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

TY - JOUR

T1 - Feasibility Trial of Cognitive Behavioral Therapy for Fatigue in Hemodialysis (BReF Intervention)

AU - Picariello, Federica

AU - Moss-Morris, Rona

AU - Norton, Sam

AU - Macdougall, Iain C

AU - Da Silva-Gane, Maria

AU - Farrington, Ken

AU - Clayton, Hope

AU - Chilcot, Joseph

N1 - Funding Information: The authors thank the patients involved in this study and the renal team at King's College Hospital and Lister Hospital for assistance with recruitment and data collection. They also thank students who assisted with data collection and interviewing of participants: Hadia Kishver, Rosanna Martinez, Freya Meynell, and Jennifer Zinser. This work was embedded within a larger PhD project funded by a Biomedical Research Studentship to Federica Picariello from the National Institute for Health Research (NIHR) Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London. R. M. M. acknowledges the financial support of the Department of Health via the NIHR Specialist Biomedical Research Centre for Mental Health award to the South London and Maudsley NHS Foundation Trust and the Institute of Psychiatry at King's College London. The views expressed in this article are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health. Conflict of interest: The authors declare no conflicts of interest. This work has not been published previously in whole or part. Data availability: The data that support the findings of this study are available on request from the corresponding author. The data are not publicly available because of privacy or ethical restrictions. The study protocol has been published: https://doi.org/10.1136/bmjopen-2017-020842. The statistical analysis plan and statistical code are also available on request. Ethical approval: The study received ethical approval from the London Bridge NHS Research Ethics Committee (17/LO/1406) and received local Research and Development approval. The study was cosponsored by King's College London and King's College Hospital NHS Foundation Trust. All participants provided written informed consent. The study adhered to the Declaration of Helsinki (1964) ethical standards. Funding Information: R. M. M. acknowledges the financial support of the Department of Health via the NIHR Specialist Biomedical Research Centre for Mental Health award to the South London and Maudsley NHS Foundation Trust and the Institute of Psychiatry at King's College London . The views expressed in this article are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health. Funding Information: This work was embedded within a larger PhD project funded by a Biomedical Research Studentship to Federica Picariello from the National Institute for Health Research (NIHR) Biomedical Research Centre at South London and Maudsley NHS Foundation Trust and King's College London . Publisher Copyright: © 2020 American Academy of Hospice and Palliative Medicine Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

PY - 2021/6/1

Y1 - 2021/6/1

N2 - 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.

AB - 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.

KW - Fatigue

KW - cognitive behavioral therapy

KW - dialysis

KW - kidney failure

KW - quality of life

UR - http://www.scopus.com/inward/record.url?scp=85096935942&partnerID=8YFLogxK

U2 - 10.1016/j.jpainsymman.2020.10.005

DO - 10.1016/j.jpainsymman.2020.10.005

M3 - Article

SN - 0885-3924

VL - 61

SP - 1234-1246.e5

JO - Journal of Pain and Symptom Management

JF - Journal of Pain and Symptom Management

IS - 6

ER -