An interventional study of SMART and Sham brain training (Sudoku) in Multiple Sclerosis, sponsored by University of Lincoln. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2023-12-05.
Sponsored by University of Lincoln · Not applicable, Interventional, and Treatment
Background: Multiple Sclerosis (MS) is a chronic condition of the central nervous system; around 1 in 600 people in the United Kingdom have MS. Many people with MS (70%) have cognitive difficulties, which they experience as distressing and disabling, and there is currently a lack of treatment options to improve these difficulties.
SMART (Strengthening Mental Abilities with Relational Training) - a theory-based online cognitive training programme, which has been shown to improve general cognitive abilities - has not been tested with people who have MS.
Aims: To conduct a feasibility study to inform development of a definitive trial of SMART for improving cognitive functioning in people with MS. The investigators will assess:
Plan: To address Aims 1-5, the investigators will recruit 60 adults with MS who are experiencing cognitive difficulties, identified from MS clinics.
Participants will complete baseline assessments of their cognitive abilities and answer questionnaires about their cognitive difficulties, personal priorities, mood, fatigue, self-efficacy, quality of life, and healthcare services used.
Assessments will be administered by a researcher, face-to-face or remotely.
Participants will be randomly allocated to one of three arms (20 per group):
Group 1: Receives SMART intervention online - plus usual care (MS Nurse support). SMART intervention involves completing a series of logic problems, which are designed to train skills that scaffold complex cognition.
Group 2: Receives usual care alone. Group 3: Receives a 'control' intervention online - plus usual care.
Baseline measures will be re-administered at three- and six-months post-randomisation. Researchers and patient-partners (people with personal experience of MS, who will act as co-researchers) will also interview 30 participants about their experience of the study and treatment. All qualitative data will be transcribed and thematically analysed in terms of a priori feasibility aims. Quantitative data will enable sample-size calculation for a definitive study and determine signal of efficacy.
Background:
Cognitive deficits have been identified as the most debilitating impact of MS. These deficits interfere with daily living, manifesting as inattention (e.g., getting easily distracted), forgetting (e.g., leaving the stove on after cooking), and problem-solving difficulties (e.g., getting confused when completing a multi-stage task like cooking). The burden of these deficits reduces quality of life and restricts daily activities and employment - and correspondingly, diminishes patient perceptions of personal competence and self-worth. Cognitive rehabilitation is not routinely offered in the National Health Service (NHS) - and, when it is offered, largely focuses on teaching people to compensate for deficits (e.g., using external memory aids) rather than retraining cognitive skills. A recent state-of-the-field review from international MS experts has called for research towards identifying effective, evidence-based, and clinically feasible interventions to address cognitive deficits in MS. There is evident uncertainty about how to intervene effectively, and this is recognised by the James Lind Alliance as a top-10 priority area for research-funding.
Our trial tests the feasibility of a highly accessible and low-resource format of cognitive rehabilitation (online training). Given NHS resource constraints, the scale of the problem, and concerns about face-to-face consultation in the context of COVID-19, new and cost-effective ways of implementing promising cognitive rehabilitation interventions are needed. Low-resource online formats are more likely to be implemented if found to be clinically effective, enable wider access for patients, and provide active support for self-management - consistent with (1) models of care for managing longer-term conditions and (2) the digital healthcare agenda.
As a feasibility trial, outcomes are unlikely to immediately effect changes to NHS practice. However, this is a necessary step towards developing a definitive trial - and will give us a signal of efficacy, a prerequisite for progression to a definitive trial. If found to be clinically- and cost-effective, the latter trial could create a step-change in MS cognitive rehabilitation - improving service-delivery and optimising support with limited additional resources.
Aim:
To conduct a feasibility study to inform development of a definitive trial of SMART (an online 'brain training' treatment) for improving cognitive functioning in people with MS.
The investigators will assess:
Research plan:
The investigators will conduct a three-arm feasibility Randomised Controlled Trial (RCT) comparing (1) SMART + treatment-as-usual (TAU) with (2) TAU and (3) active control ('sham') training + TAU.
Consenting eligible patients will complete a baseline cognitive assessment battery and questionnaires assessing impact of living with MS, health-related quality of life, subjective cognitive difficulties, and service/resource-use.
After completing baseline assessments, participants will be randomly allocated to one of three arms (using minimisation to balance participant characteristics across arms):
A Research Fellow will complete blinded outcomes at 3- and 6-months post-randomisation, by re-administering baseline measures. Quantitative data will enable sample-size calculation for a definitive study and determine signal of efficacy. After the first follow-up assessment (>3 months post-randomisation) a sub-sample of participants will engage in feasibility-feedback interviews.
