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Depression Attention for Women Now (The DAWN Study) (DAWN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01096316
Recruitment Status : Completed
First Posted : March 31, 2010
Results First Posted : August 27, 2014
Last Update Posted : February 4, 2016
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Jurgen Unutzer, University of Washington

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Depressive Disorder Behavioral: Depression Care Management Not Applicable

Detailed Description:

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Reducing Disparities and Improving Care for Depression in OB-GYN Clinics: Depression Attention for Women Now (The DAWN Study)
Study Start Date : November 2009
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 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.
Behavioral: Depression Care Management
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.
Other Name: Study Intervention

No Intervention: 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.

Primary Outcome Measures :
  1. Depression Treatment Outcome [ Time Frame: 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),

  2. Functional Outcome [ Time Frame: 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.

Secondary Outcome Measures :
  1. Quality of Depression Care Indicators [ Time Frame: 12 months ]
    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

  2. Potential Facilitators and Barriers to Sustainability [ Time Frame: 18 months ]
    Providers' and administrators' perceived barriers and facilitators to continue providing the intervention after study end.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01096316

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United States, Washington
Women's Clinic at Harborview Medical Center
Seattle, Washington, United States, 98104
Women's Health Care Center at University of Washington Medical Center (Roosevelt Clinic)
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
National Institute of Mental Health (NIMH)
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Principal Investigator: Jurgen Unutzer, MD, MPH, MA University of Washington
Publications of Results:
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Responsible Party: Jurgen Unutzer, Professor and Chair, Psychiatry & Behavioral Sciences, University of Washington Identifier: NCT01096316    
Other Study ID Numbers: 37061-G
1R01MH085668 ( U.S. NIH Grant/Contract )
First Posted: March 31, 2010    Key Record Dates
Results First Posted: August 27, 2014
Last Update Posted: February 4, 2016
Last Verified: January 2016
Keywords provided by Jurgen Unutzer, University of Washington:
mood disorders
depressive disorder
Additional relevant MeSH terms:
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Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders