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]g = 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 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.
['Picariello|Federica|F|', 'Moss-Morris|Rona|R|', 'Norton|Sam|S|', 'Macdougall|Iain C|IC|', 'Da Silva-Gane|Maria|M|', 'Farrington|Ken|K|', 'Clayton|Hope|H|', 'Chilcot|Joseph|J|']
D015928:Cognitive Behavioral Therapy D003863:Depression D005221:Fatigue D005240:Feasibility Studies D006801:Humans D011788:Quality of Life D006435:Renal Dialysis
cognitive behavioral therapy Fatigue quality of life dialysis kidney failure