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

[SNT Gatchaman]

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]

 

[SNT Gatchaman]

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

The participant groups and personnel (research team) will not be blinded given the difficulty of masking the conditions.

The multicomponent intervention was developed by an expert committee consisting of: psychologists, nurses, physiotherapists and people with Long COVID. It was developed following the framework of Central Sensitivity Syndrome, using empirical evidence and contextual information.

The psycho-education will consist of 9 sessions of 90 min: one per week, in groups with a maximum of 16 participants. The topics covered during these sessions with a specialized therapist will include: (1) education in neuroscience relating to the symptomatology of Long COVID; (2) Mindfulness; (3) Cognitive Behavioral Therapy; and (4) Strategies for self-healing. The physical rehabilitation will consist of 9 sessions of 60 min: one per week, conducted by an expert physiotherapist. Each session will work on 4 areas, following a progressive approach: (1) warm-up and aerobic exercises (25 min); (2) functional and muscle-strengthening exercises (10 min); (3) proprioception exercises (10 min); and (4) breathing exercises (10 min).

This clinical trial does not test participants for medications or perform any invasive tests. It can therefore be considered low risk and no specific insurance will be taken out. However, the research team agrees that in the case of detecting a participant with a clear risk, such as depression, or with a re-exacerbation of Long COVID symptomatology, such as dyspnoea, the therapist, physiotherapist and research team must inform the participant’s referring doctor/ nurse at their primary health care center. If the participant suffers a crisis or an exacerbation that requires urgent attention, either during the intervention sessions or the study, the emergency service of the primary care center where the sessions are taking place will be notified in order to immediately assess the participant’s condition. A member of the participant’s family will also be contacted if necessary, and/or if requested by the participant. Confidentiality will be maintained at all times to avoid the stigmatization of the participant.

Quality of life will be the primary outcome and will be measured using the EuroQol5D-5L scale.

Well-being will be assessed using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS)

Mental health problems, such as anxiety and depression, will be assessed using the Hospital Anxiety and Depression Scale (HADS).

Resilience will be measured using the Connor-Davidson Resilience Scale (CD-RISC).

Physical condition will be assessed using the International Physical Activity Questionnaire (IPAQ) and the Chalder Fatigue Scale.

 

[Hutan]

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.

"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. "

 

[Hutan]

Team from Barcelona, Spain.

If the participant suffers a crisis or an exacerbation that requires urgent attention, either during the intervention sessions or the study, the emergency service of the primary care center where the sessions are taking place will be notified in order to immediately assess the participant’s condition. A member of the participant’s family will also be contacted if necessary, and/or if requested by the participant. Confidentiality will be maintained at all times to avoid the stigmatization of the participant.

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?

 

[alktipping]

The scales they have chosen to use tell you all you need to know. Avoid these people like the plague .

 

[Sean]

It was developed following the framework of Central Sensitivity Syndrome,

So, a bust from the start.

 

[rvallee]

Oh, another one? Just like all the dozens of others, too? Even have the marketing plan all prepared for it, as is tradition? And it's literally the current standard approach, widely deployed on hundreds of thousands for 4+ years of LC, and years before that? Even though it obviously doesn't work? But they keep pretending that it does, while continuing to "test" it? Well, who could object to that, then? Much serious research.

It was developed following the framework of Central Sensitivity Syndrome

Fuck it, why not based on water having memory? Or ghosts? Or gravitational waves?

I wonder why modern health care is losing the information battle. Such a deep mystery.