Depression Attention for Women Now (The DAWN Study)

NCT01096316 | Completed Results DMC

• 2 other identifiers: 37061-G1R01MH085668
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 2

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.

Conditions

Depressive Disorder

Keywords

mood disorders; depressive disorder; women; depression

Outcome Measures

Primary Outcomes (2)

• Depression Treatment Outcome

  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),

  12 months

• Functional Outcome

  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.

  12 months

Secondary Outcomes (2)

• Quality of Depression Care Indicators

  12 months

• Potential Facilitators and Barriers to Sustainability

  18 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

Depression Care Management BEHAVIORAL

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.

Also known as: Study Intervention

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Women's Clinic at Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Women's Health Care Center at University of Washington Medical Center (Roosevelt Clinic)

Seattle, Washington, 98195, United States

Location

Related Publications (3)

• 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.

  PMID: 24807320 RESULT

• 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.

  PMID: 23969800 RESULT

• 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.

  PMID: 23939510 RESULT

MeSH Terms

Conditions

Depressive Disorder; Mood Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Limitations and Caveats

Patients were recruited from university-affiliated OB/GYN clinics, which potentially limits generalizability to other OB/GYN populations; non-English speaking women were not included; and antidepressant adherence was based on self-report data.

Results Point of Contact

• Title: Jurgen Unutzer MD MPH MA, Professor and Chair
• Organization: Dept Psychiatry & Behavioral Sciences University of Washington

unutzer@uw.edu

206-543-3752

Study Officials

• Jurgen Unutzer, MD, MPH, MA

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Psychiatry & Behavioral Sciences

Study Record Dates

• First Submitted: March 25, 2010
• First Posted: March 31, 2010
• Study Start: November 1, 2009
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: February 4, 2016
• Results First Posted: August 27, 2014

Record last verified: 2016-01

Locations

US (2)