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临床试验/NCT01045655
NCT01045655已完成不适用

For Moms: Culturally Relevant Treatment Services for Perinatal Depression

University of Washington2 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2010年1月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nancy Grote

Research Associate Professor

University of Washington

研究点 (2)

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