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

A Pilot Trial of the ROSE Postpartum Depression Prevention Intervention in Antepartum Patients Admitted to High-risk Obstetrics Unit

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Postpartum Depression
• Postpartum Anxiety

Interventions

Type	Name	Description
BEHAVIORAL	ROSE	The ROSE (Reach Out, Stay Strong, Essentials for mothers of newborns) program is an evidence-based intervention that has been proven to reduce cases of post-partum depression among low-income and racially and ethnically diverse women. ROSE is administered to pregnant women in small group settings, typically in the same location that prenatal care is being provided (in this study, a hospital setting). It is divided into four 90-minute group sessions and teaches interpersonal psychotherapy-based skills that mitigate identified risk factors for PPD such as social support, stress management skills and communication. ROSE curriculum will be implemented using groups in a continuous cycle, with patients entering into the intervention curriculum at the time of their enrollment and continuing through until all 4 total sessions have been accomplished.
OTHER	Standard of Care	Usual hospital care with no behavioral intervention

Timeline

• Start date: 2021-07-05
• Primary completion: 2022-05-02
• Completion: 2022-05-02
• First posted: 2022-02-04
• Last updated: 2022-06-13

Locations

1 site across 1 country: United States