Multiple sclerosis Nervous System Diseases
Conditions
Interventions
This is a single-blind randomised control pilot trial. This study will use a treatment as usual, wait-list control group (TAU) comparison examined over four time points, as part of both preliminary cl
feasibility / piloting
evaluation and implementation. Here we are focused on the feasibility/piloting phase.
Cognitive Occupation-Based Programme for People with MS:
The Template for Intervention Description and Replicatio
Sponsors
NUI Galway
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: People with MS: 1. Aged 18 years of age or older 2. Fluent in written and spoken English 3. Diagnosis of multiple sclerosis 4. Cognitive difficulties, as shown by a score of >22 on the MSNQ 5. Clinically stable (we define “clinically stable” as not having an active relapse) 6. Can provide informed consent 7. No neurologic history other than MS, including evidence of current dementia 8. No history of major depressive disorder, schizophrenia, or bipolar disorder I or II 9. No history of diagnosed substance use or dependence disorder 10. Not currently undergoing any other form of cognitive rehabilitation 11. Living in the community Occupational Therapists: 1. Currently working in Ireland as an occupational therapist 2. CORU-registered 3. Have experience working with people with MS 4. Can commit to the requirements of the study
Exclusion criteria
Exclusion criteria: People with MS: 1. Cognitive impairment that would affect reliable participation or capacity to give informed consent 2. Are incarcerated or institutionalized 3. Significant neurological condition or organic brain damage (unrelated to MS). Occupational Therapists: 1. Not meeting the inclusion criteria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Goal Attainment Scaling at the 12-week follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 25/11/2019: At 12 weeks and 6 months follow-up: 1. Prediction of future cognitive decline measured using the Symbol Digit Modality Test 2. Cognitive function assessed by the California Verbal Learning Test II 3. Visual attention and task switching assessed by the Trail Making Test 4. Visuospatial learning and memory assessed using the Brief Visuospatial Memory Test-Revised 5. Memory assessed by the Everyday Memory Questionnaire Revised and by a relative's report 6. Impact of fatigue on participant’s life assessed by the Modified Fatigue Impact Scale 7. Self-efficacy assessed using the Generalised Self-Efficacy Scale (GSES) 8. Quality of life assessed by the Multiple Sclerosis Quality of Life-54 (MSQoL-54) 9. Mental health assessed using the General Health Questionnaire (GHQ-12) Previous secondary outcome measures: At 12 weeks and 6 months follow-up: 1. Prediction of future cognitive decline measured using the Symbol Digit Modality Test 2. Cognitive function assessed by the California Verbal Learning Test II 3. Visual attention and task switching assessed by the Trail Making Test 4. Memory assessed by the Everyday Memory Questionnaire 5. Self-report of cognitive difficulties assessed by the Perceived Deficits Questionnaire 6. Trait and state anxiety assessed by the Spielberger Trait Anxiety Inventory 7. Perceived stress assessed by the Perceived Stress Scale 8. Impact of fatigue on participant’s life assessed by the Modified Fatigue Impact Scale 9. Quality of life assessed by the Multiple Sclerosis Quality of Life -54 (MSQoL-45) 10. Self-efficacy assessed by the Generalised Self-Efficacy Scale (GSES) 11. Pain assessed by the Brief Pain inventory 12. Depression assessed by the Beck’s Depression Inventory II | — |
Countries
Ireland
Outcome results
None listed