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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00260169
Other study ID # R01MH067949
Secondary ID R01MH067949DSIR
Status Completed
Phase N/A
First received November 29, 2005
Last updated December 9, 2013
Start date November 2005
Est. completion date January 2009

Study information

Verified date December 2013
Source University of Southern California
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 432
Est. completion date January 2009
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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).
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.

Locations

Country Name City State
United States H. Claude Hudson Comprehensive Health Center Los Angeles California
United States LAC+USC Outpatient Department Los Angeles California
United States USC Family Practice Center at California Hospital Los Angeles California

Sponsors (2)

Lead Sponsor Collaborator
University of Southern California National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Dwight-Johnson M, Lagomasino IT, Hay J, Zhang L, Tang L, Green JM, Duan N. Effectiveness of collaborative care in addressing depression treatment preferences among low-income Latinos. Psychiatr Serv. 2010 Nov;61(11):1112-8. doi: 10.1176/appi.ps.61.11.1112 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Depression treatment preferences as measured by a conjoint analysis survey and qualitative interviews Measured at Week 16 No
Secondary Depression outcomes as measured by the Patient Health Questionnaire-9 Measured at Week 16 No
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