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Multifaceted Depression and Cardiovascular Program (MDCP)

Primary Purpose

Depression, Depressive Disorder, Behavioral Symptoms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Collaborative depression care management
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression focused on measuring Major Depression, Heart Disease, Hispanics, Collaborative Depression Care Management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Current suicidal ideation
  • Score of 8 or greater on the Alcohol Use Disorders Identification Test (AUDIT)
  • Recent use of lithium or antipsychotic medication

Sites / Locations

  • University of Southern California School of Social Work

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Collaborative depression care

Arm Description

All enrolled patients will receive collaborative depression care management.

Outcomes

Primary Outcome Measures

Depressive symptoms reduction
Achieve minimum a 50% reduction in depressive symptoms from baseline at 6- and 12-month follow-up

Secondary Outcome Measures

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

Full Information

First Posted
February 20, 2014
Last Updated
February 20, 2014
Sponsor
University of Southern California
Collaborators
Los Angeles County Department of Public Health
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1. Study Identification

Unique Protocol Identification Number
NCT02069912
Brief Title
Multifaceted Depression and Cardiovascular Program
Acronym
MDCP
Official Title
Multifaceted Depression and Cardiovascular Program for Low-Income Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
Los Angeles County Department of Public Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Depressive Disorder, Behavioral Symptoms, Mood Disorders
Keywords
Major Depression, Heart Disease, Hispanics, Collaborative Depression Care Management

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
108 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Collaborative depression care
Arm Type
Experimental
Arm Description
All enrolled patients will receive collaborative depression care management.
Intervention Type
Behavioral
Intervention Name(s)
Collaborative depression care management
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depressive symptoms reduction
Description
Achieve minimum a 50% reduction in depressive symptoms from baseline at 6- and 12-month follow-up
Time Frame
Measured at months 6 and 12
Secondary Outcome Measure Information:
Title
Improvement in quality of life
Description
Change score in quality-of-life 12-item Short-Form Health Survey, Minnesota Living with Heart Failure, Sheehan Disability Scale outcomes
Time Frame
Measured at months 6 and 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Current suicidal ideation Score of 8 or greater on the Alcohol Use Disorders Identification Test (AUDIT) Recent use of lithium or antipsychotic medication
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen R Ell, DSW
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Southern California School of Social Work
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089-0411
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25262042
Citation
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.
Results Reference
derived

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Multifaceted Depression and Cardiovascular Program

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