Reducing Fetal Exposure to Maternal Depression to Improve Infant Risk Mechanisms

NCT03011801 | Completed DMC

• 2 other identifiers: MH109662R01MH109662
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 2

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.

Conditions

Depression

Outcome Measures

Primary Outcomes (4)

• Presence of a Major Depressive Episode on SCID interview

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

  12 months post pregnancy

• Symptom Checklist 20 (SCL20)

  Self reported Depression Scores. higher scores=more depression

  post intervention (approximately 2-3 months post baseline)

• Symptom Checklist 20 (SCL20)

  Self reported Depression Scores. higher scores=more depression

  6 months post intervention

• Symptom Checklist 20 (SCL20)

  Self reported Depression Scores. higher scores=more depression

  12 months post intervention

Secondary Outcomes (6)

• Edinburgh Postnatal Depression Scale (EPDS)

  post intervention (approximately 2-3 months post baseline)

• Edinburgh Postnatal Depression Scale (EPDS)

  6 months post intervention

• Edinburgh Postnatal Depression Scale (EPDS)

  12 months post intervention

• Work and Social Adjustment Scale (WSAS)

  post intervention (approximately 2-3 months post baseline)

• Work and Social Adjustment Scale (WSAS)

  6 month post intervention

Study Arms (2)

Behavioral: Interpersonal Therapy

EXPERIMENTAL

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

Enhanced Usual Care

PLACEBO COMPARATOR

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

Interventions

Interpersonal Therapy BEHAVIORAL

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

Also known as: IPT

Behavioral: Interpersonal Therapy

Enhanced usual care BEHAVIORAL

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

Also known as: Maternity Support Services (MSS)

Enhanced Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• National Institute of Mental Health (NIMH): collaborator
• University of Denver: collaborator

Study Sites (2)

University of Denver

Denver, Colorado, 80208, United States

Location

University of Illinois

Urbana, Illinois, 61801, United States

Location

Related Publications (2)

• 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 DERIVED

• 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 DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Benjamin L Hankin, PhD

  University of Illinois Urbana Champaign

  PRINCIPAL INVESTIGATOR

• Elysia P Davis, PhD

  University of Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 5, 2017
• Study Start: September 1, 2017
• Primary Completion: June 30, 2022
• Study Completion: May 28, 2024
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 1 year after publication of relevant paper in refereed journal
• Access Criteria: appropriate, reasonable scientific request to co-PIs

Locations

US (2)