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

New York State Psychiatric Institute

Status and phase

Completed

Phase 4

Conditions

Depression

Treatments

Behavioral: Parenting education program (PEP)

Behavioral: Interpersonal psychotherapy for depression in pregnancy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00251043

4830/6040R (Other Identifier)

R01MH069915-01A2 (U.S. NIH Grant/Contract)

R01MH069915 (U.S. NIH Grant/Contract)

#4830/6040R

Details and patient eligibility

About

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

Full description

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.

Enrollment

142 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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