Skip to content

Reducing Fetal Exposure to Maternal Depression to Improve Infant Risk Mechanisms

Reducing Fetal Exposure to Maternal Depression to Improve Infant Risk Mechanisms

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03011801
Enrollment
234
Registered
2017-01-05
Start date
2017-09-01
Completion date
2024-05-28
Last updated
2024-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

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).

Interventions

reducing conflict in relationships, increasing social support in relationships, improving communication, reducing depressive symptoms

BEHAVIORALEnhanced usual care

Treatment as Usual, including eclectic and supportive therapy, as well as psychiatric medication

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
University of Denver
CollaboratorOTHER
University of Illinois at Urbana-Champaign
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Presence of a Major Depressive Episode on SCID interview12 months post pregnancyPresence of a depression diagnosis as measured by a semi-structured diagnostic evaluation
Symptom Checklist 20 (SCL20)post intervention (approximately 2-3 months post baseline)Self reported Depression Scores. higher scores=more depression

Secondary

MeasureTime frameDescription
Edinburgh Postnatal Depression Scale (EPDS)post intervention (approximately 2-3 months post baseline)Self reported Depression Scores. higher scores=more depression
Work and Social Adjustment Scale (WSAS)post intervention (approximately 2-3 months post baseline)general maternal functioning

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026