Who Benefits Most From Cognitive Rehabilitation for Multiple Sclerosis?

NCT05509426 | Unknown

• 1 other identifier: 21063
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

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

  Feedback interviews will be conducted to understand the acceptability and feasibility of the intervention.

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

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

  Rates of enrolment and drop out will be recorded. Fidelity of the intervention will be assessed by video recording.

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

• Estimating sample size needed for Phase III RCT.

  Sample size calculations will be conducted during the primary analysis.

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

• Completion rates of outcome measures.

  Based on how many participants complete all of the outcome measures.

  6 months.

Secondary Outcomes (10)

• Multiple Sclerosis Impact Scale-29

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

• Everyday Memory Questionnaire-participant.

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

• Everyday Memory Questionnaire-relative.

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

• General Health Questionnaire-30.

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

• Fatigue Severity Scale.

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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: Cognitive Rehabilitation

Usual Clinical Care

NO INTERVENTION

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.

Interventions

Cognitive Rehabilitation 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.

Intervention Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Nottingham: lead
• National Multiple Sclerosis Society: collaborator
• University of Lincoln: collaborator

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Roshan das Nair, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roshan das Nair, PhD

CONTACT

+44(0)115 8230589; roshan.dasnair@nottigham.ac.uk

Lauren A Taylor, BSc, MRes

CONTACT

lauren.taylor@nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: August 22, 2022
• Study Start: August 15, 2022
• Primary Completion: July 1, 2023
• Study Completion: November 1, 2023
• Last Updated: September 9, 2022

Record last verified: 2022-09

Locations

GB (1)