Reducing Fetal Exposure to Maternal Depression to Improve Infant Risk Mechanisms

Depression Clinical Trial

Official title:

Reducing Fetal Exposure to Maternal Depression to Improve Infant Risk Mechanisms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03011801
• Other study ID #: MH109662
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: December 28, 2022

Study information

• Verified date: October 2020
• Source: University of Illinois at Urbana-Champaign
• Contact: Benjamin L Hankin, PhD
• Phone: 217-300-9334
• Email: hankinb[@]illinois.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 28, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Interpersonal Therapy
reducing conflict in relationships, increasing social support in relationships, improving communication, reducing depressive symptoms
• Enhanced usual care
Treatment as Usual, including eclectic and supportive therapy, as well as psychiatric medication

Locations

Country	Name	City	State
United States	University of Denver	Denver	Colorado
United States	University of Illinois	Urbana	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign	National Institute of Mental Health (NIMH), University of Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of a Major Depressive Episode on SCID interview	Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation	12 months post pregnancy
Primary	Symptom Checklist 20 (SCL20)	Self reported Depression Scores. higher scores=more depression	post intervention (approximately 2-3 months post baseline)
Primary	Symptom Checklist 20 (SCL20)	Self reported Depression Scores. higher scores=more depression	6 months post intervention
Primary	Symptom Checklist 20 (SCL20)	Self reported Depression Scores. higher scores=more depression	12 months post intervention
Secondary	Edinburgh Postnatal Depression Scale (EPDS)	Self reported Depression Scores. higher scores=more depression	post intervention (approximately 2-3 months post baseline)
Secondary	Edinburgh Postnatal Depression Scale (EPDS)	Self reported Depression Scores. higher scores=more depression	6 months post intervention
Secondary	Edinburgh Postnatal Depression Scale (EPDS)	Self reported Depression Scores. higher scores=more depression	12 months post intervention
Secondary	Work and Social Adjustment Scale (WSAS)	general maternal functioning	post intervention (approximately 2-3 months post baseline)
Secondary	Work and Social Adjustment Scale (WSAS)	general maternal functioning	6 month post intervention
Secondary	Work and Social Adjustment Scale (WSAS)	general maternal functioning	12 month post intervention