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.
調査の概要
詳細な説明
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).
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Washington
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Seattle、Washington、アメリカ、98104
- Women's Clinic at Harborview Medical Center
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Seattle、Washington、アメリカ、98195
- Women's Health Care Center at University of Washington Medical Center (Roosevelt Clinic)
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的: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.
他の名前:
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介入なし: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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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Depression Treatment Outcome
時間枠: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
時間枠: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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Quality of Depression Care Indicators
時間枠: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
時間枠: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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協力者と研究者
スポンサー
捜査官
- 主任研究者:Jurgen Unutzer, MD, MPH, MA、University of Washington
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
うつ病性障害の臨床試験
Depression Care Managementの臨床試験
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Medstar Health Research InstituteAmenity Health, Inc.終了しました
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George Washington UniversityTranscultural Psychosocial Organization Nepal完了
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New York UniversitySt. Luke's-Roosevelt Hospital Center完了
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Fondation Lenval積極的、募集していない
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New York UniversityIndiana University; Moi University完了
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Boston Medical CenterNational Institute on Minority Health and Health Disparities (NIMHD); Center for Community Health...完了肥満 | 喘息 | 血圧 | 小児発達 | ヘルスケアの利用 | 児童虐待 | 医療格差 | 満たされていない基本的な社会的ニーズアメリカ
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Fondation Oeuvre de la Croix Saint-Simon引きこもった