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Remediation of Emotional Deficits in Multiple Sclerosis and Traumatic Brain Injury

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04408274
Enrollment
29
Registered
2020-05-29
Start date
2013-05-31
Completion date
2017-08-31
Last updated
2020-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis, Traumatic Brain Injury

Keywords

Processing Speed, Intervention, Multiple Sclerosis, Traumatic Brain Injury, Cognition

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.

Interventions

BEHAVIORALPlacebo Control

Sponsors

Kessler Foundation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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

MeasureTime frameDescription
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026