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Online mindfulness-based cognitive therapy for fatigue in patients with sarcoidosis (TIRED): a randomised controlled trial.

The Lancet. Respiratory medicine
March 1, 2023
Vivienne Kahlmann et al. (8 authors)
Randomized Controlled TrialMulticenter StudyJournal ArticleResearch Support, Non-U.S. Gov'tHuman StudyClinical
Study Details

Study Goal

The researchers aimed to assess the effects of a 12-week online mindfulness-based cognitive therapy (eMBCT) on fatigue in patients with sarcoidosis.

Results Summary

The study found that eMBCT significantly improved fatigue, anxiety, depression, mindfulness, and general health status compared to the control group, with a mean change in FAS score of -4.53 in the eMBCT group versus -1.28 in the control group.

Population

Adults (18+) with stable sarcoidosis and a Fatigue Assessment Scale (FAS) score >21.

Effective Dosage

Not specified (12-week online program).

Duration

12 weeks.

Interactions

None mentioned.

Extracted Claims (12)
InterventionDirectionEndpointPopulationDosageImpactClaim #
12-week online mindfulness-based cognitive therapy (eMBCT)
decrease
fatigue
patients with sarcoidosis-associated fatigue
-
improves
#1
12-week online mindfulness-based cognitive therapy (eMBCT)
decrease
anxiety
patients with sarcoidosis-associated fatigue
-
improves
#2
12-week online mindfulness-based cognitive therapy (eMBCT)
decrease
depression
patients with sarcoidosis-associated fatigue
-
improves
#3
12-week online mindfulness-based cognitive therapy (eMBCT)
increase
mindfulness
patients with sarcoidosis-associated fatigue
-
improves
#4
12-week online mindfulness-based cognitive therapy (eMBCT)
increase
health status
patients with sarcoidosis-associated fatigue
-
improves
#5
12-week online mindfulness-based cognitive therapy (eMBCT)
decrease
anxiety
patients with sarcoidosis-associated fatigue
mean between-group difference 1.69, 95% CI 0.22-3.16; p=0.025
had a significant improvement in anxiety
#6
12-week online mindfulness-based cognitive therapy (eMBCT)
decrease
depressive symptoms
patients with sarcoidosis-associated fatigue
1.52, 0.08-2.95; p=0.039
had a significant improvement in depressive symptoms
#7
12-week online mindfulness-based cognitive therapy (eMBCT)
increase
mindfulness
patients with sarcoidosis-associated fatigue
3.1, 0.70-5.49; p=0.022
had a significant improvement in mindfulness
#8
12-week online mindfulness-based cognitive therapy (eMBCT)
increase
general health status
patients with sarcoidosis-associated fatigue
6.28, 2.51-10.06; p=0.002
had a significant improvement in general health status
#9
12-week online mindfulness-based cognitive therapy (eMBCT)
decrease
FAS score
patients with sarcoidosis-associated fatigue
-4.53 (SD 5.77; p<0.0001)
mean change in FAS score at T1 was -4.53
#10
control
decrease
FAS score
patients with sarcoidosis-associated fatigue
-1.28 (3.80; p=0.026)
mean change in FAS score at T1 was -1.28
#11
12-week online mindfulness-based cognitive therapy (eMBCT)
decrease
FAS score
patients with sarcoidosis-associated fatigue
3.26 [95% CI 1.18 to 5.33; p=0.0025]
between-group difference in FAS score at T1
#12
Abstract

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.

Medical Subject Headings (MeSH)
HumansMindfulnessProspective StudiesCognitive Behavioral TherapyFatigueSurveys and QuestionnairesQuality of Life
Study Links
Quality Scores
SafetyNot Assessed
Efficacy85/10
Quality80/10
Citation Metrics
Total Citations15
Citations/Year7.5
Relative Citation Ratio4.37
NIH Percentile91.4%
Research Impact Scores
APT Score0.75
Weight Score2.91
Normalized Score0.70