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Open Access Study protocol

Multi-centre parallel arm randomised controlled trial to assess the effectiveness and cost-effectiveness of a group-based cognitive behavioural approach to managing fatigue in people with multiple sclerosis

Peter W Thomas12, Sarah Thomas1*, Paula Kersten3, Rosemary Jones4, Alison Nock5, Vicky Slingsby5, Colin Green6, Roger Baker127, Kate Galvin2 and Charles Hillier5

Author Affiliations

1 Dorset Research and Development Support Unit, Poole Hospital NHS Foundation Trust, Poole, Dorset, UK

2 The School of Health and Social Care, Bournemouth University, Bournemouth, Dorset, UK

3 School of Health Sciences, University of Southampton, Hampshire, UK

4 Joint Clinical Research Unit, BrAMS Building, University Hospitals and Frenchay Hospital Bristol, UK

5 Dorset MS Service, Poole Hospital NHS Foundation Trust, Poole, Dorset, UK

6 Peninsula Medical School, University of Exeter, Devon, UK

7 Dorset Healthcare NHS Foundation Trust, Bournemouth, Dorset, UK

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BMC Neurology 2010, 10:43  doi:10.1186/1471-2377-10-43

Published: 16 June 2010

Abstract

Background

Fatigue is one of the most commonly reported and debilitating symptoms of multiple sclerosis (MS); approximately two-thirds of people with MS consider it to be one of their three most troubling symptoms. It may limit or prevent participation in everyday activities, work, leisure, and social pursuits, reduce psychological well-being and is one of the key precipitants of early retirement. Energy effectiveness approaches have been shown to be effective in reducing MS-fatigue, increasing self-efficacy and improving quality of life. Cognitive behavioural approaches have been found to be effective for managing fatigue in other conditions, such as chronic fatigue syndrome, and more recently, in MS. The aim of this pragmatic trial is to evaluate the clinical and cost-effectiveness of a recently developed group-based fatigue management intervention (that blends cognitive behavioural and energy effectiveness approaches) compared with current local practice.

Methods/Design

This is a multi-centre parallel arm block-randomised controlled trial (RCT) of a six session group-based fatigue management intervention, delivered by health professionals, compared with current local practice. 180 consenting adults with a confirmed diagnosis of MS and significant fatigue levels, recruited via secondary/primary care or newsletters/websites, will be randomised to receive the fatigue management intervention or current local practice. An economic evaluation will be undertaken alongside the trial. Primary outcomes are fatigue severity, self-efficacy and disease-specific quality of life. Secondary outcomes include fatigue impact, general quality of life, mood, activity patterns, and cost-effectiveness. Outcomes in those receiving the fatigue management intervention will be measured 1 week prior to, and 1, 4, and 12 months after the intervention (and at equivalent times in those receiving current local practice). A qualitative component will examine what aspects of the fatigue management intervention participants found helpful/unhelpful and barriers to change.

Discussion

This trial is the fourth stage of a research programme that has followed the Medical Research Council guidance for developing and evaluating complex interventions. What makes the intervention unique is that it blends cognitive behavioural and energy effectiveness approaches. A potential strength of the intervention is that it could be integrated into existing service delivery models as it has been designed to be delivered by staff already working with people with MS. Service users will be involved throughout this research.

Trial registration

Current Controlled Trials ISRCTN76517470