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Mommy-Baby Treatment for Perinatal Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01744041
Recruitment Status : Completed
First Posted : December 6, 2012
Last Update Posted : March 10, 2017
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Postpartum Depression Behavioral: Dyadic Interpersonal Psychotherapy Other: Enhanced Treatment as Usual Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Perinatal Depression: Dyadic-IPT to Improve Health of Mother and Baby
Study Start Date : November 2012
Actual Primary Completion Date : January 31, 2017
Actual Study Completion Date : January 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

Arm Intervention/treatment
Experimental: Dyadic Interpersonal Psychotherapy
Brief Interpersonal Psychotherapy during pregnancy followed by dyadic mother-infant psychotherapy for one year postpartum
Behavioral: Dyadic Interpersonal Psychotherapy
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.

Active Comparator: Enhanced Treatment as Usual
Personalized referral to community resources for depression treatment
Other: Enhanced Treatment as Usual
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.

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  • Structured Clinical Interview (SCID-IV) diagnosis of Major Depressive Disorder, dysthymia, or Depressive Disorder, Not otherwise Specified
  • English Speaking

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01744041

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United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
National Institute of Mental Health (NIMH)
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Principal Investigator: Shannon Lenze, Ph.D. Washington Univeristy
Publications of Results:
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Responsible Party: Washington University School of Medicine Identifier: NCT01744041    
Other Study ID Numbers: 201203136
K23MH090245 ( U.S. NIH Grant/Contract )
First Posted: December 6, 2012    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Keywords provided by Washington University School of Medicine:
Additional relevant MeSH terms:
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Depression, Postpartum
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications