Comparative Effectiveness Research for Eliminating Disparities

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.

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).