Entrenamiento innovador multimodal y de atención para mejorar la comunicación emocional en veteranos con TBI y PTSD
Poor emotion recognition has been associated with poor quality of interpersonal relationships, loss of employment, behavioral problems, reduced social reintegration, social isolation and even suicide. Deficits in emotion recognition are common in traumatic brain injury (TBI) and in post-traumatic stress disorder (PTSD) but these deficits have not been well studied in Veterans with both mild TBI (mTBI) and PTSD. Currently there are no interventions for emotion recognition in Veterans with mTBI and PTSD, and interventions for severe TBI have lacked training of both facial and vocal emotion recognition. In a preliminary study of an innovative combination of facial and vocal modalities, a multimodal affect recognition training (MMART) showed promise but lacked attention training that is an essential component in recognizing emotions in our daily lives. Given the need to improve relationships and productivity in Veterans with mTBI and PTSD, a study is needed to determine the effectiveness of a MMART combined with attention training.
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Background. Deficits in emotion recognition are common in traumatic brain injury (TBI) and in post-traumatic stress disorder (PTSD) but these deficits have not been well studied in Veterans with both mild TBI (mTBI) and PTSD. Poor emotion recognition has been associated with poor quality of interpersonal relationships, loss of employment, behavioral problems, reduced social reintegration, social isolation and even suicide. Currently there are no interventions for emotion recognition deficits in Veterans with mTBI and PTSD, and interventions conducted in civilians with severe TBI have lacked training of both facial and vocal emotion recognition. In a preliminary study of an innovative combination of facial and vocal modalities, a multimodal affect recognition training (MMART) showed promise with significant improvement on the Florida Affect Battery (FAB) but lacked attention training that is an essential component in recognizing rapidly changing emotions in our everyday lives. Attention training using Brain HQ targets the required attention factors underlying emotion recognition. Given the need to improve relationships and productivity in Veterans with mTBI and PTSD, a randomized controlled trial is needed to determine the effectiveness of an innovative MMART combined with attention training to improve emotion recognition and everyday function.
Objective & Hypotheses. The objective of this randomized controlled trial is to determine the treatment effect of a MultiModal Affect Recognition Training (MMART) combined with attention training in Veterans with TBI/PTSD.
Hypothesis 1. MMART combined with attention training will significantly improve performance on tests of emotion recognition.
Hypothesis 2: Treatment gains will translate to functional activities. Primary measures. Florida Affect Battery (FAB) and the Community Reintegration in Service members (CRIS).
Secondary measures. Emotion Recognition Task (ERT), attention index of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), the Continuous Performance Task and the TBI Quality of Life (TBI-QOL) Ability to Participate in Social Roles and Activities.
Methods. 20 Veterans with mTBI and PTSD will be randomized to either the combined training or an inactive control group. Both groups will attend 16, one-hour in-person sessions over 8 weeks. Outcomes will be assessed at pre-, post-, 3 month-post-treatment. A linear regression will be used to determine significant improvement of the treatment group over the control group, with t-tests to demonstrate within group improvement. Effect size calculations will be used to determine the power needed for a future Merit proposal.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Florida
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Gainesville, Florida, Estados Unidos, 32608-1135
- North Florida/South Georgia Veterans Health System, Gainesville, FL
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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:
- Veterans with a diagnosis of mTBI and PTSD based on VA/Department of Defense guidelines.
- Emotion recognition deficit
- Attention deficit
- Corrected vision within normal limits
- Hearing within normal limits
- Fluent in English
Exclusion Criteria:
- Premorbid history of schizophrenia
- Bipolar disorder
- Chronic medical or neurological diseases
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 |
|---|---|
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Experimental: MMART and attention training
Training to recognize affect and prosodic expressions of emotions combined with attention training. |
8 session, trains participants to recognize expression of emotion from a variety of stimuli, including dynamic stimuli (e.g., video instead of still pictures) and it employs both facial and vocal examples of emotion expression.
Otros nombres:
computerized attention drill training
Otros nombres:
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Comparador de placebos: Brain Health Workshop and National Geographic Movies
an inactive arm that matches sessions of intervention. BHW is education about the brain and cognition. National Geographic movies are viewed with the clinician and the participant answers questions about the movies. |
an education presentation on brain function and cognitive principles of learning with homework and quizzes on information covered.
Otros nombres:
participant will watch movies and answer questions after
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Florida Affect Battery (FAB), assessing change
Periodo de tiempo: week 1, week 11, week 22
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A standardized assessment of emotional affect and prosody recognition. normative scores range from 0-100 for each of the 12 subscales. Higher scores indicate better emotion recognition. |
week 1, week 11, week 22
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Community Reintegration of Service Members, assessing change
Periodo de tiempo: week 1, week 11, week 22
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Satisfaction questionnaire of community participation. Scores range from .43 to 2.15. 43 items with five rating options of 1-5. Higher scores indicate better community participation. |
week 1, week 11, week 22
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Emotion Recognition Task, assessing change
Periodo de tiempo: week 1, week 11, week 22
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Computerized assessment of emotional affect recognition. Correct responses range from 0-48 (higher scores indicate better emotion recognition) and correct response time ranges from 0 to infinity (lower scores indicate quicker response time). |
week 1, week 11, week 22
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Continuous Performance Task, assessing change
Periodo de tiempo: week 1, week 11, week 22
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Computerized measures of sustained attention. 100 trials with accuracy ranging from 0-100 (higher scores indicate better attention) and response time from 0-60 (lower scores indicate quicker response time). |
week 1, week 11, week 22
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Attention Index of the Repeatable Battery for the Assessment of Neuropsychological Status, assessing change
Periodo de tiempo: week 1, week 11, week 22
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Digit span and symbol digit to assess attention. Scaled scores range from 1-19, with higher scores indicating better attention. |
week 1, week 11, week 22
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Traumatic Brain injury quality of life
Periodo de tiempo: week 1, week 11, week 22
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Quality of life questionnaire about community participation. 59 items with scores ranging from 59-295, with higher scores indicating better community participation. |
week 1, week 11, week 22
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Julia K. Waid-Ebbs, PhD, North Florida/South Georgia Veterans Health System, Gainesville, FL
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
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
- Trastornos relacionados con el trauma y el estrés
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Desordenes mentales
- Heridas y Lesiones
- Trauma craneoencefálico
- Trauma, Sistema Nervioso
- Trastornos de Estrés, Traumáticos
- Lesiones Cerebrales
- Trastornos de estrés postraumático
- Tecnología, industria y agricultura
- Tecnología
- Medios audiovisuales
- Tecnología educativa
- Películas
Otros números de identificación del estudio
- D4411-P
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Final data sets will be maintained locally and a de-identified, anonymized dataset will be made available in response to specific requests that meet the criteria described within this document and to data repositories i.e. FITBIR.
Marco de tiempo para compartir IPD
at closure of study and as long as FITBIR retains the data
Criterios de acceso compartido de IPD
dependent on FITBIR criteria
Tipo de información de apoyo para compartir IPD
- CÓDIGO_ANALÍTICO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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