ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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).

Official Title

InBloom App vs ROSE Outcomes and Mechanisms

Quick Facts

Study Start:2023-07-17
Study Completion:2026-02-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05518162

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 17-32 weeks pregnant
  2. * enrolled for prenatal care in one of the five identified practices
  3. * English speaking
  4. * able to use an app (audio/visual/dexterity)
  5. * 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).
  1. * patients with acute mental health needs
  2. * cannot communicate in English
  3. * demonstrate significant cognitive impairment
  4. * are planning to place the child for adoption
  5. * PHQ-9 depression score \> 19
  6. * younger than age 18

Contacts and Locations

Study Locations (Sites)

University of Rochester Medical Center
Rochester, New York, 14642
United States

Collaborators and Investigators

Sponsor: University of Rochester

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-17
Study Completion Date2026-02-28

Study Record Updates

Study Start Date2023-07-17
Study Completion Date2026-02-28

Terms related to this study

Additional Relevant MeSH Terms

  • Post-partum Depression