Reducing Fetal Exposure to Maternal Depression to Improve Infant Risk Mechanisms
- Conditions
- Depression
- Registration Number
- NCT03011801
- Lead Sponsor
- University of Illinois at Urbana-Champaign
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 234
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Symptom Checklist 20 (SCL20) 12 months post intervention Self reported Depression Scores. higher scores=more depression
Presence of a Major Depressive Episode on SCID interview 12 months post pregnancy Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation
- Secondary Outcome Measures
Name Time Method Edinburgh Postnatal Depression Scale (EPDS) 12 months post intervention Self reported Depression Scores. higher scores=more depression
Work and Social Adjustment Scale (WSAS) 12 month post intervention general maternal functioning
Trial Locations
- Locations (2)
University of Denver
🇺🇸Denver, Colorado, United States
University of Illinois
🇺🇸Urbana, Illinois, United States
University of Denver🇺🇸Denver, Colorado, United States