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.
| Team | Dr N Moghaddam (Psychology, University of Lincoln) Prof Graham Law (LinCTU, University of Lincoln) Dr Elise Rowan (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/consortium | CaHRU & 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 aim | This 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. |
| Objectives | 1. 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. |
| Methods | Mixed-methods feasibility randomised controlled trial (fRCT), comparing three groups. |
| Outcomes | The 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. |
| Outputs | 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 and Feasibility Studies. 2022; 8:195. |
| Impact | The study aims to develop a full clinical trial to assess efficacy of SMART to improve cognitive function in people with MS. |