DepressionNCT00570427
Improving Depression Treatment for Older Minority Adults
A study testing Problem Solving Therapy (PST) and Medication Management in people with Depression, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
The purpose of this study is to improve access to quality depression care for older, low-income, minority adults in public sector health care. The study will examine current depression care in a public sector geriatric clinic that serves mostly Spanish-speaking Latinos and pilot study assessments and treatments in… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Problem Solving Therapy (PST) and Medication Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Jun 2008
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of the LAC+USC Medical Center Geriatric Clinic
- English- or Spanish-speaking
- Positive for depression on the Geriatric Depression Scale
- Current major depressive disorder or dysthymia
- All adult family members, especially caregivers, and all regular clinic providers eligible for interviews
Who cannot join
- History of bipolar disorder or psychosis
- Significant cognitive impairment (score less than 24 on the Mini-Mental Status Examination, adjusted for age and education)
- Acute suicidal ideation
Trial locations and contacts
1 site in 1 country.
United States1 site
LAC+USC Medical Center Geriatric Clinic
Los Angeles, California, 90033
About this study
The purpose of this study is to improve access to quality depression care for older, low-income, minority adults in public sector health care. The study will examine current depression care in a public sector geriatric clinic that serves mostly Spanish-speaking Latinos and pilot study assessments and treatments in order to lay the groundwork for a large study of quality improvement for depressed older minorities
Read the detailed description
Depressive disorders affect 5-10% of older primary care patients, although rates may be higher among Latinos, especially among immigrants and those less acculturated. Late-life depression may be chronic and recurrent and results in significant morbidity and mortality. Despite a growing evidence base for the treatment of geriatric depression, only half of depressed older adults receive mental health care; fewer than 10% receive specialty services. Treatment rates are even lower for low-income, ethnic minorities who may be more ill and disabled, may lack adequate insurance and have different treatment preferences, and who frequently face barriers to accessing care. Recent quality improvement interventions for geriatric depression have targeted primary care, the location where older patients and ethnic minorities are most likely to receive mental health services. A recent multi-site, randomized trial of collaborative care for geriatric depression in primary care offered patients their choice of treatments, including antidepressant medication or 6-8 sessions of a structured psychotherapy. Although the intervention had few cultural accommodations, both processes and outcomes of care improved for depressed older minorities. However, because the study only included Latinos who were English-speaking and mostly high school graduates, these results may not generalize to a large proportion of ethnic minorities.
This study first examines current rates of depression and patterns of depression treatment in a public-sector geriatric clinic that serves mostly Spanish-speaking Latinos. Then depressed patients are identified and their depression treatment preferences and barriers to care are assessed. Patients are enrolled in a 6-month patient-centered, evidence-based intervention, and they, family members, and clinic medical providers are interviewed at program end to assess the feasibility, acceptability, and possible effectiveness of the intervention.
- Conditions
- Depression
- Being tested
- Problem Solving Therapy (PST), Medication Management
- Keywords
- psychotherapy, behavior therapy, counseling, aging, medically underserved population
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem Solving Therapy (PST)Behavioural
Counseling
Medication ManagementBehavioural
If a participant chooses to receive antidepressant medication while in the study, a depression care specialist works with the participant's usual primary care provider to initiate an appropriate prescription and to follow-up with side effects, adherence, efficacy, etc. on a monthly or biweekly basis.
| Study group | Role | What they receive |
|---|---|---|
| 1. | Experimental | All participants Receives: Behavioral: Problem Solving Therapy (PST); Behavioral: Medication Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression severity, depression treatment preferences, and barriers to care
Measured: baseline and 6 months
Secondary outcomes (1)
Feasibility, acceptability, and effectiveness of intervention
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startFeb 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- University of California, Los Angeles
- Investigators
- Isabel T. Lagomasino, MD MSHS, Principal investigator, Department of Psychiatry, Keck School of Medicine, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570427
- Sponsor's protocol ID
- AG0091
- Other IDs
- 5P30AG021684, 1557 G GD102
- Status last verified
- Feb 2009
- First submitted
- 7 Dec 2007
- Last updated
- 25 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dwight-Johnson M, Lagomasino IT. Addressing depression treatment preferences of ethnic minority patients. Gen Hosp Psychiatry. 2007 May-Jun;29(3):179-81. doi: 10.1016/j.genhosppsych.2007.02.001. No abstract available.
PubMed 17484933Vega WA, Karno M, Alegria M, Alvidrez J, Bernal G, Escamilla M, Escobar J, Guarnaccia P, Jenkins J, Kopelowicz A, Lagomasino IT, Lewis-Fernandez R, Marin H, Lopez S, Loue S. Research issues for improving treatment of U.S. Hispanics with persistent mental disorders. Psychiatr Serv. 2007 Mar;58(3):385-94. doi: 10.1176/ps.2007.58.3.385.
PubMed 17325113Lagomasino IT, Dwight-Johnson M, Miranda J, Zhang L, Liao D, Duan N, Wells KB. Disparities in depression treatment for Latinos and site of care. Psychiatr Serv. 2005 Dec;56(12):1517-23. doi: 10.1176/appi.ps.56.12.1517.
PubMed 16339612
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Depression Treatment for Older Minority Adults
- ClinicalTrials.gov ID
- NCT00570427
- Acronym / sponsor ID
- AG0091
- Conditions
- Depression
- Keywords
- psychotherapy, behavior therapy, counseling, aging, medically underserved population
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Collaborators
- University of California, Los Angeles
- Study start
- Feb 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 11 Dec 2007 (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.
The purpose of this study is to improve access to quality depression care for older, low-income, minority adults in public sector health care. The study will examine current depression care in a public sector geriatric clinic that serves mostly Spanish-speaking Latinos and pilot study assessments and treatments in order to lay the groundwork for a large study of quality improvement for depressed older minorities
Detailed description
Depressive disorders affect 5-10% of older primary care patients, although rates may be higher among Latinos, especially among immigrants and those less acculturated. Late-life depression may be chronic and recurrent and results in significant morbidity and mortality. Despite a growing evidence base for the treatment of geriatric depression, only half of depressed older adults receive mental health care; fewer than 10% receive specialty services. Treatment rates are even lower for low-income, ethnic minorities who may be more ill and disabled, may lack adequate insurance and have different treatment preferences, and who frequently face barriers to accessing care. Recent quality improvement interventions for geriatric depression have targeted primary care, the location where older patients and ethnic minorities are most likely to receive mental health services. A recent multi-site, randomized trial of collaborative care for geriatric depression in primary care offered patients their choice of treatments, including antidepressant medication or 6-8 sessions of a structured psychotherapy. Although the intervention had few cultural accommodations, both processes and outcomes of care improved for depressed older minorities. However, because the study only included Latinos who were English-speaking and mostly high school graduates, these results may not generalize to a large proportion of ethnic minorities.
This study first examines current rates of depression and patterns of depression treatment in a public-sector geriatric clinic that serves mostly Spanish-speaking Latinos. Then depressed patients are identified and their depression treatment preferences and barriers to care are assessed. Patients are enrolled in a 6-month patient-centered, evidence-based intervention, and they, family members, and clinic medical providers are interviewed at program end to assess the feasibility, acceptability, and possible effectiveness of the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1. | Experimental | Behavioral: Problem Solving Therapy (PST), Behavioral: Medication ManagementAll participants |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients of the LAC+USC Medical Center Geriatric Clinic
- English- or Spanish-speaking
- Positive for depression on the Geriatric Depression Scale
- Current major depressive disorder or dysthymia
- All adult family members, especially caregivers, and all regular clinic providers eligible for interviews
Key exclusion criteria (3 listed)
- History of bipolar disorder or psychosis
- Significant cognitive impairment (score less than 24 on the Mini-Mental Status Examination, adjusted for age and education)
- Acute suicidal ideation
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 |
|---|---|---|
| Problem Solving Therapy (PST)Counseling | Behavioural | 1. |
| Medication ManagementIf a participant chooses to receive antidepressant medication while in the study, a depression care specialist works with the participant's usual primary care provider to initiate an appropriate prescription and to follow-up with side effects, adherence, efficacy, etc. on a monthly or biweekly basis. | Behavioural | 1. |
Primary outcome
Depression severity, depression treatment preferences, and barriers to care
Time frame: baseline and 6 months
1 secondary outcome
Feasibility, acceptability, and effectiveness of intervention
Time frame: 6 months
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 25 Feb 2009.
- Background: PubMed 17484933Dwight-Johnson M, Lagomasino IT. Addressing depression treatment preferences of ethnic minority patients. Gen Hosp Psychiatry. 2007 May-Jun;29(3):179-81. doi: 10.1016/j.genhosppsych.2007.02.001. No abstract available.
- Background: PubMed 17325113Vega WA, Karno M, Alegria M, Alvidrez J, Bernal G, Escamilla M, Escobar J, Guarnaccia P, Jenkins J, Kopelowicz A, Lagomasino IT, Lewis-Fernandez R, Marin H, Lopez S, Loue S. Research issues for improving treatment of U.S. Hispanics with persistent mental disorders. Psychiatr Serv. 2007 Mar;58(3):385-94. doi: 10.1176/ps.2007.58.3.385.
- Background: PubMed 16339612Lagomasino IT, Dwight-Johnson M, Miranda J, Zhang L, Liao D, Duan N, Wells KB. Disparities in depression treatment for Latinos and site of care. Psychiatr Serv. 2005 Dec;56(12):1517-23. doi: 10.1176/appi.ps.56.12.1517.
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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
Department of Psychiatry, Keck School of Medicine, University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem Solving Therapy (PST) and Medication Management in people with Depression, run by National Institute on Aging (NIA) at 1 site 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 5 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 25 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 severity, depression treatment preferences, and barriers to care (time frame: baseline and 6 months). 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 NCT00570427, which also lists 3 linked publications.
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 25 Feb 2009.