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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00251043 |
This study will evaluate the effectiveness of interpersonal psychotherapy in treating pregnant women with depression.
Condition | Intervention | Phase |
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Depression |
Behavioral: Interpersonal psychotherapy for depression in pregnancy (IPT-P) Behavioral: Parenting education program (PEP) |
Phase IV |
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 |
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 |
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1: Experimental
Participants will receive interpersonal psychotherapy for depression in pregnancy
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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.
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2: Active Comparator
Participants will receive parenting education program
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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.
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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.
Ages Eligible for Study: | 18 Years to 47 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Margaret G. Spinelli, MD | New York State Psychiatric Institute |
Principal Investigator: | Jean Endicott, PhD | New York State Psychiatric Institute |
Responsible Party: | New York State Psychiatric Institute ( Margaret G. Spinelli, MD ) |
Study ID Numbers: | R01 MH069915, R01 MH069915-01A2, DSIR 83-ATAS |
Study First Received: | November 7, 2005 |
Last Updated: | September 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00251043 |
Health Authority: | United States: Federal Government |
Pregnancy Antepartum Depression Major Depression |
Depression Mental Disorders Mood Disorders |
Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |