Who benefits most from cognitive rehabilitation? A feasability trial
Research type
Research Study
Full title
Determining Who Benefits Most from Cognitive Rehabilitation for Attention and Memory in Multiple Sclerosis: A Randomised Controlled Feasibility Trial
IRAS ID
293754
Contact name
Roshan das Nair
Contact email
Sponsor organisation
University of Nottingham
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 20 days
Research summary
Lay summary of study results: We included participants who were aged 18 to under 70, diagnosed with MS at least three months prior, displaying cognitive deficits, proficient in English, equipped with a device supporting Microsoft Teams, and willing to provide informed consent. We excluded participants with severe hearing or vision problems, such that they were unable to complete the assessments, concurrent medical or psychiatric conditions that were preventing engagement, and those involved in other psychological intervention trials.
Participants were recruited through the neurology service at Nottingham University Hospitals (NUH) NHS Trust, branches of the MS Society, and our Patient and Public Involvement (PPI) group. Participants were randomly allocated to either the intervention plus usual care group or the usual care only group on a 3:1 ratio in favour of the intervention group. A blinded member of the research team, not involved in intervention delivery, used an internet-based randomisation system to obtain allocations for each participant in REDCap.
Thirty-six people with MS were recruited between August 2022 and March 2023. The intervention group and the usual care group were comparable for most of the descriptive and clinical characteristics. The usual care group had a higher average age, a slightly higher number of years of education and years since diagnosis.
Fifty-seven people with MS were either referred to this study by neurologists or expressed interest in taking part. People with MS had the option of self-referring which allowed people from across the UK to take part. We advertised the study on Twitter and through the MS Society. Most participants came through the self-referral route. The PPI group had the highest conversion rate, meaning that this group had the most expressions of interest that converted into participants, followed by referrals from neurologists.
Two participants withdrew from the trial once it had begun.
As a feasibility trial, we did not have a primary outcome. We found some significant differences between the intervention group and the usual care group. There was a significant difference between groups for the Selective Reminding Test (SRT), favouring the cognitive rehabilitation group. We found a significant large effect size for the SRT for both the total recall (t(28)=2.428, p<.01, partial eta squared=-1.048,) and consistent long-term recall sub-scores (t(28)=2.154. p=.02, partial eta squared=.930) indicating that the cognitive rehabilitation programme had a large effect on verbal learning and recall. We did not find a statistically significant difference on the 10/36 spatial recall test, the Symbol Digit Modalities Test (SDMT) or the subjective questionnaires including the Everyday Memory Questionnaire, the Multiple Sclerosis Impact Scale (MSIS), the EQ-5D quality of life scale or the Fatigue Severity Scale.
We carried out a subgroup analysis to understand whether there were preliminary signals of efficacy for the algorithm we previously developed to identify who benefits most from cognitive rehabilitation. Following our subgroup analysis, we found significant differences between people with MS who were predicted to be more likely to benefit compared to those predicted to be less likely to benefit on the SRT (t(21)=2.118, p=.02, partial eta squared=.891), EMQ (t(19)=2.633, p=.008, partial eta squared=1.151) and EQ-5D (t(19)=2.817, p<.01, partial eta squared=1.231), favouring the most likely to benefit group. A large effect size was found for all these tests. These results could indicate that the cognitive rehabilitation programme may have a greater effect for those predicted to be most likely to benefit compared to those predicted to be less likely to benefit.
Similarly, at 6-months post-randomisation, we found significant differences between the intervention group and usual care group on the SRT. We also found large effect sizes for the EQ-5D visual analogue scale which measures quality of life and moderate effect sizes for the MSIS, although these were not significant.
Feedback interviews were conducted with six participants from the intervention group and analysed using the framework matrix developed for the CRAMMS trial as a guide with adaptations made to align with the aims of this study. All participants consented to being recorded and to anonymised quotes being used in research papers. Five themes were derived: (1) management of cognition before the trial, (2) online format of the intervention, (3) perceived cognitive changes, (4) perceived mechanism of change of cognitive function, and (5) possible improvements to the intervention.
Based on the Avery criteria (https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fdoi.org%2F10.1136%2Fbmjopen-2016-013537&data=05%7C02%7Cderby.rec%40hra.nhs.uk%7C9a8b9f057061487fb0ee08de6256767b%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639056320658149659%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=4mLqGX0Q36ClvP271%2FtDXnRjlBmkawK%2F1Ymgj%2FZRmu8%3D&reserved=0), we believe that this trial highlighted that online cognitive rehabilitation is feasible and largely acceptable to people with MS to reduce cognitive decline and improve overall quality of life, and therefore, a full trial is warranted to understand whether this is effective. The suggestions for improvements to the work booklet provided during the feedback interviews should be considered before a full trial is conducted.
Cognition is a term that refers to the processes that occur in our brain. These cognitive processes include memory, attention, language, information processing, perception, planning, problem solving and so on. 'Cognitive' difficulties mean an individual is experiencing difficulty in any or all of these areas, and these difficulties are thought to effect up to 70% of people with multiple sclerosis (MS). Cognitive rehabilitation is a specialised form of support that focuses on helping or supporting people with MS to improve their cognition, and in turn teaches them to use both internal and external tools to address these difficulties. Despite the many studies that have explored the effectiveness of this intervention, results have been inconclusive. These studies have recruited a broad range of people which may have contributed to the inconclusive results, as it is very unlikely that all people with MS would benefit in exactly the same way. Therefore, we need to explore which subgroups of people with MS benefit most from cognitive rehabilitation.
The aim of this study is to explore which subgroups of people with MS are more likely to benefit from cognitive rehabilitation, to assess the feasibility of conducting a larger study and the acceptability of study procedures. The current study will take place online using video conferencing software.
We will aim to recruit 36 people with MS who report experiencing cognitive difficulties. These participants will be randomly assigned to one of the two groups: (1) online group-based cognitive rehabilitation plus usual care; (2) usual care only. There will be 24 people in the intervention group and 12 people in the control group. The intervention group will be divided into four groups of six for the cognitive rehabilitation and will receive 10 weekly sessions of online cognitive rehabilitation.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
22/EM/0051
Date of REC Opinion
10 May 2022
REC opinion
Further Information Favourable Opinion