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Remediation of Emotional Deficits in Multiple Sclerosis and Traumatic Brain Injury

Kessler Foundation logo

Kessler Foundation

Status

Completed

Conditions

Traumatic Brain Injury
Multiple Sclerosis

Treatments

Behavioral: Emotional Processing Training
Behavioral: Placebo Control

Study type

Interventional

Funder types

Other

Identifiers

NCT04408274
R-764-13

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

29 participants in 2 patient groups, including a placebo group

Computerized Tests
Experimental group
Treatment:
Behavioral: Emotional Processing Training
Placebo Control
Placebo Comparator group
Treatment:
Behavioral: Placebo Control

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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