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

Abstract

BackgroundFatigue 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/DesignThis 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.DiscussionThis 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 registrationCurrent Controlled Trials ISRCTN76517470

A pragmatic parallel arm multi-centre randomised controlled trial to assess the effectiveness and cost-effectiveness of a group-based fatigue management programme (FACETS) for people with multiple sclerosis

“…The main exclusion criteria were: (1) having taken part in a fatigue programme in the last year, (2) cognitive impairments, (3) a relapse in the previous 3 months or (4) having started treatment with disease modifying or antidepressant drugs within the previous 3 months. The full eligibility criteria are described in the protocol 14. Participants were recruited in three UK centres (Poole, Bristol, Southampton/Portsmouth) from primary or secondary care, or via MS Society newsletters/websites.…”

“…However, we consider this variation to be a strength of the trial as it increases its applicability to a wider range of centres. Individuals who had attended a fatigue management programme in the past year were excluded from the trial as were those who had received a fatigue intervention from a health professional in the past 3 months (see protocol) 14. To increase external validity, no attempt was made in the FACETS arm to restrict or control participants’ access to current local practice or to standardise it across healthcare settings or treatment arms.…”

“…Participants assigned to the CLP arm completed all outcome measures within an identical time frame to those in the FACETS arm (see published protocol14 and results tables). All questionnaire outcomes were self-reported for both groups, presented in a booklet format with a large font and administered and returned through the post.…”

“…See protocol14 and online web supplement for further detail. These included: (1) subscales of the FAI,18 (2) the Fatigue Symptom Inventory,21 (3) the Hospital Anxiety and Depression Scale,22 (4) the physical and psychological subscales of the MSIS-29, V.1,19 (5) the Medical Outcomes Short-Form Survey, V.2 (SF-36v2),23 (6) health state values and quality adjusted life years (QALYs) derived from the EuroQoL 5-Dimensions questionnaire (EQ-5D)24 and the Short-form 6-Dimensions questionnaire (SF-6D),25 (7) self-reported health and social services resource utilisation with a 3-month recall period (collected at follow-up 2 only) and (8) objective measures of physical activity over a 48 h period (weekday/weekend day) using ActivPAL accelerometers (total energy expenditure over 48 h period) 26…”

Exploring strategies used following a group-based fatigue management programme for people with multiple sclerosis (FACETS) via the Fatigue Management Strategies Questionnaire (FMSQ)

“…The effectiveness of FACETS was demonstrated in a randomised controlled trial with improvements (small-to-medium effect sizes) in fatigue self-efficacy, fatigue severity and quality of life up to 1 year postintervention 26–28. Exploring why and how complex interventions work can enhance further development and implementation and inform the design of future interventions 29.…”