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

Study Overview
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Brief Summary
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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.

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

Conditions
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Multiple Sclerosis, Cognitive Impairment

Intervention / Treatment
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* Behavioral: Self-management cognitive rehabilitation group intervention
* Behavioral: Control intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive intervention group<br>Cognitive rehabilitation program designed to be tested in this study | Behavioral: Self-management cognitive rehabilitation group intervention<br>* 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.<br>|
| Active Comparator: Control group<br> | Behavioral: Control intervention<br>* 8-week group program that is not specifically directed to management of cognitive impairments.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive strategy use |  | pre intervention, post intervention, 3,6,12 month followup | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive self-efficacy |  | pre-intervention, post intervention, 3,6,12 month followup | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Cognitive impairment, Self-management programs, Occupational Therapy, Rehabilitation