Remediation of Emotional Deficits in Multiple Sclerosis and Traumatic Brain Injury

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04408274
• Other study ID #: R-764-13
• Status: Completed
• Phase: N/A
• Start date: May 2013
• Est. completion date: August 2017

Study information

• Verified date: May 2020
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Multiple Sclerosis
• Sclerosis
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Behavioral:
• Emotional Processing Training

• Placebo Control

Locations

Country	Name	City	State
United States	Kessler Foundation	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)