Who Benefits Most From Cognitive Rehabilitation for Multiple Sclerosis?

NCT ID: NCT05509426

Last Updated: 2022-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-15
• Study Completion Date: 2023-11-30

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intervention Group

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.

Group Type: EXPERIMENTAL

Cognitive Rehabilitation

Intervention Type: BEHAVIORAL

This cognitive rehabilitation will be tailored to each participant's cognitive status while maintaining a systematic treatment approach to attention and memory, following a study treatment manual. The intervention will include (i) restitution strategies to retain memory and attention functions including strategies to improve encoding and retrieval, (ii) compensation strategies, including internal mnemonics, use of external devices and ways of coping with attention and memory problems, (iii) the importance of errorless learning. The emphasis will be on identifying the most appropriate strategies to help individuals overcome their cognitive problems and in providing participants with a range of techniques, which they can adapt and use according to their needs. This is group based intervention that will take place remotely using MS Teams.

Usual Clinical Care

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive Rehabilitation

This cognitive rehabilitation will be tailored to each participant's cognitive status while maintaining a systematic treatment approach to attention and memory, following a study treatment manual. The intervention will include (i) restitution strategies to retain memory and attention functions including strategies to improve encoding and retrieval, (ii) compensation strategies, including internal mnemonics, use of external devices and ways of coping with attention and memory problems, (iii) the importance of errorless learning. The emphasis will be on identifying the most appropriate strategies to help individuals overcome their cognitive problems and in providing participants with a range of techniques, which they can adapt and use according to their needs. This is group based intervention that will take place remotely using MS Teams.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Multiple Sclerosis Society

OTHER

Sponsor Role: collaborator

University of Lincoln

OTHER

Sponsor Role: collaborator

University of Nottingham

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Roshan das Nair, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Nottingham

Locations

Nottingham University Hospitals NHS Trust

Nottingham, , United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Roshan das Nair, PhD

Role: CONTACT

roshan.dasnair@nottigham.ac.uk

+44(0)115 8230589

Lauren A Taylor, BSc, MRes

Role: CONTACT

lauren.taylor@nottingham.ac.uk

Facility Contacts

Nikos Evangelou, MD

Role: primary

Other Identifiers

21063

Identifier Type: -

Identifier Source: org_study_id