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

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Trial of the ROSE Postpartum Depression Prevention Intervention in Antepartum Patients Admitted to High-risk Obstetrics Unit

Conditions
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Postpartum Depression, Postpartum Anxiety

Intervention / Treatment
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* Behavioral: ROSE
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ROSE Intervention<br> | Behavioral: ROSE<br>* 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.<br>|
| Active Comparator: Standard of Care<br> | Other: Standard of Care<br>* Usual hospital care with no behavioral intervention<br>|

What is the study measuring?
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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 |