Feasibility trial of cognitive behavioural therapy for fatigue in haemodialysis (BReF intervention)

OBJECTIVE: Fatigue affects at least half of patients who are on haemodialysis with considerable repercussions on their functioning, quality of life, and clinical outcomes. This study assessed the feasibility, acceptability, and potential benefits of a cognitive-behavioural therapy (CBT) intervention for fatigue (BReF intervention). METHODS: This was a feasibility randomised-controlled trial of the BReF intervention versus waiting-list control. Outcomes included recruitment, retention, and adherence rates. Exploratory estimates of treatment effect were computed. The statistician was blinded to allocation. RESULTS: Twenty-four prevalent haemodialysis patients experiencing clinical levels of fatigue were individually randomised (1:1) to BReF (N=12) or waiting-list control arms (N=12). 53 (16.6% 95% CI 12.7% to 21.1%) out of 320 patients approached consented and completed the screening questionnaire. It was necessary to approach 13 patients for screening for every 1 patient randomised. The rate of retention at follow-up was 75% (95% CI 53.29% to 90.23%). Moderate to large treatment effects were observed in favour of BReF on fatigue severity, fatigue-related functional impairment, depression, and anxiety SMDg=0.81, SMDg=0.93, SMDg=0.38, SMDg=0.42, respectively), but not sleep quality (SMDg=-0.31). No trial adverse events occurred. CONCLUSION: There was promising evidence in support of the need and benefits of a CBT-based intervention for fatigue in haemodialysis. However, uptake was low, possibly as a result of an already high treatment burden in this setting. Considerations on the context of delivery are necessary before pursuing a definitive trial.