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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

Overview of attention for article published in Trials, June 2015
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Title
A web-based cognitive behaviour therapy for chronic fatigue in type 1 diabetes (Dia-Fit): study protocol for a randomised controlled trial
Published in
Trials, June 2015
DOI 10.1186/s13063-015-0764-4
Pubmed ID
Authors

Juliane Menting, Stephanie Nikolaus, Jan-Frederic Wiborg, Ellen Bazelmans, Martine M. Goedendorp, Arianne C. van Bon, Joop P. van den Bergh, Marc JTM. Mol, Cees J. Tack, Hans Knoop

Abstract

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. 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 A1c and blood glucose variability. 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. Dutch trial register NTR4312 (10 December 2013).

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Geographical breakdown

Country Count As %
Colombia 1 <1%
Unknown 194 99%

Demographic breakdown

Readers by professional status Count As %
Student > Master 33 17%
Student > Bachelor 31 16%
Student > Ph. D. Student 22 11%
Researcher 19 10%
Student > Doctoral Student 12 6%
Other 30 15%
Unknown 48 25%
Readers by discipline Count As %
Medicine and Dentistry 46 24%
Psychology 38 19%
Nursing and Health Professions 23 12%
Sports and Recreations 7 4%
Social Sciences 5 3%
Other 20 10%
Unknown 56 29%