Determining Depression Treatment Preferences of Low-Income Latinos in Primary Care Settings
| Tracking Information | |||||||||
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| First Received Date ICMJE | November 29, 2005 | ||||||||
| Last Updated Date | March 10, 2009 | ||||||||
| Start Date ICMJE | November 2005 | ||||||||
| Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Depression treatment preferences as measured by a conjoint analysis survey and qualitative interviews [ Time Frame: Measured at Week 16 ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Depression treatment preferences as measured by a conjoint analysis survey and qualitative interviews; measured at Week 16 | ||||||||
| Change History | Complete list of historical versions of study NCT00260169 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Depression outcomes as measured by the Patient Health Questionnaire-9 [ Time Frame: Measured at Week 16 ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE |
Depression outcomes as measured by the Patient Health Questionnaire-9; measured at Week 16 | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Determining Depression Treatment Preferences of Low-Income Latinos in Primary Care Settings | ||||||||
| Official Title ICMJE | Patient-Centered Depression Care in the Public Sector | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Depression | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 432 | ||||||||
| Completion Date | January 2009 | ||||||||
| Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: For Participating Patients:
For Providers:
For Administrators:
Exclusion Criteria: For Participating Patients:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00260169 | ||||||||
| Other Study ID Numbers ICMJE | R01 MH067949, DSIR 82-SEPC | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Isabel Lagomasino, MD, MSHS, University of Southern California | ||||||||
| Study Sponsor ICMJE | National Institute of Mental Health (NIMH) | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||||||
| Verification Date | March 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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