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Cited by 108Fibromyalgia and Chronic Fatigue Syndrome ResearchLong-Term Effects of COVID-19Traumatic Brain Injury Research

Rehabilitative treatments for chronic fatigue syndrome: long-term follow-up from the PACE trial

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Sharpe, Michael, Goldsmith, Kimberley A, Johnson, Anthony L, Chalder, Trudie, Walker, Jane, White, Peter D·2015·The Lancet Psychiatry
DOI 10.1016/s2215-0366(15)00317-x
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Abstract

Background The PACE trial found that, when added to specialist medical care (SMC), cognitive behavioural therapy (CBT), or graded exercise therapy (GET) were superior to adaptive pacing therapy (APT) or SMC alone in improving fatigue and physical functioning in people with chronic fatigue syndrome 1 year after randomisation. In this pre-specified follow-up study, we aimed to assess additional treatments received after the trial and investigate long-term outcomes (at least 2 years after randomisation) within and between original treatment groups in those originally included in the PACE trial.Methods The PACE trial was a parallel-group randomised controlled trial of patients meeting Oxford criteria for chronic fatigue syndrome who were recruited from six secondary care clinics in the UK between March 18, 2005, and Nov 28, 2008. Participants were randomly allocated to receive SMC alone or plus APT, CBT, or GET. Primary outcomes (were fatigue measured with Chalder fatigue questionnaire score and physical functioning with short form-36 subscale score, assessed 1 year after randomisation. In this long-term follow-up, we sent postal questionnaires to assess treatment received after the trial and outcomes a minimum of 2 years after randomisation. We assessed long-term differences in outcomes within and between originally randomised groups. The PACE trial is registered at http://isrctn.org, number ISRCTN54285094.Findings Between May 8, 2008, and April 26, 2011, 481 (75%) participants from the PACE trial returned questionnaires. Median time from randomisation to return of long-term follow-up assessment was 31 months (IQR 30-32; range 24-53). 210 (44%) participants received additional treatment (mostly CBT or GET) after the trial; with participants originally assigned to SMC alone (73 [63%] of 115) or APT (60 [50%] of 119) more likely to seek treatment than those originally assigned to GET (41 [32%] of 127) or CBT (36 [31%] of 118; p<0·0001). Improvements in fatigue and physical functioning reported by participants originally assigned to CBT and GET were maintained (within-group comparison of fatigue and physical functioning, respectively, at long-term follow-up as compared with 1 year: CBT -2·2 [95% CI -3·7 to -0·6], 3·3 [0·02 to 6·7]; GET -1·3 [-2·7 to 0·1], 0·5 [-2·7 to 3·6]). Participants allocated to APT and to SMC alone in the trial improved over the follow-up period compared with 1 year (fatigue and physical functioning, respectively: APT -3·0 [-4·4 to -1·6], 8·5 [4·5 to 12·5]; SMC -3·9 [-5·3 to -2·6], 7·1 [4·0 to 10·3]). There was little evidence of differences in outcomes between the randomised treatment groups at long-term follow-up.Interpretation The beneficial effects of CBT and GET seen at 1 year were maintained at long-term follow-up a median of 2·5 years after randomisation. Outcomes with SMC alone or APT improved from the 1 year outcome and were similar to CBT and GET at long-term follow-up, but these data should be interpreted in the context of additional therapies having being given according to physician choice and patient preference after the 1 year trial final assessment. Future research should identify predictors of response to CBT and GET and also develop better treatments for those who respond to neither.Funding UK Medical Research Council, Department of Health for England, Scottish Chief Scientist Office, Department for Work and Pensions, National Institute for Health Research (NIHR), NIHR Biomedical Research Centre for Mental Health at South London and Maudsley NHS Foundation Trust, King's College London.

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  • At follow-ups longer than 12 months post-treatment, two studies reported non-significant effects on fatigue severity: g = 0.12 (95% CI -0.23 to 0.47) and g = -0.21 (95% CI -0.47 to 0.05).

    “For follow-ups longer than 12 months post-treatment, two studies provided information on fatigue severity: [45] reported a ~ 3.5-year follow-up to [46] (g = 0.12, 95%CI -0.23 to 0.47), and [47] reported a two-year follow-up to [42] (g = -0.21, 95%CI -0.47 to 0.05).”

    From Efficacy and Acceptance of Cognitive Behavioral Therapy in Adults with Chronic Fatigue Syndrome: A Meta-analysis. (2024) · cites this paper as [47]

    The long-term follow-up sample section reports assessment a median of 31 months after randomisation, and Differences between randomised treatment groups at long-term follow-up reports no significant difference in mean fatigue scores. This supports the PACE follow-up portion of the citing sentence, but our copy does not report the attributed g = -0.21 or its 95% CI; the other effect estimate belongs to a separately cited study. (LLM, conf=0.83)

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Authors
Sharpe, M., Goldsmith, K. A., Johnson, A. L., Chalder, T., Walker, J., & White, P. D.
Affiliations
  • University of Oxford (GB)
  • King's College London (GB)
  • MRC Clinical Trials Unit at UCL (GB)
  • Queen Mary University of London (GB)
Corresponding author
Sharpe, Michael
ORCID
Venue
The Lancet Psychiatry
Publisher
Elsevier BV
Published
2015-12
Volume
2
Issue
12
Pages
1067-1074
ISSN
2215-0366 (ISSN-L)
DOI
10.1016/s2215-0366(15)00317-x
OpenAlex
W2155523469
Cited by
108
References
22
Citations by year
2026: 3 · 2025: 6 · 2024: 11 · 2023: 7 · 2022: 6 · 2021: 11 · 2020: 5 · 2019: 11 · 2018: 11 · 2017: 21 · 2016: 14 · 2015: 2
FWCI
12.98
Type
journal article
Language
en
Open access
Licence
Locations
  • The Lancet Psychiatry (publishedVersion)
  • PubMed (publishedVersion)
  • Research Portal (King's College London) (submittedVersion, cc-by-nc-nd)
Funders
  • South London and Maudsley NHS Foundation Trust
  • National Institute for Health and Care Research (DRF-2011-04-061)
  • Medical Research Council
  • Menzies Centre for Australian Studies, King's College London, University of London
Topics
  • Health Sciences › Medicine › Psychiatry and Mental health › Fibromyalgia and Chronic Fatigue Syndrome Research
  • Health Sciences › Medicine › Neurology › Long-Term Effects of COVID-19
  • Health Sciences › Medicine › Epidemiology › Traumatic Brain Injury Research
Keywords
chronic fatigue syndrome, PACE trial, cognitive behavioral therapy, graded exercise therapy, specialist care, long-term follow-up, fatigue, physical function, Chalder Fatigue Questionnaire, SF-36, treatment-seeking behavior, rehabilitation therapy, attrition
MeSH terms
Adult, Female, Follow-Up Studies, Humans, Male, Middle Aged, Rehabilitation, Time Factors, Fatigue Syndrome, Chronic, Treatment Outcome

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