The feasibility and acceptability of an early intervention in primary care to prevent chronic fatigue syndrome (CFS) in adults: randomised controlled trial

Hazel O'Dowd; Lucy Beasant; Jenny Ingram; Alan Montgomery; Will Hollingworth; Daisy Gaunt; Simon M Collin; Sarah Horne; Beth Jones; Esther Crawley

doi:10.1186/s40814-020-00595-0

The feasibility and acceptability of an early intervention in primary care to prevent chronic fatigue syndrome (CFS) in adults: randomised controlled trial

Pilot Feasibility Stud. 2020 May 12:6:65. doi: 10.1186/s40814-020-00595-0. eCollection 2020.

Authors

Affiliations

¹ 1CFS/NHS Bristol, The Lodge, Cossham Hospital, Lodge Road, Kingswood, Bristol, BS15 1LF UK.
² 2Bristol Medical School, University of Bristol, Bristol, BS8 1NU UK.
³ 3School of Medicine, University of Nottingham, Nottingham, NG7 2UH UK.
⁴ 4Bristol Randomised Trials Collaboration, Bristol Medical School, University of Bristol, Bristol, BS8 2PS UK.
⁵ 5CFS/NHS Bristol, Cossham Hospital, Bristol, BS15 1LF UK.

Abstract

Background: Chronic 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.

Methods: This 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.

Results: Forty-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.

Conclusions: A 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 registration: International Standard Randomised Controlled Trials, ISRCTN72645894. Retrospectively registered on 17 May 2013.

Keywords: Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME); Early intervention; Feasibility; Primary care; Randomised controlled trial.