Identification and Therapy of Postpartum Depression

Official Title: “Identification and Therapy of Postpartum Depression”

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

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.

Intervention(s) in this Clinical Trial

• Behavioral: Care Management for Postpartum Depression
  • Depression Care Manager calls postpartum women and encourages women to seek appropriate depression care. In this context the depression care manager helps the women to identify barriers to appropriate care, her preferred method of care, and resources available. Calls are made initially at 2 calls per month, followed by one call per month and calls every other month for women who are doing well. Women assigned to this group receive research assessments at 3, 6, and 12 months postpartum. They also receive information about community and health plan resources available for women with depression.
• Behavioral: TAU
  • Participants receive treatment as usual for postpartum depression. Women assigned to this arm receive research assessments at 3, 6, and 12 months postpartum. At the baseline home visit where diagnostic assessments are completed women are given information about community and health plan resources if they choose to seek care for depression symptoms. Women are also given phone contact numbers for the research program.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: TAU
  • Participants will receive treatment as usual
• Experimental: DCM
  • Participants will receive care management for postpartum depression

Primary Measures

• Depressive symptoms, social functioning, and health
  • Time Frame: Measured at Months 3, 6, and 12 postpartum
    Safety Issue?: Yes
• Preferences for depression treatment
  • Time Frame: Measured at baseline and Month 12
    Safety Issue?: Yes

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 Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: National Institute of Mental Health (NIMH) NIH

Overall Clinical Trial Officials and Contacts

Katherine L. Wisner, MD, RN Principal Investigator University of Pittsburgh  

Overall Contact: Katherine L. Wisner, MD, MPH 412-246-6564 wisnerkl@upmc.edu

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00282776

Study ID Number: R01 MH71825

ClinicalTrials.gov Identifier: NCT00282776

Health Authority: United States: Federal Government

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