A Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS): a randomised pilot trial to improve cognition and daily functioning for people with multiple sclerosis

Completed (inferred)MS (type not specified)ISRCTN11462710

What it found

Paper found, not read

A paper reports the results; we have not read it yet. See Papers below.

What it measured

Main measures

  • Goal Attainment Scaling at the 12-week follow-up

Other measures (1)

  • 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 M

    Thinking and memoryFatiguePainMood and sleepQuality of life (reported by participants)

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

Inclusion: 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: 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

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 The aim of this research is to test the feasibility of running a large-scale trial of an occupational therapy intervention called a Cognitive Occupation-Based programme for people with Multiple Sclerosis (COB-MS), as well as its preliminary effectiveness. That is, the aim of the research is to assess whether or not it is possible to properly test this programme and whether or not it is likely to work. The study will focus on how acceptable the intervention is and how well the trial runs. Ten occupational therapists will run the COB-MS with 100 people with MS. This project has the potential to directly influence clinical practice and benefit the lives of people with MS, by enabling them to manage their disease symptoms in a positive way that allows them to live well with MS. Cognitive impairments are common in multiple sclerosis and affect daily life in many ways. We propose a new way in which people living with MS can empower themselves to live active and fulfilling lives - a novel intervention that enables people with MS who are experiencing difficulties with their cognition to live positively. Here we propose an intervention that tackles cognitive difficulties early, allows patients to manage their own symptoms and is transferable to real-world situations. Who can participate? People with MS and occupational therapists who work with people with MS. What does the study involve? Participants will randomly be assigned to receive the COB-MS programme or treatment as usual. The COB-MS programme takes place over nine weeks in eight sessions lasting 60-90 minutes. Participants will be asked to fill in questionnaires before and after the treatment period. At the end of the period, the participants in the control group will be offered the COB-MS treatment. Occupational therapists taking part will be asked to provide their feedback on the treatment programme. Added 23/09/2020: Due to the impact of COVID-19 this trial is now been conducted online: data collection and delivery of the intervention. What are the possible benefits and risks of participating? Potential benefits of participation include: access to a free cognitive occupation-based programme, designed specifically for people living with MS; informational benefits relating to the management of MS; and a greater understanding of the individual’s role in their MS management. When this research project is concluded, all participants will receive a summary of the main findings. Of note, it could take in excess of 6 months before final results are published. Though there is no foreseen risk of participating, there is the potential that a person or persons may become upset when discussing cognitive or other difficulties, in which case, our research staff has the skills necessary to deal with such occurrences. Where is the study run from? National University of Ireland Galway When is the study starting and how long is it expected to run for? October 2019 to July 2022 Who is funding the study? Health Research Board, Ireland Who is the main contact? Dr Sinéad Hynes sinead.hynes@nuigalway.ie

Papers

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History

    1. Started

      Oct 2019

    2. Finished

      Jul 2022

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