Multiple Sclerosis
Conditions
Keywords
cognitive rehabilitation
Brief summary
The effects of multiple sclerosis (MS) on cognition, thought to occur in 50-75% of persons with MS, have gained increasing recognition as one of the major disabling symptoms of the disease. While numerous studies have addressed the emotional and physical impact of MS, little attention has been given to strategies that might help manage the cognitive changes commonly experienced by persons with MS. The proposed study will test a novel computer-assisted cognitive rehabilitation intervention, MAPSS-MS (Memory, Attention, & Problem Solving Skills for Persons with MS). The MAPSS-MS integrates the powerful effects of group interventions to build self-efficacy for new cognitive compensatory strategies/behaviors with individual home-based computer-assisted training. The computer training will assist individuals to develop cognitive skills that they can apply to everyday life using the compensatory strategies learned in the class sessions. In the recently completed exploratory study with 61 persons with MS (R21NR011076), the eight-week MAPSS-MS intervention was acceptable and feasible and had medium to large effects on the use of compensatory strategies and performance on neuropsychological tests of verbal memory. The proposed study will test the refined MAPSS-MS intervention with a larger more diverse sample (N=180) across multiple sites, extend the period of post-intervention follow-up to 6 months and establish whether performance improvements on neuropsychological tests make the important transfer to improved neuro-cognitive functioning in everyday life. The specific aims of this study are to: (1) Evaluate the efficacy of the novel MAPSS-MS cognitive rehabilitation intervention to improve overall neuro-cognitive competence in activities of daily living including verbal memory performance, use of compensatory cognitive strategies and performance on cognitive-related instrumental activities of daily living (IADL) among persons with MS; (2) Evaluate the efficacy of the MAPSS-MS intervention to improve self-efficacy and related aspects of cognitive performance (non-verbal learning/memory, information processing speed and attention, verbal fluency and complex scanning and tracking) among persons with MS; and (3) Determine the number of intervention participants who achieve and maintain their self-identified cognitive goals three and six months following the intervention. The effects of the intervention on outcome variables will be assessed using a randomized controlled trial design with a comparison group receiving usual care computer games. Measurements of study variables will occur at baseline, immediately after the MAPSS-MS intervention, and three months and six months after the intervention is complete. Statistical analysis will include descriptive statistics and HLM analysis to account for the nested design. The intent-to-treat approach will be used. Public Health Statement: This research will provide new knowledge about an innovative intervention to improve memory, use of compensatory strategies, and performance of cognitive activities and instrumental activities of daily living for persons with MS. If effective, the intervention would provide a new and feasible approach to target a serious, debilitating problem commonly experienced by persons with MS.
Interventions
BEHAVIORALMAPSS-MS
MAPSS-MS is a computer-assisted cognitive rehabilitation intervention. It is a combination of home computer training and 8-weeks of group sessions on lifestyle change and compensatory cognitive strategies.
OTHERUsual Care plus computer games
Participants assigned to this arm receive their usual medical care and referral to the My Brain Games website.
