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

University of Rochester

Status: Active, not recruiting

Conditions: Post-partum Depression

Treatments: Device: InBloom; Behavioral: ROSE

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05518162

RSRB00007456

R44MH112216 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 152 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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152 participants in 4 patient groups

women receiving InBloom app

Experimental group

Treatment:

Device: InBloom

women receiving ROSE as usual

Active Comparator group

Treatment:

Behavioral: ROSE

historical controls- no treatment

No Intervention group

Description:

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).

electronic health record utilization data

No Intervention group

Description:

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.