Depression Attention for Women Now (The DAWN Study) - Full Text View

Sponsor:	University of Washington
Collaborator:	National Institute of Mental Health (NIMH)
Information provided by:	University of Washington
ClinicalTrials.gov Identifier:	NCT01096316

Purpose

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	Intervention
Depressive Disorder	Behavioral: Depression Care Management

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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)

Resource links provided by NLM:

MedlinePlus related topics: Depression

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:

Depression Treatment Outcome [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Impact of the intervention on depression treatment outcomes, including change in depressive symptoms and treatment response.
Functional Outcome [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Impact of the intervention on functional outcomes of patients.

Secondary Outcome Measures:

Quality of Depression Care Indicators [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Intervention impact on quality of depression care indicators and satisfaction with depression care.
Potential Facilitators and Barriers to Sustainability [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Providers' and administrators' perceived barriers and facilitators to continue providing the intervention after study end.

Estimated Enrollment:	236
Study Start Date:	November 2009
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Arms

Assigned Interventions

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.

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).

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

PHQ-9 score ≥5 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01096316

Contacts

Contact: Eddie Edmondson, LICSW	206-744-1751	eedmonds@uw.edu
Contact: Wayne Katon, MD	206-543-7177	wkaton@uw.edu

Locations

United States, Washington
Women's Clinic at Harborview Medical Center	Recruiting
Seattle, Washington, United States, 98104
Contact: Virginia Eader, BA 206-744-3244 veader@uw.edu
Contact: Eddie Edmondson, LICSW 206-744-1751 eedmonds@uw.edu
Principal Investigator: Wayne Katon, MD
Women's Health Care Center at University of Washington Medical Center (Roosevelt Clinic)	Recruiting
Seattle, Washington, United States, 98195
Contact: Leiszle Ziemba, BA 206-744-3244 leiszlez@uw.edu
Contact: Eddie Edmondson, LICSW 206-744-1751 eedmonds@uw.edu
Principal Investigator: Wayne Katon, MD

Sponsors and Collaborators

University of Washington

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

Wayne Katon, MD

University of Washington

More Information

No publications provided

Responsible Party:	Wayne Katon, MD - Principal Investigator, University of Washington
ClinicalTrials.gov Identifier:	NCT01096316 History of Changes
Other Study ID Numbers:	37061-G, 1R01MH085668
Study First Received:	March 25, 2010
Last Updated:	July 20, 2010
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Washington:

mood disorders
depressive disorder
women
depression

Additional relevant MeSH terms:

Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012