Back to resultsRemediation of Emotional Deficits in Multiple Sclerosis and Traumatic Brain Injury
Primary Purpose
Multiple Sclerosis, Traumatic Brain Injury
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emotional Processing Training
Placebo Control
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis focused on measuring Processing Speed, Intervention, Multiple Sclerosis, Traumatic Brain Injury, Cognition
Eligibility Criteria
Inclusion Criteria:
- diagnosis of Multiple Sclerosis or Traumatic Brain Injury
- Fluent in English
- processing speed impairment (based on evaluation)
Exclusion Criteria:
- currently taking steroids and/or benzodiazepines
- prior stroke or neurological diease
- history of significant pyschiatric 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 Foundation
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Computerized Tests
Placebo Control
Arm Description
Outcomes
Primary Outcome Measures
Change in scores on Facial Expression Identification Task (FEIT)
The FEIT assesses one's ability to correctly identify and discriminate emotions from faces
Secondary Outcome Measures
Change in scores on Emotion Regulation Questionnaire (ERQ)
The ERQ is a self-report measure of the use of 2 emotional regulation strategies: cognitive reappraisal and expressive suppression
Change in scores on Satisfaction with Life Scale (SWLS)
The SWLS is a self-report measure of quality of life
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04408274
Brief Title
Remediation of Emotional Deficits in Multiple Sclerosis and Traumatic Brain Injury
Official Title
Remediation of Emotional Deficits in Multiple Sclerosis and Traumatic Brain Injury: A Piolt Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will examine the efficacy of a clinical intervention for improving emotional processing in individuals with MS and TBI.(1)The main outcome measure will be changes in emotional processing measures from pre to post treatment.
(2)This study will also assess the impact of the emotional processing intervention on changes in pre and post treatment depression and anxiety, as well as fatigue.(3) This study will additionally measure the impact of the emotional processing intervention on cognitive functioning, specifically processing speed, attention and executive abilities. This will be accomplished through the completion of a neuropsychological battery prior to and following the completion of treatment.(4)Finally, the investigators will measure the impact of the intervention on quality of life and social functioning, utilizing a pre and post treatment assessment consisting of measures of self-efficacy, quality of life, functional abilities, and awareness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Traumatic Brain Injury
Keywords
Processing Speed, Intervention, Multiple Sclerosis, Traumatic Brain Injury, Cognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Computerized Tests
Arm Type
Experimental
Arm Title
Placebo Control
Arm Type
Placebo Comparator
Intervention Type
Behavioral
Intervention Name(s)
Emotional Processing Training
Intervention Type
Behavioral
Intervention Name(s)
Placebo Control
Primary Outcome Measure Information:
Title
Change in scores on 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
Change in scores on 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
Change in scores on 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 Multiple Sclerosis or Traumatic Brain Injury
Fluent in English
processing speed impairment (based on evaluation)
Exclusion Criteria:
currently taking steroids and/or benzodiazepines
prior stroke or neurological diease
history of significant pyschiatric 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
Facility Information:
Facility Name
Kessler Foundation
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Remediation of Emotional Deficits in Multiple Sclerosis and Traumatic Brain Injury
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