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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
45
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.
Usual hospital care with no behavioral intervention
Strong Hospital
Rochester, New York, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 weeks postpartum
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.