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Completed

NCT Number: NCT04408274

Remediation of Emotional Deficits in Multiple Sclerosis and Traumatic Brain Injury

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases Trauma, Nervous System Traumatic Brain Injury Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kessler Foundation

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Emotional Processing Training

Behavioral

Placebo control

Behavioral

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
May 29, 2020
Registry last updated
May 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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