Sponsors
University of Texas at Austin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
Care providers are not informed of the participant's participation in a particular arm. Staff collecting outcome data are not aware of the participant's assignment to intervention or usual care.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Clinically definite diagnosis of MS; * Age 18 to 60; * Capable of understanding and complying with the study protocol; * Able to read and write in English; * Visual acuity of at least 20/70 with correction in order to work on the computer screen; * Stable disease at the time of entry into the study (relapse free for at least 90 days); * Subjective concerns about their cognitive functioning (based on the Perceived Deficits Questionnaire); and * Home internet access;
Exclusion criteria
* Other medical causes of dementia or other neurological disorders that may impact cognition or emotions; * Evidence of major psychiatric disorder; or * Major functional limitations that preclude them from participating in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neuro-cognitive Competence in Daily Living - California Verbal Learning Test-II | 6 months post-intervention | Verbal memory performance (verbal learning and remembering) as measured by performance on the California Verbal Learning Test II (CVLT-II). Total score represents the number of words recalled from a 16 item list over 5 trials. Higher scores represent greater verbal learning and remembering. Scores can range from 0 to 80. |
| Use of Compensatory Cognitive Strategies | 6 months post-intervention | Scores on the Strategy Subscale of the Multi-Factorial Memory Memory Questionnaire. The subscale includes 19 various memory aids and strategies and respondents are asked to rate how frequently they used each strategy during the past 2 weeks using a 5 point scale (never to all the time). Scores can range from 0 to 76. HIgher scores indicate greater use of compensatory memory strategies. |
| Cognitive-related Instrumental Activities of Daily Living (IADL) Among Persons With MS | 6 months post intervention | Scores on the Everyday Problems Test - Revised (EPT-R). This scale assess the cognitive ability to reason and solve problems encountered in daily living. The revised version included 30 items and scores can range from 0 to 30. HIgher scores indicate better performance on problem solving. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Auditory Information Processing Speed and Flexibility | 6 months post intervention | The Paced Auditory Serial Addition Test (PASAT) - 3 second was used as the measure of auditory information processing speed and flexibility. Scores represent the number of correct responses during the 3 minute test and can range from 0 to 60. Higher scores indicate better information processing speed and flexibility. |
| Self-Efficacy | 6 months post intervention | Scores on the 17 item general self-efficacy scale. Respondents rate their confidence in their ability to affect outcomes in various contexts and situations using a 5-point Likert scale. Scores can range from 17 to 85 with higher scores representing greater perceived self-efficacy expectations. |
| Psychomotor Processing Speed | 6 months post intervention | The Symbol Digit Modalities Test (SDMT) was used to measure psychomotor processing speed, complex scanning and visual tracking. Respondents have 90 seconds to pair digits/numbers with abstract geometric symbols. Total scores represent the number of correct matches within the time period and can range from 0 to 110. Higher scores reflect better information processing speed. |
| Verbal Fluency | 6 months post intervention | Controlled Oral Word Association Test (COWAT) is a measure of verbal fluency and word finding. It requires participants to generate words from initial letters (normally F, A and S) under time constraints, normally 60 seconds per letter. The score reflects the number of words generated across the trials and can vary from 0 to the maximum number generated. Higher scores reflect a greater number of words and greater fluency and word finding. |
| Nonverbal Learning and Memory | 6 months post intervention | Brief Visuospatial Memory Test, 2nd ed (BVMT-R) asses visuospatial memory and was used as a measure of non-verbal learning and memory. The total recall score was used in this study and this score represents the sum of all valid items generated across learning trials 1-3. In each trial, 0-12 points can be obtained. The recognition (yes/no) is scored by one or zero points with a maximum of 12 points. The total score for the total recall ranges from 0 to 36. HIgher scores indicate better memory and recall. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from three large metropolitan communities in Texas: Houston, San Antonio and Dallas. Participants were recruited via physician referral, targeted mailings to persons with MS on the mailing list of the National MS Society, contact with support groups, and notices in MS newletters and websites.
Participants by arm
| Arm | Count |
|---|---|
| Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) Participants randomized to this arm receive the MAPSS-MS intervention. The MAPSS-MS is an an 8 week computer assisted cognitive rehabilitation intervention. The group based component of the intervention emphasizes use of compensatory cognitive strategies as well as lifestyle modifications to enhance cognition. Participants also complete home computer training (minimum 3 times per week for 45 minutes) using a special suite of games designed by Lumosity.
MAPSS-MS: MAPSS-MS is a computer-assisted cognitive rehabilitation intervention. It is a combination of home computer training and 8-weeks of group sessions on lifestyle change and compensatory cognitive strategies. | 93 |
| Usual Care Plus Computer Games Participants randomized to this arm receive usual care and are referred to MY BRAIN GAMES web site.
