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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

NCT05225025 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2022-06-13

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Mae Stone Goode Foundation

    collaborator OTHER

  • University of Rochester

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-05
Primary Completion
2022-05-02
Completion
2022-05-02

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05225025 on ClinicalTrials.gov