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CompletedNCT04408274Updated May 29, 2020

Remediation of Emotional Deficits in Multiple Sclerosis and Traumatic Brain Injury

An interventional study of Emotional Processing Training and Placebo Control in Multiple Sclerosis and Traumatic Brain Injury, sponsored by Kessler Foundation. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2020-05-29.

Sponsored by Kessler Foundation · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
29
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Multiple Sclerosis
  • Traumatic Brain Injury

Keywords

  • Processing Speed
  • Intervention
  • Multiple Sclerosis
  • Traumatic Brain Injury
  • Cognition
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 29 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Kessler Foundation is the lead sponsor of 170 studies on the registry; 58 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • diagnosis of Multiple Sclerosis or Traumatic Brain Injury
  • Fluent in English
  • processing speed impairment (based on evaluation)

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
29 participants (actual)

Study arms

  • Experimental
    Computerized Tests

    Behavioral: Emotional Processing Training

  • Placebo comparator
    Placebo Control

    Behavioral: Placebo Control

Interventions

  • BehavioralEmotional Processing Training
  • BehavioralPlacebo Control
06

What researchers measure

Primary outcomes

  1. Change in scores on Facial Expression Identification Task (FEIT)

    The FEIT assesses one's ability to correctly identify and discriminate emotions from faces

    Time frame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)

Secondary outcomes

  1. 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

    Time frame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)

  2. Change in scores on Satisfaction with Life Scale (SWLS)

    The SWLS is a self-report measure of quality of life

    Time frame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)

07

Study locations

1 site
  • Kessler Foundation
    East Hanover, New Jersey 07936, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04408274
Lead sponsor
Kessler Foundation
Responsible party
Jean Lengenfelder (Associate Director, Traumatic Brain Injury Lab, Kessler Foundation) — Principal investigator
First posted
May 29, 2020
Start date
May 2013
Primary completion
Aug 2017
Completion
Aug 2017
Last update
May 29, 2020

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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