Depression
Conditions
Keywords
Depression, Perinatal care, Postpartum period, Pregnancy, Female, Low-income population
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).
Interventions
BEHAVIORALMOMCare
8 sessions of brief interpersonal psychotherapy or medication management; maintenance sessions through 12 months postpartum.
Sponsors
National Institute of Mental Health (NIMH)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SCL-20 depression | baseline, 3, 6 12, 18 month follow-ups |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Maternal health services utilization use and estimated costs | baseline, 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 |
| Number of depression treatment sessions attended | 3, 6, 12, 18 month follow-ups |
Countries
United States
Outcome results
None listed