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Development and Evaluation of a Cognitive Rehabilitation Program for Persons With Multiple Sclerosis

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by Tel Aviv University.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Eynat Shevil, Tel Aviv University Identifier:
First received: February 24, 2011
Last updated: December 24, 2013
Last verified: December 2013

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.

Condition Intervention
Multiple Sclerosis
Cognitive Impairment
Behavioral: Self-management cognitive rehabilitation group intervention
Behavioral: Control intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Development and Evaluation of a Cognitive Rehabilitation Program for Persons With Multiple Sclerosis

Resource links provided by NLM:

Further study details as provided by Tel Aviv University:

Primary Outcome Measures:
  • Cognitive strategy use [ Time Frame: pre intervention, post intervention, 3,6,12 month followup ]

Secondary Outcome Measures:
  • Cognitive self-efficacy [ Time Frame: pre-intervention, post intervention, 3,6,12 month followup ]

Estimated Enrollment: 50
Study Start Date: February 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive intervention group
Cognitive rehabilitation program designed to be tested in this study
Behavioral: 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 group Behavioral: Control intervention
8-week group program that is not specifically directed to management of cognitive impairments.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01303770

Rabin Medical Center, Multiple Sclerosis Clinic
Petah Tikva, Israel, 49100
Sponsors and Collaborators
Tel Aviv University
Principal Investigator: Eynat Shevil, PhD Tel Aviv University
  More Information

Responsible Party: Eynat Shevil, Dr. Eynat Shevil, Tel Aviv University Identifier: NCT01303770     History of Changes
Other Study ID Numbers: MSCogRehab
PIRG03-GA-2008-230959 ( Other Grant/Funding Number: European Commission FP7 Marie Curie IRG )
Study First Received: February 24, 2011
Last Updated: December 24, 2013

Keywords provided by Tel Aviv University:
Multiple Sclerosis
Cognitive impairment
Self-management programs
Occupational Therapy

Additional relevant MeSH terms:
Multiple Sclerosis
Cognition Disorders
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Neurocognitive Disorders
Mental Disorders processed this record on April 28, 2017