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Comparison of adaptive pacing therapy, cognitive behaviour therapy, graded exercise therapy, and specialist medical care for chronic fatigue syndrome (PACE): a randomised trial
Open accessAbstract
Background Trial findings show cognitive behaviour therapy (CBT) and graded exercise therapy (GET) can be effective treatments for chronic fatigue syndrome, but patients' organisations have reported that these treatments can be harmful and favour pacing and specialist health care. We aimed to assess effectiveness and safety of all four treatments.Methods In our parallel-group randomised trial, patients meeting Oxford criteria for chronic fatigue syndrome were recruited from six secondary-care clinics in the UK and randomly allocated by computer-generated sequence to receive specialist medical care (SMC) alone or with adaptive pacing therapy (APT), CBT, or GET. Primary outcomes were fatigue (measured by Chalder fatigue questionnaire score) and physical function (measured by short form-36 subscale score) up to 52 weeks after randomisation, and safety was assessed primarily by recording all serious adverse events, including serious adverse reactions to trial treatments. Primary outcomes were rated by participants, who were necessarily unmasked to treatment assignment; the statistician was masked to treatment assignment for the analysis of primary outcomes. We used longitudinal regression models to compare SMC alone with other treatments, APT with CBT, and APT with GET. The final analysis included all participants for whom we had data for primary outcomes. This trial is registered at http://isrctn.org, number ISRCTN54285094.Findings We recruited 641 eligible patients, of whom 160 were assigned to the APT group, 161 to the CBT group, 160 to the GET group, and 160 to the SMC-alone group. Compared with SMC alone, mean fatigue scores at 52 weeks were 3·4 (95% CI 1·8 to 5·0) points lower for CBT (p = 0·0001) and 3·2 (1·7 to 4·8) points lower for GET (p = 0·0003), but did not differ for APT (0·7 [-0·9 to 2·3] points lower; p = 0·38). Compared with SMC alone, mean physical function scores were 7·1 (2·0 to 12·1) points higher for CBT (p = 0·0068) and 9·4 (4·4 to 14·4) points higher for GET (p = 0·0005), but did not differ for APT (3·4 [-1·6 to 8·4] points lower; p=0·18). Compared with APT, CBT and GET were associated with less fatigue (CBT p = 0·0027; GET p = 0·0059) and better physical function (CBT p=0·0002; GET p<0·0001). Subgroup analysis of 427 participants meeting international criteria for chronic fatigue syndrome and 329 participants meeting London criteria for myalgic encephalomyelitis yielded equivalent results. Serious adverse reactions were recorded in two (1%) of 159 participants in the APT group, three (2%) of 161 in the CBT group, two (1%) of 160 in the GET group, and two (1%) of 160 in the SMC-alone group.Interpretation CBT and GET can safely be added to SMC to moderately improve outcomes for chronic fatigue syndrome, but APT is not an effective addition.Funding UK Medical Research Council, Department of Health for England, Scottish Chief Scientist Office, Department for Work and Pensions.
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“Cognitive–behavioural therapy (CBT) has been shown to reduce symptoms and increase functioning in adults with FSS,27–30”
From Comparing group-based acceptance and commitment therapy (ACT) with enhanced usual care for adolescents with functional somatic syndromes: A study protocol for a randomised trial (2016) · cites this paper as [28]
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“Research has shown that CBT improves physical functioning and fatigue reduction immediately and some time after treatment [9,10].”
From Cognitive behavior therapy in patients with chronic fatigue syndrome: The role of illness acceptance and neuroticism. (2013) · cites this paper as [9]
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“CBT aimed at increasing functioning, and its objective and content are comparable with manuals of other CBT trials [9,12].”
From Cognitive behavior therapy in patients with chronic fatigue syndrome: The role of illness acceptance and neuroticism. (2013) · cites this paper as [9]
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“The introduction to graded exercise as a means of moderating maladaptive illness behaviour and increasing physical function is also considered an important element in the treatment and has been found effective for chronic fatigue syndrome [21].”
