NCT05225025

A Pilot Trial of the Reach Out, Stay Strong, Essentials for Mothers of Newborns (ROSE) Postpartum Depression Prevention Intervention in Pregnant Patients Admitted to Strong Hospital

Completed NA Last updated 13 June 2022

What this trial tests

NA trial testing ROSE in Postpartum Depression in 45 participants. Completed in 2 May 2022.

Timeline

5 July 2021

Primary endpoint
2 May 2022

2 May 2022

Quick facts

Lead sponsor	University of Rochester
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	45
Start date	5 July 2021
Primary completion	2 May 2022
Estimated completion	2 May 2022
Sites	1 location across United States

Drugs / interventions tested

• ROSE
• Standard of Care

Conditions studied

• Postpartum Depression — all drugs for Postpartum Depression →
• Postpartum Anxiety — all drugs for Postpartum Anxiety →

Sponsor

University of Rochester

Who can join

18 and older, female only, with Postpartum Depression or Postpartum Anxiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a pilot, single-center, randomized controlled trial. It will

1. determine feasibility and acceptability of an evidence-based intervention for prevention of postpartum depression with antepartum patients on a high-risk obstetric unit,
2. determine what adaptations may be needed for an inpatient population
3. determine what retention strategies are most successful and acceptable for this patient population
4. estimate the effect size of an intervention for in-hospital distress, anxiety and depression
5. estimate the effect size of an intervention to reduce the risk of a post-partum depression diagnosis or depressive symptoms.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Feasibility, Acceptability, and Exploratory Efficacy of Implementing an Intervention for Preventing Postpartum Depression in Antepartum Hospitalized Patients With High-Risk Pregnancy Complications: A Mixed-Methods Experimental Study.
   Toscano M, Rubano A, Santos SR, Hartman R, et al · · 2026 · PMID 42209333 · DOI 10.1016/j.whi.2026.04.002