Clinical trial NCT02027636: Comparative Effectiveness Research for Eliminating Disparities
Official title: UPR-CHA Research Center of Excellence- Supplement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Latinos
Mental Health
Disparities
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of Puerto Rico
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2014-01-06
Enrollment: 257
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in Depression Severity at baseline, end of treatment (2-3 months), and 6-month follow-up
timeFrame: Baseline, At each intervention visit (approximately weekly up to end of treatment at 2-3 months), and at 6-month follow-up
Secondary outcomes:
measure: Change in Past 30-day Functioning at baseline, end of treatment (2-3 months), and 6-month follow-up
timeFrame: Baseline, At each intervention visit (approximately weekly up to end of treatment at 2-3 months), and at 6-month follow-up
Other outcomes:
Locations:
city: Somerville
country: United States
facility: Cambridge Health Alliance
state: Massachusetts
city: San Juan
country: Puerto Rico
facility: University of Puerto Rico
Study officials:
affiliation: Cambridge Health Alliance
name: Margarita Alegria, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Puerto Rico
name: Glorisa Canino, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: