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GETSET Trial

Centre for Psychiatry

Project Lead Investigator: Peter White
Trial Manager: Lucy Clark

Overview

What is the GETSET trial?

This was the first trial to test the effectiveness of adding Guided graded Exercise Self-help (GES) to specialist medical care (SMC) for people suffering from chronic fatigue syndrome (CFS), also known as myalgic encephalomyelitis (ME). The participants in the trial were recruited from two CFS clinics: one in East London and one in Kent. All participants had been diagnosed as suffering from CFS/ME, as described in the NICE guidelines, and were on a waiting list for a therapy. Participants were randomly allocated to GES plus SMC or SMC alone. GES offers ways for patients to deal with and improve the symptoms of CFS/ME and its effects on disability. Those randomised to SMC alone continued on the waiting list, whilst those offered GES were, in addition, given a booklet  which describes a six-step graded exercise self-help programme. They were also offered four individual supportive guidance sessions from a physiotherapist. The sessions supported the participant in how to apply the GES programme, (with up to 90 minutes of four face-to-face/telephone and/or Skype sessions), by a physiotherapist experienced in treating people with CFS/ME. The trial recruited 211 participants, aged 18 and over. Follow up occurred 12 weeks after entering the trial, with mailed questionnaires. A longer term follow up also occurred one year after entering the trial.
    
What is CFS/ME?
 
CFS/ME is a common disorder. Estimates vary, but it is believed that between one in 40 and one in 250 of the population will suffer from the illness at any one time. CFS/ME causes disability as a result of persistent, abnormal tiredness and other symptoms, which are made worse by activity. Other symptoms can include disturbed or unrefreshing sleep, problems concentrating or remembering, pain in the muscles and/or joints, headaches, sore throats and tenderness in the neck. The diagnosis of CFS/ME requires that a large number of other possible causes of the symptoms, such as thyroid gland disease and severe depressive illness, are excluded.
 
What were the interventions being tested?
 
The two interventions were specialist medical care (SMC) alone and Guided graded Exercise Self-help (GES) in addition to SMC.
SMC: All participants received SMC, which means that they followed the advice of their GP and specialist doctor as usual. Specialist doctors could  prescribe or advise regarding medication as indicated for symptomatic treatment of associated symptoms (e.g. insomnia and pain) and comorbid conditions (e.g. depressive illness).
GES: In addition to receiving SMC, participants in the GES arm were given a copy of a self-help booklet describing a six-step programme of graded exercise. A physiotherapist trained to support GES then either saw the participant face-to-face in the clinic or by speaking via telephone/Skype for a 30 minute appointment. The physiotherapist then provided up to three further 20-minute telephone or Skype support appointments over the next 8 weeks. The emphasis of guidance/support was to help the participant to better understand the principles of GES, and to help the participant solve any problems associated with doing GES. The physiotherapist followed a support guidance checklist to aid them.
 
What were the outcomes to test the interventions?
 
We chose a fatigue scale and a self-reported physical function scale as our two primary outcomes. Other outcomes included a global self-rating regarding overall health and CFS, a measure of anxiety and depression, a measure of physical symptoms, and measures of global functioning and physical activity and healthcare and other costs. All these measures were rated by the participant. More details can be found in the published protocol.
 
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