Remediation of Emotional Deficits in Multiple Sclerosis and Traumatic Brain Injury

May 28, 2020 updated by: Jean Lengenfelder, Kessler Foundation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

29

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Jersey
      • East Hanover, New Jersey, United States, 07936
        • Kessler Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Control
Behavioral: Placebo Control
Experimental: Computerized Tests
Behavioral: Emotional Processing Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in scores on Facial Expression Identification Task (FEIT)
Time Frame: 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
Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in scores on Emotion Regulation Questionnaire (ERQ)
Time Frame: 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
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)
Time Frame: 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
Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kessler Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

April 17, 2018

First Submitted That Met QC Criteria

May 28, 2020

First Posted (Actual)

May 29, 2020

Study Record Updates

Last Update Posted (Actual)

May 29, 2020

Last Update Submitted That Met QC Criteria

May 28, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-764-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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