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Effectiveness of Interpersonal Psychotherapy in Treating Pregnant Women With Depression
This study is currently recruiting participants.
Study NCT00251043   Information provided by National Institute of Mental Health (NIMH)
First Received: November 7, 2005   Last Updated: March 12, 2009   History of Changes

November 7, 2005
March 12, 2009
September 2005
April 2010   (final data collection date for 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 ]
  • CGI
  • Edinburgh Postnatal Depression Scale
  • Hamilton Rating Scale for Depression
Complete list of historical versions of study NCT00251043 on ClinicalTrials.gov Archive Site
Mother-infant bonding [ Time Frame: Measured at Weeks 4, 8, 12, 16, and 24 postpartum ] [ Designated as safety issue: No ]
Mother-Infant Bonding
 
Effectiveness of Interpersonal Psychotherapy in Treating Pregnant Women With Depression
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.

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.

Phase IV
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Depression
  • Behavioral: Interpersonal psychotherapy for depression in pregnancy (IPT-P)
  • Behavioral: Parenting education program (PEP)
  • Experimental: Participants will receive interpersonal psychotherapy for depression in pregnancy
  • Active Comparator: Participants will receive parenting education program
Spinelli MG, Endicott J. Controlled clinical trial of interpersonal psychotherapy versus parenting education program for depressed pregnant women. Am J Psychiatry. 2003 Mar;160(3):555-62.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
150
April 2010
April 2010   (final data collection date for primary outcome measure)

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
Female
18 Years to 47 Years
Yes
 
United States
 
NCT00251043
Margaret G. Spinelli, MD, New York State Psychiatric Institute
R01 MH069915, R01 MH069915-01A2, DSIR 83-ATAS
National Institute of Mental Health (NIMH)
 
Principal Investigator: Margaret G. Spinelli, MD New York State Psychiatric Institute
Principal Investigator: Jean Endicott, PhD New York State Psychiatric Institute
National Institute of Mental Health (NIMH)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP