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

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MOMCare
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Perinatal care, Postpartum period, Pregnancy, Female, Low-income population

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MOMCare intervention

Care Plus

Arm Description

Depression care treatment with study depression care specialist (brief interpersonal psychotherapy or pharmacotherapy)

Usual care group; referral to community mental health treatment

Outcomes

Primary Outcome Measures

SCL-20 depression

Secondary Outcome Measures

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

Full Information

First Posted
January 8, 2010
Last Updated
January 13, 2016
Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01045655
Brief Title
MOMCare: Culturally Relevant Treatment Services for Perinatal Depression
Acronym
MOMCare
Official Title
For Moms: Culturally Relevant Treatment Services for Perinatal Depression
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Perinatal care, Postpartum period, Pregnancy, Female, Low-income population

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MOMCare intervention
Arm Type
Experimental
Arm Description
Depression care treatment with study depression care specialist (brief interpersonal psychotherapy or pharmacotherapy)
Arm Title
Care Plus
Arm Type
No Intervention
Arm Description
Usual care group; referral to community mental health treatment
Intervention Type
Behavioral
Intervention Name(s)
MOMCare
Intervention Description
8 sessions of brief interpersonal psychotherapy or medication management; maintenance sessions through 12 months postpartum.
Primary Outcome Measure Information:
Title
SCL-20 depression
Time Frame
baseline, 3, 6 12, 18 month follow-ups
Secondary Outcome Measure Information:
Title
Maternal health services utilization use and estimated costs
Time Frame
baseline, 3, 6 12, 18 month follow-ups
Title
Pregnancy, delivery, birth outcomes
Time Frame
6 month follow-up
Title
Child services & outcomes (immunizations, well-child visits)
Time Frame
6, 12, 18 month follow-ups
Title
Depression free days & Quality Adjusted Life Years (EuroQol)
Time Frame
3, 6, 12, 18 month follow-ups
Title
Quality of depression care process
Time Frame
3, 6, 12, 18 month follow-ups
Title
Number of depression treatment sessions attended
Time Frame
3, 6, 12, 18 month follow-ups
Title
PHQ-9 depression
Time Frame
screening, baseline, 3, 6, 12, 18 month follow-ups
Title
Edinburgh Postnatal Depression Scale
Time Frame
baseline, 3, 6, 12, 18 month follow-ups
Title
Social Functioning (Work & Social Adjustment, Social & Leisure, Social Support)
Time Frame
baseline, 3, 6, 12, 18 month follow-ups
Title
Inventory of Functional Status After Childbirth (IFSAC)
Time Frame
6, 12, 18 month follow-ups

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy K Grote, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26345179
Citation
Grote NK, Katon WJ, Russo JE, Lohr MJ, Curran M, Galvin E, Carson K. COLLABORATIVE CARE FOR PERINATAL DEPRESSION IN SOCIOECONOMICALLY DISADVANTAGED WOMEN: A RANDOMIZED TRIAL. Depress Anxiety. 2015 Nov;32(11):821-34. doi: 10.1002/da.22405. Epub 2015 Sep 8.
Results Reference
result
PubMed Identifier
28076671
Citation
Grote NK, Katon WJ, Russo JE, Lohr MJ, Curran M, Galvin E, Carson K. A Randomized Trial of Collaborative Care for Perinatal Depression in Socioeconomically Disadvantaged Women: The Impact of Comorbid Posttraumatic Stress Disorder. J Clin Psychiatry. 2016 Nov;77(11):1527-1537. doi: 10.4088/JCP.15m10477.
Results Reference
derived
PubMed Identifier
25016216
Citation
Grote NK, Katon WJ, Lohr MJ, Carson K, Curran M, Galvin E, Russo JE, Gregory M. Culturally relevant treatment services for perinatal depression in socio-economically disadvantaged women: the design of the MOMCare study. Contemp Clin Trials. 2014 Sep;39(1):34-49. doi: 10.1016/j.cct.2014.07.001. Epub 2014 Jul 10.
Results Reference
derived

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MOMCare: Culturally Relevant Treatment Services for Perinatal Depression

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