University of Washington
Seattle, Washington, 98105, United States
NCT Number: NCT01045655
The study will evaluate the effectiveness of a culturally relevant, multi-component intervention for antenatal depression. The intervention includes an engagement session, and the woman's choice of brief interpersonal psychotherapy and/or pharmacotherapy in a stepped care treatment for depression model.
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Notify Me18 year and older
Female
Interventional
Not applicable
Seattle, Washington, 98105, United States
The randomized control trial will evaluate the effects of a culturally relevant, multi-component intervention for antenatal depression. MOMCare has the potential to overcome patient, provider, and system-level barriers to care and engage depressed, low-income women in evidence-based treatments to reduce antenatal depressive symptoms, improve maternal psychosocial functioning, and ameliorate postpartum depression. Specific Aim 1: To evaluate the impact of MOMCare on treatment engagement and retention. Specific Aim 2: To evaluate the impact of MOMCare on maternal clinical symptoms and functional outcomes. Specific Aim 3: To conduct an incremental cost-effectiveness analysis for a health care and welfare agency perspective that includes a) tracking the medical costs of health service use in MOMCare and usual care patients; b) monitoring the use of infant preventative health services in both groups; and c) tracking the percentage of women on Medicaid and the percentage working in both groups.
The intervention will be assessed through a practical randomized controlled trial in which we have recruited 168 pregnant women with major depression and/or dysthymia who were on Medicaid and/or received Maternal Support Services (MSS) in selected public health centers in Seattle - King County (PHSKC). Patients who were eligible and consented to study enrollment were randomly assigned to either usual care (UC) or MOMCare. Baseline and four follow-up assessments (3 - 18 months post-baseline) are scheduled for study participants in both groups. The MOMCare intervention includes a choice of brief interpersonal psychotherapy or collaborative management of antidepressant medication. Treatment response will be monitored, and the treatment will be adjusted as necessary (adding treatments, increasing dosages).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
8 sessions of brief interpersonal psychotherapy or medication management; maintenance sessions through 12 months postpartum.
Time frame: baseline, 3, 6 12, 18 month follow-ups
Time frame: baseline, 3, 6 12, 18 month follow-ups
Time frame: 6 month follow-up
Time frame: 6, 12, 18 month follow-ups
Time frame: 3, 6, 12, 18 month follow-ups
Time frame: 3, 6, 12, 18 month follow-ups
Time frame: 3, 6, 12, 18 month follow-ups
Time frame: screening, baseline, 3, 6, 12, 18 month follow-ups
Time frame: baseline, 3, 6, 12, 18 month follow-ups
Time frame: baseline, 3, 6, 12, 18 month follow-ups
Time frame: 6, 12, 18 month follow-ups
University of Washington
Other
For Moms: Culturally Relevant Treatment Services for Perinatal Depression
Acronym: MOMCare
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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