Treating Emotional Processing Impairments in Individuals With TBI
Primary Purpose
Traumatic Brain Injury
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emotional Processing Training
Placebo Control Exercises
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Emotional Processing, Cognition, Traumatic Brain Injury, Intervention
Eligibility Criteria
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
Sites / Locations
- Kessler FoundationRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental Group
Control Group
Arm Description
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 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. .
Outcomes
Primary Outcome Measures
Facial Expression Identification Task (FEIT)
The FEIT assesses one's ability to correctly identify and discriminate emotions from faces.
Secondary Outcome Measures
Emotion Regulation Questionnaire (ERQ)
The ERQ is a self-report measure of the use of 2 emotional regulation strategies: cognitive reappraisal and expressive suppression.
Satisfaction with Life Scale (SWLS)
The SWLS is a self-report measure of quality of life.
Full Information
NCT ID
NCT03373331
First Posted
December 8, 2017
Last Updated
February 23, 2021
Sponsor
Kessler Foundation
Collaborators
New Jersey Commission on Brain Injury Research
1. Study Identification
Unique Protocol Identification Number
NCT03373331
Brief Title
Treating Emotional Processing Impairments in Individuals With TBI
Official Title
Treating Emotional Processing Impairments in Individuals With TBI: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (Actual)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation
Collaborators
New Jersey Commission on Brain Injury Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The current project will examine the impact of an emotional processing intervention on emotional processing abilities in a sample of 50 persons with moderate to severe TBI. Outcome will be assessed across 3 domains. We will document changes resulting from treatment: (1) in emotional processing tasks (2) in other areas of function including QOL, social functioning, mood and cognition that are also likely to be impacted (3) in brain structure and function. The examination of efficacy in the above three areas will further our knowledge of emotional processing deficits in TBI and more importantly, identify an effective means of treating such deficits.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Emotional Processing, Cognition, Traumatic Brain Injury, Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
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.
.
Intervention Type
Behavioral
Intervention Name(s)
Emotional Processing Training
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Placebo Control Exercises
Intervention Description
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).
Primary Outcome Measure Information:
Title
Facial Expression Identification Task (FEIT)
Description
The FEIT assesses one's ability to correctly identify and discriminate emotions from faces.
Time Frame
Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
Secondary Outcome Measure Information:
Title
Emotion Regulation Questionnaire (ERQ)
Description
The ERQ is a self-report measure of the use of 2 emotional regulation strategies: cognitive reappraisal and expressive suppression.
Time Frame
Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
Title
Satisfaction with Life Scale (SWLS)
Description
The SWLS is a self-report measure of quality of life.
Time Frame
Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angela Smiith, MA
Phone
973-324-8448
Email
asmith@kesslerfoundation.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Genova, PhD
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Foundation
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
Treating Emotional Processing Impairments in Individuals With TBI
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