Depression Attention for Women Now (The DAWN Study) (DAWN)
Reducing Disparities and Improving Care for Depression in OB-GYN Clinics: Depression Attention for Women Now (The DAWN Study)
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.
研究概览
详细说明
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).
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Washington
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Seattle、Washington、美国、98104
- Women's Clinic at Harborview Medical Center
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Seattle、Washington、美国、98195
- Women's Health Care Center at University of Washington Medical Center (Roosevelt Clinic)
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：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:
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The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM).
First, a unique engagement session develops rapport with the DCM, providing education and identifying health concerns.
DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the rest of the 12-month intervention.
Patients choose either medication or Problem-Solving Treatment-Primary Care therapy.
Depressive symptoms are assessed at each visit with the PHQ-9, as well as response to medications or to PST, with a total of 8 PST-PC sessions.
Patients with inadequate response after 8 weeks to the first choice will switch or combine treatments.
Providers are given extensive feedback about the patient's health care concerns.
其他名称：
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无干预：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.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Depression Treatment Outcome
大体时间：12 months
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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),
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12 months
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Functional Outcome
大体时间：12 months
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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.
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12 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Quality of Depression Care Indicators
大体时间：12 months
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Intervention impact on quality of depression care indicators and satisfaction with depression care.
Number of participants receiving 4 or more mental health visits are reported.
Receiving 4 or more mental health visits has previously been used in depression randomized control trials as a measure of the quality of depression treatment received by a patient
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12 months
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Potential Facilitators and Barriers to Sustainability
大体时间：18 months
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Providers' and administrators' perceived barriers and facilitators to continue providing the intervention after study end.
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18 months
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合作者和调查者
调查人员
- 首席研究员：Jurgen Unutzer, MD, MPH, MA、University of Washington
出版物和有用的链接
一般刊物
- Melville JL, Reed SD, Russo J, Croicu CA, Ludman E, LaRocco-Cockburn A, Katon W. Improving care for depression in obstetrics and gynecology: a randomized controlled trial. Obstet Gynecol. 2014 Jun;123(6):1237-1246. doi: 10.1097/AOG.0000000000000231.
- Cerimele JM, Vanderlip ER, Croicu CA, Melville JL, Russo J, Reed SD, Katon W. Presenting symptoms of women with depression in an obstetrics and gynecology setting. Obstet Gynecol. 2013 Aug;122(2 Pt 1):313-318. doi: 10.1097/AOG.0b013e31829999ee.
- LaRocco-Cockburn A, Reed SD, Melville J, Croicu C, Russo JE, Inspektor M, Edmondson E, Katon W. Improving depression treatment for women: integrating a collaborative care depression intervention into OB-GYN care. Contemp Clin Trials. 2013 Nov;36(2):362-70. doi: 10.1016/j.cct.2013.08.001. Epub 2013 Aug 9. Erratum In: Contemp Clin Trials. 2014 Jan;37(1):166.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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