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

March 23, 2012 updated by: New York State Psychiatric Institute

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • New York State Psychiatric Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Participants will Psychotherapy weekly for 12 weeks
Behavioral: Interpersonal psychotherapy for depression in pregnancy
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
Active Comparator: 2
Parenting Education will include 45-minute weekly sessions for 12 week
Behavioral: Parenting education program (PEP)
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

New York State Psychiatric Institute

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Margaret G. Spinelli, MD, New York State Psychiatric Institute
  • Principal Investigator: Jean Endicott, PhD, New York State Psychiatric Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

November 7, 2005

First Submitted That Met QC Criteria

November 7, 2005

First Posted (Estimate)

November 9, 2005

Study Record Updates

Last Update Posted (Estimate)

March 26, 2012

Last Update Submitted That Met QC Criteria

March 23, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #4830/6040R
  • R01MH069915 (U.S. NIH Grant/Contract)
  • R01MH069915-01A2 (U.S. NIH Grant/Contract)
  • 4830/6040R (Other Identifier: New York State Psychiatric Institute)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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