title: A web-based cognitive behaviour therapy for chronic fatigue in type 1 diabetes (Dia-Fit): study protocol for a randomised controlled trial.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Dutch trial register NTR4312 (10 December 2013).
authors.affiliation: Expert Center for Chronic Fatigue (ECCF), Radboud University Medical Center, P.O. Box 9101, 6500, HB, Nijmegen, The Netherlands. Juliane.Menting@radboudumc.nl.
authors.forename: Juliane
authors.initials: J
authors.lastname: Menting
authors.affiliation: Expert Center for Chronic Fatigue (ECCF), Radboud University Medical Center, P.O. Box 9101, 6500, HB, Nijmegen, The Netherlands. Stephanie.Nikolaus@radboudumc.nl.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Nikolaus
authors.affiliation: Expert Center for Chronic Fatigue (ECCF), Radboud University Medical Center, P.O. Box 9101, 6500, HB, Nijmegen, The Netherlands. j.f.wiborg@gmail.com.
authors.forename: Jan-Frederic
authors.initials: JF
authors.lastname: Wiborg
authors.affiliation: Department of Medical Psychology, Radboud University Medical Center, Nijmegen, The Netherlands. Ellen.Bazelmans@radboudumc.nl.
authors.forename: Ellen
authors.initials: E
authors.lastname: Bazelmans
authors.affiliation: Department of Health Psychology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands. m.m.goedendorp@umcg.nl.
authors.forename: Martine M
authors.initials: MM
authors.lastname: Goedendorp
authors.affiliation: Department of Internal Medicine, Rijnstate Ziekenhuis, Arnhem, The Netherlands. ACvanBon@rijnstate.nl.
authors.forename: Arianne C
authors.initials: AC
authors.lastname: van Bon
authors.affiliation: Department of Internal Medicine, VieCuri Medisch Centrum, Venlo, The Netherlands. j@vdbergh.org.
authors.forename: Joop P
authors.initials: JP
authors.lastname: van den Bergh
authors.affiliation: Department of Internal Medicine, Canisius-Wilhelmina Ziekenhuis, Nijmegen, The Netherlands. m.mol@cwz.nl.
authors.forename: Marc J T M
authors.initials: MJ
authors.lastname: Mol
authors.affiliation: Department of Internal Medicine, Radboud University Medical Center, Nijmegen, The Netherlands. Cees.Tack@radboudumc.nl.
authors.forename: Cees J
authors.initials: CJ
authors.lastname: Tack
authors.affiliation: Expert Center for Chronic Fatigue (ECCF), Radboud University Medical Center, P.O. Box 9101, 6500, HB, Nijmegen, The Netherlands. Hans.Knoop@radboudumc.nl.
authors.forename: Hans
authors.initials: H
authors.lastname: Knoop
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D015415:Biomarkers / Q000097:blood; D001786:Blood Glucose / Q000378:metabolism; D002908:Chronic Disease; D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy / Q000379:methods*; D003922:Diabetes Mellitus, Type 1 / Q000097:blood / Q000150:complications* / Q000175:diagnosis; D005221:Fatigue / Q000175:diagnosis / Q000209:etiology / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D020407:Internet; D008297:Male; D008875:Middle Aged; D009426:Netherlands; D012107:Research Design; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013813:Therapy, Computer-Assisted / Q000379:methods*; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D015415:Biomarkers; D001786:Blood Glucose; D006442:Glycated Hemoglobin; C517652:hemoglobin A1c protein, human