Evidence map›Paper›PMID 31959235›Full record

ArticleTrials2020

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.

Marieke Houniet-de Gier, Heleen Beckerman, Kimberley van Vliet, Hans Knoop, Vincent de Groot

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

Marieke Houniet-de GierDepartment of Rehabilitation Medicine, MS Center Amsterdam, Amsterdam Neuroscience Research Institute, Amsterdam University Medical Centers, Vrije Universiteit, P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands. m.degier1@amsterdamumc.nl.ORCID http://orcid.org/0000-0001-5214-4258
Heleen BeckermanDepartment of Rehabilitation Medicine, MS Center Amsterdam, Amsterdam Neuroscience Research Institute, Amsterdam University Medical Centers, Vrije Universiteit, P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands.
Kimberley van VlietDepartment of Rehabilitation Medicine, MS Center Amsterdam, Amsterdam Neuroscience Research Institute, Amsterdam University Medical Centers, Vrije Universiteit, P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands.
Hans KnoopDepartment of Medical Psychology, Amsterdam Public Health Research Institute, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.
Vincent de GrootDepartment of Rehabilitation Medicine, MS Center Amsterdam, Amsterdam Neuroscience Research Institute, Amsterdam University Medical Centers, Vrije Universiteit, P.O. Box 7057, 1007 MB, Amsterdam, The Netherlands.

Funding

Stichting MS Research 16-937 MS
6 · The paper itself

Abstract

backgroundCognitive behavioural therapy (CBT) has been found to be effective in reducing fatigue severity in MS patients directly following treatment. However, long-term effects are inconsistent leaving room for improvement. In addition, individual face-to-face CBT draws heavily on limited treatment capacity, and the travel distance to the treatment centre can be burdensome for patients. Therefore, we developed "MS Fit", a blended CBT for MS-related fatigue, based on a face-to-face CBT protocol found effective in a previous study, and "MS Stay Fit", internet-based booster sessions to improve long-term effectiveness of CBT for MS-related fatigue. This article presents the protocol of two randomised clinical trials (RCTs) conducted within one study investigating (1) the non-inferiority of MS Fit compared with evidence-based face-to-face CBT for MS-related fatigue and (2) the effectiveness of MS Stay Fit on the long-term outcome of fatigue compared with no booster sessions. METHODS/

designThe first part of this study is an observer-blinded non-inferiority multicentre RCT, in which 166 severely fatigued MS patients will be randomly assigned (1:1 ratio, computer-generated sequence) to either face-to-face CBT or blended CBT (MS Fit) for fatigue. The primary endpoint is at 20 weeks after baseline. After this post-treatment assessment, patients will be randomly assigned again (1:1 ratio, computer generated sequence) to either MS Stay Fit consisting of two booster sessions at 2 and 4 months after end of treatment or no booster sessions. The primary endpoint of the second study is 52 weeks after baseline. Primary outcome measure in both studies is fatigue severity assessed with the fatigue severity subscale of the Checklist Individual Strength (CIS20r). Outcomes will be assessed at baseline (T0), at the end of treatment (T20), and after 39 and 52 weeks (T39 and T52). DISCUSSION: If MS Fit is found to be non-inferior to face-to-face CBT, it will improve the accessibility of this treatment. In addition, the study aims to test whether it is possible to improve long-term effectiveness of CBT for MS-related fatigue with MS Stay Fit.

trial registrationDutch Trial Register (NTR6966), registered 18 January 2018 https://www.trialregister.nl/trial/6782 WORLD HEALTH ORGANIZATION (WHO) TRIAL REGISTRATION DATA SET: All items from the WHO Trial Registration Data Set can be found within the protocol.

Indexed as

Cognitive Behavioral TherapyFatigueInternet-Based InterventionMultiple SclerosisCombined Modality TherapyEquivalence Trials as TopicHumansMulticenter Studies as TopicSingle-Blind MethodBlended careBooster sessionsCognitive behavioural therapyFatigueInternetLong-term effectivenessMultiple sclerosisNon-inferiority trialRandomised clinical trialStudy protocol

Identifiers

PMID31959235
PMCPMC6971870

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.