Perinatal Depression: Dyadic-IPT to Improve Health of Mother and Baby
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in Edinburgh Depression Scale From Baseline
研究概览
简要总结
Perinatal depression is a major public health problem, affecting 15% of women during pregnancy through the postpartum period, with adverse consequences for the mother, the fetus, the infant, and the family. Despite increasing evidence of the importance of this critical risk interval, little research has investigated the effects of depression treatment during pregnancy on infant outcomes. The purpose of this study is to test the feasibility, acceptability, and effectiveness of a new intervention, Interpersonal psychotherapy for the mother-infant dyad (IPT-Dyad). This intervention begins during pregnancy and continues with the mother and infant until one year postpartum. The investigators hypothesize that IPT-Dyad will be better than treatment as usual in reducing depressive symptoms, improving psychosocial functioning,increasing parenting self-efficacy, improving infant emotional development, and enhancing mother-infant relationship quality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Pregnant women
- •18 years and older
- •between 12 and 30 weeks gestation
- •Score greater than or equal to 13 on Edinburgh Depression Scale
- •Structured Clinical Interview (SCID-IV) diagnosis of Major Depressive Disorder, dysthymia, or Depressive Disorder, Not otherwise Specified
- •English Speaking
排除标准
- •Substance abuse or dependence in past 3 months
- •Active suicidal or homicidal ideation
- •Bipolar disorder, psychotic disorder
- •unstable medical condition or other medical/obstetrical complication
- •Evidence of severe intimate partner violence
- •Ongoing psychosocial or pharmacotherapy for depression
研究组 & 干预措施
Dyadic Interpersonal Psychotherapy
Brief Interpersonal Psychotherapy during pregnancy followed by dyadic mother-infant psychotherapy for one year postpartum
干预措施: Dyadic Interpersonal Psychotherapy (Behavioral)
Enhanced Treatment as Usual
Personalized referral to community resources for depression treatment
干预措施: Enhanced Treatment as Usual (Other)
结局指标
主要结局
Change in Edinburgh Depression Scale From Baseline
时间窗: Change from baseline at End of pregnancy (between 37-39 weeks gestation); change from baseline at 3 months postpartum; change from baseline at 6 months postpartum; change from baseline at 9 months postpartum; change from baseline at 12 months postpartum
Edinburgh Postnatal Depression Scale, a 10-item scale of depression severity, scores range from 0 to 30 with higher scores indicating worse outcome.
次要结局
未报告次要终点