- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00356304
Motivational Interviewing to Improve Medication Adherence Among Hispanic Adults With Depression
Antidepressant Adherence Among Hispanics: A Motivational Interviewing Approach
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Depression is a serious mental illness characterized by symptoms that can interfere with a person's ability to work, study, eat, sleep, and enjoy activities that were once pleasurable. Studies have shown that people of Hispanic descent tend to underutilize mental health care services. Additionally, Hispanics have demonstrated lower compliance and completion rates for antidepressant treatment. This may be due to low socioeconomic status, lack of family financial support, and inadequate communication with mental health care providers. Motivational interviewing is a goal-oriented type of therapy that focuses on eliciting behavior change by identifying and mobilizing a person's values. This study will determine the effectiveness of culturally sensitive motivational interviewing in improving antidepressant medication adherence in Hispanics.
Participants in this 6-month, open-label study will be randomly assigned to receive either motivational interviewing in addition to their antidepressant therapy or treatment as usual. All participants will first attend a 45-minute screening visit, which will include questionnaires and an interview about psychiatric symptoms, medication attitudes, and medication adherence behavior. Participants will also receive an electronic medication container that will record how consistently medication is taken. Participants assigned to motivational interviewing will then attend two 1-hour sessions of motivational interviewing over 2 consecutive weeks, followed by a third session 8 weeks later. The group assigned to treatment as usual will not partake in motivational interviewing, but will continue to receive their normal care. All participants will return to the study site for follow-up assessments, which will include measures of antidepressant adherence, at Months 2 and 5.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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New Jersey
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New Brunswick, New Jersey, Estados Unidos, 08901
- University Behavioral Healthcare
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Self-identifies as Hispanic
- DSM-IV diagnosis of any unipolar depressive disorder (i.e., MDD, dysthymia, or depressive disorder not otherwise specified)
- Currently taking antidepressant medication
Exclusion Criteria:
- Clinically significant suicidal ideation
- DSM-IV diagnosis of any substance-related disorder, bipolar disorder, or psychotic disorder/features within 12 months prior to study entry
- Unstable general medical condition
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: 2
Los participantes recibirán el tratamiento habitual.
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Participants will continue with their normal treatment regimen as usual.
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Experimental: 1
Participants will receive motivational interviewing in addition to their antidepressant therapy
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Participants assigned to motivational interviewing will attend two 1-hour sessions of motivational interviewing over 2 consecutive weeks, followed by a third session 8 weeks later.
Motivational interviewing is a type of counselling.
Each session is of approximately 1 hour duration.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Medication Adherence, as Measured by Electronic Pill Container
Periodo de tiempo: Measured immediately post-treatment and at Months 2 and 5 months follow-ups
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Medication container caps (MEMS) recorded each instance where the antidepressant medication container was opened.
An adherence index was derived the represented the percentage of days, within the medication period, where the container was opened.
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Measured immediately post-treatment and at Months 2 and 5 months follow-ups
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Treatment Retention
Periodo de tiempo: Measured at Month 5
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Measured at Month 5
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Beck Depression Inventory-II (BDI-II)
Periodo de tiempo: Measured at Month 5
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The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression. Higher total scores indicate more severe depressive symptoms. |
Measured at Month 5
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Medication Attitudes
Periodo de tiempo: Measured at Month 5
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Measured at Month 5
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Alejandro Interian, PhD, Rutgers, The State University of New Jersey
Publicaciones y enlaces útiles
Publicaciones Generales
- Interian A, Martinez IE, Guarnaccia PJ, Vega WA, Escobar JI. A qualitative analysis of the perception of stigma among Latinos receiving antidepressants. Psychiatr Serv. 2007 Dec;58(12):1591-4. doi: 10.1176/ps.2007.58.12.1591.
- Escobar JI, Cook B, Chen CN, Gara MA, Alegria M, Interian A, Diaz E. Whether medically unexplained or not, three or more concurrent somatic symptoms predict psychopathology and service use in community populations. J Psychosom Res. 2010 Jul;69(1):1-8. doi: 10.1016/j.jpsychores.2010.01.001. Epub 2010 Feb 16.
- Interian A, Lewis-Fernandez R, Gara MA, Escobar JI. A randomized-controlled trial of an intervention to improve antidepressant adherence among Latinos with depression. Depress Anxiety. 2013 Jul;30(7):688-96. doi: 10.1002/da.22052. Epub 2013 Jan 8.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- K23MH074860 (Subvención/contrato del NIH de EE. UU.)
- DSIR 8K-RT
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