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

Completed
Conditions
Fatigue, Type 1 diabetes mellitus, vermoeidheid, diabetes mellitus type 1
Registration Number
NL-OMON27693
Lead Sponsor
Radboud University Medical Center
Brief Summary

/A

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
120
Inclusion Criteria

1. Between 18 and 70 years old

2. Being diagnosed with type 1 diabetes at least 1 year ago

Exclusion Criteria

1. Moderate to severe renal failure operationalised as having a glomerular filtration rate (GFR) = 45
2. Blindness or severe visual impairment
3. Medical history of congestive heart failure
4. Medical history of a stroke in the past five years
5. Body Mass Index (BMI) ≥ 40
6. Wheelchair-dependent
7. Other concurrent psychiatric or medical co-morbidity that could explain the fatigue

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Fatigue severity assessed with the subscale fatigue of the Checklist Individual Strength (CIS). Timepoints: baseline, T1 (5 months after start of the intervention), T2 (6 months after the end of the intervention)
Secondary Outcome Measures
NameTimeMethod
1. Limitations in daily functioning assessed with the Sickness Impact Profile 8 (SIP8). The SIP8 measures functional disability in eight different domains of functioning. Timepoints: baseline, T1, T2.<br /><br>2. Diabetes regulation assessed with HbA1c levels and glucose variability. Timepoints: baseline, T1, T2.
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