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Remediation of Emotional Processing Deficits in MS

Primary Purpose

Multiple Sclerosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Emotional Processing Training
Placebo control exercises
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring emotional processing, multiple sclerosis, cognition

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Kessler Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Experimental Group

Control Group

Arm 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).

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.

Outcomes

Primary Outcome Measures

Emotional Processing
Change in scores on computerized tests of emotional processing

Secondary Outcome Measures

Emotional Function
Change in scores on self-report of emotional functioning, measured via questionnaire
Self report of Quality of Life
Change in scores on self-report of quality of life, measured via questionnaire

Full Information

First Posted
December 8, 2017
Last Updated
July 8, 2020
Sponsor
Kessler Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03373344
Brief Title
Remediation of Emotional Processing Deficits in MS
Official Title
Remediation of Emotional Processing Deficits in MS: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
March 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kessler Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
emotional processing, multiple sclerosis, cognition

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm 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).
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Emotional Processing Training
Intervention Description
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
Intervention Name(s)
Placebo control exercises
Intervention Description
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).
Primary Outcome Measure Information:
Title
Emotional Processing
Description
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 Outcome Measure Information:
Title
Emotional Function
Description
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)
Title
Self report of Quality of Life
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Genova, PhD
Organizational Affiliation
Research Scientist
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Foundation
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Remediation of Emotional Processing Deficits in MS

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