- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00260169
Determining Depression Treatment Preferences of Low-Income Latinos in Primary Care Settings
Patient-Centered Depression Care in the Public Sector
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Los Angeles, California, United States, 90007
- H. Claude Hudson Comprehensive Health Center
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Los Angeles, California, United States, 90015
- USC Family Practice Center at California Hospital
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Los Angeles, California, United States, 90033
- LAC+USC Outpatient Department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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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).
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Active Comparator: 2
Participants will receive enhanced usual care
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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.
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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
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Measured at Week 16
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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
Collaborators
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01MH067949 (U.S. NIH Grant/Contract)
- DSIR 82-SEPC
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