We hypothesised that remotely delivered CBA and PEP would effectively alleviate fatigue severity and impact across IRD.
Methods: We performed a pragmatic, multi-centre, UK hospital-based, investigator-blinded, three53 arm randomised controlled trial of usual care (UC) alongside telephone-delivered CBA or PEP, tested against UC alone. Patients with any stable IRD were eligible if they reported significant and persisting fatigue. Treatment allocation was assigned by a web-based randomisation system. CBA and PEP sessions were delivered over 6 months by trained health professionals in rheumatology. Co-primary outcomes were fatigue severity (Chalder Fatigue Scale, CFS) and impact (Fatigue Severity Scale, FSS) at 56 weeks. The primary analysis was by full analysis set. This study was registered at ClinicalTrials.gov, number NCT03248518.
Findings: From September 2017 to September 2019, we randomly assigned 368 participants to either PEP (n=124), CBA (n=122) or UC alone (n=122), of whom n=275 female, n=92 male were enrolled, mean (sd) age 57.0 (12.7). Analyses included for CFS, n=101, 107, 107 and for FSS n=101, 106, 107 in the PEP, CBA and UC alone groups, respectively. PEP and CBA significantly improved fatigue severity (CFS mean difference (md) -3.03, 97.5% CI -5.05 to -1·02, p=0·001 and md -2·36, 97.5% CI -4·28 to -0·44, p=0.006, respectively) and fatigue impact (FSS md -0·64, 97.5% CI -0·95 to - 0·33, p<0.001 and -0·58, 97.5% CI -0·87 to -0·28, p<0.001, respectively) compared to UC alone at 56 weeks. No trial-related serious adverse events were observed.
Interpretation: Telephone-delivered CBA and PEP produced and maintained statistically and clinically significant reductions in the severity and impact of fatigue in a variety of IRD. These interventions should be considered as a key component of IRD management in routine clinical practice.