This trial has been completed.

Conditions depressive disorder, major, postpartum depression
Treatments dyadic interpersonal psychotherapy, enhanced treatment as usual
Sponsor Washington University School of Medicine
Collaborator National Institute of Mental Health (NIMH)
Start date November 2012
End date January 2017
Trial size 42 participants
Trial identifier NCT01744041, 201203136, K23MH090245


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Primary purpose treatment
Masking no masking
Brief Interpersonal Psychotherapy during pregnancy followed by dyadic mother-infant psychotherapy for one year postpartum
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)
Personalized referral to community resources for depression treatment
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 Outcomes

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

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title Perinatal Depression: Dyadic-IPT to Improve Health of Mother and Baby
Principal investigator Shannon Lenze, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in March 2017.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.