TIRED trial: A randomized controlled trial of a web-based psychological Intervention to reduce stress and fatigue in patients with sarcoidosis
Recruiting
- Conditions
- sarcoidosis
- Registration Number
- NL-OMON28318
- Lead Sponsor
- funding sarcoïdose.nl
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 138
Inclusion Criteria
Diagnosis of sarcoidosis according to the ATS/ERS/WASOG criteria (1)
-FAS score > 21 points
-Age above 18 years
-Stable disease according 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 or psychologist.
-Currently in a physical rehabilitation program
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in score on the fatigue assessment scale (FAS) after 12 weeks
- Secondary Outcome Measures
Name Time Method -Long-term change in fatigue (FAS score after 24 weeks)<br>-QoL (KSQ score) at all time points<br>-Stress, anxiety and depression (HADS scores) at all time points<br>-Score on the FMI at all timepoints<br>-Visual analogue scales at all time points<br>-Patient satisfaction with eMBCT<br>-Hair cortisol levels before and after intervention . <br>-Blood biomarkers (ACE and S-IL2R) at baseline and 12 weeks<br>-Correlation between fatigue, S-IL2R and hair cortisol.<br>- Exploratory analysis of new blood biomarkers<br>