From Internet-delivered treatment for patients suffering from severe functional somatic disorders: Protocol for a randomized controlled trial (2023) · cites this paper as [21]
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“CBT has been adapted and tested with CFS patients yielding superior results compared to standard medical treatment, relaxation, and adaptive pacing therapy (Sharpe et al., 1996; Deale et al., 1997; White et al., 2011), with moderate effect sizes (d = 0.48) (Malouff et al., 2008).”
From The relationship between improvement in insomnia severity and long-term outcomes in the treatment of chronic fatigue (2018) · cites this paper as White et al., 2011
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“In the first study, CBT and GET has been found to improve subjective sleep-disturbance significantly more than control-conditions at 1-year follow-up (White et al., 2011).”
From The relationship between improvement in insomnia severity and long-term outcomes in the treatment of chronic fatigue (2018) · cites this paper as White et al., 2011
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“However, post-exertional malaise – which has been proposed as a cardinal symptom for myalgic encephalomyelitis/CFS in the latest NICE-guidelines [14]– could not be systematically aggregated as it was seldom assessed and not uniformly reported [29, 35, 42].”
From Efficacy and Acceptance of Cognitive Behavioral Therapy in Adults with Chronic Fatigue Syndrome: A Meta-analysis. (2024) · cites this paper as [42]
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Metadata
- Authors
- White, P., Goldsmith, K., Johnson, A., Potts, L., Walwyn, R., DeCesare, J., Baber, H., Burgess, M., Clark, L., Cox, D., Bavinton, J., Angus, B., Murphy, G., Murphy, M., O'Dowd, H., Wilks, D., McCrone, P., Chalder, T., & Sharpe, M.
- Affiliations
- King's College London (GB)
- Queen Mary University of London (GB)
- South London and Maudsley NHS Foundation Trust (GB)
- Barts Health NHS Trust (GB)
- John Radcliffe Hospital (GB)
- The Royal Free Hospital (GB)
- Western General Hospital (GB)
- University of Edinburgh (GB)
- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2011-03
- Volume
- 377
- Issue
- 9768
- Pages
- 823-836
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- PMC
- PMC3065633
- OpenAlex
- W2136415723
- Cited by
- 897
- References
- 37
- Citations by year
- 2026: 22 · 2025: 44 · 2024: 54 · 2023: 47 · 2022: 48 · 2021: 61 · 2020: 56 · 2019: 55 · 2018: 52 · 2017: 84 · 2016: 75 · 2015: 78 · 2014: 52 · 2013: 67 · 2012: 60
- FWCI
- 47.56
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Licence
- Locations
- The Lancet (publishedVersion)
- Europe PMC (PubMed Central) (publishedVersion)
- PubMed Central (publishedVersion)
- PubMed (publishedVersion)
- Insight (University of Cumbria) (acceptedVersion)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- Edinburgh Research Explorer (University of Edinburgh) (submittedVersion, other-oa)
- UCL Discovery (University College London) (submittedVersion)
- Research Portal (King's College London) (submittedVersion)
- UEA Digital Repository (University of East Anglia) (submittedVersion)
- Funders
- the UK Medical Research Council (MRC G0200434)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Fibromyalgia and Chronic Fatigue Syndrome Research
- Health Sciences › Medicine › Clinical Neurology › Long-Term Effects of COVID-19
- Health Sciences › Health Professions › Physical Therapy, Sports Therapy and Rehabilitation › Musculoskeletal pain and rehabilitation
- Keywords
- chronic fatigue syndrome, cognitive behavioral therapy, graded exercise therapy, specialist care, fatigue, physical function, treatment safety, adverse events, PACE trial, treatment effectiveness comparison, patient-reported outcomes, Chalder Fatigue Questionnaire, SF-36 physical functioning, serious adverse events
- MeSH terms
- Activities of Daily Living, Adaptation, Physiological, Adult, Exercise Therapy, Female, Humans, Male, Surveys and Questionnaires, Specialization, Fatigue Syndrome, Chronic, Cognitive Behavioral Therapy, Treatment Outcome
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