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J Pain Symptom Manage · Jun 2021
Randomized Controlled TrialFeasibility 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, and Joseph Chilcot.
- Health Psychology Section, Psychology Department, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK. Electronic address: federica.picariello@kcl.ac.uk.
- J Pain Symptom Manage. 2021 Jun 1; 61 (6): 1234-1246.e5.
ContextFatigue affects at least half of patients who are on hemodialysis (HD) with considerable repercussions on their functioning, quality of life, and clinical outcomes.ObjectivesThis study assessed the feasibility, acceptability, and potential benefits of a cognitive behavioral therapy intervention for renal fatigue (BReF intervention).MethodsThis 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.ResultsTwenty-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.ConclusionThere 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.Copyright © 2020 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.
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