Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2015 Jun 6:16:262.
doi: 10.1186/s13063-015-0764-4.

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

Juliane Menting  1 , Stephanie Nikolaus  2 , Jan-Frederic Wiborg  3 , Ellen Bazelmans  4 , Martine M Goedendorp  5 , Arianne C van Bon  6 , Joop P van den Bergh  7 , Marc J T M Mol  8 , Cees J Tack  9 , Hans Knoop  10
Affiliations
Randomized Controlled Trial

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

Juliane Menting et al. Trials. .

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/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 A1c 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).

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Model of perpetuating factors of fatigue in patients with T1DM
Fig. 2
Fig. 2
Flowchart of the trial design. T0 = baseline assessment; T1 = second assessment; T2 = post-treatment assessment for patients on the waiting list, T3 = follow-up assessment
See this image and copyright information in PMC

References

    1. Guariguata L, Whiting DR, Hambleton I, Beagley J, Linnenkamp U, Shaw JE. Global estimates of diabetes prevalence for 2013 and projections for 2035. Diabetes Res Clin Pract. 2014;103:137–49. doi: 10.1016/j.diabres.2013.11.002. - DOI - PubMed
    1. Federation ID. IDF Diabetes Atlas. 2013. http://www.idf.org/diabetesatlas. Accessed 22 May 2015.
    1. Goedendorp MM, Tack CJ, Steggink E, Bloot L, Bazelmans E, Knoop H. Chronic fatigue in type 1 diabetes: highly prevalent but not explained by hyperglycemia or glucose variability. Diabetes Care. 2014;37:73–80. doi: 10.2337/dc13-0515. - DOI - PubMed
    1. Weijman I, Ros WJ, Rutten GE, Schaufeli WB, Schabracq MJ, Winnubst JA. Frequency and perceived burden of diabetes self-management activities in employees with insulin-treated diabetes: relationships with health outcomes. Diabetes Res Clin Pract. 2005;68:56–64. doi: 10.1016/j.diabres.2004.08.004. - DOI - PubMed
    1. Lasselin J, Laye S, Barreau JB, Rivet A, Dulucq MJ, Gin H, et al. Fatigue and cognitive symptoms in patients with diabetes: relationship with disease phenotype and insulin treatment. Psychoneuroendocrinology. 2012;37:1468–78. doi: 10.1016/j.psyneuen.2012.01.016. - DOI - PubMed

Publication types

MeSH terms

Associated data