NCT04975685: SMART_MS

Strengthening Mental Abilities With Relational Training (SMART) in Multiple Sclerosis (MS): A Feasibility Trial

Status unknown NA Last updated 5 December 2023

What this trial tests

NA trial testing SMART in Multiple Sclerosis in 60 participants. Status unknown.

Timeline

7 February 2022

Primary endpoint
30 April 2024

30 April 2024

Quick facts

Lead sponsor	University of Lincoln
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	60
Start date	7 February 2022
Primary completion	30 April 2024
Estimated completion	30 April 2024
Sites	1 location across United Kingdom

Drugs / interventions tested

• SMART
• Sham brain training (Sudoku)

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

University of Lincoln

Who can join

Adults 18 to 89, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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:

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

1. Usability and acceptability of a cognitive training intervention (SMART) for people with multiple sclerosis (MS): A prefeasibility formative evaluation.
   Frost AC, Golijani-Moghaddam N, Burge R, Dawson DL, et al · · 2022 · cited 1× · PMID 37881304 · DOI 10.3310/nihropenres.13274.1
2. Feasibility and acceptability of Strengthening Mental Abilities with Relational Training (SMART) for cognitive difficulties in multiple sclerosis: a randomised controlled trial
   Golijani-Moghaddam N, Dawson DL, Evangelou N, Turton J, et al · · 2026 · DOI 10.21203/rs.3.rs-8086622/v1
3. Strengthening Mental Abilities with Relational Training (SMART) in multiple sclerosis (MS): study protocol for a feasibility randomised controlled trial.
   Golijani-Moghaddam N, Dawson DL, Evangelou N, Turton J, et al · · 2022 · PMID 36056385 · DOI 10.1186/s40814-022-01152-7
4. Strengthening Mental Abilities with Relational Training (SMART) in Multiple Sclerosis (MS): Study Protocol for a Feasibility Randomised Controlled Trial
   Moghaddam N, Dawson DL, Evangelou N, Turton J, et al · · 2021 · DOI 10.21203/rs.3.rs-1145797/v1