Reducing Fetal Exposure to Maternal Depression to Improve Infant Risk Mechanisms

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.

Study Overview

• Status: Unknown
• Conditions: Depression
• Intervention / Treatment: Behavioral: Interpersonal Therapy; Behavioral: Enhanced usual care

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).

• Study Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80208
      • Recruiting
      • University of Denver
      • Contact: Elysia Davis, PhD; Phone Number: 303-871-3790; Email: Elysia.Davis@du.edu
  • Illinois
    • Urbana, Illinois, United States, 61801
      • Enrolling by invitation
      • University of Illinois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Behavioral: Interpersonal Therapy; Individual psychotherapy that includes an initial engagement session and a total of 8 sessions. IPT focuses on psychoeducation and interpersonal skill building to decrease interpersonal conflict and increase interpersonal support and competence.	Behavioral: Interpersonal Therapy; reducing conflict in relationships, increasing social support in relationships, improving communication, reducing depressive symptoms; Other Names: IPT
Placebo Comparator: Enhanced Usual Care; Maternity support services (MSS) is the usual standard of care for pregnant women. A multi-disciplinary team of obstetric care providers routinely screen women for possible depression diagnosis. If a woman screens positive, she is seen by a behavioral health specialist (BHS) for further assessment and to initiate treatment, if necessary. The goals of MSS include offering services to promote healthy pregnancies and positive birth and parenting outcomes, including integrating mental health and prenatal care. Women with elevated depressive symptoms are seen by BHS throughout the pregnancy and postpartum period and then bridged to mental health treatment. BHS provides eclectic-based care but does not provide IPT.	Behavioral: Enhanced usual care; Treatment as Usual, including eclectic and supportive therapy, as well as psychiatric medication; Other Names: Maternity Support Services (MSS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Symptom Checklist 20 (SCL20)	Self reported Depression Scores. higher scores=more depression	post intervention (approximately 2-3 months post baseline)
Symptom Checklist 20 (SCL20)	Self reported Depression Scores. higher scores=more depression	6 months post intervention
Symptom Checklist 20 (SCL20)	Self reported Depression Scores. higher scores=more depression	12 months post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Edinburgh Postnatal Depression Scale (EPDS)	Self reported Depression Scores. higher scores=more depression	post intervention (approximately 2-3 months post baseline)
Edinburgh Postnatal Depression Scale (EPDS)	Self reported Depression Scores. higher scores=more depression	6 months post intervention
Edinburgh Postnatal Depression Scale (EPDS)	Self reported Depression Scores. higher scores=more depression	12 months post intervention
Work and Social Adjustment Scale (WSAS)	general maternal functioning	post intervention (approximately 2-3 months post baseline)
Work and Social Adjustment Scale (WSAS)	general maternal functioning	6 month post intervention
Work and Social Adjustment Scale (WSAS)	general maternal functioning	12 month post intervention

Collaborators and Investigators

• Sponsor: University of Illinois at Urbana-Champaign
• Collaborators: National Institute of Mental Health (NIMH); University of Denver

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): December 28, 2022

Study Registration Dates

• First Submitted: January 4, 2017
• First Submitted That Met QC Criteria: January 4, 2017
• First Posted (Estimate): January 5, 2017

Study Record Updates

• Last Update Posted (Actual): February 15, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: MH109662

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: NIMH Data Archive

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No