This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
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: January 13, 2016
Last verified: January 2016
  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
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: For Moms: Culturally Relevant Treatment Services for Perinatal Depression

Further study details as provided by Nancy Grote, University of Washington:

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

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

Enrollment: 168
Study Start Date: January 2010
Study Completion Date: August 2014
Primary Completion Date: April 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   (Adult, Senior)
Sexes 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
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 )
Study First Received: January 8, 2010
Last Updated: January 13, 2016

Keywords provided by Nancy Grote, 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 July 21, 2017