Treating Emotional Processing Impairments in Individuals With TBI
Treating Emotional Processing Impairments in Individuals With TBI: A Randomized Controlled Trial
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Emotional processing deficits have a significant negative impact on the lives of persons with TBI. There is emerging research indicating that, in addition to cognitive and behavioral impairments, social and emotional difficulties following TBI are common and are related to significant problems in social relationships, poor social participation, impaired empathy, and a high degree of caregiver stress. Emotional processing is a critical component of social cognition, including the abilities to both identify and discriminate basic universal emotions. The stability of emotional processing deficits following TBI indicates that these impairments likely impact individuals with TBI consistently across the lifespan, and do not appear to resolve with time.
The goals of the trial are to (a) Evaluate the effectiveness of an emotional processing intervention to improve performance on tests of emotional processing in individuals with TBI, (b) Evaluate the improvement of secondary outcomes of psychological, cognitive, and functional abilities following the emotional processing intervention in individuals with TBI, (c) To examine differences in brain activation patterns during emotional processing following treatment in individuals with TBI, BOLD activation in the experimental group will be compared to BOLD patterns of the control group during performance of the QFDT, a facial affect recognition task.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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New Jersey
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East Hanover, New Jersey, Estados Unidos, 07936
- Recrutamento
- Kessler Foundation
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- diagnosis of Traumatic Brain Injury (TBI)
- can read and speak English fluently
Exclusion Criteria:
- prior stroke or neurological disease.
- history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Epilepsy, Bipolar Disorder
- significant alcohol or drug abuse history
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Experimental Group
Participants in the experimental group will receive emotional processing training exercises administered on a laptop computer.
They will undergo 12 sessions of 45-60 minutes each (twice a week for 6 weeks).
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Participants in the experimental group will receive computerized exercises administered on a laptop computer.
They will undergo 12 sessions of 45-60 minutes each (twice a week for 6 weeks).
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Comparador de Placebo: Control Group
Participants in the control group will meet with the examiner the same frequency and for the same duration as those in the experimental group. They will receive placebo control exercises administered on a laptop computer. . |
Participants in the control group will receive computerized control exercises administered on a laptop computer.
They will undergo 12 sessions of 45-60 minutes each (twice a week for 6 weeks).
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Facial Expression Identification Task (FEIT)
Prazo: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
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The FEIT assesses one's ability to correctly identify and discriminate emotions from faces.
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Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Emotion Regulation Questionnaire (ERQ)
Prazo: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
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The ERQ is a self-report measure of the use of 2 emotional regulation strategies: cognitive reappraisal and expressive suppression.
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Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
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Satisfaction with Life Scale (SWLS)
Prazo: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
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The SWLS is a self-report measure of quality of life.
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Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Helen Genova, PhD, Kessler Foundation
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- R-875-15
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