Strengthening mental abilities with relational training in mild cognitive impairment (SMART MCI): a feasibility trial

PROJECT TITLE STRENGTHENING MENTAL ABILITIES WITH RELATIONAL TRAINING IN MILD COGNITIVE IMPAIRMENT (SMART-MCI): A FEASIBILITY TRIAL
Funding body NIHR RfPB
Total funding £ 37205
Team
  • Nima Moghaddam (School of Psychology, UoL)
  • Stephanie Maloney (University of Lincoln UoL)
  • Prof Graham Law, LinCTU, University of Lincoln (UoL)
  • Dr Elise Rowan, LinCTU, University of Lincoln (UoL)
  • Dr Nikos Evangelou (University of Nottingham)
  • Prof Roshan das Nair (University of Nottingham)
  • Dr David L. Dawson (University of Lincoln UoL)
  • Dr James Turton (PPI Lead)
  • Dr Bryan Roche (Maynooth University)
  • Dr Annie Hawton (University of Exeter)
  • Dr Rupert Burge (University of Lincoln UoL)
  • Priya Sharma, LinCTU, University of Lincoln (UoL)
  • Alexandra C Frost (University of Nottingham)
  • Dr Zahid Asghar (University of Lincoln UoL)
Team/consortium
  • University of Lincoln
  • University of Nottingham
  • University of Exeter
  • Maynooth University
Overarching aim To assess the acceptability and feasibility of the SMART programme as a prospective intervention for improving cognitive functioning in people with MCI.
Objectives We will assess:

  1. Acceptability and feasibility of the intervention, delivery format, inclusion/exclusion criteria, baseline and outcome measures, randomisation protocol, and study procedures
  2. Participant recruitment and retention rates
  3. Signal of efficacy
  4. Missing data
Methods Consenting eligible patients will complete a baseline cognitive assessment battery and questionnaires assessing impact of living with MCI, 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 block randomisation to balance numbers across arms):

  1. SMART +TAU. Participants in this arm will receive treatment-as-usual (TAU) plus the experimental SMART intervention (theory-based cognitive training, described under Intervention below).
  2. TAU. Participants in this arm will receive treatment-as-usual (TAU).
  3. Sham training (active control: Sudoku) +TAU. Participants in this arm will receive treatment-as-usual (TAU) plus a control (sham) cognitive training intervention: Sudoku.

A Research Fellow will complete blinded outcomes at 3- and 6-months post-randomisation, by re-administering baseline measures.
Outcomes The outcomes in this study relate to the acceptability and feasibility of both the SMART intervention and applied research methods:

  • Intervention drop-out rate: Numbers in the intervention condition that drop out (complete <6 sessions) and reasons for intervention non-completion
  • Recruitment and retention rates: Numbers eligible/interested/consented. and randomised (and reasons for non-participation), number completing baseline and outcome assessments.
  • Completion rates of outcome measures: Missing response data.
Outputs Peer reviewed publications

Conference presentations
Impact The hope is that a fully developed intervention will be tested in a full clinical trial.