Remediation of Emotional Processing Deficits in MS

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03373344
• Other study ID #: R-920-16
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: March 2020

Study information

• Verified date: July 2020
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: March 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Behavioral:
• Emotional Processing Training
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
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).

Locations

Country	Name	City	State
United States	Kessler Foundation	East Hanover	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emotional Processing	Change in scores on computerized tests of emotional processing	Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
Secondary	Emotional Function	Change in scores on self-report of emotional functioning, measured via questionnaire	Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
Secondary	Self report of Quality of Life	Change in scores on self-report of quality of life, measured via questionnaire	Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)