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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eynat Shevil, Tel Aviv University
ClinicalTrials.gov Identifier:
NCT01303770
First received: February 24, 2011
Last updated: December 24, 2013
Last verified: December 2013
  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

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01303770

Locations
Israel
Rabin Medical Center, Multiple Sclerosis Clinic
Petah Tikva, Israel, 49100
Sponsors and Collaborators
Tel Aviv University
Investigators
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: December 24, 2013
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 July 23, 2014