NCT02069912

Brief Summary

  1. 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. 2.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.
  3. 3.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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
108

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Nov 2006

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 24, 2014

Completed
Last Updated

November 22, 2023

Status Verified

February 1, 2014

Enrollment Period

2.3 years

First QC Date

February 20, 2014

Last Update Submit

November 20, 2023

Conditions

DepressionDepressive DisorderBehavioral SymptomsMood Disorders

Keywords

Major DepressionHeart DiseaseHispanicsCollaborative Depression Care Management

Outcome Measures

Primary Outcomes (1)

  • Depressive symptoms reduction

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

    Measured at months 6 and 12

Secondary Outcomes (1)

  • Improvement in quality of life

    Measured at months 6 and 12

Study Arms (1)

Collaborative depression care

EXPERIMENTAL

All enrolled patients will receive collaborative depression care management.

Behavioral: Collaborative depression care management

Interventions

Collaborative depression care managementBEHAVIORAL

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.

Collaborative depression care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California School of Social Work

Los Angeles, California, 90089-0411, United States

Location

Related Publications (1)

  • 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.

    PMID: 25262042DERIVED

MeSH Terms

Conditions

DepressionDepressive DisorderBehavioral SymptomsMood DisordersDepressive Disorder, MajorHeart Diseases

Condition Hierarchy (Ancestors)

BehaviorMental DisordersCardiovascular Diseases

Study Officials

  • Kathleen R Ell, DSW

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2014

First Posted

February 24, 2014

Study Start

November 1, 2006

Primary Completion

February 1, 2009

Study Completion

February 1, 2009

Last Updated

November 22, 2023

Record last verified: 2014-02

Locations

US(1)