Skip to main content
OpenTrials
Completed

NCT Number: NCT03373344

Remediation of Emotional Processing Deficits in MS

This study will test the effectiveness of an emotional processing intervention in individuals with MS in a double blind placebo controlled randomized clinical trial. We will utilize an intervention which has been successfully used in other populations, including Schizophrenia and Traumatic Brain Injury. Our pilot data shows that this intervention is effective in individuals with MS as well

Completed

Looking for future studies?

Notify Me

Key information

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

About this study

This study will test the effectiveness of an emotional processing intervention in individuals with MS in a double blind placebo controlled randomized clinical trial RCT). We will utilize an intervention which has been successfully used in other populations, including Schizophrenia and Traumatic Brain Injury. Our pilot data shows that this intervention is effective in individuals with MS, as well.

All participants will undergo a baseline evaluation assessing emotional processing abilities, cognitive functioning, and psychological functioning. Participants will then be randomized into two groups. During the treatment phase, the experimental group will receive the proposed intervention while the control group will receive a "placebo" treatment. Neuropsychological assessment will be repeated at the end of the intervention.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • between the ages of 18-65.
  • diagnosis of Relapsing-Remitting Multiple Sclerosis.
  • can read and speak English fluently.

Exclusion criteria

  • history of prior stroke or other neurological disease or injury.
  • history of significant psychiatric 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

Participants in the experimental group will receive computerized exercises administered on a laptop computer. They will undergo 12 sessions of 45-60 minutes each (twice a week for 6 weeks).

Placebo control exercises

Behavioral

Participants in the control group will receive computerized control exercises administered on a laptop computer. They will undergo 12 sessions of 45-60 minutes each (twice a week for 6 weeks).

Primary outcomes

  1. Emotional Processing

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

    Change in scores on computerized tests of emotional processing

Secondary outcomes

  1. Emotional Function

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

    Change in scores on self-report of emotional functioning, measured via questionnaire

  2. Self report of Quality of Life

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

    Change in scores on self-report of quality of life, measured via questionnaire

Sponsors and collaborators

Lead sponsor

Kessler Foundation

Other

Registry information

Official study title

Remediation of Emotional Processing Deficits in MS: A Randomized Clinical Trial

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Dec 14, 2017
Registry last updated
Jul 10, 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.

Published trials that share one or more normalized conditions with this study.