Strengthening Mental Abilities with Relational Training in Multiple Sclerosis: A feasibility trial (SMART MS)

PROJECT TITLE STRENGTHENING MENTAL ABILITIES WITH RELATIONAL TRAINING IN MULTIPLE SCLEROSIS: A FEASIBILITY TRIAL (SMART MS)
Funding body NIHR Research for Patient Benefit
Total funding £149,377
Team
  • Dr N Moghaddam (Psychology, UoL)
  • Prof Graham Law, CaHRU and LinCTU, University of Lincoln (UoL) with
  • Prof R das Nair (University of Nottingham)
  • Prof N Evangelou (University of Nottingham)
  • Dr D Dawson (Psychology, UoL)
  • 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 (UoL)
  • School of Psychology, UoL
  • 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 Peer reviewed publications:

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