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

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Depression; Postpartum Anxiety
• Intervention / Treatment: Behavioral: ROSE; Other: Standard of Care

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Rochester, New York, United States, 14642
      • Strong Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care	Other: Standard of Care; Usual hospital care with no behavioral intervention
Experimental: ROSE Intervention	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject-reported in-hospital distress	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.	14 days
Subject-reported depressive symptom severity	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.	6 weeks postpartum
Subject-reported anxiety symptom severity	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.	6 weeks postpartum
Clinical diagnosis of depression	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.	6 weeks postpartum

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
satisfaction with ROSE behavioral health intervention	Satisfaction score will be measured using the Client Satisfaction Questionnaire-8 (CSQ-8). The scores range from 8-32, with greater satisfaction indicated by higher scores.	14 days and 6 weeks postpartum
self-reported mother-infant bonding	Mother-infant bonding will be assessed over four domains by the Postpartum Bonding Questionnaire (PBQ). Scores range from 0-125, with worse outcome indicated by higher scores.	6 weeks postpartum
self-reported functional status	Functional status will be assessed using the Inventory of Functional Status After Childbirth (IFSAC) measure. Scores range from 36-144, with higher scores indicating better outcome.	6 weeks postpartum
percentage of eligible subjects who enrolled in the study		baseline
percentage of enrolled subjects who completed all inpatient study activities		14 days
percentage of enrolled subjects who completed all inpatient plus outpatient study activities		6 weeks postpartum

Collaborators and Investigators

• Sponsor: University of Rochester
• Collaborators: Mae Stone Goode Foundation

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2021
• Primary Completion (Actual): May 2, 2022
• Study Completion (Actual): May 2, 2022

Study Registration Dates

• First Submitted: January 7, 2022
• First Submitted That Met QC Criteria: January 24, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Puerperal Disorders; Depression; Depressive Disorder; Depression, Postpartum
• Other Study ID Numbers: STUDY00005941

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No