For Moms: Culturally Relevant Treatment Services for Perinatal Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 2
- 主要终点
- SCL-20 depression
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
SCL-20 depression
时间窗: baseline, 3, 6 12, 18 month follow-ups
次要结局
- 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)
研究者
Nancy Grote
Research Associate Professor
University of Washington
