跳至主要内容
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-Champaign2 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
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
234
试验地点
2
主要终点
Presence of a Major Depressive Episode on SCID interview

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
否

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

研究组 & 干预措施

Behavioral: Interpersonal Therapy

Experimental

Individual psychotherapy that includes an initial engagement session and a total of 8 sessions. IPT focuses on psychoeducation and interpersonal skill building to decrease interpersonal conflict and increase interpersonal support and competence.

干预措施: Interpersonal Therapy (Behavioral)

Enhanced Usual Care

Placebo Comparator

Maternity support services (MSS) is the usual standard of care for pregnant women. A multi-disciplinary team of obstetric care providers routinely screen women for possible depression diagnosis. If a woman screens positive, she is seen by a behavioral health specialist (BHS) for further assessment and to initiate treatment, if necessary. The goals of MSS include offering services to promote healthy pregnancies and positive birth and parenting outcomes, including integrating mental health and prenatal care. Women with elevated depressive symptoms are seen by BHS throughout the pregnancy and postpartum period and then bridged to mental health treatment. BHS provides eclectic-based care but does not provide IPT.

干预措施: Enhanced usual care (Behavioral)

结局指标

主要结局

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

Symptom Checklist 20 (SCL20)

时间窗: 12 months post intervention

Self reported Depression Scores. higher scores=more depression

Symptom Checklist 20 (SCL20)

时间窗: post intervention (approximately 2-3 months post baseline)

Self reported Depression Scores. higher scores=more depression

Symptom Checklist 20 (SCL20)

时间窗: 6 months post intervention

Self reported Depression Scores. higher scores=more depression

次要结局

  • Work and Social Adjustment Scale (WSAS)(12 month post intervention)
  • Edinburgh Postnatal Depression Scale (EPDS)(12 months post intervention)
  • Edinburgh Postnatal Depression Scale (EPDS)(post intervention (approximately 2-3 months post baseline))
  • Edinburgh Postnatal Depression Scale (EPDS)(6 months post intervention)
  • Work and Social Adjustment Scale (WSAS)(post intervention (approximately 2-3 months post baseline))
  • Work and Social Adjustment Scale (WSAS)(6 month post intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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