DepressionNCT00260169
Determining Depression Treatment Preferences of Low-Income Latinos in Primary Care Settings
A study testing Collaborative care treatment in people with Depression, run by University of Southern California at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Collaborative care treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 432 participants
- Where
- 3 sitesUnited States
- Study dates
- Nov 2005to Jan 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- For Participating Patients:
- Acutely suicidal
- Screens positive for bipolar disorder, psychotic disorder, or cognitive impairment
Trial locations and contacts
3 sites in 1 country.
United States3 sites
H. Claude Hudson Comprehensive Health Center
Los Angeles, California, 90007
USC Family Practice Center at California Hospital
Los Angeles, California, 90015
LAC+USC Outpatient Department
Los Angeles, California, 90033
About this study
Official title: 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.
Read the 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.
- Conditions
- Depression
- Being tested
- Collaborative care treatment, Enhanced usual care
- Keywords
- Treatment Preferences, Public sector, Latino
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative care treatmentBehavioural
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 careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive collaborative care Receives: Behavioral: Collaborative care treatment |
| 2 | Active comparator | Participants will receive enhanced usual care Receives: Behavioral: Enhanced usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression treatment preferences as measured by a conjoint analysis survey and qualitative interviews
Measured: Measured at Week 16
Secondary outcomes (1)
Depression outcomes as measured by the Patient Health Questionnaire-9
Measured: Measured at Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startNov 2005
- Primary completionOct 2007
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Isabel T. Lagomasino, MD, MSHS, University of Southern California
- Investigators
- Isabel T. Lagomasino, MD, MSHS, Principal investigator, University of Southern CaliforniaMegan Dwight-Johnson, MD, MPH, Principal investigator, VA Medical Center-West Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260169
- Sponsor's protocol ID
- R01MH067949
- Other IDs
- R01MH067949, DSIR 82-SEPC
- Status last verified
- Dec 2013
- First submitted
- 29 Nov 2005
- Last updated
- 10 Dec 2013
- Results posted
- No
Publications
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/ps.2010.61.11.1112.
PubMed 21041350
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered Depression Care in the Public Sector
- ClinicalTrials.gov ID
- NCT00260169
- Acronym / sponsor ID
- R01MH067949
- Conditions
- Depression
- Keywords
- Treatment Preferences, Public sector, Latino
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2005
- Primary completion
- Oct 2007 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 1 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine ways to make depression care more responsive to the needs of consumers in primary care clinics serving low-income Latinos.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Collaborative care treatmentParticipants will receive collaborative care |
| 2 | Active comparator | Behavioral: Enhanced usual careParticipants will receive enhanced usual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Attending one of the study clinics for primary care
- English or Spanish-speaking
- Screens positive for major depressive disorder or dysthymia
- All primary care providers providing at least one day of services at one of the study clinics
- Administrative, medical, and nursing directors from each study site and directors of affiliated local mental health clinics
Key exclusion criteria (3 listed)
- Acutely suicidal
- Screens positive for bipolar disorder, psychotic disorder, or cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collaborative care treatmentPatients 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). | Behavioural | 1 |
| Enhanced usual careUsual 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. | Behavioural | 2 |
Primary outcome
Depression treatment preferences as measured by a conjoint analysis survey and qualitative interviews
Time frame: Measured at Week 16
1 secondary outcome
Depression outcomes as measured by the Patient Health Questionnaire-9
Time frame: Measured at Week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2013.
- Results publication: PubMed 21041350Dwight-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/ps.2010.61.11.1112.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabel T. Lagomasino, MD, MSHS principal investigator
University of Southern California
Megan Dwight-Johnson, MD, MPH principal investigator
VA Medical Center-West Los Angeles
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative care treatment in people with Depression, run by University of Southern California at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression treatment preferences as measured by a conjoint analysis survey and qualitative interviews (time frame: Measured at Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00260169, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2013.