Remediation of Emotional Processing Deficits in MS

Kessler Foundation39 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Multiple Sclerosis

Interventions

Emotional Processing TrainingBEHAVIORAL

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 exercisesBEHAVIORAL

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Kessler Foundation

East Hanover, New Jersey, United States

Outcomes

Primary Outcomes

Emotional Processing

Change in scores on computerized tests of emotional processing

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

Secondary Outcomes

Emotional Function

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

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

Self report of Quality of Life

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

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

Data from ClinicalTrials.gov

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