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A web-based cognitive behaviour therapy for chronic fatigue in type 1 diabetes (Dia-Fit): study protocol for a randomised controlled trial

BACKGROUND: Fatigue is frequently reported by patients with type 1 diabetes mellitus. A recent study showed that 40 % of patients experienced severe fatigue that lasted for more than six months and was accompanied by substantial impairments in daily functioning. Currently, there is no effective trea...

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Autores principales: Menting, Juliane, Nikolaus, Stephanie, Wiborg, Jan-Frederic, Bazelmans, Ellen, Goedendorp, Martine M., van Bon, Arianne C., van den Bergh, Joop P., Mol, Marc JTM., Tack, Cees J., Knoop, Hans
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4461902/
https://www.ncbi.nlm.nih.gov/pubmed/26044447
http://dx.doi.org/10.1186/s13063-015-0764-4
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author Menting, Juliane
Nikolaus, Stephanie
Wiborg, Jan-Frederic
Bazelmans, Ellen
Goedendorp, Martine M.
van Bon, Arianne C.
van den Bergh, Joop P.
Mol, Marc JTM.
Tack, Cees J.
Knoop, Hans
author_facet Menting, Juliane
Nikolaus, Stephanie
Wiborg, Jan-Frederic
Bazelmans, Ellen
Goedendorp, Martine M.
van Bon, Arianne C.
van den Bergh, Joop P.
Mol, Marc JTM.
Tack, Cees J.
Knoop, Hans
author_sort Menting, Juliane
collection PubMed
description BACKGROUND: Fatigue is frequently reported by patients with type 1 diabetes mellitus. A recent study showed that 40 % of patients experienced severe fatigue that lasted for more than six months and was accompanied by substantial impairments in daily functioning. Currently, there is no effective treatment available for chronic fatigue in patients with type 1 diabetes. Cognitive behaviour therapy aimed at cognitions and behaviours that perpetuate fatigue is effective in reducing fatigue in other chronic diseases. Recent research showed that these cognitions and behaviours are also potential determinants of fatigue in type 1 diabetes. We designed Dia-Fit, a web-based cognitive behaviour therapy for severe and chronic fatigue in patients with type 1 diabetes. This patient-tailored intervention is aimed at reducing fatigue by changing cognitions and behaviours assumed to maintain fatigue. The efficacy of Dia-Fit will be investigated in this study. METHODS/DESIGN: A randomised controlled trial will be conducted in 120 patients with type 1 diabetes who are chronically and severely fatigued. Patients will be randomised to a treatment or waiting list group. The treatment group will receive Dia-Fit, a blended care therapy consisting of up to eight internet modules and face-to-face sessions with a therapist during a five-month period. The treatment will be tailored to the fatigue-maintaining cognitions and behaviours that are relevant for the patient and are determined at baseline. The waiting list group will receive Dia-Fit after a waiting period of five months. The primary outcome measure is fatigue severity. Secondary outcome measures are functional impairment and glucose control determined by haemoglobin A(1c) and blood glucose variability. DISCUSSION: To our knowledge, this is the first study investigating the efficacy of a cognitive behavioural intervention for chronic fatigue in patients with type 1 diabetes. TRIAL REGISTRATION: Dutch trial register NTR4312 (10 December 2013).
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spelling pubmed-44619022015-06-11 A web-based cognitive behaviour therapy for chronic fatigue in type 1 diabetes (Dia-Fit): study protocol for a randomised controlled trial Menting, Juliane Nikolaus, Stephanie Wiborg, Jan-Frederic Bazelmans, Ellen Goedendorp, Martine M. van Bon, Arianne C. van den Bergh, Joop P. Mol, Marc JTM. Tack, Cees J. Knoop, Hans Trials Study Protocol BACKGROUND: Fatigue is frequently reported by patients with type 1 diabetes mellitus. A recent study showed that 40 % of patients experienced severe fatigue that lasted for more than six months and was accompanied by substantial impairments in daily functioning. Currently, there is no effective treatment available for chronic fatigue in patients with type 1 diabetes. Cognitive behaviour therapy aimed at cognitions and behaviours that perpetuate fatigue is effective in reducing fatigue in other chronic diseases. Recent research showed that these cognitions and behaviours are also potential determinants of fatigue in type 1 diabetes. We designed Dia-Fit, a web-based cognitive behaviour therapy for severe and chronic fatigue in patients with type 1 diabetes. This patient-tailored intervention is aimed at reducing fatigue by changing cognitions and behaviours assumed to maintain fatigue. The efficacy of Dia-Fit will be investigated in this study. METHODS/DESIGN: A randomised controlled trial will be conducted in 120 patients with type 1 diabetes who are chronically and severely fatigued. Patients will be randomised to a treatment or waiting list group. The treatment group will receive Dia-Fit, a blended care therapy consisting of up to eight internet modules and face-to-face sessions with a therapist during a five-month period. The treatment will be tailored to the fatigue-maintaining cognitions and behaviours that are relevant for the patient and are determined at baseline. The waiting list group will receive Dia-Fit after a waiting period of five months. The primary outcome measure is fatigue severity. Secondary outcome measures are functional impairment and glucose control determined by haemoglobin A(1c) and blood glucose variability. DISCUSSION: To our knowledge, this is the first study investigating the efficacy of a cognitive behavioural intervention for chronic fatigue in patients with type 1 diabetes. TRIAL REGISTRATION: Dutch trial register NTR4312 (10 December 2013). BioMed Central 2015-06-06 /pmc/articles/PMC4461902/ /pubmed/26044447 http://dx.doi.org/10.1186/s13063-015-0764-4 Text en © Menting et al. 2015 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Study Protocol
Menting, Juliane
Nikolaus, Stephanie
Wiborg, Jan-Frederic
Bazelmans, Ellen
Goedendorp, Martine M.
van Bon, Arianne C.
van den Bergh, Joop P.
Mol, Marc JTM.
Tack, Cees J.
Knoop, Hans
A web-based cognitive behaviour therapy for chronic fatigue in type 1 diabetes (Dia-Fit): study protocol for a randomised controlled trial
title A web-based cognitive behaviour therapy for chronic fatigue in type 1 diabetes (Dia-Fit): study protocol for a randomised controlled trial
title_full A web-based cognitive behaviour therapy for chronic fatigue in type 1 diabetes (Dia-Fit): study protocol for a randomised controlled trial
title_fullStr A web-based cognitive behaviour therapy for chronic fatigue in type 1 diabetes (Dia-Fit): study protocol for a randomised controlled trial
title_full_unstemmed A web-based cognitive behaviour therapy for chronic fatigue in type 1 diabetes (Dia-Fit): study protocol for a randomised controlled trial
title_short A web-based cognitive behaviour therapy for chronic fatigue in type 1 diabetes (Dia-Fit): study protocol for a randomised controlled trial
title_sort web-based cognitive behaviour therapy for chronic fatigue in type 1 diabetes (dia-fit): study protocol for a randomised controlled trial
topic Study Protocol
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4461902/
https://www.ncbi.nlm.nih.gov/pubmed/26044447
http://dx.doi.org/10.1186/s13063-015-0764-4
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