3,525 studies on the registry are indexed under Multiple Sclerosis; 668 are open to participants now.
This study's planned enrollment of 60 is above the median of 50 across 2,386 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →University of Lincoln is the lead sponsor of 25 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Participants in this arm will receive treatment-as-usual (TAU) plus the experimental SMART intervention (theory-based cognitive training)
Behavioral: SMART
Participants in this arm will receive treatment-as-usual (TAU) plus a control (sham) cognitive training intervention
Behavioral: Sham brain training (Sudoku)
Participants in this arm will receive treatment-as-usual (TAU). Content of TAU for cognitive concerns, based on our clinical experience and knowledge, is often informational support from an MS Nurse with signposting to the MS Society/MS Trust websites.
SMART (Strengthening Mental Abilities Through Relational Training) is a web-based cognitive training program that directly trains 'relational skills' - skills necessary to understand how concepts relate to one another, which underpin complex cognition.
Sudoku was selected to control for expectancy effects based on popular conceptions that it broadly improves cognitive functions, coupled with little evidence supporting this notion, and its use as an active control in similar trials.
Recruitment and retention rates
Numbers eligible/interested/consented and randomised (and reasons for non-participation), number completing baseline and outcome assessments at Follow-up 1
Time frame: 16 months
Completion rates of outcome measures
Missing response-data
Time frame: 6 months
Intervention drop-out rate
Numbers in the intervention condition that drop out (complete \<6 sessions) and reasons for intervention non-completion
Time frame: 3 months
Perceived Deficits Questionnaire (PDQ)
Estimates of (group-level) effect-sizes with 95% Confidence Intervals (CIs) and proportions achieving reliable/clinically significant change (exploring signal of efficacy)
Time frame: Change between baseline and 3-month follow-up. Additional follow-up at 6 months.
Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Estimates of (group-level) effect-sizes with 95% Confidence Intervals (CIs) and proportions achieving reliable/clinically significant change (exploring signal of efficacy)
Time frame: Change between baseline and 3-month follow-up. Additional follow-up at 6 months.
Symbol Digit Modalities Test (SDMT)
Estimates of (group-level) effect-sizes with 95% Confidence Intervals (CIs) and proportions achieving reliable/clinically significant change (exploring signal of efficacy)
Time frame: Change between baseline and 3-month follow-up. Additional follow-up at 6 months.
Generalized Anxiety Disorder Scale-7 (GAD-7)
Estimates of (group-level) effect-sizes with 95% Confidence Intervals (CIs) and proportions achieving reliable/clinically significant change (exploring signal of efficacy)
Time frame: Change between baseline and 3-month follow-up. Additional follow-up at 6 months.
Patient Health Questionnaire-9 (PHQ-9)
Estimates of (group-level) effect-sizes with 95% Confidence Intervals (CIs) and proportions achieving reliable/clinically significant change (exploring signal of efficacy)
Time frame: Change between baseline and 3-month follow-up. Additional follow-up at 6 months.
Modified Fatigue Impact Scale-5-Item (MFIS-5)
Estimates of (group-level) effect-sizes with 95% Confidence Intervals (CIs) and proportions achieving reliable/clinically significant change (exploring signal of efficacy)
Time frame: Change between baseline and 3-month follow-up. Additional follow-up at 6 months.
Personal Questionnaire (PQ)
Estimates of (group-level) effect-sizes with 95% Confidence Intervals (CIs) and proportions achieving reliable/clinically significant change (exploring signal of efficacy)
Time frame: Change between baseline and 3-month follow-up. Additional follow-up at 6 months.
EQ-5D-5L
Estimates of (group-level) effect-sizes with 95% Confidence Intervals (CIs) and proportions achieving reliable/clinically significant change (exploring signal of efficacy)
Time frame: Change between baseline and 3-month follow-up. Additional follow-up at 6 months.
MS Impact Scale-29 (MSIS-29)
Estimates of (group-level) effect-sizes with 95% Confidence Intervals (CIs) and proportions achieving reliable/clinically significant change (exploring signal of efficacy)
Time frame: Change between baseline and 3-month follow-up. Additional follow-up at 6 months.
ICECAP-A
Estimates of (group-level) effect-sizes with 95% Confidence Intervals (CIs) and proportions achieving reliable/clinically significant change (exploring signal of efficacy)
Time frame: Change between baseline and 3-month follow-up. Additional follow-up at 6 months.
Plan to share: No
Started Feb 2022 (actual). Primary completion is estimated for Apr 2024, 26 months after the start.
Of 868 non-industry interventional studies with no phase under Multiple Sclerosis, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 26 months is above that.
Counting every sponsor, half of 889 studies reached it within 21 months; a quarter within 9 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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University of Lincoln