Protocol Cognitive behavioral therapy, exercise training, and cognitive remediation for patients with [LC]: protocol of an open-label [RCT] 2025, Gouraud+

[SNT Gatchaman]

Cognitive behavioral therapy, exercise training, and cognitive remediation for patients with post-COVID-19 condition: protocol of an open-label randomized controlled trial

Spoiler: Authors

Gouraud, Clément; Ancellin-Geay, Agathe; Verot, Corentin; Bergeras, Isabelle; Poudevigne, Laura; Cormier, Lucile; Gilbert, Séverine; Limosin, Frédéric; Lacoste, Laurence; Ribayrol, Diane; Vedrines, Charles Ouazana; Pitron, Victor; Mesbahi-Ihadjadene, Karima; Abdoul, Hendy; Rousseau, Jessica; Kachaner, Alexandra; Ranque, Brigitte; Thoreux, Patricia; Lemogne, Cédric

BACKGROUND
Effective rehabilitation programs targeting transdiagnostic mechanisms of persistent physical symptoms are needed in long COVID. We present a transparency-focused description of the protocol of an open-label randomized controlled trial designed to evaluate the efficacy and tolerance of a multidisciplinary intensive rehabilitation program versus usual care.

METHODS
After a day-hospital multidisciplinary evaluation program including minimal psychoeducation and personalized recommendations, patients presenting with persistent symptoms after COVID-19 are proposed to participate to the study. The intervention consists of a 6-week rehabilitation program with groups of 3 to 5 patients attending three day-hospital sessions per week. The rehabilitation program combines adapted physical activity (three sessions per week with progressive exertion thresholds), cognitive remediation (two computer-based personalized sessions per week) and cognitive behavioral therapy (CBT, two sessions per week: one group session and one individual session). CBT sessions encompass psychoeducation, cognitive restructuring, behavioral activation and gradual exposure, and problem-solving skills. Our primary outcome is health-related quality of life (HRQoL) at 6 months, measured with the Physical Component Score (PCS) of the 12-item Short-Form Health Survey. The secondary outcomes are the Mental Component Score (MCS) at 6 months, PCS and MCS at 3 months, the main persistent symptoms (fatigue, dyspnea, cognitive complaints, pain) and associated psychological burden at 3 and 6 months, and patients satisfaction at 3 months. All included patients undergo an inclusion visit including a physical condition evaluation, a neuropsychological assessment, a first consultation with the CBT therapist, and the completion of several questionnaires for the secondary outcomes (Pichot scale, Borg scale, Cognitive Difficulties Scale, pain numeric scale, and Somatic Symptom disorder-B criteria scale). These evaluations are repeated at 3- and 6-month follow-up. All analyses will be performed in intention to treat following CONSORT Statement recommendations.

DISCUSSION
Our goal is to demonstrate that a multidisciplinary intensive rehabilitation program combining adapted physical activity, cognitive remediation, and CBT leads to an improvement in HRQoL in the long term (i.e., six months after a multidisciplinary evaluation program including minimal psychoeducation and personalized recommendations) in patients with long COVID, while being feasible, acceptable, and safe.

TRIAL REGISTRATION
NCT number NCT05532904, registration date: 2022–09-07.

Web | DOI | PDF | BMC Psychology | Open Access

 

[SNT Gatchaman]

All outcomes, primary and secondary , were patient-reported outcome measures (PROMs) as prespecified in the original protocol

A further limitation of this care protocol lies in the impossibility of blinding patients, and therefore outcome assessors, as the outcomes consisted of PROMs.

Sigh.

 

[alktipping]

I just read the title as punitive behaviour therapy .

 

[SNT Gatchaman]

Regarding adapted physical activity, the original protocol involved an initial exposure to an effort intensity calculated from the results of the previously performed stress test, which corresponds to the proposed protocol for physical activity rehabilitation for other chronic conditions. However, given the massive functional limitations of some patients with long COVID and the feedback of patients included in the first group who reported poor tolerance of exercise training sessions, even for the first exertion thresholds, we decided to propose minimal or even no effort for the first exertion threshold, with a possibility given to the patients to change this for the next sessions. This observation is also consistent with the hypothesis of classical conditioning partially accounting for post-, per- or even pre-exertional symptom exacerbation, which emphasizes the importance of addressing cognitive biases that may hinder appropriate re-exposure.

We also observed poor adherence of the first group of patients to the hypothesis of cognitive and behavioral factors contributing to symptom persistence, contrasting with individual feedback from the multidisciplinary day-hospital CASPer-COVID evaluation program during which the patients were screened for eligibility and provided with minimal psychoeducation regarding these factors.

Based on patients’ feedback, we analyzed that further psychoeducation on cognitive and behavioral mechanisms in group session might have occurred too late in the original rehabilitation program, leaving purely physical interpretations of post-exertional symptom unchallenged. Therefore, in accordance with other CBT programs in long COVID, we then decided to introduce early the hypothesis of cognitive and behavioral perpetuating factors (i.e., during the first CBT group session) as well as the ‘micro-choices’ paradigm (during first the first CBT individual session) to provide patients with alternative explanations of symptoms triggered by exercise and foster adherence to exposure therapy components of CBT.

 

[Sean]

Not only has nothing changed in the BPS school, they are becoming more resistant to change and admitting error.

