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 | Completed

• 1 other identifier: STUDY00005941
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a pilot, single-center, randomized controlled trial. It will

1. 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. 2.determine what adaptations may be needed for an inpatient population
3. 3.determine what retention strategies are most successful and acceptable for this patient population
4. 4.estimate the effect size of an intervention for in-hospital distress, anxiety and depression
5. 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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• satisfaction with ROSE behavioral health intervention

  14 days and 6 weeks postpartum

• self-reported mother-infant bonding

  6 weeks postpartum

• self-reported functional status

  6 weeks postpartum

Study Arms (2)

ROSE Intervention

EXPERIMENTAL

Behavioral: ROSE

Standard of Care

ACTIVE COMPARATOR

Other: Standard of Care

Interventions

ROSE 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.

ROSE Intervention

Standard of Care OTHER

Usual hospital care with no behavioral intervention

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• Mae Stone Goode Foundation: collaborator

Study Sites (1)

Strong Hospital

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 7, 2022
• First Posted: February 4, 2022
• Study Start: July 5, 2021
• Primary Completion: May 2, 2022
• Study Completion: May 2, 2022
• Last Updated: June 13, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)