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Identification and Therapy of Postpartum 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  Identification and Therapy of Postpartum Depression
Official Title  Identification and Therapy of Postpartum Depression
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.

Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Depressive symptoms, social functioning, and health [ Time Frame: Measured at Months 3, 6, and 12 postpartum ] [ Designated as safety issue: Yes ]
Preferences for depression treatment [ Time Frame: Measured at baseline and Month 12 ] [ Designated as safety issue: Yes ]
Secondary Outcome Measure 
Condition  Depression
Intervention  Behavioral: Care Management for Postpartum Depression
Behavioral: TAU
MEDLINE PMIDs
Links Click here for the Women's Behavioral HealthCARE Website This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  616
Start Date  August 2006
Completion Date March 2010
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
Gender Female
Ages 18 Years and older
Accepts Healthy Volunteers Yes
Contacts ††
Contact: Katherine L. Wisner, MD, MPH     412-246-6564     wisnerkl@upmc.edu    
Contact: Mary McShea, MS     412-246-5349     mcsheamc@upmc.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00282776
Organization ID R01 MH71825
Secondary IDs †† DSIR 82-SEMS
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Katherine L. Wisner, MD, RN     University of Pittsburgh    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date March 2008
First Received Date  January 25, 2006
Last Updated Date March 3, 2008

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




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