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Mommy-Baby Treatment for Perinatal Depression

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01744041
First received: November 27, 2012
Last updated: December 4, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Depressive Disorder, Major
Postpartum Depression
 Behavioral: Dyadic Interpersonal Psychotherapy
Other: Enhanced Treatment as Usual

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Perinatal Depression: Dyadic-IPT to Improve Health of Mother and Baby

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Change in Edinburgh Depression Scale from Baseline [ Time Frame: 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: November 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dyadic Interpersonal Psychotherapy
Brief Interpersonal Psychotherapy during pregnancy followed by dyadic mother-infant psychotherapy for one year postpartum
 Behavioral: Dyadic Interpersonal Psychotherapy
Active Comparator: Enhanced Treatment as Usual
Personalized referral to community resources for depression treatment
 Other: Enhanced Treatment as Usual

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women
  • 18 years and older
  • between 12 and 30 weeks gestation
  • Score greater than or equal to 13 on Edinburgh Depression Scale
  • SCID-IV diagnosis of MDD, dysthymia, or Depressive Disorder, NOS
  • English Speaking

Exclusion Criteria:

  • Substance abuse or dependence in past 3 months
  • Acitive 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01744041

Locations
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63105
Sponsors and Collaborators
Washington University School of Medicine
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Shannon Lenze, Ph.D. Washington Univeristy
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01744041     History of Changes
Other Study ID Numbers: 201203136, K23MH090245
Study First Received: November 27, 2012
Last Updated: December 4, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Washington University School of Medicine:
depression
pregnancy
postpartum
psychotherapy

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Depressive Disorder, Major
Behavioral Symptoms
 Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications

ClinicalTrials.gov processed this record on May 21, 2013