Morera Mireia, Arévalo Antonio, Garriga Cristina, Corral-Magaña Marta, García-Arqué Mari Carmen, Gragea-Nocete Marta, Pérez Díaz Cristina, Roca Ramon, Llistosella Maria
Primary Health Care, Consorci Sanitari de Terrassa, Barcelona, Spain.
Fundació Joan Costa Roma, Consorci Sanitari de Terrassa, Barcelona, Spain.
Front Public Health. 2025 May 19;13:1604971. doi: 10.3389/fpubh.2025.1604971. eCollection 2025.
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 randomized 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 < 0.05.
DISCUSSION/CONCLUSION: The results will be disseminated to individuals with Long COVID and their families throughout their primary health care center. 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.
https://register.clinicaltrials.gov/prs/beta/studies/S000ENW100000080/recordSummary, Identifier NCT06492590.
长期新冠对受影响个体的生活质量影响重大，因此，本研究旨在分析多组分干预方案对改善长期新冠患者生活质量的有效性。
将进行一项双臂平行随机对照试验。招募被诊断为长期新冠但无任何严重精神障碍的个体。估计每组样本量约为54名参与者。一名心理学家和一名物理治疗师将于2025年1月至3月进行干预。参与者将接受由18节课程组成的心理教育和身体康复专项培训，每周进行两次。数据收集将于2025年1月开始，2025年10月结束。将在以下时间点收集数据：基线时，干预前（T0）；9周后，干预后（T1）；24周后，随访（T2），并将评估生活质量、幸福感、焦虑、抑郁恢复力、疲劳和身体活动。将进行意向性分析，并使用科恩d值计算效应量。所有统计分析将使用R软件版本4.2.2进行，置信水平为95%，统计显著性水平为<0.05。
讨论/结论：研究结果将通过其初级保健中心向长期新冠患者及其家属公布。医疗保健专业人员将接受专项培训，以便能够开展和实施干预措施。此外，研究结果将通过会议和出版物向科学界公布。
https://register.clinicaltrials.gov/prs/beta/studies/S000ENW100000080/recordSummary，标识符NCT06492590。
