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DepressionNCT03011801

Reducing Fetal Exposure to Maternal Depression to Improve Infant Risk Mechanisms

A study testing Interpersonal Therapy in people with Depression, run by University of Illinois at Urbana-Champaign at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Depression
What is being tested?
Interpersonal Therapy
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
234 participants
Where
2 sitesUnited States
Study dates
1 Sep 2017to 28 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • University of Denver

    Denver, Colorado, 80208

  • University of Illinois

    Urbana, Illinois, 61801

Other trials in United States

About this study

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.

Read the 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).

Conditions
Depression
Being tested
Interpersonal Therapy, Enhanced usual care
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interpersonal TherapyBehavioural

    Also called IPT

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

  • Enhanced usual careBehavioural

    Also called Maternity Support Services (MSS)

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

Study groups in NCT03011801
Study groupRoleWhat they receive
Behavioral: Interpersonal TherapyExperimentalIndividual 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.
Receives: Behavioral: Interpersonal Therapy
Enhanced Usual CarePlacebo comparatorMaternity 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.
Receives: Behavioral: Enhanced usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence of a Major Depressive Episode on SCID interview

    Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation

    Measured: 12 months post pregnancy

  2. Symptom Checklist 20 (SCL20)

    Self reported Depression Scores. higher scores=more depression

    Measured: post intervention (approximately 2-3 months post baseline)

  3. Symptom Checklist 20 (SCL20)

    Self reported Depression Scores. higher scores=more depression

    Measured: 6 months post intervention

  4. Symptom Checklist 20 (SCL20)

    Self reported Depression Scores. higher scores=more depression

    Measured: 12 months post intervention

Secondary outcomes (6)

  1. Edinburgh Postnatal Depression Scale (EPDS)

    Self reported Depression Scores. higher scores=more depression

    Measured: post intervention (approximately 2-3 months post baseline)

  2. Edinburgh Postnatal Depression Scale (EPDS)

    Self reported Depression Scores. higher scores=more depression

    Measured: 6 months post intervention

  3. Edinburgh Postnatal Depression Scale (EPDS)

    Self reported Depression Scores. higher scores=more depression

    Measured: 12 months post intervention

  4. Work and Social Adjustment Scale (WSAS)

    general maternal functioning

    Measured: post intervention (approximately 2-3 months post baseline)

  5. Work and Social Adjustment Scale (WSAS)

    general maternal functioning

    Measured: 6 month post intervention

  6. Work and Social Adjustment Scale (WSAS)

    general maternal functioning

    Measured: 12 month post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2017 (estimated)
  2. Study start1 Sep 2017
  3. Primary completion30 Jun 2022
  4. Study completion28 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
234 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03011801
Sponsor's protocol ID
MH109662
Other IDs
R01MH109662
Status last verified
Dec 2024
First submitted
4 Jan 2017
Last updated
6 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: NIMH Data Archive

Publications

  • Demers CH, Hankin BL, Deer LK, Gallop RJ, Hoeflich Haase M, Hoffman MC, Styner MA, Grote NK, Davis EP. Infant hippocampal and amygdala volume in an observational follow-up from a randomized clinical trial for maternal prenatal depression. Nat Commun. 2026 Oct 16;17(1):10649. doi: 10.1038/s41467-026-78276-4.

    PubMed 42888210

  • 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.

    PubMed 38680516

  • 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.

    PubMed 37074698

Questions about this trial

What is this clinical trial studying?

A study testing Interpersonal Therapy in people with Depression, run by University of Illinois at Urbana-Champaign at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of a Major Depressive Episode on SCID interview (time frame: 12 months post pregnancy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03011801, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.

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