Who Benefits Most From Cognitive Rehabilitation for Multiple Sclerosis

Determining Who Benefits Most From Cognitive Rehabilitation for Attention and Memory in Multiple Sclerosis: A Randomised Controlled Feasibility Trial

Status unknownNot a drug-phase studyMS (type not specified)NCT05509426

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

What was tested

Treatment tested

  • Cognitive Rehabilitation

What it measured

Main measures

  • Acceptability and feasibility of conducting an online group-based cognitive rehabilitation programme.

    Between the 3-month follow-up point and the 6-month follow-up point, up to 3 months.

    Thinking and memoryFeasibility

  • Appropriateness of eligibility criteria, baseline and outcome measures, recording of sessions, and randomisation protocol.

    From the date of randomisation to date of final follow-up, up to 1 year.

  • Estimating sample size needed for Phase III RCT.

    From the start of the data analysis to study completion date, up to 6 months.

  • Completion rates of outcome measures.

    6 months.

Other measures (10)

  • Multiple Sclerosis Impact Scale-29

    Baseline, 3-months post randomisation, 6-month post randomisation

    Thinking and memory

  • Everyday Memory Questionnaire-participant.

    Baseline, 3-months post randomisation, 6-month post randomisation.

    Thinking and memory

  • Everyday Memory Questionnaire-relative.

    Baseline, 3-months post randomisation, 6-month post randomisation.

    Thinking and memory

  • General Health Questionnaire-30.

    Baseline, 3-months post randomisation, 6-month post randomisation.

    Thinking and memory

  • Fatigue Severity Scale.

    Baseline, 3-months post randomisation, 6-month post randomisation.

    Thinking and memoryFatigue

  • EuroQol-5 Dimensions, five-level version.

    Baseline, 3-months post randomisation, 6-month post randomisation.

    Thinking and memory

  • Guy's Neurological Disability Scale.

    Baseline, 3-months post randomisation, 6-month post randomisation.

    Thinking and memory

  • Brief Repeatable Battery of Neuropsychological Tests.

    Baseline, 3-months post randomisation, 6-month post randomisation.

    Thinking and memory

  • Doors and People test.

    Baseline, 3-months post randomisation, 6-month post randomisation.

    Thinking and memory

  • Trail Making Test.

    Baseline, 3-months post randomisation, 6-month post randomisation.

    Thinking and memory

Who could take part

MS (type not specified) · 18 to 70

Show the full 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.

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

About this trial

In the sponsor's words

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.

Loading reviews and guidelines…

History

    1. Started

      Aug 2022

    2. Main results due

      Jul 2023

    3. Finished

      Nov 2023

    Assembled by software from public sources.