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Clinical Trials/NCT04408274
NCT04408274
Completed
Not Applicable

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

Kessler Foundation1 site in 1 country29 target enrollmentMay 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multiple Sclerosis
Sponsor
Kessler Foundation
Enrollment
29
Locations
1
Primary Endpoint
Change in scores on Facial Expression Identification Task (FEIT)
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
August 2017
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kessler Foundation
Responsible Party
Principal Investigator
Principal Investigator

Jean Lengenfelder

Associate Director, Traumatic Brain Injury Lab

Kessler Foundation

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

Outcomes

Primary Outcomes

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 Outcomes

  • Change in scores on Satisfaction with Life Scale (SWLS)(Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8))
  • Change in scores on Emotion Regulation Questionnaire (ERQ)(Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8))

Study Sites (1)

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