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临床试验/NCT01744041
NCT01744041已完成不适用

Perinatal Depression: Dyadic-IPT to Improve Health of Mother and Baby

Washington University School of Medicine2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2012年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
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

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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