Strengthening Mental Abilities with Relational Training in Mild Cognitive Impairment (MCI): A feasibility trial

Funded by NIHR Research for Patient Benefit, awarded £37,205. 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 MCI.

Team

• Nima Moghaddam (University of Lincoln)
• Stephanie Maloney (University of Lincoln)
• Prof Graham Law (LinCTU, University of Lincoln)
• Dr Elise Rowan (LinCTU, University of Lincoln)
• Dr Nikos Evangelou (University of Nottingham)
• Prof Roshan das Nair (University of Nottingham)
• Dr David L. Dawson (University of Lincoln)
• Dr James Turton (PPI Lead)
• Dr Bryan Roche (Maynooth University)
• Dr Annie Hawton (University of Exeter)
• Dr Rupert Burge (University of Lincoln)
• Priya Sharma (LinCTU, University of Lincoln)
• Alexandra C Frost (University of Nottingham)
• Dr Zahid Asghar (University of Lincoln)
• Dr Tanja Kleinhappel (LinCTU, University of Lincoln)

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: Acceptability and feasibility of the intervention, delivery format, inclusion/exclusion criteria, baseline and outcome measures, randomisation protocol, and study procedures, participant recruitment and retention rates, signal of efficacy, 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

Impact

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