- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00536406
Evaluating a Behavioral Activities Treatment Program for Depressed Nursing Home Residents (BE-ACTIV)
BE-ACTIV: Treating Depression in Nursing Homes
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Depression is a common mental disorder that affects nearly half of all older people living in nursing homes. Depression can severely impact people's lives, causing them to often feel sad and hopeless, as well as affect people's sleep patterns, concentration, and energy levels. In addition, nursing homes are often understaffed and very busy, making it difficult for older people with depression to receive a proper diagnosis and adequate treatment. Recent studies have shown that an increase in pleasurable activities among residents in nursing homes can improve symptoms of depression. The purpose of this study is to determine whether symptoms of depression can be reduced by increasing opportunities for nursing home residents to engage in pleasant events and build better relationships with nursing home staff members.
Participating nursing homes will be randomly assigned to have their residents receive behavioral activity treatment (BE-ACTIV) or treatment as usual for 12 weeks. Potential participating nursing home residents will complete two brief tests regarding memory, attention, and symptoms of depression. An hour-long interview will then be conducted during which eligible participating residents will discuss their symptoms of depression, rate their health and level of functioning, and assess the quality of their relationship with a staff member. Residents receiving BE-ACTIV will meet with a therapist for weekly 30-minute sessions for 10 weeks. During these sessions, residents will discuss their activity participation and any pleasant events that they recently experienced. Therapists and nursing home activities staff will work together to incorporate more activities of interest into each resident's schedule. Residents of nursing homes assigned to receive treatment as usual will be asked to rate their mood once a week for 10 weeks. Researchers will observe each resident, regardless of treatment group, for 5-minute intervals at various times during the study to assess mood and activity levels. All participating residents will undergo a second interview after 10 weeks to discuss any changes or improvements in mood, symptoms of depression, activity level, or their relationship with staff members. All participating residents will be assessed after 3 months and again after 6 months post-treatment to determine whether the BE-ACTIV program was successful in improving symptoms of depression.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Kentucky
-
Louisville, Kentucky, Estados Unidos, 40292
- University of Louisville
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Nursing home residents in long-term care beds with an expected stay of 3 months or more
- Geriatric Depression Scale score of at least 11
- Meets DSM-IV criteria for major depressive disorder or research diagnostic criteria for minor depressive disorder
Exclusion Criteria:
- Mini Mental State Exam score below 14
- Referred to hospice care for a terminal condition
- Current unstable or terminal medical condition
- Suicidal
- Meets DSM-IV criteria for bipolar disorder
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: A
Participants will receive the BE-ACTIV treatment
|
BE-ACTIV is 10-week behavioral treatment involving increasing pleasant events.
|
|
Comparador activo: B
Participants will receive treatment as usual
|
TAU includes usual treatment in nursing care facility.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Depression diagnosis and depressive symptoms as assessed by the Geriatric Depression Scale
Periodo de tiempo: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
|
Functioning as assessed by the Dartmouth COOP Scales for Social Functioning
Periodo de tiempo: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Staff attention
Periodo de tiempo: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
|
Positive affect
Periodo de tiempo: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
|
Activity participation
Periodo de tiempo: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
|
Behavior problems
Periodo de tiempo: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
|
Resident satisfaction
Periodo de tiempo: Measured at Weeks 12, 24, and 48
|
Measured at Weeks 12, 24, and 48
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Suzanne Meeks, PhD, University of Louisville
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 (Actual)
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
- R01MH074865 (Subvención/contrato del NIH de EE. UU.)
- DATR A4-GPS
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. .
Ensayos clínicos sobre BE-ACTIV
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-
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-
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-
KeifeRx, LLCWorldwide Clinical Trials; Life Molecular Imaging GmbH; Sun Pharmaceuticals Industries...Aún no reclutando
-
Be BiopharmaTerminadoHemofilia B | Hemofilia B, moderadamente severa o graveEstados Unidos
-
Yale UniversityTerminadoSalud mental | Intervenciones de apoyo entre paresEstados Unidos
-
KU LeuvenFlemish Agency for Care and HealthTerminadoPersonas mayores | Implementación | Prevención de caídasBélgica
-
Abbott Medical DevicesActivo, no reclutandoEstenosis aórtica severa sintomáticaEstados Unidos, Francia
-
University of AlbertaUniversity of CalgaryActivo, no reclutandoComplicaciones Postoperatorias | Cirugía | MovilidadCanadá
-
Baskent UniversityHacettepe UniversityTerminadoEntrenamiento de ejercicio | Fisioterapia | Metabolismo energético | AmputadosPavo