Mommy-Baby Treatment for Perinatal Depression

Depressive Disorder, Major Clinical Trial

Official title:

Perinatal Depression: Dyadic-IPT to Improve Health of Mother and Baby

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01744041
• Other study ID #: 201203136
• Secondary ID: K23MH090245
• Status: Completed
• Phase: N/A
• Start date: November 2012
• Est. completion date: January 31, 2017

Study information

• Verified date: December 2021
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 31, 2017
• Est. primary completion date: January 31, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Depressive Disorder, Major
• Postpartum Depression

Intervention

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.

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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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