Strengthening Mental Abilities With Relational Training (SMART) in Multiple Sclerosis (MS): A Feasibility Trial
NCT ID: NCT04975685
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
60 participants
INTERVENTIONAL
2022-02-07
2024-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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:
1. Acceptability to participants of the intervention, delivery format, inclusion/exclusion criteria, baseline and outcome measures, randomisation protocol, and study procedures
2. The framework for a cost-effectiveness analysis alongside a definitive trial
3. Participant recruitment and retention rates
4. Sample-size needed for fully powered trial
5. Signal of efficacy
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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:
1. Acceptability to participants of the intervention, delivery format, inclusion/exclusion criteria, baseline and outcome measures, randomisation protocol, and study procedures
2. The framework for a cost-effectiveness analysis alongside a definitive trial
3. Participant recruitment and retention rates
4. Sample-size needed for fully powered trial
5. Signal of efficacy
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):
1. SMART + TAU
2. 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.
3. Sham training (active control: Sudoku) + TAU. The investigators selected Sudoku 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. Sham-training will be delivered online, over the same timeframe/regimen as SMART treatment, and with telephone support to facilitate access - controlling for modality, schedule of engagement, and relational support.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
TAU + SMART
Participants in this arm will receive treatment-as-usual (TAU) plus the experimental SMART intervention (theory-based cognitive training)
SMART
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.
TAU + Sham training
Participants in this arm will receive treatment-as-usual (TAU) plus a control (sham) cognitive training intervention
Sham brain training (Sudoku)
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.
TAU (treatment-as-usual)
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.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SMART
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.
Sham brain training (Sudoku)
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age 18-89 (to meet the standardisation criteria of psychometric assessments)
* Cognitive difficulties as assessed by Perceived Deficits Questionnaire (PDQ) self-report (≥27) and Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) testing (≤1 standard deviation below normative reference-value)
* Able to read and speak English to standard necessary for completing assessment and intervention procedures
* Able and willing to access a computer/tablet/smart-phone with internet connection throughout the study
* Able and willing to give informed consent
Exclusion Criteria
* Previously received SMART training
* Vision or hearing problems precluding completion of procedures
18 Years
89 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Exeter
OTHER
Nottinghamshire Healthcare NHS Trust
OTHER_GOV
National University of Ireland, Maynooth
OTHER
University of Nottingham
OTHER
University of Lincoln
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nima Moghaddam, DClinPsy
Role: PRINCIPAL_INVESTIGATOR
University of Lincoln
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nottingham Centre for Multiple Sclerosis and Neuroinflammation
Nottingham, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Nikos Evangelou
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Golijani-Moghaddam N, Dawson DL, Evangelou N, Turton J, Hawton A, Law GR, Roche B, Rowan E, Burge R, Frost AC, das Nair R. Strengthening Mental Abilities with Relational Training (SMART) in multiple sclerosis (MS): study protocol for a feasibility randomised controlled trial. Pilot Feasibility Stud. 2022 Sep 3;8(1):195. doi: 10.1186/s40814-022-01152-7.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
21002
Identifier Type: -
Identifier Source: org_study_id