Treating Emotional Processing Impairments in Individuals With TBI
Treating Emotional Processing Impairments in Individuals With TBI: A Randomized Controlled Trial
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
New Jersey
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East Hanover, New Jersey, Förenta staterna, 07936
- Rekrytering
- Kessler Foundation
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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).
|
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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Placebo-jämförare: 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).
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Facial Expression Identification Task (FEIT)
Tidsram: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
|
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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Emotion Regulation Questionnaire (ERQ)
Tidsram: 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.
|
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)
Tidsram: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
|
The SWLS is a self-report measure of quality of life.
|
Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Helen Genova, PhD, Kessler Foundation
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- R-875-15
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