Remediation of Emotional Deficits in Multiple Sclerosis and Traumatic Brain Injury

Not Applicable

Completed

• Conditions: Multiple Sclerosis; Traumatic Brain Injury
• Interventions: Behavioral: Emotional Processing Training; Behavioral: Placebo Control

• Registration Number: NCT04408274
• Lead Sponsor: Kessler Foundation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Study First Submitted: 2018-04-17
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-28
• Last Update Submitted: 2020-05-28
• Study First Posted: 2020-05-29
• Last Update Posted: 2020-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Computerized Tests	Emotional Processing Training	-
Placebo Control	Placebo Control	-

Primary Outcome Measures

Name	Time	Method
Change in scores on Facial Expression Identification Task (FEIT)	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 Outcome Measures

Name	Time	Method
Change in scores on Emotion Regulation Questionnaire (ERQ)	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)	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

Trial Locations

Locations (1)

Kessler Foundation; 🇺🇸 East Hanover, New Jersey, United States