Protocol Respiratory biofeedback and psycho-education for patients with post COVID-19 symptoms and bodily distress […] POSITIV, 2025, Dinse, Kleinschnitz+

[SNT Gatchaman]

Respiratory biofeedback and psycho-education for patients with post COVID-19 symptoms and bodily distress: study protocol of the randomized, controlled explorative intervention trial POSITIV
Dinse, Hannah; Skoda, Eva-Maria; Schweda, Adam; Jansen, Christoph; Schmidt, Kira; Konik, Margarethe; Rohn, Hana; Witzke, Oliver; Stettner, Mark; Kleinschnitz, Christoph; Bäuerle, Alexander; Teufel, Martin

A high number of individuals report suffering from physical and psychological sequelae symptoms after COVID-19—the so-called post COVID-19 condition. Commonly reported complaints include physical symptoms such as fatigue, headache, attention and concentration deficits or dyspnea and anxiety, symptoms of post-traumatic stress, or depression. Evidence-based treatment recommendations are still lacking up to this point. Associations between physical and psychological symptoms in chronic diseases are known for a long time. Support in coping with the disease and improvement of self-efficacy can have a positive effect on the course of diseases. For this reason, we designed a randomized, controlled explorative intervention trial as a treatment of bodily distress disorder in COVID-19 recovered persons.

Patients with a post COVID-19 condition meeting to the criteria of the WHO, along with a bodily distress disorder, are randomized in an intervention and control arm (TAU). Randomization takes place after a diagnostic interview, screening, and informed consent. In total, 60 patients will be included in the trial (30 per group). The intervention group receives a cognitive behavioral therapy as a video-conference-based group therapy (6 weeks) and mobile, respiratory biofeedback treatment (for 4 weeks). At several time points, both groups are assessed in terms of psychological and physical health status, treatment expectation, and satisfaction with the intervention. Furthermore, they will get biofeedback examination appointments.

The primary outcome is the change in self-efficacy; secondary outcomes include assessed parameters of mental health, somatic symptoms, and satisfaction with the intervention. Data will be analyzed primarily using R and SPSS. The randomized, controlled, explorative intervention trial POSITIV is one of the very first interventions for patients with post COVID-19 condition and psychological burden due to their different symptoms.

The aim of the study is to generate new evidence and help patients to cope with the disease and thus, increase their quality of life and reduce symptomatology. We expect with a high probability that the patients’ self-efficacy and health status will improve as a result of the intervention.

German Clinical Trial Register (DRKS); DRKS-ID: DRKS00030565. Registered on December 22, 2022.

Link | PDF (Trials) [Open Access]

 

[SNT Gatchaman]

What is unique about the presented intervention is that it is based on the consideration of the multifactorial pathogenesis of post COVID-19. For this reason, patients in the intervention group will receive respiratory biofeedback training, which can influence by learning processes the autonomic nervous system, in addition to cognitive behavioral group therapy to support coping with the disease. Thus, the aim is to improve patients’ self-efficacy in comparison to the control group.

Unique, n. Being the only one of its kind. Unlike anything else.

The secondary outcomes are used to monitor of assessed parameters on mental health, somatic symptoms, and quality control of the intervention. This includes (1) distress, (2) depression, (3) anxiety, (4) quality of life, (5) symptoms of a post-traumatic stress disorder, (6) sense of coherence, (7) somatic symptom burden, (8) symptoms of somatic symptom disorder, (9) symptoms of post COVID- 19, (10) patient satisfaction, (11) patient motivation, and (12) patient expectation

We expect with a high probability that the patients’ self‑efficacy and health status will improve as a result of the intervention.

Totes the mostest and bestest equipoise.

The data management team focus on unbiased endpoint evaluation and data quality, ensuring the trial meets regulatory and scientific standards.

Using subjective questionnaires... in an unblinded study.

Due to the study design, a complete blinding for patients will be impossible.

However, the final analysis is performed by a blind analyst to ensure objective evaluation.

"Objective".

The documentation of adverse events and serious adverse events is conducted in separate tables and line listings for comprehensive analysis to ensure the highest level of safety, although we do not anticipate any serious or adverse events. However, should any unexpected serious adverse events occur (such as suicidal risks or severe depressive symptoms), participants will have access to expert consultation from the study team to ensure they receive the necessary support.

Nothing can go wrong there.

 

[Utsikt]

They submitted the protocol in Dec 2023 after recruitment.

From the last review Dec 2024:

Reviewer: Kirsty Loudon

Reviewer's report:

This is a review by a Senior SPIRIT protocol editor for Trials.

I noted I reviewed this manuscript initially on the 15th March 2024, 9 months ago, when I asked for confirmation when recruitment finished. I am concerned, that I am being asked to review this revised protocol, over two months after the follow up has been completed. This goes against the timelines for publishing in Trials, as it appears that the recruitment was complete when the paper was submitted 2nd October 2023 and thus should have been rejected during screening. As it has been in the system for over a year, I am unsure what to do, so will pass on the responsibility to the associate editor.

 

[rvallee]

This feels like it was written by a very junior intern. Maybe it comes off better in its original German, but the problem isn't grammar, it's the infantile notions behind. Looks completely unserious, and not surprising given Kleinschnitz. It's really awful that the medical profession is incapable of dealing with miscreants like this. It would be exactly like funding a prominent HIV denier for AIDS research.

The primary outcome is the change in self-efficacy

This is not a serious primary outcome.

We expect with a high probability that the patients’ self-efficacy and health status will improve as a result of the intervention

Yes, that's the problem. We know they expect that, despite there being zero reason to. Because this is corrupt pseudoscience, not research.

However, the final analysis is performed by a blind analyst to ensure objective evaluation.

This is not what objective means, and there is no amount of being lost in translation that can make up for that. This is like saying "I'm taking the stairs down to get to the roof".

People talk a lot about late-stage capitalism, but late-stage medicine brain has the same problems, the same rot and induced misery simply to please a small number of extremists, and to protect stakeholders in industries that should have long ago ceased to exist, but have achieved regulatory capture.