Mommy-Baby Treatment for Perinatal Depression

NCT01744041 | Completed Results DMC

• 2 other identifiers: 201203136K23MH090245
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Perinatal depression is a major public health problem, affecting 15% of women during pregnancy through the postpartum period, with adverse consequences for the mother, the fetus, the infant, and the family. Despite increasing evidence of the importance of this critical risk interval, little research has investigated the effects of depression treatment during pregnancy on infant outcomes. The purpose of this study is to test the feasibility, acceptability, and effectiveness of a new intervention, Interpersonal psychotherapy for the mother-infant dyad (IPT-Dyad). This intervention begins during pregnancy and continues with the mother and infant until one year postpartum. The investigators hypothesize that IPT-Dyad will be better than treatment as usual in reducing depressive symptoms, improving psychosocial functioning,increasing parenting self-efficacy, improving infant emotional development, and enhancing mother-infant relationship quality.

Conditions

Depressive Disorder, Major; Postpartum Depression

Keywords

depression; pregnancy; postpartum; psychotherapy

Outcome Measures

Primary Outcomes (1)

• Change in Edinburgh Depression Scale From Baseline

  Edinburgh Postnatal Depression Scale, a 10-item scale of depression severity, scores range from 0 to 30 with higher scores indicating worse outcome.

  Change from baseline at End of pregnancy (between 37-39 weeks gestation); change from baseline at 3 months postpartum; change from baseline at 6 months postpartum; change from baseline at 9 months postpartum; change from baseline at 12 months postpartum

Study Arms (2)

Dyadic Interpersonal Psychotherapy

EXPERIMENTAL

Brief Interpersonal Psychotherapy during pregnancy followed by dyadic mother-infant psychotherapy for one year postpartum

Behavioral: Dyadic Interpersonal Psychotherapy

Enhanced Treatment as Usual

ACTIVE COMPARATOR

Personalized referral to community resources for depression treatment

Other: Enhanced Treatment as Usual

Interventions

Dyadic Interpersonal Psychotherapy BEHAVIORAL

This intervention consists of a brief psychotherapeutic intervention, Interpersonal Psychotherapy, during pregnancy. Interpersonal Psychotherapy focuses on improving social relationships and interpersonal communication to improve mood. The postpartum phase also utilizes developmentally appropriate strategies to improve the mother-infant relationship.

Dyadic Interpersonal Psychotherapy

Enhanced Treatment as Usual OTHER

This intervention consists of personalized referrals to specialty mental health providers, spiritual counselors, or other needed social services. It includes some non-specific supportive techniques delivered primarily via telephone.

Enhanced Treatment as Usual

Eligibility Criteria

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

You may qualify if:

• Pregnant women
• years and older
• between 12 and 30 weeks gestation
• Score greater than or equal to 13 on Edinburgh Depression Scale
• Structured Clinical Interview (SCID-IV) diagnosis of Major Depressive Disorder, dysthymia, or Depressive Disorder, Not otherwise Specified
• English Speaking

You may not qualify if:

• Substance abuse or dependence in past 3 months
• Active suicidal or homicidal ideation
• Bipolar disorder, psychotic disorder
• unstable medical condition or other medical/obstetrical complication
• Evidence of severe intimate partner violence
• Ongoing psychosocial or pharmacotherapy for depression

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Publications (3)

• Lenze SN, Rodgers J, Luby J. A pilot, exploratory report on dyadic interpersonal psychotherapy for perinatal depression. Arch Womens Ment Health. 2015 Jun;18(3):485-91. doi: 10.1007/s00737-015-0503-6. Epub 2015 Jan 22.

  PMID: 25604869 RESULT

• Lenze SN, Potts MA. Brief Interpersonal Psychotherapy for depression during pregnancy in a low-income population: A randomized controlled trial. J Affect Disord. 2017 Mar 1;210:151-157. doi: 10.1016/j.jad.2016.12.029. Epub 2016 Dec 20.

  PMID: 28038377 RESULT

• Lenze SN, Potts MA, Rodgers J, Luby J. Lessons learned from a pilot randomized controlled trial of dyadic interpersonal psychotherapy for perinatal depression in a low-income population. J Affect Disord. 2020 Jun 15;271:286-292. doi: 10.1016/j.jad.2020.03.084. Epub 2020 Apr 15.

  PMID: 32479328 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depression, Postpartum; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Behavioral Symptoms; Behavior

Limitations and Caveats

This is a small pilot study designed to assess feasibility and not efficacy of this intervention. The primary outcome measure was a self-report scale that may not reflect unbiased outcomes. There was a substantial drop-out rate in each study arm.

Results Point of Contact

• Title: Dr. Shannon Lenze
• Organization: Washington University - School of Medicine

slenze@wustl.edu

3143622752

Study Officials

• Shannon Lenze, Ph.D.

  Washington Univeristy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2012
• First Posted: December 6, 2012
• Study Start: November 1, 2012
• Primary Completion: January 31, 2017
• Study Completion: January 31, 2017
• Last Updated: January 11, 2022
• Results First Posted: January 11, 2022

Record last verified: 2021-12

Locations

US (1)