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Testing non-inferiority of blended versus face-to-face cognitive behavioural therapy for severe fatigue in patients with multiple sclerosis and the effectiveness of blended booster sessions aimed at improving long-term outcome following both therapies: study protocol for two observer-blinded randomized clinical trials

Crossref DOI link: https://doi.org/10.1186/s13063-019-3825-2

Published Online: 2020-01-20

Published Print: 2020-12

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Houniet-de Gier, Marieke https://orcid.org/0000-0001-5214-4258
Beckerman, Heleen

van Vliet, Kimberley

Knoop, Hans

de Groot, Vincent
Funding

Funding for this research was provided by:

Stichting MS Research (16-937 MS)
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Text and Data Mining valid from 2020-01-20

Version of Record valid from 2020-01-20
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Article History

Received: 2 August 2019

Accepted: 22 October 2019

First Online: 20 January 2020

Ethics approval and consent to participate

: This study has been reviewed and approved by the medical ethics committee of the Amsterdam University Medical Centers, VU University Medical Center (registration number 2017.538, NL62622.029.17), and by the local ethics committees of the participating hospitals and rehabilitation centres. The study is registered in the Dutch Trial Register (NTR6966). Written informed consent will be obtained from all participants. Any changes in the protocol will be sent for approval to the medical ethics committee first. After approval, the adjusted protocol will be sent to all primary researchers from the participating centres.

: The results of this study will be submitted for publication as scientific articles in peer-reviewed, open-access journals. The results will also be presented at national and international conferences for clinicians, researchers and patients. Publication is not restricted to the outcome of the study; all results (positive and negative) will be incorporated in the article.

: The authors declare that they have no competing interests.

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