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Effectiveness of Interpersonal Psychotherapy in Treating Pregnant Women With Depression

This study is currently recruiting participants.
Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Effectiveness of Interpersonal Psychotherapy in Treating Pregnant Women With Depression
Official Title  Antepartum Study on Use of Interpersonal Psychotherapy at 3 New York City Sites
Brief Summary

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

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 Phase Phase IV
Study Type  Interventional
Study Design  Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  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 Measure  Mother-infant bonding [ Time Frame: Measured at Weeks 4, 8, 12, 16, and 24 postpartum ] [ Designated as safety issue: No ]
Condition  Depression
Intervention  Behavioral: Interpersonal psychotherapy for depression in pregnancy (IPT-P)
Behavioral: Parenting education program (PEP)
MEDLINE PMIDs 12611838
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  150
Start Date  September 2005
Completion Date April 2010
Eligibility 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
Gender Female
Ages 18 Years to 47 Years
Accepts Healthy Volunteers Yes
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00251043
Organization ID R01 MH069915
Secondary IDs †† R01 MH069915-01A2, DSIR 83-ATAS
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Margaret G. Spinelli, MD     New York State Psychiatric Institute    
Principal Investigator:     Jean Endicott, PhD     New York State Psychiatric Institute    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date February 2008
First Received Date  November 7, 2005
Last Updated Date February 14, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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