Protocol Assessing a multicomponent intervention to improve quality of life in individuals with Long COVID COVIDL/MIQoL: study protocol…, 2025, Morera+

Assessing a multicomponent intervention to improve quality of life in individuals with Long COVID COVIDL/MIQoL: study protocol for a randomized controlled trial
Morera, Mireia; Arévalo, Antonio; Garriga, Cristina; Corral-Magaña, Marta; García-Arqué, Mari Carmen; Gragea-Nocete, Marta; Pérez Díaz, Cristina; Roca, Ramon; Llistosella, Maria

INTRODUCTION
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.

METHODS
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 p < 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.

CLINICAL TRIAL REGISTRATION
https://register.clinicaltrials.gov/prs/beta/studies/S000ENW100000080/recordSummary, Identifier NCT06492590.

Link | PDF (Frontiers in Public Health) [Open Access]

 

Usual unblinded, subjective outcomes crap. CBT and GET. Modern Neuroscience™.

 

"Cos, we really do have the appropriate amount of equipoise about whether this treatment will work to undertake the study without bias. The fact that we include a plan to subsequently train healthcare professionals on how to implement the intervention in our study protocol says nothing about our certainty that this treatment will be successful. But, you know, fine ships progressing safely to the harbour as expected and all that. And this trial design has proven itself to be very useful in the past. "

 

Team from Barcelona, Spain.

What an odd consideration to note in a protocol. I guess it's just a convenient side effect that the hushing up of any crisis or exacerbation will help avoid loss of confidence on the part of other participants, and makes it a whole lot easier to brush it under the carpet.

Why exactly should any symptom exacerbation during the study be thought to cause stigmatisation? Is the implicit suggestion that anyone who experiences such an exacerbation might be seen as a failure?

 

It was developed following the framework of Central Sensitivity Syndrome,

So, a bust from the start.