A randomized controlled Trial of a web-based psychological Intervention to REDuce stress and fatigue in patients with sarcoidosis (TIRED-trial)
Completed
- Conditions
- sarcoidosis10024967
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 138
Inclusion Criteria
Diagnosis of sarcoidosis according to the ATS/ERS/WASOG criteria
Score on the fatigue assessment scale (FAS) > 21 points
Age above 18 years
Stable disease acccording to the treating physician and sarcoidosis-related
therapy unchanged during 8 weeks before inclusion
Exclusion Criteria
No access to internet
Not able to read/write in Dutch
Currently treated by a psychiatrist/psychologist
Currently in a physical rehabilitation program
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome is the change in total score of the FAS at T1 (difference<br /><br>between intervention and control group)</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Long-term change in fatigue (FAS score at 24 weeks)<br /><br>- QoL (KSQ score) at 12 and 24 weeks<br /><br>- Stress, anxiety and depression (HADS score) at 12 and 24 weeks<br /><br>- Visual analogue scales at 0, 12 and 24 weeks<br /><br>- Correlation between fatigue, S-IL2R and hair cortisol.<br /><br>- Patient satisfaction with eMBCT<br /><br>- Hair cortisol at 12 weeks<br /><br>- Blood biomarkers (ACE and S-IL2R) at 16 and 24 weeks<br /><br>- Exploratory analysis of potential biomarkers for fatigue in sarcoidosis</p><br>