Who Benefits Most From Cognitive Rehabilitation for Multiple Sclerosis?

University of Nottingham

Status: Enrolling

Conditions: Multiple Sclerosis

Treatments: Behavioral: Cognitive Rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05509426

21063

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Intervention Group

Experimental group

Description:

This group will receive an online cognitive rehabilitation programme, offered in addition to usual clinical care, to groups of 4-6 participants weekly for 10 sessions.

Treatment:

Behavioral: Cognitive Rehabilitation

Usual Clinical Care

No Intervention group

Description:

This group will receive only their usual clinical care, which may include information on cognitive problems as per clinical practice but not specific cognitive rehabilitation.