Entrevistas motivacionales para reducir el consumo de sustancias entre pacientes con depresión
8 de junio de 2015 actualizado por: University of California, San Francisco
El estudio tiene como objetivo evaluar la eficacia de una intervención para reducir el consumo de alcohol y drogas y los síntomas de depresión, mejorar el estado funcional y promover la utilización adecuada de los servicios de salud, en una muestra de 300 adultos que buscan tratamiento para la depresión y que también reportan consumo peligroso de alcohol o drogas con depresión. .
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
Este estudio aborda preguntas importantes sobre cómo identificar y tratar a los pacientes en psiquiatría que acuden a los servicios con consumo de alcohol o drogas que pueden exacerbar la depresión.
Los investigadores proponen un estudio de Intervención Motivacional Breve (BMI, por sus siglas en inglés) para reducir el consumo de drogas y alcohol entre los pacientes con depresión, y para mejorar el compromiso con un Programa de Recuperación de la Dependencia Química de Kaiser (CDRP, por sus siglas en inglés) según sea necesario.
Los pacientes con depresión que consumen drogas o alcohol, incluso a niveles inferiores al diagnóstico, corren un alto riesgo de que se intensifiquen los problemas relacionados con las sustancias.
El BMI es un enfoque innovador basado en la evidencia que podría disminuir el consumo de drogas y alcohol y mejorar los resultados.
Pero no se ha probado en pacientes con depresión.
La muestra de este estudio incluirá a 300 pacientes ambulatorios en tratamiento por depresión en Kaiser Permanente Northern California Hayward/Fremont Psychiatry.
Los criterios de inclusión se basan en el uso de drogas (cualquier uso de drogas ilícitas y uso no recetado de medicamentos recetados) y el consumo de riesgo (es decir, ≥ 3 tragos en un día para mujeres y ≥ 4 tragos en un día para hombres), y moderado a severo. Síntomas de depresión en la ingesta.
Trescientos pacientes serán aleatorizados para recibir una sesión de BMI en persona y dos sesiones telefónicas de BMI dentro de las 6 semanas posteriores a la admisión (intervención) o un folleto sobre los riesgos del consumo de drogas y alcohol (control).
Los investigadores prevén que la intervención será eficaz para reducir la frecuencia del consumo de drogas y el consumo de riesgo en las entrevistas telefónicas de seguimiento a los 3, 6 y 12 meses; mejorar el estado de ánimo y los resultados funcionales; aumento de la retención en el tratamiento de la depresión (número de visitas a psiquiatría, según los estándares del Conjunto de datos e información sobre la eficacia de la atención médica (HEDIS)); y facilitar que el paciente inicie el tratamiento del programa de dependencia química si es necesario, y será rentable.
Para mejorar la atención del paciente, también proporcionará información importante sobre la integración de la intervención de alcohol y drogas en psiquiatría y la mejor manera de ayudar a los pacientes a acceder a los servicios especializados de CDRP cuando sea necesario.
Tipo de estudio
Intervencionista
Inscripción (Actual)
307
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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California
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Union City, California, Estados Unidos, 94545
- Kaiser Permanente Medical Center Southern Alameda County
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Criterios de inclusión:
- Consumo de riesgo (es decir, ≥ 3 bebidas al día para mujeres y ≥ 4 bebidas al día para hombres)
- Uso de drogas (incluido cualquier uso de drogas ilícitas y uso no recetado de medicamentos recetados en los 30 días anteriores)
- Síntomas de depresión moderados o mayores según una puntuación de ≥ 5 en el Cuestionario de Salud del Paciente (PHQ-9)
Criterio de exclusión:
- Manía o psicosis actual
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Entrevista motivacional
La intervención de entrevista motivacional (MI) consistió en una sesión de MI en persona de 45 minutos seguida de dos sesiones telefónicas de "refuerzo" de 15 minutos
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Comparador activo: Control
Los participantes recibieron un folleto sobre los riesgos del consumo de alcohol y drogas.
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Los participantes recibieron un folleto sobre los riesgos del consumo de alcohol y drogas.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Consumo de riesgo de alcohol en los 30 días anteriores (Número de días de consumo de riesgo de consumo de alcohol autoinformado)
Periodo de tiempo: 6 meses
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Número autoinformado de días de consumo de riesgo (más de 3 tragos por día para mujeres / 4 o más tragos por día para hombres) en los 30 días anteriores.
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6 meses
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Uso de drogas en los 30 días anteriores (Número de días de uso de drogas autoinformado)
Periodo de tiempo: 6 meses
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Número autoinformado de días de uso de drogas (uso de drogas ilegales o uso indebido de medicamentos recetados) en los 30 días anteriores.
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6 meses
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Consumo de riesgo de alcohol en los 30 días anteriores (Número de días de consumo de riesgo de consumo de alcohol autoinformado)
Periodo de tiempo: 12 meses
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Número autoinformado de días de consumo de riesgo (más de 3 tragos por día para mujeres / 4 o más tragos por día para hombres) en los 30 días anteriores.
Examinamos el cambio entre el uso a los 6 meses y el uso a los 12 meses para medir el impacto de la intervención a largo plazo.
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12 meses
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Uso de drogas en los 30 días anteriores (Número de días de uso de drogas autoinformado)
Periodo de tiempo: 12 meses
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Número autoinformado de días de uso de drogas (uso de drogas ilegales o uso indebido de medicamentos recetados) en los 30 días anteriores.
Examinamos el cambio en el uso entre 6 meses y 12 meses para medir el impacto de la intervención a largo plazo.
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12 meses
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Síntomas de depresión (puntuación del Cuestionario de salud del paciente (PHQ-9))
Periodo de tiempo: 12 meses
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medido en entrevistas telefónicas de seguimiento. El PHQ-9 evalúa la frecuencia de 9 tipos de problemas en las últimas 2 semanas; las respuestas van de 0 (nada) a 3 (casi todos los días).
Si al menos 4 de 9 son >0, la suma de las puntuaciones de los ítems se utiliza para indicar la gravedad de la depresión: 1-4 Mínimo; 5-9 Leve; 10-14 Moderado; 15-19 moderadamente grave; 20-27 Severo.
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12 meses
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Tratamiento de salud mental adecuado (Número de participantes que reciben tratamiento continuo de 12 semanas en el Departamento de Psiquiatría para pacientes ambulatorios de Kaiser Permanente)
Periodo de tiempo: 3 meses
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Número de participantes que reciben tratamiento continuo de 12 semanas en el Departamento de Psiquiatría para pacientes ambulatorios de Kaiser Permanente
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3 meses
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Derek D Satre, PhD, University of California, San Francisco
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
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Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de octubre de 2010
Finalización primaria (Actual)
1 de agosto de 2014
Finalización del estudio (Actual)
1 de agosto de 2014
Fechas de registro del estudio
Enviado por primera vez
7 de abril de 2015
Primero enviado que cumplió con los criterios de control de calidad
17 de abril de 2015
Publicado por primera vez (Estimar)
20 de abril de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
10 de junio de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
8 de junio de 2015
Última verificación
1 de junio de 2015
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 10-03323
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .