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Cognitive-Behavioral Treatment for Mild Alzheimer's Patients and Their Caregivers (CBTAC)

1 de noviembre de 2017 actualizado por: Simon Forstmeier, University of Zurich

Cognitive-Behavioral Treatment for Patients With Mild Alzheimer's Dementia: A Randomized Controlled Trial

The purpose of this study is to determine whether a comprehensive cognitive-behavioral therapy-based, multi-component treatment programme is effective in the treatment of neuropsychiatric symptoms of patients with mild Alzheimer's dementia.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

Mild Alzheimer's dementia (AD) cases are with 15 millions worldwide the largest fraction of all AD cases. Most patients are cared for by their family at home. Neuropsychiatric symptoms are very common in AD, even as early as in mild AD: About 90% of all mild AD cases experience neuropsychiatric symptoms, most frequently depression, anxiety, and irritability. These symptoms are associated with greater morbidity, reduced quality of life for the patient, increased burden and depression for the caregiver, higher costs of care, and nursing home placement. Thus, interventions aimed at treating these symptoms could have a tremendous effect on pa-tients, caregivers, and society.

This study is a randomized, controlled trial (RCT) evaluating a comprehensive CBT-based, multi-component treatment programme consisting of eight modules (diagnosis and goal-setting; psycho-education; engagement in pleasant activities; cognitive restructuring; life review; training caregiver in behavior management techniques; interventions for the caregiver; couples counseling) and 20 sessions.

This trial aims at significantly reducing depressive and other neuropsychiatric symptoms in the AD patients, and secondary in reducing burden and depressive symptoms of the caregivers. Patients with AD alone or mixed AD and vascular dementia that are in the mild stage and suffer under any neuropsychiatric symptom will be included. The patients and their caregiver will be randomized to either the CBT-based intervention or to the control condition that receives treatment as usual (TAU).

Tipo de estudio

Intervencionista

Inscripción (Actual)

50

Fase

  • Fase 2

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

  • Suiza
      • Zurich, Suiza, 8032
        • Psychiatric University Hospital, Clinic for Geriatric Medicine

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

50 años a 95 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Patients have to meet NINCDS-ADRDA criteria for probable or possible AD (McKhann et al., 1984). Mixed Alzheimer and Vascular dementia cases will also be included.
  • Only AD cases with a mild dementia severity will be included, determined by the Clinical Dementia Rating (CDR) scale (i.e. scores of 0.5 or 1, Morris, 1993) and by the Mini Mental State Examination (MMSE) (i.e. scores of 20 or more, Folstein, Folstein, & McHugh, 1975).
  • The patient must suffer under any non-cognitive symptom that motivates him to accept psy-chotherapeutic help.
  • A caregiver must be available to take part in most of the therapy sessions.

Exclusion Criteria:

  • concomitant alcohol or drug addiction and a history of a malignant disease, severe organ failure, metabolic or hematologic disorders, neurosurgery or neurological condition such as Parkinson's disease, epilepsy, postencephalitic and postconcussional syndrome

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: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Cognitive Behavioral Therapy (CBT)
Comprehensive, CBT-based, multi-component treatment. Comprehensive CBT intervention in addition to standard treatment
Conductual: Comprehensive, CBT-based, multi-component treatment
It includes eight modules: diagnosis and goal setting; psychoeducation; engagement in pleasant activities; cognitive restructuring; live review; training caregiver in behavior man-agement techniques; interventions for the caregiver; and couples counselling. It consists of 20 weekly sessions (plus appr. 5 single session with caregiver).
Otros nombres:
  • Intervención psicosocial
Comparador activo: Treatment as usual (TAU)
Standard Treatment (medical and psychosocial)
Conductual: Treatment as usual
Each patient/caregiver must receive at least three out of six interventions: (1) psychoeducation on dementia and treatment of dementia (oral and written); (2) appropriate medical treatment; (3) social counseling by specialized staff; (4) memory training in group setting; (5) self-help group for the patient; (6) self-help group for the caregiver.
Otros nombres:
  • Tratamiento estándar

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
Change from baseline in Geriatric Depression Scale (GDS)
Periodo de tiempo: Pre-treatment, posttreatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Pre-treatment, posttreatment (expected average of 9 months after protreatment), 6- and 12-months follow-up

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
Change from baseline in Neuropsychiatric Inventory (NPI)
Periodo de tiempo: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Change from baseline in Bayer-Activities of Daily Living (B-ADL)
Periodo de tiempo: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Change from baseline in Stress Coping Inventory (SCI)
Periodo de tiempo: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Change from baseline in Apathy Evaluation Scale (AES)
Periodo de tiempo: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Caregiver: Change from baseline in Center for Epidemiologic Studies Depression Scale (CES-D)
Periodo de tiempo: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Caregiver: Change from baseline in Trait scale of the State Trait Anxiety Inventory (STAI)
Periodo de tiempo: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Caregiver: Change from baseline in Anger-in and anger-out scales of the State Trait Anger Expression Inventory (STAXI)
Periodo de tiempo: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Caregiver: Change from baseline in Short-Form Health Survey (SF-12)
Periodo de tiempo: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Caregiver: Change from baseline in Zarit Burden Interview (ZBI)
Periodo de tiempo: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Caregiver: Change from baseline in Stress Coping Inventory (SCI)
Periodo de tiempo: Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up
Pre-treatment, post-treatment (expected average of 9 months after protreatment), 6- and 12-months follow-up

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of Zurich

Colaboradores

Psychiatric University Hospital, Zurich

Investigadores

  • Investigador principal: Simon Forstmeier, Ph.D., University of Zurich
  • Silla de estudio: Andreas Maercker, M.D.,Ph.D., University of Zurich
  • Silla de estudio: Egemen Savaskan, M.D., Psychiatric University Hospital, Zurich
  • Silla de estudio: Tanja Roth, Ph.D., Psychiatric University Hospital, Zurich

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.

Publicaciones Generales

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 febrero de 2011

Finalización primaria (Actual)

1 de septiembre de 2017

Finalización del estudio (Actual)

1 de septiembre de 2017

Fechas de registro del estudio

Enviado por primera vez

3 de enero de 2011

Primero enviado que cumplió con los criterios de control de calidad

7 de enero de 2011

Publicado por primera vez (Estimar)

10 de enero de 2011

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

6 de noviembre de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

1 de noviembre de 2017

Última verificación

1 de noviembre de 2017

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 10-130034/1a

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. .

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