Remediation of Emotional Deficits in Multiple Sclerosis and Traumatic Brain Injury

NCT ID: NCT04408274

Last Updated: 2020-05-29

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

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2017-08-31

Brief Summary

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This study will examine the efficacy of a clinical intervention for improving emotional processing in individuals with MS and TBI.(1)The main outcome measure will be changes in emotional processing measures from pre to post treatment.

(2)This study will also assess the impact of the emotional processing intervention on changes in pre and post treatment depression and anxiety, as well as fatigue.(3) This study will additionally measure the impact of the emotional processing intervention on cognitive functioning, specifically processing speed, attention and executive abilities. This will be accomplished through the completion of a neuropsychological battery prior to and following the completion of treatment.(4)Finally, the investigators will measure the impact of the intervention on quality of life and social functioning, utilizing a pre and post treatment assessment consisting of measures of self-efficacy, quality of life, functional abilities, and awareness.

Detailed Description

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Conditions

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Multiple Sclerosis Traumatic Brain Injury

Keywords

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Processing Speed Intervention Multiple Sclerosis Traumatic Brain Injury Cognition

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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Computerized Tests

Group Type EXPERIMENTAL

Emotional Processing Training

Intervention Type BEHAVIORAL

Placebo Control

Group Type PLACEBO_COMPARATOR

Placebo Control

Intervention Type BEHAVIORAL

Interventions

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Emotional Processing Training

Intervention Type BEHAVIORAL

Placebo Control

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* diagnosis of Multiple Sclerosis or Traumatic Brain Injury
* Fluent in English
* processing speed impairment (based on evaluation)

Exclusion Criteria

* currently taking steroids and/or benzodiazepines
* prior stroke or neurological diease
* history of significant pyschiatric 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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Jean Lengenfelder

Associate Director, Traumatic Brain Injury Lab

Responsibility Role PRINCIPAL_INVESTIGATOR

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-764-13

Identifier Type: -

Identifier Source: org_study_id