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Reducing Fetal Exposure to Maternal Depression to Improve Infant Risk Mechanisms

NCT ID: NCT03011801

Last Updated: 2024-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2024-05-28

Brief Summary

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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

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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).

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Interpersonal Therapy

Intervention Type BEHAVIORAL

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

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.

Group Type PLACEBO_COMPARATOR

Enhanced usual care

Intervention Type BEHAVIORAL

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

Interventions

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Interpersonal Therapy

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

Intervention Type BEHAVIORAL

Enhanced usual care

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

Intervention Type BEHAVIORAL

Other Intervention Names

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IPT Maternity Support Services (MSS)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of Denver

OTHER

Sponsor Role collaborator

University of Illinois at Urbana-Champaign

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin L Hankin, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois Urbana Champaign

Elysia P Davis, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Denver

Locations

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University of Denver

Denver, Colorado, United States

Site Status

University of Illinois

Urbana, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 38680516 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37074698 (View on PubMed)

Other Identifiers

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R01MH109662

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MH109662

Identifier Type: -

Identifier Source: org_study_id