Reducing Disparities and Improving Care for Depression in OB-GYN Clinics: Depression Attention for Women Now (The DAWN Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 205
- 试验地点
- 2
- 主要终点
- Functional Outcome
研究概览
简要总结
Major depressive disorder (MDD) is a common disabling illness that disproportionately affects women, with prevalence rates two times those of men. In addition to suffering, MDD has been shown to have a marked effect on social and vocational functioning, with increased disability, lost productivity, and excess mortality. Women with MDD have an increased prevalence of comorbid anxiety disorders and medical conditions.
Our model of care utilizes a social worker as a depression care manager (DCM) to support both patients and physicians in optimizing care in the OB-GYN clinical setting. This intervention will be compared to usual care for depression.
详细描述
A large number of women receive their routine care in OB-GYN clinics, including a disproportionate percentage of low-income and minority women. For many of these women, OG-GYNs are the only provider they see on a regular basis. OB-GYNs take care of women across their lifespan, addressing gynecologic, health care maintenance, pregnancy and primary care concerns in their everyday practices. There are multiple aspects of OG-GYN care that are uniquely suited for detection and treatment of depression, but there are also significant barriers to such care that must be addressed.
In this randomized controlled trial, we are testing this depression care management program for women attending two OB-GYN clinics in the University of Washington health care system. Our research aims to test the hypothesis that a depression care management intervention, integrated into the OB-GYN clinic setting, will improve treatment outcomes for depression, functional outcomes, and satisfaction with depression care. The results of our research will greatly impact clinical care by satisfying an unmet need for effective depression services for women seen in OB-GYN clinical settings.
The study compares a depression care management intervention, delivered by a depression care manager, to usual care for depression in the clinics. The primary aims of the study are to evaluate, compared to usual care, a depression intervention consisting of enhanced education, engagement, and depression care management (with a choice of antidepressant medication monitoring and/or provision of brief psychotherapy).
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
- None
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
- •PHQ-9 score ≥10 for Major Depressive Disorder (with 1 cardinal symptom) and/or ≥10 for Dysthymia (with 1 cardinal symptom)
- •MINI confirmation of PHQ-9 diagnoses
- •Access to a telephone
- •English-speaking
排除标准
- •High suicide risk (PHQ-9 response)
- •≥2 prior suicide attempts
- •Lifetime history of schizophrenia or bipolar disorder (MINI response)
- •Substance abuse/dependence within the previous 3 months (CAGE-AID)
- •Current severe intimate partner violence
- •Currently seeing a psychiatrist
研究组 & 干预措施
Intervention
The intervention will integrate care between a depression care manager, consulting study team (psychiatry, psychology, OB-GYN researchers) and OB-GYN clinic providers. The 3-part intervention includes:
- enhanced education of patients and providers
- engagement of patients
- depression care management with patient choice of initial antidepressant medication or Problem-Solving Treatment-Primary Care and behavioral activation.
干预措施: Depression Care Management (Behavioral)
Usual Care
Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
结局指标
主要结局
Functional Outcome
时间窗: 12 months
Impact of the intervention on functional outcomes of patients. Functional impairment was measured using the Sheehan Disability Scale. The Sheehan disability scale is the average of 3 items assessing impairment in social, work and family responsibilities. Each item is rated 0 (no impairment) to 10 (totally impaired) and the 3 ratings are averaged for the Sheehan disability scale reported below.
Depression Treatment Outcome
时间窗: 12 months
Impact of the intervention on depression treatment outcomes, including change in depressive symptoms and treatment response. In particular, the depression scale from the Hopkins Symptom Checklist 20 (SCL-20) was used to assess depression severity at the assessments. The SCL-20 ranges from 0 (no depression) to 4 (severe depression),
次要结局
- Potential Facilitators and Barriers to Sustainability(18 months)
- Quality of Depression Care Indicators(12 months)
研究者
Jurgen Unutzer
Professor and Chair, Psychiatry & Behavioral Sciences
University of Washington