Depression Clinical Trial
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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