Remediation of Emotional Processing Deficits in MS

Kessler Foundation

Status: Completed

Conditions: Multiple Sclerosis

Treatments: Behavioral: Emotional Processing Training; Behavioral: Placebo control exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT03373344

R-920-16

Details and patient eligibility

About

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

Full 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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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39 participants in 2 patient groups, including a placebo group

Experimental Group

Experimental group

Description:

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).

Treatment:

Behavioral: Emotional Processing Training

Control Group

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Placebo control exercises