Clinical trial NCT05509426: Who Benefits Most From Cognitive Rehabilitation for Multiple Sclerosis?
Official title: Determining Who Benefits Most From Cognitive Rehabilitation for Attention and Memory in Multiple Sclerosis: A Randomised Controlled Feasibility Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: University of Nottingham
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
name: University of Lincoln
First posted: 2022-08-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Over the last 20 years, there have been many studies investigating the efficacy of attention and memory rehabilitation for people with multiple sclerosis (MS) however, there appears to be a lack of conclusive evidence regarding the true effectiveness of this intervention. This could be because the participant samples recruited to these studies are often extremely varied in terms of socio-demographics and clinical characteristics, and it would be very unlikely that all people with MS would benefit from these interventions uniformly. Therefore, there is a need to explore which subgroups of people with MS benefit most from cognitive rehabilitation so that this information can be used to help clinicians and services make decisions as to whom this intervention is offered. Cognitive rehabilitation is not routinely provided on the NHS due to lack of resources. This research is important as it will allow these resources to be optimised and made available to those who need them, but also to allow clinicians to understand whether their patient is likely to benefit from cognitive rehabilitation before it is offered.

The primary aim of this study is to assess the feasibility and acceptability of undertaking a randomised controlled trial (RCT) to investigate the effectiveness of an online group-based cognitive rehabilitation programme with specific groups of people with MS. The secondary aim is to understand the impact that this intervention may have on various aspects of cognition such as memory, attention, and information processing. This will be assessed through various questionnaires and objective neuropsychological tests.

In addition, an algorithm has been developed following the secondary data analysis of a large RCT investigating group-based cognitive rehabilitation for people with MS. This algorithm may be able to determine who benefits most from cognitive rehabilitation, we will therefore use this as part of the data analysis to understand if the algorithm has the potential to be an accurate clinical prediction tool.

After completion of the cognitive rehabilitation, a small number of participants in the intervention group will be invited to take part in feedback interviews to give their views on the feasibility and acceptability of the group-based online cognitive rehabilitation and provide any suggestions for improvements for future trials.


Eligibility criteria: Inclusion Criteria:

* 18 or over and under 70 years of age.
* Have MS, diagnosed at least 3 months prior to recruitment.
* Have cognitive deficits, defined as performance below the 25th percentile on the Brief Repeatable Battery of Neuropsychological Tests (BRBN).
* Able to speak English sufficiently to complete the cognitive assessments and take part in group sessions.
* Have access to laptop or PC that supports MS Teams.
* Able to give informed consent.

Exclusion Criteria:

* Vision or hearing problems, such that they are unable to complete the cognitive assessments, judged assessor.
* Have concurrent severe medical or psychiatric conditions which would prevent participants from engaging in treatment, if allocated.
* Are involved in other psychological intervention trials.

Primary outcomes:
measure: Acceptability and feasibility of conducting an online group-based cognitive rehabilitation programme.
timeFrame: Between the 3-month follow-up point and the 6-month follow-up point, up to 3 months.
measure: Appropriateness of eligibility criteria, baseline and outcome measures, recording of sessions, and randomisation protocol.
timeFrame: From the date of randomisation to date of final follow-up, up to 1 year.
measure: Estimating sample size needed for Phase III RCT.
timeFrame: From the start of the data analysis to study completion date, up to 6 months.
measure: Completion rates of outcome measures.
timeFrame: 6 months.
Secondary outcomes:
measure: Multiple Sclerosis Impact Scale-29
timeFrame: Baseline, 3-months post randomisation, 6-month post randomisation
measure: Everyday Memory Questionnaire-participant.
timeFrame: Baseline, 3-months post randomisation, 6-month post randomisation.
measure: Everyday Memory Questionnaire-relative.
timeFrame: Baseline, 3-months post randomisation, 6-month post randomisation.
measure: General Health Questionnaire-30.
timeFrame: Baseline, 3-months post randomisation, 6-month post randomisation.
measure: Fatigue Severity Scale.
timeFrame: Baseline, 3-months post randomisation, 6-month post randomisation.
measure: EuroQol-5 Dimensions, five-level version.
timeFrame: Baseline, 3-months post randomisation, 6-month post randomisation.
measure: Guy's Neurological Disability Scale.
timeFrame: Baseline, 3-months post randomisation, 6-month post randomisation.
measure: Brief Repeatable Battery of Neuropsychological Tests.
timeFrame: Baseline, 3-months post randomisation, 6-month post randomisation.
measure: Doors and People test.
timeFrame: Baseline, 3-months post randomisation, 6-month post randomisation.
measure: Trail Making Test.
timeFrame: Baseline, 3-months post randomisation, 6-month post randomisation.
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
affiliation: University of Nottingham
name: Roshan das Nair, PhD
role: PRINCIPAL_INVESTIGATOR
References: