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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Isabel T. Lagomasino, MD, MSHS, University of Southern California
ClinicalTrials.gov Identifier:
NCT00260169
First received: November 29, 2005
Last updated: December 9, 2013
Last verified: December 2013
  Purpose

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 Intervention
Depression
Behavioral: Collaborative care treatment
Behavioral: Enhanced usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Patient-Centered Depression Care in the Public Sector

Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Depression treatment preferences as measured by a conjoint analysis survey and qualitative interviews [ Time Frame: Measured at Week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depression outcomes as measured by the Patient Health Questionnaire-9 [ Time Frame: Measured at Week 16 ] [ Designated as safety issue: No ]

Enrollment: 432
Study Start Date: November 2005
Study Completion Date: January 2009
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00260169

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

Publications:
Responsible Party: Isabel T. Lagomasino, MD, MSHS, Study Principal Investigator, University of Southern California
ClinicalTrials.gov Identifier: NCT00260169     History of Changes
Other Study ID Numbers: R01 MH067949, R01MH067949, DSIR 82-SEPC
Study First Received: November 29, 2005
Last Updated: December 9, 2013
Health Authority: United States: Federal Government

Keywords provided by University of Southern California:
Treatment Preferences
Public sector
Latino

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

ClinicalTrials.gov processed this record on October 23, 2014