Abstract
BackgroundChronic fatigue syndrome (CFS, also known as myalgic encephalomyelitis (ME)) is defined as fatigue that is disabling, is accompanied by additional symptoms and persists for ≥ 4 months. Treatment of CFS/ME aims to help patients manage their symptoms and make lifestyle adjustments. We do not know whether intervening early in primary care (< 4 months after onset of fatigue) can prevent the development of CFS/ME.MethodsThis was a feasibility randomised controlled trial with adults (age ≥ 18 years) comparing usual care with usual care plus an early intervention (EI; a combination of psycho-education and cognitive behavioural therapy, CBT). This study took place in fourteen primary care practices in Bristol, England and aimed to identify issues around recruitment and retention for a full-scale trial. It was not powered to support statistical analysis of differences in outcomes. Integrated qualitative methodology was used to explore the feasibility and acceptability of recruitment and randomisation to the intervention.ResultsForty-four patients were recruited (1 August 2012–November 28, 2013), falling short of our predicted recruitment rate of 100 patients in 8 months. Qualitative data from GPs showed recruitment was not feasible because it was difficult to identify potential participants within 4 months of symptom onset. Some referring GPs felt screening investigations recommended by NICE were unnecessary, and they had difficulty finding patients who met the eligibility criteria. Qualitative data from some participant interviews suggested that the intervention was not acceptable in its current format. Although the majority of participants found parts of the intervention acceptable, many reported one or more problems with acceptability. Participants who discontinued the intervention or found it problematic did not relate to the therapeutic model, disliked telephone consultations or found self-reflection challenging.ConclusionsA randomised controlled trial to test an early intervention for fatigue in adults in primary care is not feasible using this intervention and recruitment strategy.Trial registrationInternational Standard Randomised Controlled Trials, ISRCTN72645894. Retrospectively registered on 17 May 2013
Highlights
Fatigue lasting more than 1 month is reported by 10– 24% of attendees in general practice [1,2,3]
We report on the feasibility [7] and acceptability of recruiting participants into a randomised controlled trial of an early intervention for early-onset, disabling fatigue to inform the design of a full-scale trial comparing usual care with EI plus usual care
Of 90 potentially eligible patients referred to the study (Fig. 1), 44 patients were recruited 11 either did not respond to the invitation in the patient information sheet (PIS) or were not given a PIS by the General Practitioner (GP)
Summary
Fatigue lasting more than 1 month is reported by 10– 24% of attendees in general practice [1,2,3]. The population prevalence of chronic fatigue syndrome/myalgic encephalopathy (CFS/ME), where fatigue has persisted beyond 4 months, is 0.2–2%. The conclusions indicated areas for early intervention based on addressing particular characteristics, including anxiety, depression, somatization and perfectionism [5]. Addressing these ‘predisposing’ factors using cognitive behavioural approaches could reduce the probability of a patient with disabling fatigue lasting 1–4 months becoming the debilitating long-term condition that is CFS/ME. Chronic fatigue syndrome (CFS, known as myalgic encephalomyelitis (ME)) is defined as fatigue that is disabling, is accompanied by additional symptoms and persists for ≥ 4 months. We do not know whether intervening early in primary care (< 4 months after onset of fatigue) can prevent the development of CFS/ME
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