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Reducing Fetal Exposure to Maternal Depression to Improve Infant Risk Mechanisms

NCT03011801 — Not applicable, Completed, 234 participants, University of Illinois at Urbana-Champaign

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RegistryNCT03011801
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: single, treatment
Enrollment234 (Actual)
SponsorUniversity of Illinois at Urbana-Champaign (Other); collaborators: National Institute of Mental Health (NIMH), University of Denver
ConditionsDepression
InterventionsInterpersonal Therapy, Enhanced usual care (Behavioral)
Datesstart 2017-09-01, primary completion 2022-06-30, completion 2024-05-28, first posted 2017-01-05, last updated 2024-12-06
Locations2 sites in United States

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-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.

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+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).

+Arms and interventions

ArmTypeInterventionsDescription
Behavioral: Interpersonal TherapyExperimentalBehavioral: Interpersonal TherapyIndividual 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.
Enhanced Usual CarePlacebo comparatorBehavioral: Enhanced usual careMaternity 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.
  • Interpersonal Therapy (Behavioral), also known as IPT: reducing conflict in relationships, increasing social support in relationships, improving communication, reducing depressive symptoms
  • Enhanced usual care (Behavioral), also known as Maternity Support Services (MSS): Treatment as Usual, including eclectic and supportive therapy, as well as psychiatric medication

+Outcome measures

Primary outcomes

  • Presence of a Major Depressive Episode on SCID interview [12 months post pregnancy]: Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation
  • Symptom Checklist 20 (SCL20) [post intervention (approximately 2-3 months post baseline)]: Self reported Depression Scores. higher scores=more depression
  • Symptom Checklist 20 (SCL20) [6 months post intervention]: Self reported Depression Scores. higher scores=more depression
  • Symptom Checklist 20 (SCL20) [12 months post intervention]: Self reported Depression Scores. higher scores=more depression

Secondary outcomes

  • Edinburgh Postnatal Depression Scale (EPDS) [post intervention (approximately 2-3 months post baseline)]: Self reported Depression Scores. higher scores=more depression
  • Edinburgh Postnatal Depression Scale (EPDS) [6 months post intervention]: Self reported Depression Scores. higher scores=more depression
  • Edinburgh Postnatal Depression Scale (EPDS) [12 months post intervention]: Self reported Depression Scores. higher scores=more depression
  • Work and Social Adjustment Scale (WSAS) [post intervention (approximately 2-3 months post baseline)]: general maternal functioning
  • Work and Social Adjustment Scale (WSAS) [6 month post intervention]: general maternal functioning
  • Work and Social Adjustment Scale (WSAS) [12 month post intervention]: general maternal functioning

+Eligibility

Sex: Female, ages: 18 Years to any

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

+Locations (2)

FacilityCityCountryStatus
University of DenverDenver, ColoradoUnited States
University of IllinoisUrbana, IllinoisUnited States

+Publications

  • Results publication: Davis EP, Demers CH, Deer L, Gallop RJ, Hoffman MC, Grote N, Hankin BL. Impact of prenatal maternal depression on gestational length: post hoc analysis of a randomized clinical trial. EClinicalMedicine. 2024 Apr 22;72:102601. doi: 10.1016/j.eclinm.2024.102601. eCollection 2024 Jun. PMID 38680516
  • Results publication: Hankin BL, Demers CH, Hennessey EP, Perzow SED, Curran MC, Gallop RJ, Hoffman MC, Davis EP. Effect of Brief Interpersonal Therapy on Depression During Pregnancy: A Randomized Clinical Trial. JAMA Psychiatry. 2023 Jun 1;80(6):539-547. doi: 10.1001/jamapsychiatry.2023.0702. PMID 37074698

+Investigators

+Funding

NIH grants: R01MH109662

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