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

Post-partum Depression Clinical Trial

Official title:

InBloom App vs ROSE Outcomes and Mechanisms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05518162
• Other study ID #: RSRB00007456
• Secondary ID: R44MH112216
• Status: Recruiting
• Phase: N/A
• Start date: July 17, 2023
• Est. completion date: July 1, 2025

Study information

• Verified date: September 2023
• Source: University of Rochester
• Contact: Tamara Bilinski
• Phone: 585-275-3138
• Email: tamara_bilinski[@]urmc.rochester.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 152
• Est. completion date: July 1, 2025
• Est. primary completion date: July 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Post-partum Depression

Intervention

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.

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.

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of Rochester	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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