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J Neurol Neurosurg Psychiatry. 2018 Sep;89(9):970-976. doi: 10.1136/jnnp-2017-317463. Epub 2018 Mar 16.

Randomised controlled trial of a self-guided online fatigue intervention in multiple sclerosis.

Author information

1
Institut für Neuroimmunologie und Multiple Sklerose (INIMS), Zentrum für Molekulare Neurobiologie (ZMNH), Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.
2
Klinik für Neurologie, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany.
3
Section of Health Psychology, Psychology Department, King's College London, London, UK.
4
Sektion Pflegeforschung, Institut für Sozialmedizin und Epidemiologie, Universität zu Lübeck, Lübeck, Germany.
5
GAIA AG, Hamburg, Germany.
6
Department of Psychology, City University of London, London, UK.
7
Institut für Medizinische Statistik, Universitätsmedizin Göttingen, Göttingen, Germany.
8
Klinik für Neurologie, Medizinische Fakultät, Heinrich Heine Universität, Düsseldorf, Germany.
9
COGITO Zentrum für angewandte Neurokognition und neuropsychologische Forschung, Life Science Center, Düsseldorf, Germany.
10
Charité - Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, Berlin Institute of Health, Klinik für Psychiatrie und Psychotherapie, Campus Benjamin Franklin, Berlin, Germany.
#
Contributed equally

Abstract

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).

KEYWORDS:

depression; immunology; multiple sclerosis; neuroendocrinology; neuroimmunology

PMID:
29549193
DOI:
10.1136/jnnp-2017-317463

Conflict of interest statement

Competing interests: BM is an employee of GAIA AG, the developer, owner and distributor of ELEVIDA.

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