Nurse led, home based self help treatment for patients in primary care with chronic fatigue syndrome: randomised controlled trialBMJ 2010; 340 doi: https://doi.org/10.1136/bmj.c1777 (Published 23 April 2010) Cite this as: BMJ 2010;340:c1777
- Alison J Wearden, reader in psychology1,
- Christopher Dowrick, professor of primary medical care2,
- Carolyn Chew-Graham, professor of primary care3,
- Richard P Bentall, professor of clinical psychology4,
- Richard K Morriss, professor of psychiatry and community mental health5,
- Sarah Peters, senior lecturer in psychology1,
- Lisa Riste, FINE trial manager1,
- Gerry Richardson, senior research fellow in health economics67,
- Karina Lovell, professor of mental health8,
- Graham Dunn, professor of biomedical statistics3
- on behalf of the Fatigue Intervention by Nurses Evaluation (FINE) trial writing group and the FINE trial group
- 1School of Psychological Sciences, University of Manchester, Manchester
- 2School of Population, Community and Behavioural Sciences, University of Liverpool, Liverpool
- 3School of Community Based Medicine, University of Manchester, Manchester
- 4School of Psychology, University of Bangor, Adeilad Brigantia, Bangor, Gwynedd
- 5School of Community Health Sciences, Institute of Mental Health, University of Nottingham, Nottingham
- 6Centre for Health Economics, University of York, York
- 7Hull York Medical School, University of York, Heslington, York
- 8School of Nursing, Midwifery and Social Work, University of Manchester, Manchester
- Correspondence to: A J Wearden
- Accepted 8 February 2010
Objective To evaluate the effectiveness of home delivered pragmatic rehabilitation—a programme of gradually increasing activity designed collaboratively by the patient and the therapist—and supportive listening—an approach based on non-directive counselling—for patients in primary care with chronic fatigue syndrome/myalgic encephalomyelitis or encephalitis (CFS/ME).
Design Single blind, randomised, controlled trial.
Setting 186 general practices across the north west of England between February 2005 and May 2007.
Participants 296 patients aged 18 or over with CFS/ME (median illness duration seven years) diagnosed using the Oxford criteria.
Interventions Participants were randomly allocated to pragmatic rehabilitation, supportive listening, or general practitioner treatment as usual. Both therapies were delivered at home in 10 sessions over 18 weeks by one of three adult specialty general nurses who had received four months’ training, including supervised practice, in each of the interventions. GP treatment as usual was unconstrained except that patients were not to be referred for systematic psychological therapies during the treatment period.
Main outcome measures The primary clinical outcomes were fatigue and physical functioning at the end of treatment (20 weeks) and 70 weeks from recruitment compared with GP treatment as usual. Lower fatigue scores and higher physical functioning scores denote better outcomes.
Results A total of 257 (87%) of the 296 patients who entered the trial were assessed at 70 weeks, the primary outcome point. Analysis was on an intention to treat basis, with robust treatment effects estimated after adjustment for missing data using probability weights. Immediately after treatment (at 20 weeks), patients allocated to pragmatic rehabilitation (n=95) had significantly improved fatigue (effect estimate -1.18, 95% confidence interval -2.18 to -0.18; P=0.021) but not physical functioning (-0.18, 95% CI -5.88 to +5.52; P=0.950) compared with patients allocated to treatment as usual (n=100). At one year after finishing treatment (70 weeks), there were no statistically significant differences in fatigue or physical functioning between patients allocated to pragmatic rehabilitation and those on treatment as usual (-1.00, 95% CI -2.10 to +0.11; P=0.076 and +2.57, 95% CI 3.90 to +9.03; P=0.435). At 20 weeks, patients allocated to supportive listening (n=101) had poorer physical functioning than those allocated to treatment as usual (-7.54, 95% CI -12.76 to -2.33; P=0.005) and no difference in fatigue. At 70 weeks, patients allocated to supportive listening did not differ significantly from those allocated to treatment as usual on either primary outcome.
Conclusions For patients with CFS/ME in primary care, pragmatic rehabilitation delivered by trained nurse therapists improves fatigue in the short term compared with unconstrained GP treatment as usual, but the effect is small and not statistically significant at one year follow-up. Supportive listening delivered by trained nurse therapists is not an effective treatment for CFS/ME.
Trial registration International Standard Randomised Controlled Trial Number IRCTN74156610.
We thank all the patients who took part in the study. We are also grateful for the assistance of the Liverpool Primary Care Trust, the Mersey Primary Care R&D Consortium, and the staff of the186 general practices who referred patients to our study.
Contributors: All authors participated in the overall design of the study, were involved in the ongoing management of the trial, contributed to the interpretation of the data, and contributed to several drafts of this report. In addition, AJW, the principal investigator, conceived the study, prepared the protocol, contributed to training of therapists and supervision of researchers, had overall responsibility for the day to day running of the study, interpreted the data, and took the lead on writing the report. AJW also acts as the guarantor for the study. CD and CCG participated in the training of therapists and the recruitment of general practices into the study, and advised on medical exclusions from the trial. RPB and RKM participated in the training and supervision of therapists. RKM also trained the researchers in psychiatric interviewing and advised on psychiatric exclusions from the trial. SP participated in training of therapists and recruitment of patients to the trial. LR was the trial manager, and participated in recruitment and training of research staff. LR was also responsible for staff management and overall coordination of the study. GR was the trial health economist and advised on trial assessments. KL advised on recruitment of patients to the trial and participated in the design and implementation of the therapy rating exercise. GD was the trial statistician, and advised on randomisation and all statistical aspects of the trial, developed the analysis plan, and performed the statistical analysis. All authors had full access to all study data.
Funding: The UK Medical Research Council (G200212) and the UK Department of Health funded the trial. The study was sponsored by the University of Manchester. The sponsor and the funder of the study had no role in the study design, data collection and analysis, interpretation or reporting of this work, or the decision to submit the work for publication. All authors are independent of the funding source.
Competing interests: All authors have completed the Unified Competing Interest form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: (1) No financial support for the submitted work from anyone other than their employer; (2) No financial relationships with commercial entities that might have an interest in the submitted work; (3) No spouses, partners, or children with relationships with commercial entities that might have an interest in the submitted work; (4) No non-financial interests that may be relevant to the submitted work.
Ethical approval: Ethical approval for this trial was granted by the Eastern Multicentre Research Ethics Committee, reference 03/5/62.
Data sharing: We will be happy to make our dataset available to researchers, once we have finished reporting our findings. Please contact the corresponding author.
The Fatigue Intervention by Nurses Evaluation (FINE) trial writing group consists of Alison Wearden, Richard Bentall, Carolyn Chew-Graham, Christopher Dowrick, Graham Dunn, Karina Lovell, Richard Morriss, Sarah Peters, Gerry Richardson, and Lisa Riste.
The FINE trial group consisted of Colette Bennett, Richard Bentall, Laura Booth, Joanna Brocki, Greg Cahill, Anna Chapman, Carolyn Chew-Graham, Susan Connell, Christopher Dowrick, Graham Dunn, Deborah Fleetwood, Laura Ibbotson, Diana Jerman, Karina Lovell, Jane Mann, Richard Morriss, Sarah Peters, Pauline Powell, David Quarmby, Gerry Richardson, Lisa Riste, Alison Wearden, and Jennifer Williams.
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