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

December 9, 2013 updated by: Isabel T. Lagomasino, MD, MSHS, University of Southern California

Patient-Centered Depression Care in the Public Sector

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

Study Overview

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

Enrollment (Actual)

432

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Los Angeles, California, United States, 90007
        • H. Claude Hudson Comprehensive Health Center
      • Los Angeles, California, United States, 90015
        • USC Family Practice Center at California Hospital
      • Los Angeles, California, United States, 90033
        • LAC+USC Outpatient Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Participants will receive collaborative care
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Depression treatment preferences as measured by a conjoint analysis survey and qualitative interviews
Time Frame: Measured at Week 16
Measured at Week 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Depression outcomes as measured by the Patient Health Questionnaire-9
Time Frame: Measured at Week 16
Measured at Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

November 29, 2005

First Submitted That Met QC Criteria

November 29, 2005

First Posted (Estimate)

December 1, 2005

Study Record Updates

Last Update Posted (Estimate)

December 10, 2013

Last Update Submitted That Met QC Criteria

December 9, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • R01MH067949 (U.S. NIH Grant/Contract)
  • DSIR 82-SEPC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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