Identification and Therapy of Postpartum Depression

University of Pittsburgh

Status and phase: Completed; Phase 3

Conditions: Depression

Treatments: Behavioral: TAU; Behavioral: Care Management for Postpartum Depression

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00282776

R01MH071825 (U.S. NIH Grant/Contract)

DSIR 82-SEMS

Details and patient eligibility

About

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

Full 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.

Enrollment: 628 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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628 participants in 2 patient groups

TAU

Active Comparator group

Description:

Participants will receive treatment as usual

Treatment:

Behavioral: TAU

DCM

Experimental group

Description:

Participants will receive care management for postpartum depression

Treatment:

Behavioral: Care Management for Postpartum Depression