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 (provisional) 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 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 ISRCTN7651747

Effectiveness of energy conservation management on fatigue and participation in multiple sclerosis: A randomized controlled trial

Background: Fatigue is a frequently reported and disabling symptom in multiple sclerosis (MS).Objective: To investigate the effectiveness of an individual energy conservation management (ECM) intervention on fatigue and participation in persons with primary MS-related fatigue.Methods: A total of 86 severely fatigued and ambulatory adults with a definite diagnosis of MS were randomized in a single-blind, two-parallel-arm randomized clinical trial to the ECM group or the information-only control group in outpatient rehabilitation departments. Blinded assessments were carried out at baseline and at 8, 16, 26 and 52 weeks after randomization. Primary outcomes were fatigue (fatigue subscale of Checklist Individual Strength - CIS20r) and participation (Impact on Participation and Autonomy scale - IPA).Results: Modified intention-to-treat analysis was based on 76 randomized patients (ECM, n = 36; MS nurse, n=40). No significant ECM effects were found for fatigue (overall difference CIS20r between the groups = -0.81; 95% confidence interval (CI), -3.71 to 2.11) or for four out of five IPA domains. An overall unfavourable effect was found in the ECM group for the IPA domain social relations (difference between the groups = 0.19; 95% CI, 0.03 to 0.35).Conclusion: The individual ECM format used in this study did not reduce MS-related fatigue and restrictions in participation more than an information-only control condition

Predicting fatigue in patients using home parenteral nutrition: a longitudinal study

Background: Home parenteral nutrition (HPN) is a lifesaving therapy for patients with diseases that preclude adequate oral or enteral food intake. HPN has a large impact on daily life. Many patients suffer from fatigue and depression, and they experience limits in social activities. This all contributes to a lower quality of life.Purpose: Fatigue is the most frequently mentioned problem in Dutch HPN patients. Therefore, we studied the prevalence, course and predictors of fatigue in these patients.Methods: Patients completed questionnaires at baseline and follow-up (12 months later). Measurements included fatigue, depression, functional impairment, social support, self-efficacy, coping, anxiety and acceptance. Laboratory measures, including total bilirubin, creatinine, albumin and haemoglobin levels, were obtained from the medical records. Descriptive statistics, correlations and linear regression analysis were performed.Results: The response rate was 71% (n=75). Sixty-five per cent of the patients were severely fatigued (n=49). Eighty-nine per cent experienced persistent fatigue. Baseline fatigue predicted 57% of the variance of fatigue at follow-up, and avoidance was responsible for 3% of the variance. No significant correlations between fatigue and laboratory measures were found. A cross-sectional analysis showedthat 46% of the variance of fatigue was explained by functional impairment, self-efficacy and depression.Conclusion: Severe fatigue is a persistent problem for HPNpatients. Baseline fatigue was the strongest predictor of fatigue at follow-up. Functional impairment, self-efficacy and depression are strongly related to fatigue. Early recognition and treatment of fatigue are important