Usual Care plus computer games: Participants assigned to this arm receive their usual medical care and referral to the My Brain Games website. | 90 |
| Total | 183 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 10 | 23 |
Baseline characteristics
| Characteristic | Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) | Usual Care Plus Computer Games | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 93 Participants | 90 Participants | 183 Participants |
| Age, Continuous | 49.8 years STANDARD_DEVIATION 7.5 | 49.4 years STANDARD_DEVIATION 8.5 | 49.6 years STANDARD_DEVIATION 8 |
| Employment Status Full-time | 25 Participants | 28 Participants | 53 Participants |
| Employment Status Not reported | 11 Participants | 13 Participants | 24 Participants |
| Employment Status Other | 8 Participants | 2 Participants | 10 Participants |
| Employment Status Part-time | 5 Participants | 3 Participants | 8 Participants |
| Employment Status Retired | 12 Participants | 5 Participants | 17 Participants |
| Employment Status Unemployed - Disability | 32 Participants | 39 Participants | 71 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 9 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 84 Participants | 81 Participants | 165 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Expanded Disability Status Scale (EDSS) | 5.1 units on a scale STANDARD_DEVIATION 1.63 | 5.3 units on a scale STANDARD_DEVIATION 1.5 | 5.2 units on a scale STANDARD_DEVIATION 1.56 |
| Marital Status Married | 56 Participants | 61 Participants | 117 Participants |
| Marital Status Un-married | 37 Participants | 29 Participants | 66 Participants |
| MS Type Benign Sensory | 3 Participants | 3 Participants | 6 Participants |
| MS Type Not reported | 0 Participants | 1 Participants | 1 Participants |
| MS Type Primary Progressive | 3 Participants | 5 Participants | 8 Participants |
| MS Type Progressive-Relapsing | 1 Participants | 1 Participants | 2 Participants |
| MS Type Relapsing-Remitting | 64 Participants | 61 Participants | 125 Participants |
| MS Type Secondary Progressive | 14 Participants | 10 Participants | 24 Participants |
| MS Type Unable to choose one/don't know | 8 Participants | 9 Participants | 17 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants | 17 Participants | 34 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 8 Participants | 11 Participants |
| Race (NIH/OMB) White | 73 Participants | 64 Participants | 137 Participants |
| Region of Enrollment United States | 93 participants | 90 participants | 183 participants |
| Sex: Female, Male Female | 80 Participants | 80 Participants | 160 Participants |
| Sex: Female, Male Male | 13 Participants | 10 Participants | 23 Participants |
| Years Since Diagnosis | 13.9 years STANDARD_DEVIATION 8.05 | 12.1 years STANDARD_DEVIATION 8.07 | 13.0 years STANDARD_DEVIATION 8.08 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 93 | 0 / 90 |
| other Total, other adverse events | 0 / 93 | 0 / 90 |
| serious Total, serious adverse events | 0 / 93 | 0 / 90 |
Outcome results
Primary
Cognitive-related Instrumental Activities of Daily Living (IADL) Among Persons With MS
Scores on the Everyday Problems Test - Revised (EPT-R). This scale assess the cognitive ability to reason and solve problems encountered in daily living. The revised version included 30 items and scores can range from 0 to 30. HIgher scores indicate better performance on problem solving.
Time frame: 6 months post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) | Cognitive-related Instrumental Activities of Daily Living (IADL) Among Persons With MS | 24.2 units on a scale | Standard Deviation 4.8 |
| Usual Care Plus Computer Games | Cognitive-related Instrumental Activities of Daily Living (IADL) Among Persons With MS | 23.5 units on a scale | Standard Deviation 4.4 |
p-value: 0.129ANCOVA
Primary
Neuro-cognitive Competence in Daily Living - California Verbal Learning Test-II
Verbal memory performance (verbal learning and remembering) as measured by performance on the California Verbal Learning Test II (CVLT-II). Total score represents the number of words recalled from a 16 item list over 5 trials. Higher scores represent greater verbal learning and remembering. Scores can range from 0 to 80.
Time frame: 6 months post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) | Neuro-cognitive Competence in Daily Living - California Verbal Learning Test-II | 56.1 units on a scale | Standard Deviation 12.9 |
| Usual Care Plus Computer Games | Neuro-cognitive Competence in Daily Living - California Verbal Learning Test-II | 53.6 units on a scale | Standard Deviation 12.9 |
p-value: 0.926ANCOVA
Primary
Use of Compensatory Cognitive Strategies
Scores on the Strategy Subscale of the Multi-Factorial Memory Memory Questionnaire. The subscale includes 19 various memory aids and strategies and respondents are asked to rate how frequently they used each strategy during the past 2 weeks using a 5 point scale (never to all the time). Scores can range from 0 to 76. HIgher scores indicate greater use of compensatory memory strategies.
