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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00251043
First received: November 7, 2005
Last updated: March 23, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Depression
Behavioral: Interpersonal psychotherapy for depression in pregnancy
Behavioral: Parenting education program (PEP)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Antepartum Study on Use of Interpersonal Psychotherapy at 3 New York City Sites

Resource links provided by NLM:


Further study details as provided by New York State Psychiatric Institute:

Primary Outcome Measures:
  • Depression [ Time Frame: Measured weekly for 12 weeks antepartum and Weeks 4, 8, 12, 16, and 24 postpartum ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mother-infant bonding [ Time Frame: Measured at Weeks 4, 8, 12, 16, and 24 postpartum ] [ Designated as safety issue: No ]

Enrollment: 142
Study Start Date: September 2005
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: PEP

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00251043

Locations
United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032
Sponsors and Collaborators
New York State Psychiatric Institute
Investigators
Principal Investigator: Margaret G. Spinelli, MD New York State Psychiatric Institute
Principal Investigator: Jean Endicott, PhD New York State Psychiatric Institute
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00251043     History of Changes
Other Study ID Numbers: #4830/6040R, R01MH069915, R01 MH069915-01A2, 4830/6040R
Study First Received: November 7, 2005
Last Updated: March 23, 2012
Health Authority: United States: Federal Government

Keywords provided by New York State Psychiatric Institute:
Pregnancy
Antepartum Depression
Major Depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014