Feasibility Trial of Cognitive Behavioral Therapy for Fatigue in Hemodialysis (BReF Intervention)

Context: Fatigue affects at least half of patients who are on hemodialysis (HD) with considerable repercussions on their functioning, quality of life, and clinical outcomes.

Objectives: This study assessed the feasibility, acceptability, and potential benefits of a cognitive behavioral therapy intervention for renal fatigue (BReF intervention).

Methods: This was a feasibility randomized controlled trial of the BReF intervention vs. 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 HD patients experiencing clinical levels of fatigue were individually randomized (1:1) to BReF (N = 12) or waiting-list control arms (N = 12). Fifty-three (16.6%; 95% CI = 12.7-21.1) of 320 patients approached consented and completed the screening questionnaire. It was necessary to approach 13 patients for screening for every one patient randomized. The rate of retention at follow-up was 75% (95% CI = 53.29-90.23). Moderate to large treatment effects were observed in favor of BReF on fatigue severity, fatigue-related functional impairment, depression, and anxiety (standardized mean difference [SMD] = 0.81; SMD = 0.93; SMD = 0.38; SMD = 0.42, respectively) but not sleep quality (SMD = -0.31). No trial adverse events occurred.

Conclusion: There was promising evidence in support of the need and benefits of a cognitive behavioral therapy-based intervention for fatigue in HD. 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.