Mommy-Baby Treatment for Perinatal Depression

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Washington University School of Medicine
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT01744041
First received: November 27, 2012
Last updated: August 26, 2014
Last verified: August 2014
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01744041

Contacts
Contact: Jennifer Rodgers, M.A. 314-286-2340 rodgersj@psychiatry.wustl.edu
Contact: Shannon Lenze, Ph.D. 314-362-2752 lenzes@psychiatry.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Jennifer Rodgers, M.A.    314-286-2340    rodgersj@psychiatry.wustl.edu   
Principal Investigator: Shannon Lenze, Ph.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Shannon Lenze, Ph.D. Washington Univeristy
  More Information

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: August 26, 2014
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
Depression, Postpartum
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pregnancy Complications
Puerperal Disorders

ClinicalTrials.gov processed this record on October 20, 2014