Table of Contents
Background
Sarcoidosis-associated fatigue is highly prevalent and is often reported as the most
burdensome symptom of sarcoidosis. Management of fatigue is challenging, and evidence-based
therapies are lacking. In this TIRED trial, we aimed to assess the effects of a 12-week
online mindfulness-based cognitive therapy (eMBCT) on fatigue.
Methods
This study was a prospective, open-label, multicentre randomised controlled trial,
conducted at three centres in the Netherlands. Eligible patients were 18 years or
older, had stable sarcoidosis, and a score of more than 21 points on the Fatigue Assessment
Scale (FAS). Patients were randomised into either the eMBCT or the control group.
Participants completed patient-reported outcome measures at baseline, after intervention
(T1), and 12 weeks after completion of eMBCT (T2). The primary outcome was the change
in FAS score at T1 in the eMBCT group compared with the control group, assessed with
the independent students' t test in all patients who started the study. Secondary outcomes included within-group
difference in FAS score at T1 and T2, between-group difference in FAS score at T2,
and changes in the Hospital Anxiety and Depression Scale, the Freiburg Mindfulness
Inventory–Short Form, and the Kings Sarcoidosis Questionnaire. The study was registered
at the Netherlands Trial Register, NL7816.
Findings
Between June 5, 2019, and Oct 28, 2021, 99 patients were randomly assigned to the
eMBCT (n=52) or the control (n=47) groups. Six patients withdrew consent after psychological
screening before the start of eMBCT. Baseline FAS score was similar in both groups
(34·57 [SD 6·07] for 46 patients in the eMBCT group and 35·51 [4·65] for 47 patients
in the control group). Mean change in FAS score at T1 was –4·53 (SD 5·77; p<0·0001)
in the eMBCT group and –1·28 (3·80; p=0·026) in the control group (between-group difference
3·26 [95% CI 1·18 to 5·33; p=0·0025]). Furthermore, the eMBCT group had a significant
improvement in anxiety (mean between-group difference 1·69, 95% CI 0·22–3·16; p=0·025),
depressive symptoms (1·52, 0·08–2·95; p=0·039), mindfulness (3·1, 0·70–5·49; p=0·022),
and general health status (6·28, 2·51–10·06; p=0·002) at T1, compared with the control
group.
Interpretation
12 week eMBCT improves fatigue, anxiety, depression, mindfulness, and health status
in patients with sarcoidosis-associated fatigue.
Funding
Dutch Sarcoidosis Patient Association (Sarcoidose.nl).
Translation
For the Dutch translation of the summary see Supplementary Materials section.
