Treating Emotional Processing Impairments in Individuals With TBI
Treating Emotional Processing Impairments in Individuals With TBI: A Randomized Controlled Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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New Jersey
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East Hanover, New Jersey, États-Unis, 07936
- Recrutement
- Kessler Foundation
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Comparateur 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Facial Expression Identification Task (FEIT)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Emotion Regulation Questionnaire (ERQ)
Délai: 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)
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Helen Genova, PhD, Kessler Foundation
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- R-875-15
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