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Clinical Trials/NCT00282776
NCT00282776
Completed
Phase 3

Identification and Therapy of Postpartum Depression

University of Pittsburgh1 site in 1 country628 target enrollmentAugust 2006
ConditionsDepression

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Depression
Sponsor
University of Pittsburgh
Enrollment
628
Locations
1
Primary Endpoint
Depressive symptoms, social functioning, and health
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

This study will evaluate the effectiveness of a telephone-based depression screening and care management program in treating depression in postpartum women.

Detailed Description

Depression is a serious illness that can interfere with everyday life. Researchers believe that it is one of the most common complications during and after pregnancy. Depression after pregnancy is called postpartum depression and may be caused by a rapid change in hormone levels during and immediately after pregnancy. Postpartum depression can occur anytime within the first year after childbirth and can negatively affect both mothers and their children. Mothers with postpartum depression may experience low energy, difficulty concentrating, irritability, and inability to meet their children's needs for love and affection. As a result, women with postpartum depression may feel guilty and lose confidence in themselves as parents. Research shows that children of mothers with postpartum depression may have delays in language development, difficulty with emotional bonding to others, behavioral problems, lower activity levels, sleep problems, and distress. This study will evaluate the effectiveness of a telephone-based depression screening and care management program in treating depression in postpartum women. Participants in this single blind study will be randomly assigned to receive either enhanced treatment as usual or telephone-based care management for the first year postpartum. All participants will have a 90-minute in-home interview upon study entry to assess depressive symptoms, functional status, medical history, and post-pregnancy plans. Participants assigned to care management will receive two calls in the first month postpartum, followed by monthly calls for the remainder of the first postpartum year. During each 10- to 20-minute call, participants will be asked to provide information regarding current depressive symptoms, steps they have taken to seek depression-related care, and any barriers they have encountered in the process. In addition, a care manager will act as an advocate for the participants and assist in obtaining specialized services as necessary throughout the year. Participants assigned to receive enhanced treatment as usual will not receive monthly phone calls or tailored care management. All participants will receive follow-up calls at 3, 6, and 12 months postpartum to assess outcome measures; these calls will last about 30 minutes.

Registry
clinicaltrials.gov
Start Date
August 2006
End Date
March 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Katherine Wisner

Professor of Psychiatry, Obstetrics and Gynecology and Reproductive Sciences, Epidemiology and Women's Studies

University of Pittsburgh

Eligibility Criteria

Inclusion Criteria

  • 4-6 weeks postpartum
  • English-speaking
  • Score of at least 10 on the Edinburgh Postnatal Depression Scale

Exclusion Criteria

  • DSM-IV diagnosis of bipolar disorder or psychotic episode
  • Active substance abuse within 6 months prior to study entry
  • Has not received obstetrical care
  • History of a suicide attempt within 6 months of study entry

Outcomes

Primary Outcomes

Depressive symptoms, social functioning, and health

Time Frame: Measured at Months 3, 6, and 12 postpartum

Preferences for depression treatment

Time Frame: Measured at baseline and Month 12

Study Sites (1)

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