A Pilot Trial of the ROSE Postpartum Depression Prevention Intervention in Antepartum Patients Admitted to High-risk Obstetrics Unit
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postpartum Depression
- Sponsor
- University of Rochester
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Subject-reported in-hospital distress
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
This study is a pilot, single-center, randomized controlled trial. It will
- determine feasibility and acceptability of an evidence-based intervention for prevention of postpartum depression with antepartum patients on a high-risk obstetric unit,
- determine what adaptations may be needed for an inpatient population
- determine what retention strategies are most successful and acceptable for this patient population
- estimate the effect size of an intervention for in-hospital distress, anxiety and depression
- estimate the effect size of an intervention to reduce the risk of a post-partum depression diagnosis or depressive symptoms.
Investigators
Ellen Poleshuck
Professor
University of Rochester
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
Outcomes
Primary Outcomes
Subject-reported in-hospital distress
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.