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Published in: BMC Neurology 1/2017

Open Access 01-12-2017 | Study protocol

Cognitive rehabilitation and mindfulness in multiple sclerosis (REMIND-MS): a study protocol for a randomised controlled trial

Authors: Ilse M. Nauta, Anne E. M. Speckens, Roy P. C. Kessels, Jeroen J. G. Geurts, Vincent de Groot, Bernard M. J. Uitdehaag, Luciano Fasotti, Brigit A. de Jong

Published in: BMC Neurology | Issue 1/2017

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Abstract

Background

Cognitive problems frequently occur in patients with multiple sclerosis (MS) and profoundly affect their quality of life. So far, the best cognitive treatment options for MS patients are a matter of debate. Therefore, this study aims to investigate the effectiveness of two promising non-pharmacological treatments: cognitive rehabilitation therapy (CRT) and mindfulness-based cognitive therapy (MBCT). Furthermore, this study aims to gain additional knowledge about the aetiology of cognitive problems among MS patients, since this may help to develop and guide effective cognitive treatments.

Methods/design

In a dual-centre, single-blind randomised controlled trial (RCT), 120 MS patients will be randomised into one of three parallel groups: CRT, MBCT or enhanced treatment as usual (ETAU). Both CRT and MBCT consist of a structured 9-week program. ETAU consists of one appointment with an MS specialist nurse. Measurements will be performed at baseline, post-intervention and 6 months after the interventions. The primary outcome measure is the level of subjective cognitive complaints. Secondary outcome measures are objective cognitive function, functional brain network measures (using magnetoencephalography), psychological symptoms, well-being, quality of life and daily life functioning.

Discussion

To our knowledge, this will be the first RCT that investigates the effect of MBCT on cognitive function among MS patients. In addition, studying the effect of CRT on cognitive function may provide direction to the contradictory evidence that is currently available. This study will also provide information on changes in functional brain networks in relation to cognitive function. To conclude, this study may help to understand and treat cognitive problems among MS patients.

Trial registration

This trial was prospectively registered at the Dutch Trial Registration (number NTR6459, registered on 31 May 2017).
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Metadata
Title
Cognitive rehabilitation and mindfulness in multiple sclerosis (REMIND-MS): a study protocol for a randomised controlled trial
Authors
Ilse M. Nauta
Anne E. M. Speckens
Roy P. C. Kessels
Jeroen J. G. Geurts
Vincent de Groot
Bernard M. J. Uitdehaag
Luciano Fasotti
Brigit A. de Jong
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Neurology / Issue 1/2017
Electronic ISSN: 1471-2377
DOI
https://doi.org/10.1186/s12883-017-0979-y

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