'It didn't work the first 3454 times, therefore we must try it again but even harder and with more conviction this time.'

 

[NelliePledge]

Cognitive remediation - another brick in the wall

 

[Utsikt]

Based on patients’ feedback, we analyzed that further psychoeducation on cognitive and behavioral mechanisms in group session might have occurred too late in the original rehabilitation program, leaving purely physical interpretations of post-exertional symptom unchallenged. Therefore, in accordance with other CBT programs in long COVID, we then decided to introduce early the hypothesis of cognitive and behavioral perpetuating factors (i.e., during the first CBT group session) as well as the ‘micro-choices’ paradigm (during first the first CBT individual session) to provide patients with alternative explanations of symptoms triggered by exercise and foster adherence to exposure therapy components of CBT.

They found out that patients don’t buy their explanations, so they had to do even more gaslighting.

 

[rvallee]

Our goal is to demonstrate that a multidisciplinary intensive rehabilitation program combining adapted physical activity, cognitive remediation, and CBT leads to an improvement in HRQoL in the long term

And that's why none of this will ever work. This is too much bias. They define success not as doing a proper trial giving an accurate conclusion, but as proving themselves right. Same as it ever is and will be until this madness is stopped. This has been tried hundreds of times for decades and it never works, but it's always said to work, which is why nothing they do will ever work.

Regarding adapted physical activity, the original protocol involved an initial exposure to an effort intensity calculated from the results of the previously performed stress test, which corresponds to the proposed protocol for physical activity rehabilitation for other chronic conditions. However, given the massive functional limitations of some patients with long COVID and the feedback of patients included in the first group who reported poor tolerance of exercise training sessions, even for the first exertion thresholds, we decided to propose minimal or even no effort for the first exertion threshold, with a possibility given to the patients to change this for the next sessions. This observation is also consistent with the hypothesis of classical conditioning partially accounting for post-, per- or even pre-exertional symptom exacerbation, which emphasizes the importance of addressing cognitive biases that may hinder appropriate re-exposure.

Seriously how can any of this ever work out? They literally never accept when they're wrong. This is obviously not deconditioning, especially as classical deconditioning does respond to gentle rehabilitation so even by their own definition they can't be this confused, they just refuse to accept reality. This is cult mentality, it's never wrong, even when it's maximally wrong they interpret this as being right anyway.

We also observed poor adherence of the first group of patients to the hypothesis of cognitive and behavioral factors contributing to symptom persistence, contrasting with individual feedback from the multidisciplinary day-hospital CASPer-COVID evaluation program during which the patients were screened for eligibility and provided with minimal psychoeducation regarding these factors.

They can always find people who will tell them what they want to hear, even if it's not what they're telling them, that's what they hear, and they don't even listen anyway. But it can't make it work. Reality is what happens regardless of what you believe in, but the beliefs are the only thing that matters to them, reality is just some inconvenience they can push through. Well, it's not, but they can pretend, because nothing they do actually matters.

Not only has nothing changed in the BPS school, they are becoming more resistant to change and admitting error.

'It didn't work the first 3454 times, therefore we must try it again but even harder and with more conviction this time.'

They seriously actually are digging further into it. It keeps blowing off in our faces, it keeps failing, but it's our faces being blown off, and they can't even tell the difference. This is actually more extreme than what is happening with RFK Jr and the antivaccine movement, because most antivaccine enthusiasts don't want to die or kill others for their beliefs, they're just confused and will actually get the damn shot if bodies start dropping. This here is deliberate and more than informed enough to know better, and it has already destroyed millions of lives so this is far more fanatical than most extreme antivaccine fantasies.

 

[Trish]

DISCUSSION
Our goal is to demonstrate that a multidisciplinary intensive rehabilitation program combining adapted physical activity, cognitive remediation, and CBT leads to an improvement in HRQoL

That's rather revealing. Surely the goal of clinical trials should be "to find out whether...", not "to demonstrate that..."

 

[Trish]

This is torture. It reminds me of hearing about political re-education camps with brainwashing (cognitive restructuring) and physical punishment (GET). If they include people with PEM, they risk making them much sicker, and if they do make people sicker, they should be struck off. They know the dangers.

 

[Trish]

French team in Paris, psychiatrists and sports medicine people involved.

Ethics declarations​

Ethics approval and consent to participate​

The ECHAP-COVID program (Evaluation et Comparaison d’une prise en charge multi-disciplinaire Hospitalière versus liste d’Attente en cas de symptoms Persistants après un episode aigu de COVID-19) is a prospective unicentric open-label randomized controlled trial that received ethical approval from CPP Est III by the Assistance Publique-Hôpitaux de Paris on 04/05/2022.

The study was designed in accordance with the principles outlined in the Declaration of Helsinki and adhered to relevant French legislation governing research involving human participants. Written informed consent is obtained for every participant to the ECHAP-COVID program. Monitoring of consents during the study will be realized by a Clinical Research Assistant appointed by the sponsor. independent audit planned apart from the sponsor and investigators.

Protocol amendments are submitted to regulatory authorities according to regulatory procedures and then sent to the centers by email. If the protocol is amended with substantial modification, the patient information form is updated.

As this study is not considered as including high risk intervention nor with an invasive outcome, there is no data monitoring committee involved.