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

University of Rochester

Status: Completed

Conditions: Postpartum Anxiety; Postpartum Depression

Treatments: Behavioral: ROSE; Other: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT05225025

STUDY00005941

Details and patient eligibility

About

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.

Enrollment: 45 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 2 patient groups

ROSE Intervention

Experimental group

Treatment:

Behavioral: ROSE

Standard of Care

Active Comparator group

Treatment:

Other: Standard of Care