Remediation of Emotional Deficits in Multiple Sclerosis and Traumatic Brain Injury

Study Overview
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Brief Summary
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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.

Official Title
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Remediation of Emotional Deficits in Multiple Sclerosis and Traumatic Brain Injury: A Piolt Study

Conditions
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Multiple Sclerosis, Traumatic Brain Injury

Intervention / Treatment
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* Behavioral: Emotional Processing Training
* Behavioral: Placebo Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Computerized Tests<br> | Behavioral: Emotional Processing Training<br> <br> |
| Placebo Comparator: Placebo Control<br> | Behavioral: Placebo Control<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in scores on Facial Expression Identification Task (FEIT) | The FEIT assesses one's ability to correctly identify and discriminate emotions from faces | Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8) | 
| Change in scores on Satisfaction with Life Scale (SWLS) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Processing Speed, Intervention, Multiple Sclerosis, Traumatic Brain Injury, Cognition