Remediation of Emotional Deficits in Multiple Sclerosis and Traumatic Brain Injury

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2017

Interventions

  • Behavioral: Emotional Processing Training
  • Behavioral: Placebo Control

Arms, Groups and Cohorts

  • Experimental: Computerized Tests
  • Placebo Comparator: Placebo Control

Clinical Trial Outcome Measures

Primary Measures

  • Change in scores on Facial Expression Identification Task (FEIT)
    • Time Frame: 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

Secondary Measures

  • Change in scores on Emotion Regulation Questionnaire (ERQ)
    • Time Frame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
    • 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)
    • Time Frame: 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kessler Foundation
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jean Lengenfelder, Associate Director, Traumatic Brain Injury Lab – Kessler Foundation

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