Cognitive behaviour therapy by internet for chronic fatigue in type 1 Diabetes: a randomized controlled trial.

Recent research of our own research group revealed that severe fatigue is a
common complaint in patients with type 1 diabetes. This fatigue is accompanied
by severe impairment in daily functioning. Perpetuating factors of the fatigue
in diabetes patients seem to overlap with the perpetuating factors of chronic
fatigue in other patient groups, such as patients with post-cancer fatigue and
chronic fatigue syndrome. These factors include fatigue-related dysfunctional
thoughts and behaviours. Cognitive behaviour therapy helps patients to change
these thoughts and behaviours which has been shown to have a positive effective
on fatigue and impairment in above mentioned patientgroups. The intervention
might thus also lead to a significant decrease in fatigue severity and
impairment in patients with type 1 diabetes. In addition, we expect that a
decrease in fatigue should facilitate a better management of the diabetes
itself.

The main objective of this study is to test whether cognitive behaviour therapy
delivered by internet has a significant effect on fatigue in patients with type
1 diabetes en whether this effect is sustained during a follow-up period of six
months. Secondary outcome measures are impairment in daily functioning and
HbA1c and blood glucose variability as measure for diabetesmanagement.

We will conduct a randomised controlled trial with a waiting list control
group. The executing researcher will be blinded with respect to the condition
that patients are allocated to. Assessments are planned before en directly
after the intervention or control group condition and at six months follow-up.

The intervention (cognitive behaviour therapy) consists of an introduction, six
additional sections, and an evaluation:
- The introduction includes goal setting and psychoeducation (2-3 sessions in 3
weeks) and are given on location in Nijmegen.
- The additional sections are arranged for the individual patient by his or her
therapist depending on the baseline assessment and will be delivered via
internet (maximum of 6 sections in 11 weeks). Potential additional sections are
regulation of the sleep-wake pattern, reformulation of dysfunctional
fatigue-related thoughts, regulation and gradual increase of physical activity,
reformulation of pain-related thoughts, optimalisation of social support, and
reduction of diabetes-related stress.
- The evaluation phase (2-4 session in 6 weeks) includes evaluation of the
treatment goals and the effects of therapy as well as relapse prevention and is
given at location in Nijmegen.

The risk of adverse effects is, based on previous research in other patient
groups, low. The burden for patients who participate in this research is
similar to that of other patients who receive care as usual in our specialised
treatment setting (including asessment).