Abstract
BackgroundChronic fatigue syndrome, also known as ME (CFS/ME), is a condition characterised primarily by severe, disabling fatigue, of unknown origin, which has a poor prognosis and serious personal and economic consequences. Evidence for the effectiveness of any treatment for CFS/ME in primary care, where most patients are seen, is sparse. Recently, a brief, pragmatic treatment for CFS/ME, based on a physiological dysregulation model of the condition, was shown to be successful in improving fatigue and physical functioning in patients in secondary care. The treatment involves providing patients with a readily understandable explanation of their symptoms, from which flows the rationale for a graded rehabilitative plan, developed collaboratively with the therapist. The present trial will test the effectiveness and cost-effectiveness of pragmatic rehabilitation when delivered by specially trained general nurses in primary care. We selected a client-centred counselling intervention, called supportive listening, as a comparison treatment. Counselling has been shown to be as effective as cognitive behaviour therapy for treating fatigue in primary care, is more readily available, and controls for supportive therapist contact time. Our control condition is treatment as usual by the general practitioner (GP).Methods and designThis study protocol describes the design of an ongoing, single-blind, pragmatic randomized controlled trial of a brief (18 week) self-help treatment, pragmatic rehabilitation, delivered by specially trained nurse-therapists in patients' homes, compared with nurse-therapist delivered supportive listening and treatment as usual by the GP. An economic evaluation, taking a societal viewpoint, is being carried out alongside the clinical trial. Three adult general nurses were trained over a six month period to deliver the two interventions. Patients aged over 18 and fulfilling the Oxford criteria for CFS are assessed at baseline, after the intervention, and again one year later. Primary outcomes are self-reported physical functioning and fatigue at one year, and will be analysed on an intention-to-treat basis. A qualitative study will examine the interventions' mechanisms of change, and also GPs' drivers and barriers towards referral.
Highlights
Chronic fatigue syndrome, known as ME (CFS/ME), is a condition characterised primarily by severe, disabling fatigue, of unknown origin, which has a poor prognosis and serious personal and economic consequences
The estimated prevalence in UK primary care ranges from 0.6–2.6%, depending on the criteria applied [3], while an Independent Working Party reporting to the UK Chief Medical Officer in 2002 suggested a UK population prevalence of 0.2–0.4% [4]
A 2001 systematic review of all treatments for CFS/ME concluded that cognitive behaviour therapy (CBT) and graded exercise therapy (GET) were the most promising treatments for CFS/ME, but that owing to the small number of studies available for review, the generalisability of these results could not be assured [10]
Summary
Design This is a single-blind pragmatic randomised controlled trial of a brief (18-week) self-help treatment, called pragmatic rehabilitation, for CFS/ME patients recruited from primary care, delivered by three specially trained nursetherapists in the patients' homes, and compared with both nurse-therapist delivered supportive listening, a comparison treatment that controls for therapist contact time, and treatment as usual by the General Practitioner. Three nurse-therapists deliver the pragmatic rehabilitation and supportive listening treatments in patients' homes and via telephone calls. The content of treatment as usual by the General Practitioner GPs usually try to talk to patients such as these about their symptoms in an unstructured way, investigate, provide reassurance, prescribe symptomatic relief, prescribe hypnotics, sedatives and anti-depressants, and refer For this trial, GPs are advised on how to assess CFS/ME patients, and asked not to refer to specialist services for systematic psychological therapies for CFS/ME during the eighteen week treatment period, but are otherwise invited to manage their allocated cases as usual in the way that they see fit.
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