Antepartum Study on Use of Interpersonal Psychotherapy at 3 New York City Site

Study Overview
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Brief Summary
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This study will evaluate the effectiveness of interpersonal psychotherapy in treating pregnant women with depression.

Detailed Description
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The prevalence of antepartum depression (APD) increases twofold in women with poor social supports, low socioeconomic status (SES), and negative life events. APD may cause low birth weight, premature labor, and eclampsia. APD is also one of the best predictors of postpartum depression (PPD), which in turn may lead to impaired emotional and cognitive development of the infant. Therefore, early treatment of APD is important for the well-being of both the woman and her infant. Forms of psychotherapy have been successful in treating depression in the general population, but more research is necessary to determine the safest and most effective means of treating depression in pregnant women. Interpersonal psychotherapy targets interpersonal events and relationships. Interpersonal psychotherapy adapted for ADP may be effective in reducing depression, preventing PPD, and improving maternal infant attachment. This study will compare the effectiveness of interpersonal psychotherapy for depression in pregnancy (IPT-P) with a parenting education program (PEP) in treating depressed pregnant women who may be affected by SES and psychosocial factors. Participation in this single-blind study will last through 6 months postpartum. Potential participants will first undergo initial screening, which will include a 90-minute interview with a psychiatrist and a mood assessment with an independent evaluator. Eligible participants will then be randomly assigned to receive 12 weeks of either IPT-P or PEP. Participants in both groups will attend 45-minute weekly sessions prior to delivery of their babies. At each visit, participants will complete questionnaires about mood, anxiety, mother-infant bonding, and daily function. Participants receiving IPT-P will learn ways to address emotional stressors associated with childbirth and will be regularly contacted by a therapist to discuss feelings and emotions. Participants receiving PEP will learn about the stages of pregnancy, childbirth, and early infant development. After delivery, participants will receive weekly phone calls from a therapist during the first 4 weeks. All participants will then return for five evaluation visits, occurring at Weeks 4, 8, 12, 26, and 24 postpartum. During these visits, a therapist will evaluate participants' moods and mother-infant attachment and will refer participants to treatment if needed. The first four visits will be individual evaluations and the last visit will be a group meeting with other mothers and their infants.

Official Title
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Antepartum Study on Use of Interpersonal Psychotherapy at 3 New York City Sites

Conditions
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Depression

Intervention / Treatment
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* Behavioral: Interpersonal psychotherapy for depression in pregnancy
* Behavioral: Parenting education program (PEP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Depressed Pregnant women between 18-45 years Meets diagnostic criteria for a major depressive disorder Reads and understands English or Spanish Physically healthy without serious medical illness Between 12 and 33 weeks gestation Meets diagnostic criteria of DSM-V for a major depressive disorder HAM-D score > 12 EPDS>10 Exclusion Criteria: Drug or alcohol abuse in the 6 months prior to study entry Acute risk for suicide Clinically significant co-morbid Axis1 disorders High risk pregnancy or medical conditions that affect pregnancy when participation in the study will add to risk or compromise the medical condition History of or present non-drug induced psychosis Currently taking antidepressant medication Exclude severe (HAM-D (17 items) score >24) depression prominent vegetative symptoms and or loss of appetite

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants will Psychotherapy weekly for 12 weeks | Behavioral: Interpersonal psychotherapy for depression in pregnancy<br>* IPT-P will include 45-minute weekly sessions for 12 weeks. During sessions, participants will learn ways to address emotional stressors associated with childbirth.<br>* Other names: psychotherapy;|
| Active Comparator: 2<br>Parenting Education will include 45-minute weekly sessions for 12 week | Behavioral: Parenting education program (PEP)<br>* PEP will include 45-minute weekly sessions for 12 weeks. During sessions, participants will learn about the stages of pregnancy, childbirth, and early infant development.<br>* Other names: PEP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression |  | Measured weekly for 12 weeks antepartum and Weeks 4, 8, 12, 16, and 24 postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mother-infant bonding |  | Measured at Weeks 4, 8, 12, 16, and 24 postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Antepartum Depression, Major Depression