Comparative Effectiveness Research for Eliminating Disparities (CERED)
UPR-CHA Research Center of Excellence- Supplement
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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San Juan, Porto Rico, 00936
- University of Puerto Rico
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Massachusetts
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Somerville, Massachusetts, États-Unis, 02134
- Cambridge Health Alliance
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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).
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Comparateur actif: Engagement and Counseling for Latinos (ECLA-F)
Patients in this arm (ECLA-F) receive the 6-8 session CBT plus care-management intervention, administered in person.
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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.
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Comparateur actif: Engagement and Counseling for Latinos (ECLA-T)
Patients in this arm received the 6-8 session CBT intervention via telephone.
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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.
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Aucune intervention: Usual Care
Patients 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.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Change in Depression Severity at baseline, end of treatment (2-3 months), and 6-month follow-up
Délai: Baseline, At each intervention visit (approximately weekly up to end of treatment at 2-3 months), and at 6-month follow-up
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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.
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Baseline, At each intervention visit (approximately weekly up to end of treatment at 2-3 months), and at 6-month follow-up
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Change in Past 30-day Functioning at baseline, end of treatment (2-3 months), and 6-month follow-up
Délai: Baseline, At each intervention visit (approximately weekly up to end of treatment at 2-3 months), and at 6-month follow-up
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Overall functioning over the past 30 days was measured using the World Health Organization Disability Assessment Schedule 2.0 (WHO-DAS 2.0).
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Baseline, At each intervention visit (approximately weekly up to end of treatment at 2-3 months), and at 6-month follow-up
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Margarita Alegria, Ph.D., Cambridge Health Alliance
- Chercheur principal: Glorisa Canino, Ph.D., University of Puerto Rico
Publications et liens utiles
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CHA-IRB-0465/08/10
- 3P60MD002261 (Subvention/contrat des NIH des États-Unis)
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