Development and Evaluation of a Cognitive Rehabilitation Program for Persons With Multiple Sclerosis
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Purpose
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 |
- Cognitive strategy use [ Time Frame: pre intervention, post intervention, 3,6,12 month followup ] [ Designated as safety issue: No ]
- Cognitive self-efficacy [ Time Frame: pre-intervention, post intervention, 3,6,12 month followup ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| Contact: Eynat Shevil, PhD | +972-3-6409185 | eshevil@post.tau.ac.il |
| Israel | |
| Rabin Medical Center, Multiple Sclerosis Clinic | Recruiting |
| Petah Tikva, Israel, 49100 | |
| Principal Investigator: Eynat Shevil, PhD | |
| Principal Investigator: | Eynat Shevil, PhD | Tel Aviv University |
More Information
No publications provided
| Responsible Party: | Eynat Shevil, Dr. Eynat Shevil, Tel Aviv University |
| ClinicalTrials.gov Identifier: | NCT01303770 History of Changes |
| Other Study ID Numbers: | MSCogRehab, PIRG03-GA-2008-230959 |
| Study First Received: | February 24, 2011 |
| Last Updated: | February 29, 2012 |
| Health Authority: | Israel: Ministry of Health |
Keywords provided by Tel Aviv University:
|
Multiple Sclerosis Cognitive impairment Self-management programs Occupational Therapy Rehabilitation |
Additional relevant MeSH terms:
|
Multiple Sclerosis Sclerosis Cognition Disorders Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System Nervous System Diseases |
Demyelinating Diseases Autoimmune Diseases Immune System Diseases Pathologic Processes Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013