The study is a crossover randomized controlled trial investigating the effect of increasing engagement in cognitive leisure activities for individuals with multiple sclerosis.
The study is a crossover randomized controlled trial investigating the impact of cognitive leisure activities on the cognitive functioning of individuals with multiple sclerosis (MS). The goal is to investigate whether increasing leisure activities may help prevent cognitive impairment in individuals with MS. The trial consists of two studies. The first is a randomized controlled trial examining the effects of increasing engagement in cognitive leisure activities. The second is a qualitative interview-based study to identify factors that may improve adherence and acceptance of the intervention. The study employs a randomized, controlled crossover design, with 60 participants (30 with relapsing-remitting MS, 30 with progressive MS) assigned to either an intervention group or a passive control group for 12 weeks. After the initial 12 weeks the groups are crossed over and followed up after an additional 12 weeks. The intervention group will receive instruction and support to engage in cognitive leisure activities, while the control group will continue with their usual daily activities. For a detailed description of the project, the full protocol can be found at: https://dmsc.dk/onewebmedia/CRAMS%20research%20protocol.pdf
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Participants in the active phase of the study will be asked to increase engagement in certain cognitive leisure activities. The activities are chosen on the basis of previous research and measures of cognitive reserve-building activities.
Danish Multiple Sclerosis Center, Copenhagen University Hospital, Rigshospitalet-Glostrup
Glostrup Municipality, Denmark
Change in score on the Symbol Digit Modality Test (SDMT)
An objective measure of cognitive efficiency
Time frame: Baseline, week 12, week 24
Change in score on the Multiple Sclerosis Neuropsychological Questionnaire (MSNQ)
A subjective measure of cognitive symptoms for patients with MS
Time frame: Baseline, week 12, week 24
Change in score on the California Verbal Learning Test II (CVLT II)
A test of verbal memory
Time frame: Baseline, week 12, week 24
Change in score on the Brief Visuospatial Memory Test Revised (BVMT-R)
A test of visuospatial memory
Time frame: Baseline, week 12, week 24
Change in score on the Word Fluency Test (phonological)
A test of executive functioning and verbal fluency
Time frame: Baseline, week 12, week 24
Change in score on the Five-point Test
A test of executive functioning
Time frame: Baseline, week 12, week 24
Change in score on the Cognitive Leisure and Activity Scale (CLAS)
A questionnaire assessing the participant's degree of participation in cognitive leisure activities. The scale consists of 16 items (leisure activities) on which participants rate their activity level on a scale from 0-5, with 0 indicating no participation and 5 indicating daily participation in the activity. Scores are summed, yielding a total score ranging from 0 - 80 with lower scores indicating less participation in cognitive leisure activities and higher scores indicating a higher degree of participation.
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Time frame: Baseline, week 12, week 24, week 36