	Method
Return on Investment (ROI)	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.

Trial Locations

Locations (1)

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States