MedPath

Identification and Therapy of Postpartum Depression

Phase 3
Completed
Conditions
Depression
Interventions
Behavioral: TAU
Behavioral: Care Management for Postpartum Depression
Registration Number
NCT00282776
Lead Sponsor
University of Pittsburgh
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
628
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
TAUTAUParticipants will receive treatment as usual
DCMCare Management for Postpartum DepressionParticipants will receive care management for postpartum depression
Primary Outcome Measures
NameTimeMethod
Depressive symptoms, social functioning, and healthMeasured at Months 3, 6, and 12 postpartum
Preferences for depression treatmentMeasured at baseline and Month 12
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Women's Behavioral HealthCARE Program, Suite 410, 3501 Forbes Ave

🇺🇸

Pittsburgh, Pennsylvania, United States

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