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

NCT ID: NCT05225025

Last Updated: 2022-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-05
• Study Completion Date: 2022-05-02

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

ROSE Intervention

Group Type: EXPERIMENTAL

ROSE

Intervention Type: BEHAVIORAL

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.

Standard of Care

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: OTHER

Usual hospital care with no behavioral intervention

Interventions

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.

Intervention Type: BEHAVIORAL

Standard of Care

Usual hospital care with no behavioral intervention

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Viable pregnancy between 20 weeks 0 days and 35 weeks 0 days gestation at the time of enrollment
• Anticipated admission to the hospital for >5 days due to pregnancy complication requiring hospital observation
• Age > 18 years
• Planned hospitalization at Strong Memorial Hospital through the duration of antepartum course
• Planned delivery at Strong Memorial Hospital

Exclusion Criteria

• Fetal demise in utero
• Inability to give informed consent secondary to intellectual capacity
• English is not primary language used to communicate
• Currently incarcerated
• Age < 18 years
• Planned antepartum hospitalization at another institution
• Planned delivery at another institution
• Actively suicidal or in need of acute psychiatric care

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mae Stone Goode Foundation

OTHER

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Ellen Poleshuck

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Strong Hospital

Rochester, New York, United States

Countries

United States

Other Identifiers

STUDY00005941

Identifier Type: -

Identifier Source: org_study_id