A Pilot Trial of the ROSE Postpartum Depression Prevention Intervention in Antepartum Patients Admitted to High-risk Obstetrics Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Subject-reported in-hospital distress
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
ROSE Intervention
干预措施: ROSE (Behavioral)
Standard of Care
干预措施: Standard of Care (Other)
结局指标
主要结局
Subject-reported in-hospital distress
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Ellen Poleshuck
Professor
University of Rochester