Evidence map›Paper›PMID 35500015›Full record

ArticlePloS one2022

A group resilience training program for people with multiple sclerosis: Study protocol of a multi-centre cluster-randomized controlled trial (multi-READY for MS).

Ambra Mara Giovannetti, Kenneth Ian Pakenham, Giovambattista Presti, Maria Esmeralda Quartuccio, Paolo Confalonieri, Roberto Bergamaschi, Monica Grobberio, Massimiliano Di Filippo, Mary Micheli, Giampaolo Brichetto and 4 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2022. 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
1.6field-weighted citation impact, top 17% of its field
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, 11 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
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

14 authors at 11 institutions in 3 countries.

Ambra Mara GiovannettiUnit of Neuroepidemiology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milano, Italy.ORCID 0000-0002-7496-6727
Kenneth Ian PakenhamSchool of Psychology, Faculty of Health and Behavioural Sciences, University of Queensland, Brisbane, QLD, Australia.
Giovambattista PrestiKore University Behavioral Lab, Faculty of Human and Social Sciences, Università degli Studi di Enna 'Kore', Enna, Italy.
Maria Esmeralda QuartuccioDepartment of Neurosciences, San Camillo- Forlanini Hospital, Roma, Italy.
Paolo ConfalonieriMS Centre, Unit of Neuroimmunology and Neuromuscular Diseases, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milano, Italy.
Roberto BergamaschiIRCCS Fondazione Mondino, Pavia, Italy.
Monica GrobberioLaboratorio di neuropsicologia, UOSD psicologia clinica e UOC neurologia, ASST Lariana, Como, Italy.
Massimiliano Di FilippoCentro Malattie Demielinizzanti e Laboratori di Neurologia Sperimentale, Clinica Neurologica, Università degli Studi di Perugia, Perugia, Italy.
Mary MicheliDipartimento Riabilitazione ASLUmbria2, Foligno, Italy.
Giampaolo BrichettoAISM Rehabilitation Service of Genoa, Italian Multiple Sclerosis Society, Genova, Italy.
Francesco PattiNeurology Clinic, Multiple Sclerosis Centre, University Hospital Policlinico Vittorio Emanuele, Catania, Italy.
Massimiliano CopettiUnit of Biostatistics, Fondazione IRCSS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.
Paola KrugerPatient Expert, EUPATI Fellow (European Patients Academy for Therapeutic Innovation) Italy, Roma, Italy.
Alessandra SolariUnit of Neuroepidemiology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milano, Italy.
Fondazione IRCCS Istituto Neurologico Carlo Besta · ITThe University of Queensland · AUAzienda Ospedaliero-Universitaria Policlinico - Vittorio Emanuele · ITAzienda Socio Sanitaria Territoriale Lariana · ITCarlo Forlanini Hospital · ITCasa Sollievo della Sofferenza · ITFondazione FADOI · ITMultiple Sclerosis Foundation · USRegione Puglia · ITUniversità degli Studi di Enna Kore · ITUniversity of Perugia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionREsilience and Activities for every DaY (READY) is an Acceptance and Commitment Therapy-based group resilience-training program that has preliminary empirical support in promoting quality of life and other psychosocial outcomes in people with multiple sclerosis (PwMS). Consistent with the Medical Research Council framework for developing and evaluating complex interventions, we conducted a pilot randomized controlled trial (RCT), followed by a phase III RCT. The present paper describes the phase III RCT protocol. METHODS AND ANALYSIS: This is a multi-centre cluster RCT comparing READY with a group relaxation program (1:1 ratio) in 240 PwMS from eight centres in Italy (trial registration: isrctn.org Identifier: ISRCTN67194859). Both interventions are composed of 7 weekly sessions plus a booster session five weeks later. Resilience (primary outcome), mood, health-related quality of life, well-being and psychological flexibility will be assessed at baseline, after the booster session, and at three and six month follow-ups. If face-to-face group meetings are interrupted because of COVID-19 related-issues, participants will be invited to complete their intervention via teleconferencing. Relevant COVID-19 information will be collected and the COVID-19 Peritraumatic Distress scale will be administered (ancillary study) at baseline and 3-month follow-up. Analysis will be by intention-to-treat to show superiority of READY over relaxation. Longitudinal changes will be compared between the two arms using repeated-measures, hierarchical generalized linear mixed models.

conclusionIt is expected that his study will contribute to the body of evidence on the efficacy and effectiveness of READY by comparing it with an active group intervention in frontline MS rehabilitation and clinical settings. Results will be disseminated in peer-reviewed journals and at other relevant conferences.

Indexed as

Acceptance and Commitment TherapyCOVID-19Multiple SclerosisClinical Trials, Phase III as TopicEquivalence Trials as TopicHumansItalyMulticenter Studies as TopicQuality of LifeRandomized Controlled Trials as Topic

Identifiers

PMID35500015
PMCPMC9060330
OpenAlexW4225289889

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

None linked

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.