Your browser doesn't support javascript.
A group resilience training program for people with multiple sclerosis: Study protocol of a multi-centre cluster-randomized controlled trial (multi-READY for MS).
Giovannetti, Ambra Mara; Pakenham, Kenneth Ian; Presti, Giovambattista; Quartuccio, Maria Esmeralda; Confalonieri, Paolo; Bergamaschi, Roberto; Grobberio, Monica; Di Filippo, Massimiliano; Micheli, Mary; Brichetto, Giampaolo; Patti, Francesco; Copetti, Massimiliano; Kruger, Paola; Solari, Alessandra.
  • Giovannetti AM; Unit of Neuroepidemiology, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milano, Italy.
  • Pakenham KI; School of Psychology, Faculty of Health and Behavioural Sciences, University of Queensland, Brisbane, QLD, Australia.
  • Presti G; School of Psychology, Faculty of Health and Behavioural Sciences, University of Queensland, Brisbane, QLD, Australia.
  • Quartuccio ME; Kore University Behavioral Lab, Faculty of Human and Social Sciences, Università degli Studi di Enna 'Kore', Enna, Italy.
  • Confalonieri P; Department of Neurosciences, San Camillo- Forlanini Hospital, Roma, Italy.
  • Bergamaschi R; MS Centre, Unit of Neuroimmunology and Neuromuscular Diseases, Fondazione IRCCS Istituto Neurologico Carlo Besta, Milano, Italy.
  • Grobberio M; IRCCS Fondazione Mondino, Pavia, Italy.
  • Di Filippo M; Laboratorio di neuropsicologia, UOSD psicologia clinica e UOC neurologia, ASST Lariana, Como, Italy.
  • Micheli M; Centro Malattie Demielinizzanti e Laboratori di Neurologia Sperimentale, Clinica Neurologica, Università degli Studi di Perugia, Perugia, Italy.
  • Brichetto G; Dipartimento Riabilitazione ASLUmbria2, Foligno, Italy.
  • Patti F; AISM Rehabilitation Service of Genoa, Italian Multiple Sclerosis Society, Genova, Italy.
  • Copetti M; Scientific Research Area, Italian MS Society Foundation, Genova, Italy.
  • Kruger P; Neurology Clinic, Multiple Sclerosis Centre, University Hospital Policlinico Vittorio Emanuele, Catania, Italy.
  • Solari A; Unit of Biostatistics, Fondazione IRCSS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.
PLoS One ; 17(5): e0267245, 2022.
Article in English | MEDLINE | ID: covidwho-1910594
ABSTRACT

INTRODUCTION:

REsilience 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 (11 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.

CONCLUSION:

It 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.
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: Acceptance and Commitment Therapy / COVID-19 / Multiple Sclerosis Type of study: Cohort study / Experimental Studies / Prognostic study / Qualitative research / Randomized controlled trials Topics: Vaccines Limits: Humans Country/Region as subject: Europa Language: English Journal: PLoS One Journal subject: Science / Medicine Year: 2022 Document Type: Article Affiliation country: Journal.pone.0267245

Similar

MEDLINE

...
LILACS

LIS


Full text: Available Collection: International databases Database: MEDLINE Main subject: Acceptance and Commitment Therapy / COVID-19 / Multiple Sclerosis Type of study: Cohort study / Experimental Studies / Prognostic study / Qualitative research / Randomized controlled trials Topics: Vaccines Limits: Humans Country/Region as subject: Europa Language: English Journal: PLoS One Journal subject: Science / Medicine Year: 2022 Document Type: Article Affiliation country: Journal.pone.0267245