Background: Fatigue is a major problem in rheumatoid arthritis (RA). There is evidence for cognitive behavioural therapy (CBT) delivered by clinical psychologists but few rheumatology units have psychologists.
Objectives: To compare clinical and cost-effectiveness of a group CBT programme for RA fatigue (RAFT) delivered by the rheumatology team in addition to usual care, versus usual care alone; to evaluate RAFT tutors’ experiences.
Design: Randomised controlled trial. Central trials unit computerised randomisation in four consecutive cohorts within each of 7 centres. Nested qualitative evaluation.
Setting: Seven hospital rheumatology units in England/Wales
Participants: Adults with RA and fatigue severity >6/10; no recent changes in major RA medication/glucocorticoids.
Interventions: RAFT: group CBT course delivered by rheumatology tutor pairs (nurses/occupational therapists). Usual care; brief discussion of an RA fatigue self-management booklet with the research nurse.
Main outcome measures: Primary: Fatigue impact (Bristol RA Fatigue Numerical Rating Scale) at 26 weeks. Secondary: Fatigue severity/coping (BRAF-NRS), broader fatigue impact (BRAF Multi-Dimensional Questionnaire), self-reported clinical status, quality of life, mood, self-efficacy, satisfaction (26, 52, 78, 104 weeks). Intention-to-treat analysis conducted blind to allocation, adjusted for baseline scores and centre. Cost-effectiveness explored through intervention and RA-related health/social care costs, calculating quality-adjusted life-years (QALYs) with EQ-5D-5L. Tutor interviews/focus group analysed with inductive thematic analysis.
Results: 308/333 patients completed 26 weeks (156/175 RAFT, 152/158 controls). At 26 weeks mean BRAF-NRS Impact was reduced for RAFT (-1.36, p<0.001) and controls (-0.88, p<0.004). Regression analysis showed a difference between arms in favour of RAFT of -0.59 BRAF-NRS units (95% CI -1.11, -0.06, p=0.03, effect size 0.36), sustained over two years (-0.49, CI -0.83, -0.14, p=0.01). At 26 weeks, further fatigue differences favoured RAFT: BRAF-MDQ fatigue impact -3.42 (CI -6.44, - 0.39, p=0.03); Living with Fatigue -1.19 (CI -2.17, -0.21, p=0.02); Emotional Fatigue -0.91 (CI -1.58, -0.23, p=0.01), sustained over two years. Self-efficacy favoured RAFT at 26 weeks (RASE 3.05, CI 0.43, 5.6, p=0.02), and BRAF-NRS Coping was on average different over two years (0.42, CI 0.08, 0.77, p=0.02). Fatigue severity and other clinical outcomes were not different between arms; no harms reported. RAFT satisfaction was high, with 89% patients scoring >8/10 (controls rating booklet 54%, p<0.0001); and 96%/68% recommending RAFT/booklet to others (p<0.001). There was no significant difference between arms for total societal costs including RAFT training/delivery (£434, CI £-389, +£1258) nor QALYs gained (0.008, CI -0.008, +0.023). The probability of RAFT being cost-effective was 28-35% at NICE thresholds of £20-30,000/QALY. Tutors felt RAFT’s CB approaches challenged their usual problem-solving habits but helped patients make life changes, and improved tutors’ wider clinical practice.
Limitations: Primary outcome data missing for 25 patients; EQ-5D-5L might not capture fatigue change; 30% of 2-year economic data missing.
Conclusions: RAFT improves RA fatigue impact beyond usual care alone, sustained for two years with high patient satisfaction, enhanced team skills and no harms. RAFT is <50% likely to be cost-effective but NHS costs were similar between arms.
Future work: Given the paucity of RA fatigue interventions, rheumatology teams might investigate pragmatic implementation of RAFT, which is low-cost.
Study registration: ISRCTN 52709998