search
Back to results

Reducing Fetal Exposure to Maternal Depression to Improve Infant Risk Mechanisms

Primary Purpose

Depression

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Interpersonal Therapy
Enhanced usual care
Sponsored by
University of Illinois at Urbana-Champaign
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of DenverRecruiting
  • University of Illinois

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Behavioral: Interpersonal Therapy

Enhanced Usual Care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Presence of a Major Depressive Episode on SCID interview
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation
Symptom Checklist 20 (SCL20)
Self reported Depression Scores. higher scores=more depression
Symptom Checklist 20 (SCL20)
Self reported Depression Scores. higher scores=more depression
Symptom Checklist 20 (SCL20)
Self reported Depression Scores. higher scores=more depression

Secondary Outcome Measures

Edinburgh Postnatal Depression Scale (EPDS)
Self reported Depression Scores. higher scores=more depression
Edinburgh Postnatal Depression Scale (EPDS)
Self reported Depression Scores. higher scores=more depression
Edinburgh Postnatal Depression Scale (EPDS)
Self reported Depression Scores. higher scores=more depression
Work and Social Adjustment Scale (WSAS)
general maternal functioning
Work and Social Adjustment Scale (WSAS)
general maternal functioning
Work and Social Adjustment Scale (WSAS)
general maternal functioning

Full Information

First Posted
January 4, 2017
Last Updated
February 10, 2021
Sponsor
University of Illinois at Urbana-Champaign
Collaborators
National Institute of Mental Health (NIMH), University of Denver
search

1. Study Identification

Unique Protocol Identification Number
NCT03011801
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
December 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Illinois at Urbana-Champaign
Collaborators
National Institute of Mental Health (NIMH), University of Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Behavioral: Interpersonal Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced Usual Care
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Therapy
Other Intervention Name(s)
IPT
Intervention Description
reducing conflict in relationships, increasing social support in relationships, improving communication, reducing depressive symptoms
Intervention Type
Behavioral
Intervention Name(s)
Enhanced usual care
Other Intervention Name(s)
Maternity Support Services (MSS)
Intervention Description
Treatment as Usual, including eclectic and supportive therapy, as well as psychiatric medication
Primary Outcome Measure Information:
Title
Presence of a Major Depressive Episode on SCID interview
Description
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation
Time Frame
12 months post pregnancy
Title
Symptom Checklist 20 (SCL20)
Description
Self reported Depression Scores. higher scores=more depression
Time Frame
post intervention (approximately 2-3 months post baseline)
Title
Symptom Checklist 20 (SCL20)
Description
Self reported Depression Scores. higher scores=more depression
Time Frame
6 months post intervention
Title
Symptom Checklist 20 (SCL20)
Description
Self reported Depression Scores. higher scores=more depression
Time Frame
12 months post intervention
Secondary Outcome Measure Information:
Title
Edinburgh Postnatal Depression Scale (EPDS)
Description
Self reported Depression Scores. higher scores=more depression
Time Frame
post intervention (approximately 2-3 months post baseline)
Title
Edinburgh Postnatal Depression Scale (EPDS)
Description
Self reported Depression Scores. higher scores=more depression
Time Frame
6 months post intervention
Title
Edinburgh Postnatal Depression Scale (EPDS)
Description
Self reported Depression Scores. higher scores=more depression
Time Frame
12 months post intervention
Title
Work and Social Adjustment Scale (WSAS)
Description
general maternal functioning
Time Frame
post intervention (approximately 2-3 months post baseline)
Title
Work and Social Adjustment Scale (WSAS)
Description
general maternal functioning
Time Frame
6 month post intervention
Title
Work and Social Adjustment Scale (WSAS)
Description
general maternal functioning
Time Frame
12 month post intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin L Hankin, PhD
Phone
217-300-9334
Email
hankinb@illinois.edu
Facility Information:
Facility Name
University of Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80208
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elysia Davis, PhD
Phone
303-871-3790
Email
Elysia.Davis@du.edu
Facility Name
University of Illinois
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Individual Site Status
Enrolling by invitation

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
NIMH Data Archive

Learn more about this trial

Reducing Fetal Exposure to Maternal Depression to Improve Infant Risk Mechanisms

We'll reach out to this number within 24 hrs