- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01096316
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.
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Washington
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Seattle, Washington, United States, 98104
- Women's Clinic at Harborview Medical Center
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Seattle, Washington, United States, 98195
- Women's Health Care Center at University of Washington Medical Center (Roosevelt Clinic)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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:
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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.
Other Names:
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression Treatment Outcome
Time Frame: 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
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Quality of Depression Care Indicators
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jurgen Unutzer, MD, MPH, MA, University of Washington
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 37061-G
- 1R01MH085668 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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