Remediation of Emotional Processing Deficits in MS

Study Overview
=================
Brief 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

Detailed 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.

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

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Behavioral: Emotional Processing Training
* Behavioral: Placebo control exercises


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Participants in the experimental group will receive emotional processing training exercises administered on a laptop computer. They will undergo 12 sessions of 45-60 minutes each (twice a week for 6 weeks). | Behavioral: Emotional Processing Training<br>* 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).<br>|
| Placebo Comparator: Control Group<br>Participants in the control group will meet with the examiner the same frequency and for the same duration as those in the experimental group. They will receive placebo control exercises administered on a laptop computer. | Behavioral: Placebo control exercises<br>* 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).<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
emotional processing, multiple sclerosis, cognition