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

NCT04975685 | Unknown DMC

• 1 other identifier: 21002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (3)

• Recruitment and retention rates

  Numbers eligible/interested/consented and randomised (and reasons for non-participation), number completing baseline and outcome assessments at Follow-up 1

  16 months

• Completion rates of outcome measures

  Missing response-data

  6 months

• Intervention drop-out rate

  Numbers in the intervention condition that drop out (complete \<6 sessions) and reasons for intervention non-completion

  3 months

Other Outcomes (10)

• Perceived Deficits Questionnaire (PDQ)

  Change between baseline and 3-month follow-up. Additional follow-up at 6 months.

• Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  Change between baseline and 3-month follow-up. Additional follow-up at 6 months.

• Symbol Digit Modalities Test (SDMT)

  Change between baseline and 3-month follow-up. Additional follow-up at 6 months.

Study Arms (3)

TAU + SMART

EXPERIMENTAL

Participants in this arm will receive treatment-as-usual (TAU) plus the experimental SMART intervention (theory-based cognitive training)

Behavioral: SMART

TAU + Sham training

SHAM COMPARATOR

Participants in this arm will receive treatment-as-usual (TAU) plus a control (sham) cognitive training intervention

Behavioral: Sham brain training (Sudoku)

TAU (treatment-as-usual)

NO INTERVENTION

Participants in this arm will receive treatment-as-usual (TAU). Content of TAU for cognitive concerns, based on our clinical experience and knowledge, is often informational support from an MS Nurse with signposting to the MS Society/MS Trust websites.

Interventions

SMART BEHAVIORAL

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.

TAU + SMART

Sham brain training (Sudoku) BEHAVIORAL

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.

TAU + Sham training

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of MS, received ≥3-months pre-enrolment (allowing for acute adjustment, as per other trials of cognitive rehabilitation)
• Age 18-89 (to meet the standardisation criteria of psychometric assessments)
• Cognitive difficulties as assessed by Perceived Deficits Questionnaire (PDQ) self-report (≥27) and Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) testing (≤1 standard deviation below normative reference-value)
• Able to read and speak English to standard necessary for completing assessment and intervention procedures
• Able and willing to access a computer/tablet/smart-phone with internet connection throughout the study
• Able and willing to give informed consent

You may not qualify if:

• Currently receiving cognitive rehabilitation
• Previously received SMART training
• Vision or hearing problems precluding completion of procedures

Sponsors & Collaborators

• University of Lincoln: lead
• University of Exeter: collaborator
• Nottinghamshire Healthcare NHS Trust: collaborator
• National University of Ireland, Maynooth: collaborator
• University of Nottingham: collaborator

Study Sites (1)

Nottingham Centre for Multiple Sclerosis and Neuroinflammation

Nottingham, United Kingdom

RECRUITING

Related Publications (1)

• 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 Feasibility Stud. 2022 Sep 3;8(1):195. doi: 10.1186/s40814-022-01152-7.

  PMID: 36056385 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Nima Moghaddam, DClinPsy

  University of Lincoln

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Frost

CONTACT

07811474337; alexandra.frost@nottshc.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2021
• First Posted: July 23, 2021
• Study Start: February 7, 2022
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: December 5, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)