Mommy-Baby Treatment for Perinatal Depression

Study Overview
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Brief Summary
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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.

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

Conditions
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Depressive Disorder, Major, Postpartum Depression

Intervention / Treatment
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* Behavioral: Dyadic Interpersonal Psychotherapy
* Other: Enhanced Treatment as Usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dyadic Interpersonal Psychotherapy<br>Brief Interpersonal Psychotherapy during pregnancy followed by dyadic mother-infant psychotherapy for one year postpartum | Behavioral: Dyadic Interpersonal Psychotherapy<br>* 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.<br>|
| Active Comparator: Enhanced Treatment as Usual<br>Personalized referral to community resources for depression treatment | Other: Enhanced Treatment as Usual<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, pregnancy, postpartum, psychotherapy