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

January 13, 2016 updated by: Nancy Grote, University of Washington

For Moms: Culturally Relevant Treatment Services for Perinatal Depression

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.

Study Overview

Status

Completed

Conditions

Intervention / 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).

Study Type

Interventional

Enrollment (Actual)

168

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98105
        • University of Washington

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SCL-20 depression
Time Frame: baseline, 3, 6 12, 18 month follow-ups
baseline, 3, 6 12, 18 month follow-ups

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Nancy K Grote, PhD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

January 8, 2010

First Submitted That Met QC Criteria

January 8, 2010

First Posted (Estimate)

January 11, 2010

Study Record Updates

Last Update Posted (Estimate)

January 15, 2016

Last Update Submitted That Met QC Criteria

January 13, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH084897 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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