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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Nottingham Centre for Multiple Sclerosis and Neuroinflammation
RECRUITING
Nottingham
Contact Information
Primary
Alexandra Frost
alexandra.frost@nottshc.nhs.uk
07811474337
Time Frame
Start Date: 2022-02-07
Estimated Completion Date: 2024-04-30
Participants
Target number of participants: 60
Treatments
Experimental: TAU + SMART
Participants in this arm will receive treatment-as-usual (TAU) plus the experimental SMART intervention (theory-based cognitive training)
Sham_comparator: TAU + Sham training
Participants in this arm will receive treatment-as-usual (TAU) plus a control (sham) cognitive training intervention
No_intervention: TAU (treatment-as-usual)
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.
Related Therapeutic Areas
Sponsors
Collaborators: University of Nottingham, National University of Ireland, Maynooth, University of Exeter, Nottinghamshire Healthcare NHS Trust
Leads: University of Lincoln

This content was sourced from clinicaltrials.gov