Anxiety & Depression Association of America

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

Purpose

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).

Condition

Post-partum Depression

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: Female
Accepts Healthy Volunteers: No

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

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
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.

Recruiting Locations

More Details

Status: Recruiting
Sponsor: University of Rochester

Study Contact

Tamara Bilinski
585-275-3138
tamara_bilinski@urmc.rochester.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.