Depression Attention for Women Now (The DAWN Study)

Not Applicable

Completed

• Conditions: Depressive Disorder
• Interventions: Behavioral: Depression Care Management

• Registration Number: NCT01096316
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2009-11
• Study First Submitted: 2010-03-25
• Study First Submitted QC: 2010-03-29
• Study First Posted: 2010-03-31
• Results First Submitted: 2014-06-27
• Results First Submitted QC: 2014-08-25
• Results First Posted: 2014-08-27
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-06
• Last Update Posted: 2016-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 205

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Depression Care Management	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.

Primary Outcome Measures

Name	Time	Method
Functional Outcome	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.
Depression Treatment Outcome	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),

Secondary Outcome Measures

Name	Time	Method
Potential Facilitators and Barriers to Sustainability	18 months	Providers' and administrators' perceived barriers and facilitators to continue providing the intervention after study end.
Quality of Depression Care Indicators	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

Trial Locations

Locations (2)

Women's Clinic at Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

Women's Health Care Center at University of Washington Medical Center (Roosevelt Clinic); 🇺🇸 Seattle, Washington, United States