A cognitive occupation-based programme for people with multiple sclero

A Cognitive Occupation-Based programme for people with Multiple Sclerosis: definitive trial (COB-MS)

Ongoing (inferred)MS (type not specified)ISRCTN17940936

What it found

Still running

No result yet.

What it measured

Main measures

  • Achievement of personalized patient goals the Patient-Reported Outcome Measure Goal Attainment Scaling (GAS)

    12 weeks

    Quality of life (reported by participants)

  • The physical and psychological impact of MS on daily life the Patient-Reported Outcome Measure, the Multiple Sclerosis Impact Scale (MSIS-29),

    12 weeks

    Quality of life (reported by participants)

Other measures (10)

  • Total number of correct substitutions the Symbol Digit Modality Test

    12 weeks, 6 months and 12 months

    Thinking and memory

  • Recall and Recognition Scores the California Verbal Learning Test II

    12 weeks, 6 months and 12 months

    Thinking and memory

  • Visual attention, processing speed, and executive function Trail Making Test (time in seconds)

    12 weeks, 6 months and 12 months

    Thinking and memory

  • Accuracy of recalling visual shapes in terms of location and identity the Brief Visuospatial Memory Test-Revised

    12 weeks, 6 months and 12 months

    Thinking and memory

  • Memory failures in everyday life the Patient-Reported Outcome Measure the Everyday Memory Questionnaire

    12 weeks, 6 months and 12 months

    Thinking and memoryQuality of life (reported by participants)

  • Severity and frequency of the effect of fatigue on functioning the Patient-Reported Outcome Measure the Modified Fatigue Impact Scale-5-item

    12 weeks, 6 months and 12 months

    FatigueQuality of life (reported by participants)

  • Perceived ability to handle challenges the Patient-Reported Outcome Measure, Generalised Self-Efficacy Scale

    12 weeks, 6 months and 12 months

    Quality of life (reported by participants)

  • The presence and severity of depressive symptoms Patient-Reported Outcome Measure, Patient Health Questionnaire (PHQ-9)

    12 weeks, 6 months and 12 months

    Mood and sleepQuality of life (reported by participants)

  • Measure of health-related quality of life the EQ-5D-5L

    12 weeks, 6 months and 12 months

    Quality of life (reported by participants)

  • Participants’ service use and support needs the Client Service Receipt Inventory (CSRI)

    12 weeks, 6 months and 12 months

Who could take part

MS (type not specified) · 18 to 110

Show the full criteria

Inclusion criteria

Inclusion: 1. Aged 18 years of age or older 2. Have a diagnosis of multiple sclerosis, consistent with the 2024 McDonald Criteria for the Diagnosis of Multiple Sclerosis 3, Have cognitive difficulties 4. Not currently undergoing any other form of cognitive rehabilitation 5. Fluent in written and spoken English, 6. Not experiencing an active relapse- clinically stable for three months 7. Can provide informed consent 8. Are a resident of the Republic of Ireland Exclusion: 1. Significant cognitive impairment that would affect reliable participation or capacity to give informed consent 2. Significant diagnosed neurological condition or organic brain damage (unrelated to MS)

Exclusion criteria

Not separately supplied in the registry.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

Background and study aims We know that 50%-60% of people with multiple sclerosis (MS) have some cognitive problems. These can be difficulties with short-term memory, attention, problem-solving and language. There have been no methods studied which have been proven to be effective at slowing down or reversing the decline in these functions, which have a big effect on quality of life. The study is exploring a new method of cognitive rehabilitation (COB-MS). This study will teach people with MS, in a group setting, different techniques to manage the cognitive difficulties they may encounter. Previous research in Ireland has shown the COB-MS programme may have a positive impact. People with MS experienced benefits from the programme, and the results appear promising. Now we are looking to test the COB-MS on a much larger group to see if this early study result works with a larger group of people who have MS. We want to know if the COB-MS can improve daily life for people with MS and if it is cost-effective to run. Who can participate? Adult patients with MS. What does the study involve? Once enough participants have consented to take part, they will be allocated to one of three groups. One group will be offered the COB-MS in person, one group will be offered the COB-MS online, and one group will continue with their usual care. The allocation to groups is done randomly by a computer programme. The research team do not have control over who is in what group. What are the possible benefits and risks of participating? Benefits and risks not provided at time of registration Where is the study run from? University of Galway, Ireland. When is the study starting and how long is it expected to run for? March 2026 to November 2029. Who is funding the study? Health Research Board, Ireland Who is the main contact? Dr Sinéad Hynes, sinead.hynes@universityofgalway.ie

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History

    1. Started

      Mar 2026

    2. Finished

      Nov 2029

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