Time frame: 6 months post-intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) | Use of Compensatory Cognitive Strategies | 40.2 units on a scale | Standard Deviation 11 |
| Usual Care Plus Computer Games | Use of Compensatory Cognitive Strategies | 39.5 units on a scale | Standard Deviation 11.2 |
p-value: 0.75ANCOVA
Secondary
Auditory Information Processing Speed and Flexibility
The Paced Auditory Serial Addition Test (PASAT) - 3 second was used as the measure of auditory information processing speed and flexibility. Scores represent the number of correct responses during the 3 minute test and can range from 0 to 60. Higher scores indicate better information processing speed and flexibility.
Time frame: 6 months post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) | Auditory Information Processing Speed and Flexibility | 47.6 units on a scale | Standard Deviation 11.9 |
| Usual Care Plus Computer Games | Auditory Information Processing Speed and Flexibility | 45.9 units on a scale | Standard Deviation 11.8 |
p-value: 0.293ANCOVA
Secondary
Nonverbal Learning and Memory
Brief Visuospatial Memory Test, 2nd ed (BVMT-R) asses visuospatial memory and was used as a measure of non-verbal learning and memory. The total recall score was used in this study and this score represents the sum of all valid items generated across learning trials 1-3. In each trial, 0-12 points can be obtained. The recognition (yes/no) is scored by one or zero points with a maximum of 12 points. The total score for the total recall ranges from 0 to 36. HIgher scores indicate better memory and recall.
Time frame: 6 months post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) | Nonverbal Learning and Memory | 21.9 units on a scale | Standard Deviation 7 |
| Usual Care Plus Computer Games | Nonverbal Learning and Memory | 20.1 units on a scale | Standard Deviation 6.7 |
p-value: 0.297ANCOVA
Secondary
Psychomotor Processing Speed
The Symbol Digit Modalities Test (SDMT) was used to measure psychomotor processing speed, complex scanning and visual tracking. Respondents have 90 seconds to pair digits/numbers with abstract geometric symbols. Total scores represent the number of correct matches within the time period and can range from 0 to 110. Higher scores reflect better information processing speed.
Time frame: 6 months post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) | Psychomotor Processing Speed | 54.6 units on a scale | Standard Deviation 12.2 |
| Usual Care Plus Computer Games | Psychomotor Processing Speed | 52.0 units on a scale | Standard Deviation 12.4 |
p-value: 0.045ANCOVA
Secondary
Self-Efficacy
Scores on the 17 item general self-efficacy scale. Respondents rate their confidence in their ability to affect outcomes in various contexts and situations using a 5-point Likert scale. Scores can range from 17 to 85 with higher scores representing greater perceived self-efficacy expectations.
Time frame: 6 months post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) | Self-Efficacy | 63.7 units on a scale | Standard Deviation 11.1 |
| Usual Care Plus Computer Games | Self-Efficacy | 61.1 units on a scale | Standard Deviation 12 |
p-value: 0.152ANCOVA
Secondary
Verbal Fluency
Controlled Oral Word Association Test (COWAT) is a measure of verbal fluency and word finding. It requires participants to generate words from initial letters (normally F, A and S) under time constraints, normally 60 seconds per letter. The score reflects the number of words generated across the trials and can vary from 0 to the maximum number generated. Higher scores reflect a greater number of words and greater fluency and word finding.
Time frame: 6 months post intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Memory, Attention, Problem Solving Skills in MS (MAPSS-MS) | Verbal Fluency | 39.5 words generated | Standard Deviation 12.1 |
| Usual Care Plus Computer Games | Verbal Fluency | 36.9 words generated | Standard Deviation 11.9 |
p-value: 0.037ANCOVA