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.
연구 개요
상세 설명
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).
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Washington
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Seattle, Washington, 미국, 98104
- Women's Clinic at Harborview Medical Center
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Seattle, Washington, 미국, 98195
- Women's Health Care Center at University of Washington Medical Center (Roosevelt Clinic)
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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.
다른 이름들:
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간섭 없음: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Depression Treatment Outcome
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Quality of Depression Care Indicators
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Jurgen Unutzer, MD, MPH, MA, University of Washington
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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