MOMCare: Culturally Relevant Treatment Services for Perinatal Depression

Not Applicable

Completed

• Conditions: Depression
• Interventions: Behavioral: MOMCare

• Registration Number: NCT01045655
• Lead Sponsor: University of Washington

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).

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-08
• Study First Submitted QC: 2010-01-08
• Study First Posted: 2010-01-11
• Primary Completion: 2014-04
• Study Completion: 2014-08
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-13
• Last Update Posted: 2016-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 168

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MOMCare intervention	MOMCare	Depression care treatment with study depression care specialist (brief interpersonal psychotherapy or pharmacotherapy)

Primary Outcome Measures

Name	Time	Method
SCL-20 depression	baseline, 3, 6 12, 18 month follow-ups

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States