Overview

This trial is active, not recruiting.

Conditions multiple sclerosis, cognitive impairment
Treatments self-management cognitive rehabilitation group intervention, control intervention
Sponsor Tel Aviv University
Start date February 2011
End date December 2014
Trial size 50 participants
Trial identifier NCT01303770, MSCogRehab, PIRG03-GA-2008-230959

Summary

Multiple sclerosis (MS) is a progressive neurological disease that affects over 2.5 million people worldwide. Up to 50% of persons with MS (PwMS) will experience some form of cognitive impairment as a result of the disease including disturbances in memory, attention, concentration, information processing, and executive functions such as problem solving, and self-monitoring. MS-related cognitive impairments negatively affect many aspects of functioning and independent participation in everyday life. Thus, PwMS who experience cognitive impairments face a wide array of recurring barriers that pose grave challenges to carrying out everyday activities while trying to maintain multiple life roles and as they age.

Management of cognitive symptoms can be addressed through rehabilitation which has the potential to reduce disability, prevent complications of the disease, and enhance participation, independence, and quality of life. Considering the high frequency of cognitive impairments in MS and their significant, complex impact on functioning and independence, it is critical that cognitive interventions be an essential component of MS rehabilitation.

The overarching goal of this study is to develop and test a self-management, group-based cognitive rehabilitation program designed specifically for PwMS.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
Arm
(Experimental)
Cognitive rehabilitation program designed to be tested in this study
self-management cognitive rehabilitation group intervention
8-week cognitive rehabilitation program facilitated by an occupational therapist. Program goals include increased knowledge of cognitive impairments in multiple sclerosis, increased self-efficacy to manage cognitive changes and increased use of cognitive compensatory strategies.
(Active Comparator)
control intervention
8-week group program that is not specifically directed to management of cognitive impairments.

Primary Outcomes

Measure
Cognitive strategy use
time frame: pre intervention, post intervention, 3,6,12 month followup

Secondary Outcomes

Measure
Cognitive self-efficacy
time frame: pre-intervention, post intervention, 3,6,12 month followup

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Diagnosis of MS - 18 years of age or older - Self-report of cognitive difficulties Exclusion Criteria: - Exacerbation of symptoms in past 3 months - History of TBI, CVA, epilepsy, Psychiatric condition, drug/alcohol abuse

Additional Information

Official title Development and Evaluation of a Cognitive Rehabilitation Program for Persons With Multiple Sclerosis
Principal investigator Eynat Shevil, PhD
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Tel Aviv University.