Remediation of Emotional Processing Deficits in MS

NCT ID: NCT03373344

Last Updated: 2020-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2020-03-31

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Experimental Group

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).

Group Type EXPERIMENTAL

Emotional Processing Training

Intervention Type BEHAVIORAL

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).

Control Group

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.

Group Type PLACEBO_COMPARATOR

Placebo control exercises

Intervention Type BEHAVIORAL

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).

Interventions

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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).

Intervention Type BEHAVIORAL

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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kessler Foundation

OTHER

Sponsor Role lead

Responsible Party

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Helen Genova

Research Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Helen Genova, PhD

Role: PRINCIPAL_INVESTIGATOR

Research Scientist

Locations

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Kessler Foundation

East Hanover, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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R-920-16

Identifier Type: -

Identifier Source: org_study_id

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