TIRED trial: A randomized controlled trial of a web-based psychological Intervention to reduce stress and fatigue in patients with sarcoidosis

A randomized controlled trial of a web-based psychological Intervention to reduce stress and fatigue in patients with sarcoidosis

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28318

Enrollment

138

Registered

2019-06-20

Start date

2019-06-20

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sarcoidosis

Interventions

online mindfulness-based cognitive therapy

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Change in score on the fatigue assessment scale (FAS) after 12 weeks	—

Secondary

Measure	Time frame
- Long-term change in fatigue (FAS score after 24 weeks) - QoL (KSQ score) at all time points - Stress, anxiety and depression (HADS scores) at all time points - Score on the FMI at all timepoints - Visual analogue scales at all time points - Patient satisfaction with eMBCT - Hair cortisol levels before and after intervention . - Blood biomarkers (ACE and S-IL2R) at baseline and 12 weeks - Correlation between fatigue, S-IL2R and hair cortisol. - Exploratory analysis of new blood biomarkers	—

Measure

Time frame

- Long-term change in fatigue (FAS score after 24 weeks) - QoL (KSQ score) at all time points - Stress, anxiety and depression (HADS scores) at all time points - Score on the FMI at all timepoints - Visual analogue scales at all time points - Patient satisfaction with eMBCT - Hair cortisol levels before and after intervention . - Blood biomarkers (ACE and S-IL2R) at baseline and 12 weeks - Correlation between fatigue, S-IL2R and hair cortisol. - Exploratory analysis of new blood biomarkers

—

Contacts

Public ContactKaren Moor

Erasmus MC

c.moor@erasmusmc.nl0636276594

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)