Clinical trial NCT03011801: Reducing Fetal Exposure to Maternal Depression to Improve Infant Risk Mechanisms
Official title: Reducing Fetal Exposure to Maternal Depression to Improve Infant Risk Mechanisms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: University of Denver
First posted: 2017-01-05
Enrollment: 234
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Presence of a Major Depressive Episode on SCID interview
timeFrame: 12 months post pregnancy
measure: Symptom Checklist 20 (SCL20)
timeFrame: post intervention (approximately 2-3 months post baseline)
measure: Symptom Checklist 20 (SCL20)
timeFrame: 6 months post intervention
measure: Symptom Checklist 20 (SCL20)
timeFrame: 12 months post intervention
Secondary outcomes:
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: post intervention (approximately 2-3 months post baseline)
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: 6 months post intervention
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: 12 months post intervention
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: post intervention (approximately 2-3 months post baseline)
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: 6 month post intervention
measure: Work and Social Adjustment Scale (WSAS)
timeFrame: 12 month post intervention
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Denver
state: Colorado
city: Urbana
country: United States
facility: University of Illinois
state: Illinois
Study officials:
affiliation: University of Illinois Urbana Champaign
name: Benjamin L Hankin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Denver
name: Elysia P Davis, PhD
role: PRINCIPAL_INVESTIGATOR
References: