DepressionMDCPNCT02069912
Multifaceted Depression and Cardiovascular Program
A study testing Collaborative depression care management in people with Depression and Depressive Disorder, run by University of Southern California at 1 site in United States.
Trial summary
1. Implement an evidence-based structured care approach that includes screening; acute treatment and relapse prevention follow-up tailored for public sector clinics and low-income and minority patients. 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Depressive Disorder, Behavioral Symptoms
- What is being tested?
- Collaborative depression care management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Feb 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
- Meets criteria for clinically significant depression based on a score of ≥ 2 for one of the two cardinal depression symptoms (depressed mood or loss of interest) and a Patient Health Questionnaire-9 total score of ≥ 10
- Patient with heart disease
- Has attended Los Angeles County Department of Health Services Comprehensive Health Clinics or the Cardiology Clinic at Los Angeles County+University of Southern California Medical Center
Who cannot join
- Current suicidal ideation
- Score of 8 or greater on the Alcohol Use Disorders Identification Test (AUDIT)
- Recent use of lithium or antipsychotic medication
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California School of Social Work
Los Angeles, California, 90089-0411
About this study
Official title: Multifaceted Depression and Cardiovascular Program for Low-Income Patients
- Implement an evidence-based structured care approach that includes screening; acute treatment and relapse prevention follow-up tailored for public sector clinics and low-income and minority patients.
- Adapt an evidence-based collaborative care model for primary care, implement the adapted model, evaluate and further refine the model based on the pilot experience, and produce and disseminate a detailed manual for use in public sector clinics.
- Evaluate Multifaceted Depression and Cardiovascular Program (MDCP) in an open trial to determine: its acceptance by patients, medical providers, and organizational decision-makers; patient depression treatment adherence; its direct cost; and the size and variability of change from baseline in the primary outcome measures: depressive symptoms, functional status, quality of life, health service use, and cardiac status at 6 and 12 month follow-up.
Read the detailed description
The pilot open trial was conducted to evaluate the effectiveness of a health services quality improvement intervention, Multifaceted Depression and Cardiovascular Program (MDCP), on reduction of major depressive disorder, adherence to recommended cardiac exercise and diet self-care regimens and appointment keeping, blood pressure and low density lipid levels, functional status, quality of life and use of health services among low-income, predominantly Hispanic adults with congestive heart failure (CHF) or other cardiac disease such as coronary artery disease (CAD) in public sector community-based primary care clinics. The study was based on key observations from recent studies: 1) Patients with cardiac conditions are more likely to experience clinically significant depressive symptoms than the general population, with depression being associated with poor cardiac outcomes; 2) depression rates are high among Hispanics with chronic illness; 3) Minority patients are less likely to receive care for depression, but benefit with culturally appropriate care enhancements; and 4) depression co-morbid with cardiac conditions is likely to be persistent. Low-income patient needs, depression illness characteristics, and public care system resources call for a multifaceted, collaborative chronic disease management model of depression care. MDCP is aimed at positively affecting depression and cardiac outcomes by reducing known patient, provider, and system barriers to care.
Participation in this study will last 12 months. All participants will first undergo baseline assessments that will include a 40-minute interview about personal health and feelings. All study participants will receive collaborative depression care management. They will first be provided with information about depression treatment. Participants will then have the option of choosing between two depression treatments: counseling or antidepressant medications. Participants who choose to receive treatment with counseling will receive eight weekly 45-minute counseling sessions, conducted either on the phone or at the clinic. During these sessions, participants will undergo structured problem solving therapy (PST) and will learn strategies to manage their depressive symptoms. Participants who choose to receive treatment with antidepressant medication will be prescribed medication by a study doctor and will be monitored for any side effects throughout treatment. Medication treatment may last up to 12 months but will depend upon participants' severity of depression. After completing medication treatment, participants will be offered PST counseling. All study participants will also receive supportive patient navigation services and maintenance/relapse telephone monitoring.
All participants will undergo follow-up phone interviews about their status at months 6 and 12.
- Conditions
- Depression, Depressive Disorder, Behavioral Symptoms, Mood Disorders
- Being tested
- Collaborative depression care management
- Keywords
- Major Depression, Heart Disease, Hispanics, Collaborative Depression Care Management
- Medical subject headings
- Depression, Depressive Disorder, Behavioral Symptoms, Mood Disorders, Depressive Disorder, Major, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative depression care managementBehavioural
Collaborative depression care management will include acute depression treatment with antidepressant medication and/or counseling sessions based on structured problem solving therapy. Participants will also receive supportive patient navigation services and maintenance/relapse telephone monitoring. Counseling treatment will include 8 weekly 45-minute counseling sessions that are culturally and health literacy adapted for the study population. The length of medication treatment will depend upon participants' severity of depression and may last up to 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Collaborative depression care | Experimental | All enrolled patients will receive collaborative depression care management. Receives: Behavioral: Collaborative depression care management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms reduction
Achieve minimum a 50% reduction in depressive symptoms from baseline at 6- and 12-month follow-up
Measured: Measured at months 6 and 12
Secondary outcomes (1)
Improvement in quality of life
Change score in quality-of-life 12-item Short-Form Health Survey, Minnesota Living with Heart Failure, Sheehan Disability Scale outcomes
Measured: Measured at months 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2014 (estimated)
- Study startNov 2006
- Primary completionFeb 2009
- Study completionFeb 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Los Angeles County Department of Public Health
- Responsible party
- Sponsor
- Investigators
- Kathleen R Ell, DSW, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069912
- Sponsor's protocol ID
- USCIRB-HS-06-00420
- Other IDs
- CA Health Care Foundation
- Acronym
- MDCP
- Status last verified
- Feb 2014
- First submitted
- 20 Feb 2014
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ell K, Oh H, Lee PJ, Guterman J. Collaborative health literate depression care among predominantly Hispanic patients with coronary heart disease in safety net care. Psychosomatics. 2014 Nov-Dec;55(6):555-65. doi: 10.1016/j.psym.2014.03.007. Epub 2014 Mar 26.
PubMed 25262042
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifaceted Depression and Cardiovascular Program for Low-Income Patients
- ClinicalTrials.gov ID
- NCT02069912
- Acronym / sponsor ID
- MDCP / USCIRB-HS-06-00420
- Conditions
- Depression, Depressive Disorder, Behavioral Symptoms, Mood Disorders
- Keywords
- Major Depression, Heart Disease, Hispanics, Collaborative Depression Care Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Los Angeles County Department of Public Health
- Study start
- Nov 2006
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 24 Feb 2014 (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.
- Implement an evidence-based structured care approach that includes screening; acute treatment and relapse prevention follow-up tailored for public sector clinics and low-income and minority patients.
- Adapt an evidence-based collaborative care model for primary care, implement the adapted model, evaluate and further refine the model based on the pilot experience, and produce and disseminate a detailed manual for use in public sector clinics.
- Evaluate Multifaceted Depression and Cardiovascular Program (MDCP) in an open trial to determine: its acceptance by patients, medical providers, and organizational decision-makers; patient depression treatment adherence; its direct cost; and the size and variability of change from baseline in the primary outcome measures: depressive symptoms, functional status, quality of life, health service use, and cardiac status at 6 and 12 month follow-up.
Detailed description
The pilot open trial was conducted to evaluate the effectiveness of a health services quality improvement intervention, Multifaceted Depression and Cardiovascular Program (MDCP), on reduction of major depressive disorder, adherence to recommended cardiac exercise and diet self-care regimens and appointment keeping, blood pressure and low density lipid levels, functional status, quality of life and use of health services among low-income, predominantly Hispanic adults with congestive heart failure (CHF) or other cardiac disease such as coronary artery disease (CAD) in public sector community-based primary care clinics. The study was based on key observations from recent studies: 1) Patients with cardiac conditions are more likely to experience clinically significant depressive symptoms than the general population, with depression being associated with poor cardiac outcomes; 2) depression rates are high among Hispanics with chronic illness; 3) Minority patients are less likely to receive care for depression, but benefit with culturally appropriate care enhancements; and 4) depression co-morbid with cardiac conditions is likely to be persistent. Low-income patient needs, depression illness characteristics, and public care system resources call for a multifaceted, collaborative chronic disease management model of depression care. MDCP is aimed at positively affecting depression and cardiac outcomes by reducing known patient, provider, and system barriers to care.
Participation in this study will last 12 months. All participants will first undergo baseline assessments that will include a 40-minute interview about personal health and feelings. All study participants will receive collaborative depression care management. They will first be provided with information about depression treatment. Participants will then have the option of choosing between two depression treatments: counseling or antidepressant medications. Participants who choose to receive treatment with counseling will receive eight weekly 45-minute counseling sessions, conducted either on the phone or at the clinic. During these sessions, participants will undergo structured problem solving therapy (PST) and will learn strategies to manage their depressive symptoms. Participants who choose to receive treatment with antidepressant medication will be prescribed medication by a study doctor and will be monitored for any side effects throughout treatment. Medication treatment may last up to 12 months but will depend upon participants' severity of depression. After completing medication treatment, participants will be offered PST counseling. All study participants will also receive supportive patient navigation services and maintenance/relapse telephone monitoring.
All participants will undergo follow-up phone interviews about their status at months 6 and 12.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Collaborative depression care | Experimental | Behavioral: Collaborative depression care managementAll enrolled patients will receive collaborative depression care management. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Meets criteria for clinically significant depression based on a score of ≥ 2 for one of the two cardinal depression symptoms (depressed mood or loss of interest) and a Patient Health Questionnaire-9 total score of ≥ 10
- Patient with heart disease
- Has attended Los Angeles County Department of Health Services Comprehensive Health Clinics or the Cardiology Clinic at Los Angeles County+University of Southern California Medical Center
Key exclusion criteria (3 listed)
- Current suicidal ideation
- Score of 8 or greater on the Alcohol Use Disorders Identification Test (AUDIT)
- Recent use of lithium or antipsychotic medication
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 depression care managementCollaborative depression care management will include acute depression treatment with antidepressant medication and/or counseling sessions based on structured problem solving therapy. Participants will also receive supportive patient navigation services and maintenance/relapse telephone monitoring. Counseling treatment will include 8 weekly 45-minute counseling sessions that are culturally and health literacy adapted for the study population. The length of medication treatment will depend upon participants' severity of depression and may last up to 12 months. | Behavioural | Collaborative depression care |
Primary outcome
Depressive symptoms reduction
Time frame: Measured at months 6 and 12
Achieve minimum a 50% reduction in depressive symptoms from baseline at 6- and 12-month follow-up
1 secondary outcome
Improvement in quality of life
Time frame: Measured at months 6 and 12
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 22 Nov 2023.
- Derived from this study: PubMed 25262042Ell K, Oh H, Lee PJ, Guterman J. Collaborative health literate depression care among predominantly Hispanic patients with coronary heart disease in safety net care. Psychosomatics. 2014 Nov-Dec;55(6):555-65. doi: 10.1016/j.psym.2014.03.007. Epub 2014 Mar 26.
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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.
Kathleen R Ell, DSW principal investigator
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 Collaborative depression care management in people with Depression and Depressive Disorder, run by University of Southern California 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 3 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 22 Nov 2023. 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?
Depressive symptoms reduction (time frame: Measured at months 6 and 12). 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 NCT02069912, 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 22 Nov 2023.