Who Benefits Most From Cognitive Rehabilitation for Multiple Sclerosis?
Primary Purpose
Multiple Sclerosis
Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cognitive Rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis
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.
Sites / Locations
- Nottingham University Hospitals NHS TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention Group
Usual Clinical Care
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Estimating sample size needed for Phase III RCT.
Sample size calculations will be conducted during the primary analysis.
Completion rates of outcome measures.
Based on how many participants complete all of the outcome measures.
Secondary Outcome Measures
Multiple Sclerosis Impact Scale-29
Non-cognitive questionnaire; Reliable Change Index between groups. Scores range from 9 to 36. Higher scores indicate greater psychological impact of MS on everyday life.
Everyday Memory Questionnaire-participant.
Cognitive questionnaire; Reliable Change Index between groups. Scores range from 0 to 112. Higher scores indicate more frequent memory problems.
Everyday Memory Questionnaire-relative.
Cognitive questionnaire; Reliable Change Index between groups. Scores range from 0 to 112. Higher scores indicate more frequent memory problems.
General Health Questionnaire-30.
Non-cognitive questionnaire; Reliable Change Index between groups. Scores range from 0 to 90. Higher scores indicate increased psychological distress.
Fatigue Severity Scale.
Non-cognitive questionnaire; Reliable Change Index between groups. Scores range from -3.4 to 3.4. Higher scores indicate a greater impact of fatigue.
EuroQol-5 Dimensions, five-level version.
Non-cognitive questionnaire; Reliable Change Index between groups. Scores from 0 to 100. Higher scores indicate better overall health.
Guy's Neurological Disability Scale.
Non-cognitive questionnaire; Reliable Change Index between groups. Scores range from 0 to 55. Higher scores indicate increased disability.
Brief Repeatable Battery of Neuropsychological Tests.
Cognitive test; Reliable Change Index between groups. Scores ranges vary depending on the individual test. Higher scores indicate better performance.
Doors and People test.
Cognitive test; Reliable Change Index between groups. Scores range from 0 to 20. Higher scores indicate better performance.
Trail Making Test.
Cognitive test; Reliable Change Index between groups. Scores range from 0 to 20. Higher scores indicate better performance.
Full Information
NCT ID
NCT05509426
First Posted
May 31, 2022
Last Updated
September 5, 2022
Sponsor
University of Nottingham
Collaborators
National Multiple Sclerosis Society, University of Lincoln
1. Study Identification
Unique Protocol Identification Number
NCT05509426
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nottingham
Collaborators
National Multiple Sclerosis Society, University of Lincoln
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm 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.
Arm Title
Usual Clinical Care
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability and feasibility of conducting an online group-based cognitive rehabilitation programme.
Description
Feedback interviews will be conducted to understand the acceptability and feasibility of the intervention.
Time Frame
Between the 3-month follow-up point and the 6-month follow-up point, up to 3 months.
Title
Appropriateness of eligibility criteria, baseline and outcome measures, recording of sessions, and randomisation protocol.
Description
Rates of enrolment and drop out will be recorded. Fidelity of the intervention will be assessed by video recording.
Time Frame
From the date of randomisation to date of final follow-up, up to 1 year.
Title
Estimating sample size needed for Phase III RCT.
Description
Sample size calculations will be conducted during the primary analysis.
Time Frame
From the start of the data analysis to study completion date, up to 6 months.
Title
Completion rates of outcome measures.
Description
Based on how many participants complete all of the outcome measures.
Time Frame
6 months.
Secondary Outcome Measure Information:
Title
Multiple Sclerosis Impact Scale-29
Description
Non-cognitive questionnaire; Reliable Change Index between groups. Scores range from 9 to 36. Higher scores indicate greater psychological impact of MS on everyday life.
Time Frame
Baseline, 3-months post randomisation, 6-month post randomisation
Title
Everyday Memory Questionnaire-participant.
Description
Cognitive questionnaire; Reliable Change Index between groups. Scores range from 0 to 112. Higher scores indicate more frequent memory problems.
Time Frame
Baseline, 3-months post randomisation, 6-month post randomisation.
Title
Everyday Memory Questionnaire-relative.
Description
Cognitive questionnaire; Reliable Change Index between groups. Scores range from 0 to 112. Higher scores indicate more frequent memory problems.
Time Frame
Baseline, 3-months post randomisation, 6-month post randomisation.
Title
General Health Questionnaire-30.
Description
Non-cognitive questionnaire; Reliable Change Index between groups. Scores range from 0 to 90. Higher scores indicate increased psychological distress.
Time Frame
Baseline, 3-months post randomisation, 6-month post randomisation.
Title
Fatigue Severity Scale.
Description
Non-cognitive questionnaire; Reliable Change Index between groups. Scores range from -3.4 to 3.4. Higher scores indicate a greater impact of fatigue.
Time Frame
Baseline, 3-months post randomisation, 6-month post randomisation.
Title
EuroQol-5 Dimensions, five-level version.
Description
Non-cognitive questionnaire; Reliable Change Index between groups. Scores from 0 to 100. Higher scores indicate better overall health.
Time Frame
Baseline, 3-months post randomisation, 6-month post randomisation.
Title
Guy's Neurological Disability Scale.
Description
Non-cognitive questionnaire; Reliable Change Index between groups. Scores range from 0 to 55. Higher scores indicate increased disability.
Time Frame
Baseline, 3-months post randomisation, 6-month post randomisation.
Title
Brief Repeatable Battery of Neuropsychological Tests.
Description
Cognitive test; Reliable Change Index between groups. Scores ranges vary depending on the individual test. Higher scores indicate better performance.
Time Frame
Baseline, 3-months post randomisation, 6-month post randomisation.
Title
Doors and People test.
Description
Cognitive test; Reliable Change Index between groups. Scores range from 0 to 20. Higher scores indicate better performance.
Time Frame
Baseline, 3-months post randomisation, 6-month post randomisation.
Title
Trail Making Test.
Description
Cognitive test; Reliable Change Index between groups. Scores range from 0 to 20. Higher scores indicate better performance.
Time Frame
Baseline, 3-months post randomisation, 6-month post randomisation.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roshan das Nair, PhD
Phone
+44(0)115 8230589
Email
roshan.dasnair@nottigham.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren A Taylor, BSc, MRes
Email
lauren.taylor@nottingham.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roshan das Nair, PhD
Organizational Affiliation
University of Nottingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nikos Evangelou, MD
12. IPD Sharing Statement
Learn more about this trial
Who Benefits Most From Cognitive Rehabilitation for Multiple Sclerosis?
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