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Effectiveness of Interpersonal Psychotherapy in Treating Pregnant Women With Depression

This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), February 2008

Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00251043
  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 (IPT-P)
Behavioral: Parenting education program (PEP)
Phase IV

MedlinePlus related topics:   Depression   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:   Antepartum Study on Use of Interpersonal Psychotherapy at 3 New York City Sites

Further study details as provided by National Institute of Mental Health (NIMH):

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 ]

Estimated Enrollment:   150
Study Start Date:   September 2005
Estimated Study Completion Date:   April 2010
Estimated Primary Completion Date:   April 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
1: Experimental
Participants will receive interpersonal psychotherapy for depression in pregnancy
Behavioral: Interpersonal psychotherapy for depression in pregnancy (IPT-P)
IPT-P will include 45-minute weekly sessions for 12 weeks. During sessions, participants will learn ways to address emotional stressors associated with childbirth.
2: Active Comparator
Participants will receive parenting education program
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.

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 47 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Criteria

Inclusion Criteria:

  • Pregnant
  • Meets diagnostic criteria for a major depressive disorder
  • Physically healthy
  • Between 12 and 33 weeks gestation

Exclusion Criteria:

  • Drug or alcohol abuse in the 6 months prior to study entry
  • Acute risk for suicide
  • Currently taking antidepressant medication
  Contacts and Locations

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

Locations
United States, New York
New York State Psychiatric Institute     Recruiting
      New York, New York, United States, 10032
      Contact: Margaret G. Spinelli, MD     212-543-5860     mgs8@columbia.edu    
      Contact: Jean Endicott, PhD     212-543-5536     je10@columbia.edu    
      Principal Investigator: Margaret G. Spinelli, MD            

Sponsors and Collaborators

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:

Responsible Party:   New York State Psychiatric Institute ( Margaret G. Spinelli, MD )
Study ID Numbers:   R01 MH069915, R01 MH069915-01A2, DSIR 83-ATAS
First Received:   November 7, 2005
Last Updated:   February 14, 2008
ClinicalTrials.gov Identifier:   NCT00251043
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Pregnancy  
Antepartum Depression  
Major Depression  

Study placed in the following topic categories:
Depression
Mental Disorders
Mood Disorders
Depressive Disorder, Major
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 18, 2008




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