Objectives To see if a group course delivered by rheumatology teams using cognitive-behavioural approaches, plus usual care, reduced RA fatigue impact more than usual care alone.
Methods Multicentre, 2-year randomised controlled trial in RA adults (fatigue severity>6/10, no recent major medication changes). RAFT (Reducing Arthritis Fatigue: clinical Teams using CB approaches) comprises seven sessions, codelivered by pairs of trained rheumatology occupational therapists/nurses. Usual care was Arthritis Research UK fatigue booklet. Primary 26-week outcome fatigue impact (Bristol RA Fatigue Effect Numerical Rating Scale, BRAF-NRS 0–10). Intention-to-treat regression analysis adjusted for baseline scores and centre.
Results 308/333 randomised patients completed 26 week data (156/175 RAFT, 152/158 Control). Mean baseline variables were similar. At 26 weeks, the adjusted difference between arms for fatigue impact change favoured RAFT (BRAF-NRS Effect −0.59, 95% CI –1.11 to -0.06), BRAF Multidimensional Questionnaire (MDQ) Total −3.42 (95% CI –6.44 to -0.39), Living with Fatigue −1.19 (95% CI –2.17 to -0.21), Emotional Fatigue −0.91 (95% CI –1.58 to -0.23); RA Self-Efficacy (RASE, +3.05, 95% CI 0.43 to 5.66) (14 secondary outcomes unchanged). Effects persisted at 2 years: BRAF-NRS Effect −0.49 (95% CI −0.83 to -0.14), BRAF MDQ Total −2.98 (95% CI −5.39 to -0.57), Living with Fatigue −0.93 (95% CI −1.75 to -0.10), Emotional Fatigue −0.90 (95% CI −1.44, to -0.37); BRAF-NRS Coping +0.42 (95% CI 0.08 to 0.77) (relevance of fatigue impact improvement uncertain). RAFT satisfaction: 89% scored > 8/10 vs 54% controls rating usual care booklet (p<0.0001).
Conclusion Multiple RA fatigue impacts can be improved for 2 years by rheumatology teams delivering a group programme using cognitive behavioural approaches.
Trial registration number ISRCTN52709998.
- rheumatoid arthritis
- cognitive behavioural therapy
- randomised controlled trial
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Handling editor Josef S Smolen
Presented at Some of these findings have been presented as published abstracts at international.32 33
Collaborators The RAFT study group: In addition to the listed authors, this comprises P Creamer and R Hughes (local PIs throughout), B Knops and R Cheston (intervention training and monitoring). The authors would like thank the following for their collaboration: S Green, S Webber, P Thompson, N Viner, K Mackay (local PIs); F Robinson (patient research partner) and D Carmichael (database and randomisation services, Bristol Randomised Trial Collaboration).
Contributors SH is the chief investigator responsible for the trial, led the study team, supervised the conduct of the trial, analysis and reporting and drafted the manuscript. SH, NA and JP jointly conceived the original idea and led on the trial design and protocol. PSB, WH, EHC, JRK and ED contributed to trial design. NA, SH, ED, BK and AH developed the RAFT intervention materials and delivered the tutor training and RC monitored programme delivery (quality assurance). PSB, WH, JT, BK, NT and JP led on the statistical design and analysis, including health economics. ZP, CA and CR, along with all other authors, contributed to methods of data collection, patient materials and data management. ZP managed the trial with CA, including research governance, data collection, data entry and validation. DC was responsible for randomisation. JRK, PC, EHC, NV, KM, SG, SW, PT and RH led recruitment at the 7 centres. All authors reviewed, discussed and helped interpret the findings, commented on and approved the final version of the manuscript.
Funding This research was funded by a National Institutes for Health Research Health Technology Award: 11/112/01.
Disclaimer The views expressed in this paper are those of the authors and not necessarily those of the NHS, the National Institute for Health Research or the Department of Health.
Competing interests None declared.
Patient consent for publication Not required.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Results from the health economics and qualitative evaluations will be published as two further papers.
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