MOMCare: Culturally Relevant Treatment Services for Perinatal Depression

Study Overview
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Brief Summary
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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
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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).

Official Title
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For Moms: Culturally Relevant Treatment Services for Perinatal Depression

Conditions
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Depression

Intervention / Treatment
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* Behavioral: MOMCare


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MOMCare intervention<br>Depression care treatment with study depression care specialist (brief interpersonal psychotherapy or pharmacotherapy) | Behavioral: MOMCare<br>* 8 sessions of brief interpersonal psychotherapy or medication management; maintenance sessions through 12 months postpartum.<br>|
| No Intervention: Care Plus<br>Usual care group; referral to community mental health treatment | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal health services utilization use and estimated costs |  | baseline, 3, 6 12, 18 month follow-ups | 
| Pregnancy, delivery, birth outcomes |  | 6 month follow-up | 
| 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 | 
| Quality of depression care process |  | 3, 6, 12, 18 month follow-ups | 
| Number of depression treatment sessions attended |  | 3, 6, 12, 18 month follow-ups | 
| PHQ-9 depression |  | screening, baseline, 3, 6, 12, 18 month follow-ups | 
| Edinburgh Postnatal Depression Scale |  | baseline, 3, 6, 12, 18 month follow-ups | 
| Social Functioning (Work & Social Adjustment, Social & Leisure, Social Support) |  | baseline, 3, 6, 12, 18 month follow-ups | 
| Inventory of Functional Status After Childbirth (IFSAC) |  | 6, 12, 18 month follow-ups | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depression, Perinatal care, Postpartum period, Pregnancy, Female, Low-income population