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临床试验/NCT03011801
NCT03011801已完成不适用

Reducing Fetal Exposure to Maternal Depression to Improve Infant Risk Mechanisms

University of Illinois at Urbana-Champaign4 个研究点 分布在 1 个国家目标入组 234 人开始时间: 2017年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
234
试验地点
4
主要终点
Symptom Checklist 20 (SCL20)

研究概览

简要总结

This study evaluates Interpersonal Therapy (IPT) in the treatment of depression among pregnant women with elevated depressive symptoms. Half of the women will be randomized to receive IPT, and the other half will get Treat As Usual, provided via behavioral health in the hospital.

详细描述

Exposure to maternal depressive symptoms is one of the most well established risk factors for the development of later child psychopathology. Accumulating evidence from naturalistic observational studies documents that fetal exposure to maternal depressive symptoms is associated with risk for later child mental health problems. Maternal depression is one of the most common prenatal complications with approximately 40% of women experiencing elevated levels of depressive symptoms. The majority of past research has been correlational, so potential causal conclusions have been limited. This project will break new ground by testing the hypothesis that manipulating maternal depressive symptoms will benefit infant outcomes. In this project, maternal depressive symptoms will be reduced using brief interpersonal therapy (IPT), a well-established and efficacious treatment, and testing whether this reduction leads to an improvement in the development of infant mechanisms associated with risk for later psychopathology. The investigators propose to assess 300 pregnant women who report elevated levels of depressive symptoms and their infants. Prior to the intervention, maternal measures of depressive symptoms will be collected. Then half of the women will be randomized to receive IPT and the other half will receive enhanced usual care (TAU). After completion of the intervention, maternal measures will be collected longitudinally through 14 months postpartum. Infants will be evaluated at birth and two other times. Infants will be assessed across four units of analysis (brain structure and function, physiology, behavior, and maternal-report).

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
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

入选标准

  • Adult women (over 18 years of age)
  • A singleton intrauterine pregnancy
  • English speaking
  • Elevated depressive symptoms based on screening with the Edinburgh Postnatal Depression Scale (EPDS) with score > 9

排除标准

  • Bipolar disorder and psychosis based on the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-NP)
  • Current psychotropic medication use or current CBT/IPT usage
  • An HPA axis or an endocrine disorder
  • Maternal substance use [assessed using maternal report and urine toxicology
  • Corticosteroid medication use during this pregnancy
  • Invitto fertilization
  • Presence of cervical or uterine abnormalities

结局指标

主要结局

Symptom Checklist 20 (SCL20)

时间窗: 12 months post intervention

Self reported Depression Scores. higher scores=more depression

Presence of a Major Depressive Episode on SCID interview

时间窗: 12 months post pregnancy

Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation

次要结局

  • Edinburgh Postnatal Depression Scale (EPDS)(12 months post intervention)
  • Work and Social Adjustment Scale (WSAS)(12 month post intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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