Identification and Therapy of Postpartum Depression

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Katherine Wisner, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00282776
First received: January 25, 2006
Last updated: September 30, 2013
Last verified: September 2013

January 25, 2006
September 30, 2013
August 2006
March 2012   (final data collection date for 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 ]
  • Depressive symptoms
  • Preferences for depression treatment (measured at Months 3, 6, and 12)
  • Social and everyday functioning
  • General health
Complete list of historical versions of study NCT00282776 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Identification and Therapy of Postpartum Depression
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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Depression
  • 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.
  • Active Comparator: TAU
    Participants will receive treatment as usual
    Intervention: Behavioral: TAU
  • Experimental: DCM
    Participants will receive care management for postpartum depression
    Intervention: Behavioral: Care Management for Postpartum Depression

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
628
March 2012
March 2012   (final data collection date for primary outcome measure)

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
Female
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00282776
R01 MH71825, R01MH071825, DSIR 82-SEMS
No
Katherine Wisner, University of Pittsburgh
University of Pittsburgh
National Institute of Mental Health (NIMH)
Principal Investigator: Katherine L. Wisner, MD, RN University of Pittsburgh
University of Pittsburgh
September 2013

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