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

Federica Picariello, Rona Moss-Morris, Sam Norton, Iain C Macdougall, Maria Da Silva-Gane, Ken Farrington, Hope Clayton, Joseph Chilcot

Research output: Contribution to journalArticlepeer-review

10 Citations (Scopus)
26 Downloads (Pure)


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; SMD g = 0.93; SMD g = 0.38; SMD g = 0.42, respectively) but not sleep quality (SMD g = −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.

Original languageEnglish
Pages (from-to)1234-1246.e5
JournalJournal of Pain and Symptom Management
Issue number6
Early online date14 Oct 2020
Publication statusPublished - 1 Jun 2021


  • Fatigue
  • cognitive behavioral therapy
  • dialysis
  • kidney failure
  • quality of life


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