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Reducing Fetal Exposure to Maternal Depression to Improve Infant Risk Mechanisms

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ClinicalTrials.gov Identifier: NCT03011801
Recruitment Status : Recruiting
First Posted : January 5, 2017
Last Update Posted : May 8, 2018
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
University of Denver
Information provided by (Responsible Party):
University of Illinois at Urbana-Champaign

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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Interpersonal Therapy Behavioral: Enhanced usual care Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing Fetal Exposure to Maternal Depression to Improve Infant Risk Mechanisms
Actual Study Start Date : September 1, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : March 28, 2022

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Maternity Support Services (MSS)




Primary Outcome Measures :
  1. Presence of a Major Depressive Episode on SCID interview [ Time Frame: 12 months post pregnancy ]
    Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation


Secondary Outcome Measures :
  1. Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: post intervention (approximately 2 months post baseline) ]
    Self reported Depression Scores

  2. Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: 3 months post intervention ]
    Self reported Depression Scores

  3. Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: 6 months post intervention ]
    Self reported Depression Scores

  4. Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: 12 months post intervention ]
    Self reported Depression Scores

  5. Work and Social Adjustment Scale (WSAS) [ Time Frame: post intervention (approximately 2 months post baseline) ]
    general maternal functioning

  6. Work and Social Adjustment Scale (WSAS) [ Time Frame: 3 month post intervention ]
    general maternal functioning

  7. Work and Social Adjustment Scale (WSAS) [ Time Frame: 6 month post intervention ]
    general maternal functioning

  8. Work and Social Adjustment Scale (WSAS) [ Time Frame: 12 month post intervention ]
    general maternal functioning



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03011801


Contacts
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Contact: Benjamin L Hankin, PhD 217-300-9334 hankinb@illinois.edu

Locations
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United States, Colorado
University of Denver Recruiting
Denver, Colorado, United States, 80208
Contact: Elysia Davis, PhD    303-871-3790    Elysia.Davis@du.edu   
United States, Illinois
University of Illinois Enrolling by invitation
Urbana, Illinois, United States, 61801
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
National Institute of Mental Health (NIMH)
University of Denver

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Responsible Party: University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT03011801     History of Changes
Other Study ID Numbers: MH109662
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: NIMH Data Archive

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders