Comparative Effectiveness Research for Eliminating Disparities
CERED
UPR-CHA Research Center of Excellence- Supplement
2 other identifiers
interventional
257
2 countries
2
Brief Summary
Our study tested the effectiveness of a combined cognitive behavioral therapy (CBT) and care manager intervention offered either by telephone or face-to-face with depressed Latinos identified in primary care. Eligible patients were randomized after baseline to one of three conditions; 1) ECLA-T (telephone) intervention, 2) ECLA-F (face to face) intervention, and 3) usual care. Usual care was considered care as usual in the participating clinic for a patient screening or depression. The ECLA-T intervention was based on a telephone-plus-care-management intervention that has been shown to be effective in decreasing depressive symptoms and increasing client satisfaction and self-perceived global improvement, as compared to usual care in depressed patients in primary care settings.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started May 2011
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 18, 2013
CompletedFirst Posted
Study publicly available on registry
January 6, 2014
CompletedJune 3, 2016
June 1, 2016
1.3 years
December 18, 2013
June 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Depression Severity at baseline, end of treatment (2-3 months), and 6-month follow-up
Change in severity of depression symptoms will be assessed using two different measures. The Patient Health Questionnaire-9 (PHQ-9) is a nine item depression screening tool, developed and validated for use in primary care settings. The Hopkins Symptom Checklist-20 (HSCL-20) measures depression symptom severity and distress.
Baseline, At each intervention visit (approximately weekly up to end of treatment at 2-3 months), and at 6-month follow-up
Secondary Outcomes (1)
Change in Past 30-day Functioning at baseline, end of treatment (2-3 months), and 6-month follow-up
Baseline, At each intervention visit (approximately weekly up to end of treatment at 2-3 months), and at 6-month follow-up
Study Arms (3)
Engagement and Counseling for Latinos (ECLA-F)
ACTIVE COMPARATORPatients in this arm (ECLA-F) receive the 6-8 session CBT plus care-management intervention, administered in person.
Engagement and Counseling for Latinos (ECLA-T)
ACTIVE COMPARATORPatients in this arm received the 6-8 session CBT intervention via telephone.
Usual Care
NO INTERVENTIONPatients in this arm receive usual care for depression from their primary care providers, which could include antidepressant prescription or referral to specialty mental health care.
Interventions
The Engagement and Counseling for Latinos - Face-to-face (ECLA-F) intervention is a cognitive behavioral therapy (CBT) plus care-management intervention delivered in person. The CBT component consists of 6-8 sessions, delivered by a Master's level clinician, and focusing on self-management techniques, problem-solving, and techniques for managing depression and stress. The care-management component of the intervention consisted of monitoring, assistance in scheduling appointments, and help with transportation. This intervention was identical to the telephone (ECLA-F) intervention, except for the delivery method.
The Engagement and Counseling for Latinos - Telephone (ECLA-T) intervention is a cognitive behavioral therapy (CBT) plus care-management intervention delivered via telephone. The CBT component consists of 6-8 sessions, delivered by a Master's level clinician, and focusing on self-management techniques, problem-solving, and techniques for managing depression and stress. The care-management component of the intervention consisted of monitoring, assistance in scheduling appointments, and technical assistance. This intervention was identical to the face-to-face (ECLA-F) intervention, except for the delivery method.
Eligibility Criteria
You may qualify if:
- Patients are eligible if they are Latinos, at least 18 years of age, score 10 or more on the PHQ-9 and meet at least one of the essential criteria for Major Depressive Disorder (MDD).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Cambridge Health Alliance
Somerville, Massachusetts, 02134, United States
University of Puerto Rico
San Juan, 00936, Puerto Rico
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Margarita Alegria, Ph.D.
Cambridge Health Alliance
- PRINCIPAL INVESTIGATOR
Glorisa Canino, Ph.D.
University of Puerto Rico
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief, Disparities Research Unit
Study Record Dates
First Submitted
December 18, 2013
First Posted
January 6, 2014
Study Start
May 1, 2011
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
June 3, 2016
Record last verified: 2016-06