A randomized controlled Trial of a web-based psychological Intervention to REDuce stress and fatigue in patients with sarcoidosis (TIRED-trial)

A randomized controlled Trial of a web-based psychological Intervention to REDuce stress and fatigue in patients with sarcoidosis (TIRED-trial) - TIRED trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49434

Enrollment

138

Registered

2019-04-04

Start date

2019-06-05

Completion date

Unknown

Last updated

2024-07-08

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

Conditions

sarcoidosis

Interventions

The intervention of this study consists of a 12-week eMBCT

a web-based, psychologist-guided intervention. eMBCT aims to change cognitive reactions, thoughts and behavior towards stressors. Patients will receive weekly information and exercises online and w

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The primary outcome is the change in total score of the FAS at T1 (difference between intervention and control group)	—

Secondary

Measure	Time frame
- Long-term change in fatigue (FAS score at 24 weeks) - QoL (KSQ score) at 12 and 24 weeks - Stress, anxiety and depression (HADS score) at 12 and 24 weeks - Visual analogue scales at 0, 12 and 24 weeks - Correlation between fatigue, S-IL2R and hair cortisol. - Patient satisfaction with eMBCT - Hair cortisol at 12 weeks - Blood biomarkers (ACE and S-IL2R) at 16 and 24 weeks - Exploratory analysis of potential biomarkers for fatigue in sarcoidosis	—

Measure

Time frame

- Long-term change in fatigue (FAS score at 24 weeks) - QoL (KSQ score) at 12 and 24 weeks - Stress, anxiety and depression (HADS score) at 12 and 24 weeks - Visual analogue scales at 0, 12 and 24 weeks - Correlation between fatigue, S-IL2R and hair cortisol. - Patient satisfaction with eMBCT - Hair cortisol at 12 weeks - Blood biomarkers (ACE and S-IL2R) at 16 and 24 weeks - Exploratory analysis of potential biomarkers for fatigue in sarcoidosis

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)