Comparative Effectiveness Research for Eliminating Disparities

Depression Clinical Trial

— CERED  

Official title:

UPR-CHA Research Center of Excellence- Supplement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02027636
• Other study ID #: CHA-IRB-0465/08/10
• Secondary ID: 3P60MD002261
• Status: Completed
• Phase: N/A
• First received: December 18, 2013
• Last updated: June 2, 2016
• Start date: May 2011
• Est. completion date: September 2012

Study information

• Verified date: June 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

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. The study was conducted at two sites (San Juan, PR and Boston, MA), each of which had multiple clinics. 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.

All participants received a baseline interview assessment prior to randomization. After treatment completion (2 to 3 months from baseline), patients completed an end-of-treatment (EOT) assessment, including repeated assessment of baseline measurements. A 4-month follow-up from baseline was scheduled, which replicated the EOT assessment.

For those patients in the intervention conditions, during each session the clinician used CBT and motivational enhancement strategies to engage the patient in treatment and enhance retention. The CBT intervention was composed of a shortened version of the original CBT intervention, comprised of modules that focus on identifying and correcting negative distortions or cognitions, promote behavioral activation through engaging the patient in pleasant activities, and develop supportive relationships. All sessions were tailored within the structured format considering the patient's needs and always employed a collaborative approach with the patient.

The first four sessions occurred weekly. Every other week the clinician evaluated the patient with the PHQ-9 to determine the level of depressive symptoms. After four sessions, if there was improvement two to four more bi-weekly sessions were scheduled. If there was no or minimal improvement, sessions continued weekly up to a total of 8 sessions for a maximum of 3 months treatment. Cases that showed no improvement or deterioration received more intensive monitoring from the supervising clinicians at both sites.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 257
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• Exclusion criteria include history of psychosis, use of any specialty mental health treatment within the 3 months prior to baseline or an appointment with a mental health provider within the next two months, inability to demonstrate capacity to consent or evidence of suicidal thoughts or ideation as measured by an affirmative response to questions 4 and 5 on the Paykel Suicide Questionnaire).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression

Intervention

Behavioral:
• Engagement and Counseling for Latinos (ECLA-F)
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.
• Engagement and Counseling for Latinos (ECLA-T)
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.

Locations

Country	Name	City	State
Puerto Rico	University of Puerto Rico	San Juan
United States	Cambridge Health Alliance	Somerville	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute on Minority Health and Health Disparities (NIMHD), University of Puerto Rico

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in Past 30-day Functioning at baseline, end of treatment (2-3 months), and 6-month follow-up	Overall functioning over the past 30 days was measured using the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2.0).	Baseline, At each intervention visit (approximately weekly up to end of treatment at 2-3 months), and at 6-month follow-up	No

External Links

•   Project Website