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MOMCare: Culturally Relevant Treatment Services for Perinatal Depression (MOMCare)

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ClinicalTrials.gov Identifier: NCT01045655
Recruitment Status : Completed
First Posted : January 11, 2010
Last Update Posted : January 15, 2016
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Depression Behavioral: MOMCare

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).

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: For Moms: Culturally Relevant Treatment Services for Perinatal Depression
Study Start Date : January 2010
Primary Completion Date : April 2014
Study Completion Date : August 2014
Arms and Interventions

Arm Intervention/treatment
Experimental: MOMCare intervention
Depression care treatment with study depression care specialist (brief interpersonal psychotherapy or pharmacotherapy)
Behavioral: MOMCare
8 sessions of brief interpersonal psychotherapy or medication management; maintenance sessions through 12 months postpartum.
No Intervention: Care Plus
Usual care group; referral to community mental health treatment

Outcome Measures

Primary Outcome Measures :
  1. SCL-20 depression [ Time Frame: baseline, 3, 6 12, 18 month follow-ups ]

Secondary Outcome Measures :
  1. Maternal health services utilization use and estimated costs [ Time Frame: baseline, 3, 6 12, 18 month follow-ups ]
  2. Pregnancy, delivery, birth outcomes [ Time Frame: 6 month follow-up ]
  3. Child services & outcomes (immunizations, well-child visits) [ Time Frame: 6, 12, 18 month follow-ups ]
  4. Depression free days & Quality Adjusted Life Years (EuroQol) [ Time Frame: 3, 6, 12, 18 month follow-ups ]
  5. Quality of depression care process [ Time Frame: 3, 6, 12, 18 month follow-ups ]
  6. Number of depression treatment sessions attended [ Time Frame: 3, 6, 12, 18 month follow-ups ]
  7. PHQ-9 depression [ Time Frame: screening, baseline, 3, 6, 12, 18 month follow-ups ]
  8. Edinburgh Postnatal Depression Scale [ Time Frame: baseline, 3, 6, 12, 18 month follow-ups ]
  9. Social Functioning (Work & Social Adjustment, Social & Leisure, Social Support) [ Time Frame: baseline, 3, 6, 12, 18 month follow-ups ]
  10. Inventory of Functional Status After Childbirth (IFSAC) [ Time Frame: 6, 12, 18 month follow-ups ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01045655

United States, Washington
University of Washington
Seattle, Washington, United States, 98105
Sponsors and Collaborators
University of Washington
National Institute of Mental Health (NIMH)
Principal Investigator: Nancy K Grote, PhD University of Washington
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Nancy Grote, Research Associate Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01045655     History of Changes
Other Study ID Numbers: R01MH084897 ( U.S. NIH Grant/Contract )
First Posted: January 11, 2010    Key Record Dates
Last Update Posted: January 15, 2016
Last Verified: January 2016

Keywords provided by Nancy Grote, University of Washington:
Perinatal care
Postpartum period
Low-income population

Additional relevant MeSH terms:
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders