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Clinical Trials/NCT01045655
NCT01045655
Completed
N/A

For Moms: Culturally Relevant Treatment Services for Perinatal Depression

University of Washington1 site in 1 country168 target enrollmentJanuary 2010
ConditionsDepression

Overview

Phase
N/A
Intervention
Not specified
Conditions
Depression
Sponsor
University of Washington
Enrollment
168
Locations
1
Primary Endpoint
SCL-20 depression
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

Detailed Description

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).

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
August 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Nancy Grote

Research Associate Professor

University of Washington

Eligibility Criteria

Inclusion Criteria

  • 18 or older
  • pregnant: 12-32 weeks gestation
  • able to speak English
  • telephone access
  • major depressive disorder or dysthymia
  • on Medicaid
  • receiving health care in King County, Washington

Exclusion Criteria

  • currently in psychotherapy
  • currently receiving pharmacotherapy from a psychiatrist
  • high suicide risk
  • history of bipolar disorder
  • history of schizophrenia
  • substance use or dependence in previous 3 months
  • currently in a relationship with severe interpersonal violence
  • history of repetitive self-harm behavior

Outcomes

Primary Outcomes

SCL-20 depression

Time Frame: baseline, 3, 6 12, 18 month follow-ups

Secondary Outcomes

  • Number of depression treatment sessions attended(3, 6, 12, 18 month follow-ups)
  • Edinburgh Postnatal Depression Scale(baseline, 3, 6, 12, 18 month follow-ups)
  • Maternal health services utilization use and estimated costs(baseline, 3, 6 12, 18 month follow-ups)
  • Quality of depression care process(3, 6, 12, 18 month follow-ups)
  • Pregnancy, delivery, birth outcomes(6 month follow-up)
  • PHQ-9 depression(screening, baseline, 3, 6, 12, 18 month follow-ups)
  • Child services & outcomes (immunizations, well-child visits)(6, 12, 18 month follow-ups)
  • Depression free days & Quality Adjusted Life Years (EuroQol)(3, 6, 12, 18 month follow-ups)
  • Inventory of Functional Status After Childbirth (IFSAC)(6, 12, 18 month follow-ups)
  • Social Functioning (Work & Social Adjustment, Social & Leisure, Social Support)(baseline, 3, 6, 12, 18 month follow-ups)

Study Sites (1)

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