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MOMCare: Culturally Relevant Treatment Services for Perinatal Depression

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Nancy Grote, University of Washington
ClinicalTrials.gov Identifier:
NCT01045655
First received: January 8, 2010
Last updated: May 8, 2013
Last verified: May 2013
History of Changes
  Purpose

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 Intervention
Depression
 Behavioral: MOMCare

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: For Moms: Culturally Relevant Treatment Services for Perinatal Depression

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • SCL-20 depression [ Time Frame: baseline, 3, 6 12, 18 month follow-ups ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maternal health services utilization use and estimated costs [ Time Frame: baseline, 3, 6 12, 18 month follow-ups ] [ Designated as safety issue: No ]
  • Pregnancy, delivery, birth outcomes [ Time Frame: 6 month follow-up ] [ Designated as safety issue: No ]
  • Child services & outcomes (immunizations, well-child visits) [ Time Frame: 6, 12, 18 month follow-ups ] [ Designated as safety issue: No ]
  • Depression free days & Quality Adjusted Life Years (EuroQol) [ Time Frame: 3, 6, 12, 18 month follow-ups ] [ Designated as safety issue: No ]
  • Quality of depression care process [ Time Frame: 3, 6, 12, 18 month follow-ups ] [ Designated as safety issue: No ]
  • Number of depression treatment sessions attended [ Time Frame: 3, 6, 12, 18 month follow-ups ] [ Designated as safety issue: No ]
  • PHQ-9 depression [ Time Frame: screening, baseline, 3, 6, 12, 18 month follow-ups ] [ Designated as safety issue: No ]
  • Edinburgh Postnatal Depression Scale [ Time Frame: baseline, 3, 6, 12, 18 month follow-ups ] [ Designated as safety issue: No ]
  • Social Functioning (Work & Social Adjustment, Social & Leisure, Social Support) [ Time Frame: baseline, 3, 6, 12, 18 month follow-ups ] [ Designated as safety issue: No ]
  • Inventory of Functional Status After Childbirth (IFSAC) [ Time Frame: 6, 12, 18 month follow-ups ] [ Designated as safety issue: No ]

Enrollment: 168
Study Start Date: January 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01045655

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

No publications provided

Responsible Party: Nancy Grote, Research Associate Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01045655     History of Changes
Other Study ID Numbers: R01 MH084897, R01MH084897, R01 MH084897
Study First Received: January 8, 2010
Last Updated: May 8, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Washington:
Depression
Perinatal care
Postpartum period
 Pregnancy
Female
Low-income population

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

ClinicalTrials.gov processed this record on May 23, 2013