STUDY PROTOCOL article
Front. Public Health
Sec. Public Mental Health
Volume 13 - 2025 | doi: 10.3389/fpubh.2025.1604971
This article is part of the Research TopicUpdating Long COVID: Mechanisms, Risk Factors, and Treatment Volume IIView all 5 articles
Assessing a multicomponent intervention to improve Quality of Life in individuals with Long COVID (COVIDL/MIQoL): Study Protocol for a Randomized Controlled Trial
Provisionally accepted
Mireia Morera1Antonio Arévalo1Cristina Garriga1Marta Corral-Magaña1Mari Carmen García-Arqué1Marta Gragea-Nocete1Cristina Pérez Díaz1Ramon Roca2
Maria Llistosella1,2*- 1Primary Health Care. Consorci Sanitari de Terrassa, Barcelona, Balearic Islands, Spain
- 2Terrassa Health Consortium, Terrassa, Spain
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The impact of Long COVID on the quality of life of affected individuals is significant, therefore, the aim of this study is to analyse the effectiveness of the multicomponent intervention protocol to improve quality of life in individuals with Long COVID.A randomised controlled trial with two parallel arms will be conducted. Individuals diagnosed with Long COVID, but without any severe mental disorders, will be recruited. The sample size is estimated to be around 54 participants per group. A psychologist and a physiotherapist will carry out the intervention between January and March 2025. Participants will receive specific training in psycho-education and physical rehabilitation consisting of 18 sessions, to be held twice a week. Data collection will start in January 2025 and will finish in October 2025. Data will be collected: at baseline, before the intervention (T0); after 9 weeks, post-intervention (T1); and after 24 weeks, follow-up (T2), and will assess quality of live, well-being, anxiety, depression resilience, fatigue, and physical activity. An intention-to-treat analysis will be performed and the effect size will be calculated using Cohen's d. All statistical analyses will be performed using R software version 4.2.2., with a 95% confidence level and a statistical significance level of p < 0.05. Discussion/conclusion: The results will be disseminated to individuals with Long Covid and their families throughout their primary health care centre. Healthcare professionals will receive specific training to be able to develop and implement the intervention. In addition, the results will be disseminated to the scientific community via conferences and publications.
Keywords: Long Covid, randomized controlled trial, Quality of Life, Multicomponent intervention, Mental wellbeing
Received: 02 Apr 2025; Accepted: 30 Apr 2025.
Copyright: © 2025 Morera, Arévalo, Garriga, Corral-Magaña, García-Arqué, Gragea-Nocete, Pérez Díaz, Roca and Llistosella. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Maria Llistosella, Terrassa Health Consortium, Terrassa, Spain
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