Development and Evaluation of a Cognitive Rehabilitation Program for Persons With Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT01303770|
Recruitment Status : Unknown
Verified December 2013 by Eynat Shevil, Tel Aviv University.
Recruitment status was: Active, not recruiting
First Posted : February 25, 2011
Last Update Posted : December 25, 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 or disease||Intervention/treatment||Phase|
|Multiple Sclerosis Cognitive Impairment||Behavioral: Self-management cognitive rehabilitation group intervention Behavioral: Control intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Development and Evaluation of a Cognitive Rehabilitation Program for Persons With Multiple Sclerosis|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
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.
- Cognitive strategy use [ Time Frame: pre intervention, post intervention, 3,6,12 month followup ]
- Cognitive self-efficacy [ Time Frame: pre-intervention, post intervention, 3,6,12 month followup ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01303770
|Rabin Medical Center, Multiple Sclerosis Clinic|
|Petah Tikva, Israel, 49100|
|Principal Investigator:||Eynat Shevil, PhD||Tel Aviv University|