Smart-MS

Strengthening Mental Abilities with Relational Training in Multiple Sclerosis: A feasibility trial

Funded by NIHR Research for Patient Benefit, awarded £149,377. Key contact: Dr Moghaddam.

The main aim of this study is to develop and conduct feasibility and pilot studies exploring Strengthening Mental Abilities with Relational Training (SMART) for people with MS.

For more information please visit : SMART MS (institutemh.org.uk)

TeamDr N Moghaddam (Psychology, University of Lincoln)
Prof Graham Law (LinCTU, University of Lincoln)
Prof R das Nair (University of Nottingham)
Prof N Evangelou (University of Nottingham)
Dr D Dawson (Psychology, University of Lincoln)
Mr Turton (PPI)
Dr A-M Hawton (University of Exeter)
Dr B Roche (Maynooth University, Ireland)
Team/consortiumCaHRU & Lincoln Clinical Trials Unit, University of Lincoln
School of Psychology, University of Lincoln
University of Nottingham
University of Exeter
Maynooth University, Ireland
Patient and Public contributors
Overarching aimThis study focuses on the development and feasibility/piloting phases to explore the promise of Strengthening Mental Abilities with Relational Training (SMART) for people with MS. The study will adapt the intervention for people with MS and assesses the feasibility of trialling the adapted intervention.
Objectives1. To conduct a feasibility study to inform development of a definitive trial of SMART for improving cognitive functioning in people with MS.

2. Adapt the SMART intervention for people with MS

3. Assess acceptability to participants of the intervention, delivery format, inclusion/exclusion criteria, baseline and outcome measures, randomisation protocol, and study procedures

4. Examine the framework for a cost-effectiveness analysis alongside a definitive trial.
MethodsMixed-methods feasibility randomised controlled trial (fRCT), comparing three groups.
OutcomesThe exploratory endpoints are related to signal of efficacy and indicative estimation of intervention effects for the following outcome measures:
1. PDQ
2. RBANS
Secondary outcome measures for exploratory estimation of effects:
1. HADS
2. MFIS-5
3. MSSES
4. PQ
5. EQ-5D-5L
6. MSIS-29

Study results will directly inform protocol-development for a fully powered, definitive RCT. The study will determine the acceptability to participants of the intervention, delivery format, inclusion/exclusion criteria, baseline and outcome measures, randomisation protocol, and study procedures.
OutputsPeer reviewed publications: Strengthening Mental Abilities with Relational Training (SMART) in Multiple Sclerosis (MS): Study protocol for a feasibility randomised controlled trial – The Lincoln Repository

Conference presentations:
ImpactThe study aims to develop a full clinical trial to assess efficacy of SMART to improve cognitive function in people with MS.