Determining Depression Treatment Preferences of Low-Income Latinos in Primary Care Settings

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: NCT00260169
Recruitment Status : Completed
First Posted : December 1, 2005
Last Update Posted : December 10, 2013
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Isabel T. Lagomasino, MD, MSHS, University of Southern California

Brief Summary:
This study will determine ways to make depression care more responsive to the needs of consumers in primary care clinics serving low-income Latinos.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Collaborative care treatment Behavioral: Enhanced usual care Not Applicable

Detailed Description:

Depression is a serious illness that is difficult to diagnose and treat, especially in populations that underutilize mental health services. The Latino population is one such group. Accommodating patient preferences for care, provider capacities, and administrator priorities is essential to the development of effective depression care interventions that are sustainable in public sector systems. However, little is understood regarding the depression treatment preferences of low-income Latinos who have not received quality depression care and who may not feel that they can voice their opinions about their health care. In addition, little is known about the preferences, capabilities, and priorities of providers and administrators in primary care clinics. This study will determine ways to make depression care more responsive to the needs of consumers in primary care clinics serving low-income Latinos. The study will also evaluate the effectiveness of various treatments in reducing depression.

Following baseline assessments of depression treatment preferences and resources, participants in this open label study will be randomly assigned to receive collaborative care either immediately or after a waiting period. Individuals assigned to receive immediate care will undergo treatment for 12 weeks. Other participants will receive treatment at a later time. All participants will have the option to receive one of the following treatments: (1) medication management from the Depression Care Specialist (DCS) and antidepressant medication from their primary care provider (PCP); (2) cognitive-behavioral therapy from the DCS; or (3) a combination of both treatments. Depression treatment outcomes and preferences will be measured post-intervention. Provider and administrator preferences will also be measured post-intervention and potential strategies for implementing patient-centered depression care programs will be identified.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 432 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient-Centered Depression Care in the Public Sector
Study Start Date : November 2005
Actual Primary Completion Date : October 2007
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Participants will receive collaborative care
Behavioral: Collaborative care treatment
Patients receiving collaborative care treatment choose 12 weeks of CBT and/or medication management (antidepressants prescribed by patients' primary care provider) from the study depression care specialist (DCS).

Active Comparator: 2
Participants will receive enhanced usual care
Behavioral: Enhanced usual care
Usual care participants are assigned to a 16-week wait-list for the study treatment, during which they are free to receive treatment elsewhere. A letter is given to participants' primary care providers (PCP) that indicates they screened positive for depression. In addition, patients receive an information booklet about depression and a community resource list.

Primary Outcome Measures :
  1. Depression treatment preferences as measured by a conjoint analysis survey and qualitative interviews [ Time Frame: Measured at Week 16 ]

Secondary Outcome Measures :
  1. Depression outcomes as measured by the Patient Health Questionnaire-9 [ Time Frame: Measured at Week 16 ]

Information from the National Library of Medicine

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

Inclusion Criteria:

For Participating Patients:

  • Attending one of the study clinics for primary care
  • English or Spanish-speaking
  • Screens positive for major depressive disorder or dysthymia

For Providers:

  • All primary care providers providing at least one day of services at one of the study clinics

For Administrators:

  • Administrative, medical, and nursing directors from each study site and directors of affiliated local mental health clinics

Exclusion Criteria:

For Participating Patients:

  • Acutely suicidal
  • Screens positive for bipolar disorder, psychotic disorder, or cognitive impairment

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): NCT00260169

United States, California
H. Claude Hudson Comprehensive Health Center
Los Angeles, California, United States, 90007
USC Family Practice Center at California Hospital
Los Angeles, California, United States, 90015
LAC+USC Outpatient Department
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
National Institute of Mental Health (NIMH)
Principal Investigator: Isabel T. Lagomasino, MD, MSHS University of Southern California
Principal Investigator: Megan Dwight-Johnson, MD, MPH VA Medical Center-West Los Angeles

Publications of Results:
Responsible Party: Isabel T. Lagomasino, MD, MSHS, Study Principal Investigator, University of Southern California Identifier: NCT00260169     History of Changes
Other Study ID Numbers: R01MH067949 ( U.S. NIH Grant/Contract )
R01MH067949 ( U.S. NIH Grant/Contract )
First Posted: December 1, 2005    Key Record Dates
Last Update Posted: December 10, 2013
Last Verified: December 2013

Keywords provided by Isabel T. Lagomasino, MD, MSHS, University of Southern California:
Treatment Preferences
Public sector

Additional relevant MeSH terms:
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders