Multiple Sclerosis
Conditions
Keywords
emotional processing, multiple sclerosis, cognition
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.
Interventions
BEHAVIORALEmotional 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).
BEHAVIORALPlacebo 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).
Sponsors
Kessler Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Emotional Processing | 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
| Measure | Time frame | Description |
|---|---|---|
| Emotional Function | 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 |
| Self report of Quality of Life | 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 |
Countries
United States
Outcome results
None listed