Objective Fatigue is a major disabling symptom in many chronic diseases including multiple sclerosis (MS), but treatment options are limited.Here, we tested the effectiveness of a self-guided , interactive, online fatigue management programme (ELEVIDA) based on principles of cognitive behavioural therapy (CBT) and related psychotherapeutic approaches (eg, mindfulness) for reducing fatigue in MS.
Methods Patients with MS and self-reported fatigue were recruited via the website of the German MS Society and assigned via an automated randomisation generator (1:1, no blocking or stratification) to a 12-week online intervention (ELEVIDA, n=139, 82% female, mean age 40.8, median patient determined disease steps (PDDS) 3.0) or a waitlist control group (n=136, 79% female, mean age 41.9, median PDDS 3.0). The primary outcome was the Chalder Fatigue Scale. Outcomes were assessed at baseline, at week 12 (postintervention) and at follow-up (week 24).
Results Compared with the control group, significantly greater reductions in Chalder Fatigue Scale scores were seen in the ELEVIDA group at week 12 (primary endpoint, intention-to-treat analysis: between-group mean difference 2.74 points; 95% CI 1.16 to 4.32; p=0.0007; effect size d=0.53), with effects sustained at week 24 (intention-to-treat analysis: between-group mean difference 2.19 points; 95% CI 0.57 to 3.82; p=0.0080).
Conclusions Our trial provides evidence for the effectiveness of a self-guided , internet-based intervention to reduce fatigue in MS. Interventions such as ELEVIDA may be a suitable low barrier, cost-effective treatment option for MS fatigue.
Trial registration number ISRCTN registry (number ISRCTN25692173).
- multiple sclerosis
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CH and SMG contributed equally.
Contributors JP, IKP, CH and SMG designed the study. JP, BM and CH contributed to the development of the intervention tool. JP, JMW, LF and SL obtained the data. TF analysed the data. JP, RMM, JMW, LF, SL, SK, BM, TF, IKP, CH and SMG interpreted the data. SMG wrote the paper. JP, RMM, JMW, LF, SK, BM, TF, IKP and CH revised the paper for intellectual content.
Funding This research was supported by a research grant from the Gemeinnützige Hertiestiftung (grant no. P1130079-Multiple Sklerose). SMG is supported by a Heisenberg Professorship from the Deutsche Forschungsgemeinschaft (DFG, GO1357/5-1 and 5-2).
Competing interests BM is an employee of GAIA AG, the developer, owner and distributor of ELEVIDA.
Patient consent Obtained.
Ethics approval Ethikkommission der Ärztekammer Hamburg (review number PV4772).
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement Patient level data on the primary and secondary endpoint are provided as supplementary material.