Postpartum Major Depression Clinical Trial
Official title:
Teens--Building Options and Opportunities for Moms
Postpartum depression (PPD) is depression that occurs shortly after the mother delivers her
baby. Mothers with postpartum depression may feel sad mood, low motivation or stress; some
may have problems caring for their new baby. Successful depression treatment involves early
screening and detection of postpartum depression and early access to treatment services.
The purpose of this study is to evaluate the effectiveness of a telephone-based depression
screening and care management program for postpartum women. We will evaluate the: 1) how
often (frequency) young mothers develop symptoms of depression 4 to 6 weeks after birth, 2)
how quickly (timeliness) young mother receive treatment and how effective (adequacy) are the
treatments for the symptoms of postpartum depression, 3) the effects of depression care
support on young mothers' symptoms and their ability to function at 3, 6 and 12 months after
entering the study, 4) visits to the pediatrician or nurse practitioner (preventive health
services) during their baby's first year of life, and 5) cost and cost savings associated
with depression care management.
Depression during the perinatal period is a major public health concern. Postpartum
depression (PPD) causes personal and family suffering at a time when adaptation to
parenthood is critical. Successful interventions for treating depression in medical settings
have been framed by a chronic disease management model. The key ingredient to success is a
dedicated care manager who provides education and support to patients, actively coordinates
care, and thereby improves treatment outcomes for patients. Compared to interventions in
medical office settings, telephone care management positioned at the level of the health
plan offers a systematic and efficient mechanism for ongoing treatment support of women with
PPD, particularly in a geographically dispersed population.
We propose to conduct a comprehensive project to improve treatment outcomes for depressed
postpartum women through adaptation of the depression care management model used in primary
care settings. The major components are: 1) depression screening in a population of
postpartum adolescents, 2) depression education for all who screen positive, 3) a diagnostic
interview to evaluate for depressive disorders in mothers who score above and below a
defined threshold on the screening instrument, 4) telephone-based care management
intervention, and 5) longitudinal evaluation across the first year post-birth for depression
and maternal and child public health outcomes. Focus groups will precede the major study
components. A focus group of adolescent mothers will inform the investigators about the
barriers to depression care management that encompass resource needs, acceptability of
interventions to cope with stress or depression, and access to care. A separate focus group
of community professionals of representatives from agencies or groups that provide community
supports and health services will be used to explore the perceptions of barriers to care for
new adolescent mothers. All participants in this project will be eligible for mental health
services through their health plans that serve Medicaid and commercial members.
We plan to identify 125 child or adolescent new mothers with PPD. The child or adolescent
new mothers will be assigned to depression care management. They will be supported in making
choices about depression treatment (after receiving education about options), encouraged to
access their preferred treatment (through the direct discussion of barriers and solutions),
counseled to comply with treatment recommendations, and assisted to problem-solve if failure
to respond occurs. All participants will have systematic evaluations at 3, 6, and 12 months
post-birth. Outcomes include not only maternal depressive symptom levels but also functional
and public health outcomes for mothers, families, and infants. We have developed a
multi-disciplinary team with expertise in clinical research with depressed and minority
women and health services to address these needs.
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Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care