Development and Evaluation of a Cognitive Rehabilitation Program for Persons With Multiple Sclerosis
Primary Purpose
Multiple Sclerosis, Cognitive Impairment
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Self-management cognitive rehabilitation group intervention
Control intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Cognitive impairment, Self-management programs, Occupational Therapy, Rehabilitation
Eligibility Criteria
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
Sites / Locations
- Rabin Medical Center, Multiple Sclerosis Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Cognitive intervention group
Control group
Arm Description
Cognitive rehabilitation program designed to be tested in this study
Outcomes
Primary Outcome Measures
Cognitive strategy use
Secondary Outcome Measures
Cognitive self-efficacy
Full Information
NCT ID
NCT01303770
First Posted
February 24, 2011
Last Updated
December 24, 2013
Sponsor
Tel Aviv University
1. Study Identification
Unique Protocol Identification Number
NCT01303770
Brief Title
Development and Evaluation of a Cognitive Rehabilitation Program for Persons With Multiple Sclerosis
Official Title
Development and Evaluation of a Cognitive Rehabilitation Program for Persons With Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tel Aviv University
4. Oversight
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Cognitive Impairment
Keywords
Multiple Sclerosis, Cognitive impairment, Self-management programs, Occupational Therapy, Rehabilitation
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cognitive intervention group
Arm Type
Experimental
Arm Description
Cognitive rehabilitation program designed to be tested in this study
Arm Title
Control group
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Self-management cognitive rehabilitation group intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control intervention
Intervention Description
8-week group program that is not specifically directed to management of cognitive impairments.
Primary Outcome Measure Information:
Title
Cognitive strategy use
Time Frame
pre intervention, post intervention, 3,6,12 month followup
Secondary Outcome Measure Information:
Title
Cognitive self-efficacy
Time Frame
pre-intervention, post intervention, 3,6,12 month followup
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eynat Shevil, PhD
Organizational Affiliation
Tel Aviv University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Center, Multiple Sclerosis Clinic
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Development and Evaluation of a Cognitive Rehabilitation Program for Persons With Multiple Sclerosis
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