Strengthening Mental Abilities With Relational Training (SMART) in Multiple Sclerosis (MS): A Feasibility Trial

Summary

Background: Multiple Sclerosis (MS) is a chronic condition of the central nervous system; around 1 in 600 people in the United Kingdom have MS. Many people with MS (70%) have cognitive difficulties, which they experience as distressing and disabling, and there is currently a lack of treatment options to improve these difficulties.

SMART (Strengthening Mental Abilities with Relational Training) - a theory-based online cognitive training programme, which has been shown to improve general cognitive abilities - has not been tested with people who have MS.

Aims: To conduct a feasibility study to inform development of a definitive trial of SMART for improving cognitive functioning in people with MS. The investigators will assess:

1. Acceptability to participants of the intervention, delivery format, inclusion/exclusion criteria, baseline and outcome measures, randomisation protocol, and study procedures
2. The framework for a cost-effectiveness analysis alongside a definitive trial
3. Participant recruitment and retention rates
4. Sample-size needed for fully powered trial
5. Signal of efficacy

Plan: To address Aims 1-5, the investigators will recruit 60 adults with MS who are experiencing cognitive difficulties, identified from MS clinics.

Participants will complete baseline assessments of their cognitive abilities and answer questionnaires about their cognitive difficulties, personal priorities, mood, fatigue, self-efficacy, quality of life, and healthcare services used.

Assessments will be administered by a researcher, face-to-face or remotely.

Participants will be randomly allocated to one of three arms (20 per group):

Group 1: Receives SMART intervention online - plus usual care (MS Nurse support). SMART intervention involves completing a series of logic problems, which are designed to train skills that scaffold complex cognition.

Group 2: Receives usual care alone. Group 3: Receives a 'control' intervention online - plus usual care.

Baseline measures will be re-administered at three- and six-months post-randomisation. Researchers and patient-partners (people with personal experience of MS, who will act as co-researchers) will also interview 30 participants about their experience of the study and treatment. All qualitative data will be transcribed and thematically analysed in terms of a priori feasibility aims. Quantitative data will enable sample-size calculation for a definitive study and determine signal of efficacy.

Conditions

• Multiple Sclerosis

Interventions

BEHAVIORAL

SMART

SMART (Strengthening Mental Abilities Through Relational Training) is a web-based cognitive training program that directly trains 'relational skills' - skills necessary to understand how concepts relate to one another, which underpin complex cognition.

BEHAVIORAL

Sham brain training (Sudoku)

Sudoku was selected to control for expectancy effects based on popular conceptions that it broadly improves cognitive functions, coupled with little evidence supporting this notion, and its use as an active control in similar trials.

Sponsors & Collaborators

• University of Exeter

  collaborator OTHER

• Nottinghamshire Healthcare NHS Trust

  collaborator OTHER_GOV

• National University of Ireland, Maynooth

  collaborator OTHER

• University of Nottingham

  collaborator OTHER

• University of Lincoln

  lead OTHER

Principal Investigators

• Nima Moghaddam, DClinPsy · University of Lincoln

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

89 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-02-07

Primary Completion

2024-04-30

Completion

2024-04-30

Countries

• United Kingdom

Study Locations