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Completed

NCT Number: NCT00251043

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

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

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

New York State Psychiatric Institute

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interpersonal psychotherapy for depression in pregnancy

Behavioral

IPT-P will include 45-minute weekly sessions for 12 weeks. During sessions, participants will learn ways to address emotional stressors associated with childbirth.

Other names: psychotherapy

Parenting education program (PEP)

Behavioral

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.

Other names: PEP

Primary outcomes

  1. Depression

    Time frame: Measured weekly for 12 weeks antepartum and Weeks 4, 8, 12, 16, and 24 postpartum

Secondary outcomes

  1. Mother-infant bonding

    Time frame: Measured at Weeks 4, 8, 12, 16, and 24 postpartum

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Nov 9, 2005
Registry last updated
Mar 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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