Remediation of Emotional Processing Deficits in MS

NCT03373344 | Completed

• 1 other identifier: R-920-16
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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

Conditions

Multiple Sclerosis

Keywords

emotional processing; multiple sclerosis; cognition

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Emotional Function

  Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)

• Self report of Quality of Life

  Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

PLACEBO COMPARATOR

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

Interventions

Emotional Processing Training 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).

Experimental Group

Placebo control exercises 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).

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between the ages of 18-65.
• diagnosis of Relapsing-Remitting Multiple Sclerosis.
• can read and speak English fluently.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

East Hanover, New Jersey, 07936, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Helen Genova, PhD

  Research Scientist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: December 8, 2017
• First Posted: December 14, 2017
• Study Start: November 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: July 10, 2020

Record last verified: 2020-07

Locations

US (1)