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Completed

NCT Number: NCT03011801

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Denver, Denver, Colorado, United States

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interpersonal Therapy

Behavioral

reducing conflict in relationships, increasing social support in relationships, improving communication, reducing depressive symptoms

Other names: IPT

Enhanced Usual Care

Behavioral

Treatment as Usual, including eclectic and supportive therapy, as well as psychiatric medication

Other names: Maternity Support Services (MSS)

Primary outcomes

  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

  2. Symptom Checklist 20 (SCL20)

    Time frame: post intervention (approximately 2-3 months post baseline)

    Self reported Depression Scores. higher scores=more depression

  3. Symptom Checklist 20 (SCL20)

    Time frame: 6 months post intervention

    Self reported Depression Scores. higher scores=more depression

  4. Symptom Checklist 20 (SCL20)

    Time frame: 12 months post intervention

    Self reported Depression Scores. higher scores=more depression

Secondary outcomes

  1. Edinburgh Postnatal Depression Scale (EPDS)

    Time frame: post intervention (approximately 2-3 months post baseline)

    Self reported Depression Scores. higher scores=more depression

  2. Edinburgh Postnatal Depression Scale (EPDS)

    Time frame: 6 months post intervention

    Self reported Depression Scores. higher scores=more depression

  3. Edinburgh Postnatal Depression Scale (EPDS)

    Time frame: 12 months post intervention

    Self reported Depression Scores. higher scores=more depression

  4. Work and Social Adjustment Scale (WSAS)

    Time frame: post intervention (approximately 2-3 months post baseline)

    general maternal functioning

  5. Work and Social Adjustment Scale (WSAS)

    Time frame: 6 month post intervention

    general maternal functioning

  6. Work and Social Adjustment Scale (WSAS)

    Time frame: 12 month post intervention

    general maternal functioning

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • University of Denver

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2024
First posted
Jan 5, 2017
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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