Remediation of Emotional Deficits in Multiple Sclerosis and Traumatic Brain Injury
1 other identifier
interventional
29
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable multiple-sclerosis
Started May 2013
Longer than P75 for not_applicable multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedFirst Submitted
Initial submission to the registry
April 17, 2018
CompletedFirst Posted
Study publicly available on registry
May 29, 2020
CompletedMay 29, 2020
May 1, 2020
4.3 years
April 17, 2018
May 28, 2020
Conditions
Keywords
Outcome Measures
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
Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
Secondary Outcomes (2)
Change in scores on Emotion Regulation Questionnaire (ERQ)
Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
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)
Study Arms (2)
Computerized Tests
EXPERIMENTALPlacebo Control
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- diagnosis of Multiple Sclerosis or Traumatic Brain Injury
- Fluent in English
- processing speed impairment (based on evaluation)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kessler Foundation
East Hanover, New Jersey, 07936, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Director, Traumatic Brain Injury Lab
Study Record Dates
First Submitted
April 17, 2018
First Posted
May 29, 2020
Study Start
May 1, 2013
Primary Completion
August 1, 2017
Study Completion
August 1, 2017
Last Updated
May 29, 2020
Record last verified: 2020-05