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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01278316
Rural Veterans With Post-traumatic Stress Disorder (PTSD) And Comorbid Mild Traumatic Brain Injury (TBI): A Feasibility Study
Remote Administration Of Cognitive Training Tasks In Rural Veterans With PTSD And Comorbid Mild TBI: A Feasibility Study
Descripción general del estudio
Estado
Intervención / Tratamiento
Descripción detallada
Many military personnel have experienced traumatic brain injury (TBI) and posttraumatic stress disorder (PTSD) as a result of the current Afghanistan and Iraq wars. TBI occurs when a sudden force causes the brain to move, causing damage to brain cells. PTSD is an anxiety disorder associated with serious traumatic events. Blast explosions can lead to TBI. People who experience TBI as a result of a blast injury are more likely to experience PTSD than people who have TBI not due to blast. TBI and PTSD may be associated with memory problems in some patients. Because therapy for PTSD sometimes requires learning new ways to think about things and making new responses, being able to remember the new information being learned is important. It is possible that improving memory may also improve PTSD treatment.
This is a prospective study of Operation Enduring Freedom and Operation Iraqi Freedom (Afghanistan and Iraq wars; OEF/OIF) veterans who will undergo two neuropsychological and psychiatric assessments prior and subsequent to a cognitive training intervention. This is a feasibility study to ascertain whether OEF/OIF veterans diagnosed with mild TBI and comorbid PTSD and who live in rural locations will adhere to the schedule demands required of a computer-based cognitive training protocol.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Texas
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Houston, Texas, Estados Unidos, 77030
- Michael E. DeBakey VA Medical Center
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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:
- Rural residence
- Willingness to commit to the time requirements of the study
- Undergoing treatment for posttraumatic stress disorder (PTSD) as assessed by a clinician, diagnosed with mild traumatic brain injury (TBI)
- Native English speaker
- 20-40 years
- Normal or corrected to normal vision and hearing.
Exclusion Criteria:
- Substance dependence
- Major depression with suicidal ideation
- Psychotic disorder
- History of neurological disorder other than mild traumatic brain injury (TBI) due to blast from Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) (i.e., Afghanistan and Iraq wars) deployment
- History of known or suspected learning disorder.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Cognitive training
Cognitive Intervention Tasks Participants will be asked to perform the Brain Fitness (PositScience) cognitive training tasks an hour each day, five days per week for 8-10 weeks.
Six tasks manipulating auditory and verbal information will be presented, and stimuli from all tasks are presented auditorily.
All tasks are designed to begin with the lowest level of difficulty required to attain 85% accuracy, and as performance improves, difficulty increases to maintain 85% accuracy, with difficulty decreasing if accuracy decreases.
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Participants will be asked to perform the Brain Fitness (PositScience) cognitive training tasks an hour each day, five days per week for 8-10 weeks.
Six tasks manipulating auditory and verbal information will be presented, and stimuli from all tasks are presented auditorily.
All tasks are designed to begin with the lowest level of difficulty required to attain 85% accuracy, and as performance improves, difficulty increases to maintain 85% accuracy, with difficulty decreasing if accuracy decreases.
|
Comparador activo: Control
The control group will perform computerized tasks that utilize cognitive performance, but were not systematically developed to improve cognitive performance.
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Participants will be asked to perform computerized tasks that involve auditory and verbal performance one hour each day, five days per week for 8-10 weeks.
Six tasks requiring auditory and verbal information will be presented.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Compliance rates
Periodo de tiempo: Up to ten weeks
|
Compliance is defined as number of times per week and number of hours per day of task performance
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Up to ten weeks
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Qualitative assessment
Periodo de tiempo: Up to ten weeks
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Participants' reactions to the study will be gathered with Likert scale ratings of perceived problems of delivery, ease of program use, and perceived improvement of cognition.
Open-ended responses to structured questions on likes and dislikes, suggestions for improvement, and overall satisfaction will also be implemented.
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Up to ten weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Improvement in performance over time
Periodo de tiempo: Up to ten weeks
|
Performance at the beginning of the training session of each task will be compared to performance at the completion of the training session of each task.
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Up to ten weeks
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Relation of performance to mental health
Periodo de tiempo: At ten weeks
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Scores on pre- and post- mental health measures will also be related to task performance
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At ten weeks
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mary R Newsome, PhD, Michael E. DeBakey VA Medical Center
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
- Desordenes mentales
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Heridas y Lesiones
- Trauma craneoencefálico
- Trauma, Sistema Nervioso
- Trastornos relacionados con el trauma y el estrés
- Lesiones Cerebrales
- Trastornos de Estrés, Traumáticos
- Trastornos de estrés postraumático
- Lesiones Cerebrales Traumáticas
Otros números de identificación del estudio
- H-27735
- 10K09.H (Otro identificador: MEDVAMC Research & Development Board)
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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