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Clinical Trials/NCT03011801
NCT03011801
Completed
N/A

Reducing Fetal Exposure to Maternal Depression to Improve Infant Risk Mechanisms

University of Illinois at Urbana-Champaign2 sites in 1 country234 target enrollmentSeptember 1, 2017
ConditionsDepression

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depression
Sponsor
University of Illinois at Urbana-Champaign
Enrollment
234
Locations
2
Primary Endpoint
Symptom Checklist 20 (SCL20)
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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).

Registry
clinicaltrials.gov
Start Date
September 1, 2017
End Date
May 28, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Symptom Checklist 20 (SCL20)

Time Frame: 12 months post intervention

Self reported Depression Scores. higher scores=more depression

Presence of a Major Depressive Episode on SCID interview

Time Frame: 12 months post pregnancy

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

Secondary Outcomes

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

Study Sites (2)

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