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

Not Applicable

Completed

• Conditions: Postpartum Depression; Postpartum Anxiety
• Interventions: Other: Standard of Care; Behavioral: ROSE

• Registration Number: NCT05225025
• Lead Sponsor: University of Rochester

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-05
• Study First Submitted: 2022-01-07
• Study First Submitted QC: 2022-01-24
• Study First Posted: 2022-02-04
• Primary Completion: 2022-05-02
• Study Completion: 2022-05-02
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-09
• Last Update Posted: 2022-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	-
ROSE Intervention	ROSE	-

Primary Outcome Measures

Name	Time	Method
Subject-reported in-hospital distress	14 days	Hospital distress will be measured using the Depression, Anxiety and Stress Scale-21 (DASS-21) Stress subscale. Stress subscale ranges from 0 to 42 with higher scores indicating worse outcome.
Subject-reported depressive symptom severity	6 weeks postpartum	Depressive symptom severity will be measured using the Edinburgh Postnatal Depression Scale (EPDS). The scale ranges from 0-30 with higher scores indicating worse outcome.
Subject-reported anxiety symptom severity	6 weeks postpartum	Anxiety symptom severity will be measured using the General Anxiety Disorder-7 (GAD-7) measurement scale. The scale ranges from 0 to 21 with higher scores indicating worse outcome.
Clinical diagnosis of depression	6 weeks postpartum	Diagnosis of depression will be made using the Mini International Neuropsychiatric Interview (M.I.N.I) brief structured diagnostic interview which explores, in a standardized way, the main psychiatric disorders of Axis I of the DSM-IV TR. Only modules A and B (Major depressive episode and dysthymia) will be used. This structured interview contains questions with binary answers, with Yes indicating worse outcome.

Trial Locations

Locations (1)

Strong Hospital; 🇺🇸 Rochester, New York, United States