Protocol Psychological risk factors for Long COVID and their modification: study protocol of a three-arm, randomised controlled trial (SOMA.COV) 2023 Engelmann

Andy

Andy

Retired committee member
Abstract

Background
Growing evidence suggests that in addition to pathophysiological, there are psychological risk factors involved in the development of Long COVID. Illness-related anxiety and dysfunctional symptom expectations seem to contribute to symptom persistence.

Aims
With regard to the development of effective therapies, our primary aim is to investigate whether symptoms of Long COVID can be improved by a targeted modification of illness-related anxiety and dysfunctional symptom expectations. Second, we aim to identify additional psychosocial risk factors that contribute to the persistence of Long COVID, and compare them with risk factors for symptom persistence in other clinical conditions.

Method
We will conduct an observer-blinded, three-arm, randomised controlled trial. A total of 258 patients with Long COVID will be randomised into three groups of equal size: targeted expectation management in addition to treatment as usual (TAU), non-specific supportive treatment plus TAU, or TAU only. Both active intervention groups will comprise three individual online video consultation sessions and a booster session after 3 months. The primary outcome is baseline to post-interventional change in overall somatic symptom severity.

Conclusions
The study will shed light onto the action mechanisms of a targeted expectation management intervention for Long COVID, which, if proven effective, can be used stand-alone or in the context of broader therapeutic approaches. Further, the study will enable a better understanding of symptom persistence in Long COVID by identifying additional psychological risk factors.

Open access, https://www.cambridge.org/core/jour...rial-somacov/9124BF04CA5960D429B93705B2956AE0
 
Further supporting the assumption that illness-related anxiety is involved in the development and maintenance of Long COVID, we found anxiety to be the strongest modifiable predictor of somatic symptom burden after 8 weeks in a prospective cohort study of 1185 healthcare professionals that did not contract COVID-19. In the UK general population, COVID-19-related anxiety has also been found to predict somatic symptoms, particularly fatigue. Consistent with these findings, illness-related anxiety has been found to be a risk factor for PSS before the COVID-19 pandemic in a range of medical conditions, e.g. chronic fatigue, fibromyalgia and irritable bowel syndrome.
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Reference given for that last claim is from Rosmalen's Lifelines study.

Consequently, the expectation of symptoms could be a determining factor for symptom persistence in Long COVID. Similarly, patients’ expectations of symptom severity have been found to be a crucial factor in other conditions, e.g. chronic fatigue.
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This is atrocious :mad:

[sarcasm on] We are really clever, so if we can't explain it, and can't find a reason for a physical symptom, then the patient must be mentally ill because we are never wrong.[sarcasm off]

Petra Engelmann*
Affiliation:
Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Germany
Christian Büchel
Affiliation:
Institute of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, Germany
Jördis Frommhold
Affiliation:
Institute Long Covid, Rostock, Germany
Hans F. E. Klose
Affiliation:
II. Medical Clinic and Polyclinic, University Medical Center Hamburg-Eppendorf, Germany
Ansgar W. Lohse
Affiliation:
I. Department of Internal Medicine, University Medical Center Hamburg-Eppendorf, Germany
Kerstin Maehder
Affiliation:
Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Germany
Yvonne Nestoriuc
Affiliation:
Institute of Systems Neuroscience, University Medical Center Hamburg-Eppendorf, Germany; and Department of Psychology, Helmut Schmidt University, Germany
Martin Scherer
Affiliation:
Department of General Practice and Primary Care, University Medical Center Hamburg-Eppendorf, Germany
Anna Suling
Affiliation:
Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Germany
Anne Toussaint
Affiliation:
Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Germany
Angelika Weigel
Affiliation:
Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Germany
Antonia Zapf
Affiliation:
Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Germany
Bernd Löwe
Affiliation:
Department of Psychosomatic Medicine and Psychotherapy, University Medical Center Hamburg-Eppendorf, Germany
*
Correspondence: Petra Engelmann. Email: p.engelmann@uke.de
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Andy said:
Reference given for that last claim is from Rosmalen's Lifelines study.
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Consequently, the expectation of symptoms could be a determining factor for symptom persistence in Long COVID. Similarly, patients’ expectations of symptom severity have been found to be a crucial factor in other conditions, e.g. chronic fatigue.
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What shameless BS. By 'chronic fatigue', is she, as so many other BPs-ers do, using that as shorthand for Chronic Fatigue Syndrome aka ME/CFS? If so, a) she's lying because that was never found to be the case, and b), I'd like to let her know that every one of us who suffer from this wretched disease fully expected to recover, and quickly, and were shocked when we didn't. Therefore, if we instead end up with crippling 'symptom severity', that's definitive proof for her, and all others who share her belief system, that symptom severity has NO relation to our 'expectations' whatsoever. None.
 
Well, this is why they teach in stats 101 that correlation is not causation. If you confuse them, on purpose or not, you can get lost for decades doing nothing but useless self-serving bullshit like this.

And it's fitting that people who heavily use stats will fail at 101 stuff, just as they are failing at simply listening to the patients in the first place, which is about clinical 101, or should be anyway.
 
I wonder at what stage this study is at. Long covid and ME/CFS patient organisations need to get the message out that this study should be boycotted. When the investigators approach the whole issue with such certainty (e.g. the lead author comes from the Department of Psychosomatic Medicine and Psychotherapy; the misinterpretation of the (ME/)CFS literature) then there is no chance of sound science being done.

In theory, we could stop a lot of this rubbish by educating people that the answer to post-infection diseases is not in psychosomatic theory and cutting off the supply of participants for their nonsense studies and treatment programmes.
 
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we found anxiety to be the strongest modifiable predictor of somatic symptom burden after 8 weeks in a prospective cohort study of 1185 healthcare professionals that did not contract COVID-19
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(I'd be surprised if there are many healthcare professionals that have not contracted COVID-19.)

The reference is Predictors of somatic symptom burden in healthcare professionals during the COVID-19 pandemic: an 8-week follow-up study (2022, Journal of Mental Health). Abstract is —

Aims
As biopsychosocial models propose that not only the disease but also sociodemographic and psychosocial factors contribute to the development and maintenance of symptoms, this study investigates the predictive value of these factors for bothersome somatic symptoms in SARS-CoV-2 negative healthcare professionals.

Methods
German healthcare professionals were assessed with self-rating questionnaires and underwent SARS-CoV-2 IgG antibody tests at baseline and 8 weeks later between April and August 2020. Differences in psychosocial variables between the time points were analyzed and regression analyses were performed to predict somatic symptoms at follow-up.

Results
1185 seronegative healthcare professionals completed both assessments. Previous somatic symptom burden, higher levels of anxiety, being a nurse, younger age, higher psychological symptom burden, lower efficiency, and higher fatigability at baseline predicted somatic symptom burden at follow-up. Comparisons between baseline and follow-up showed a significant improvement in psychological impairment and deterioration of physical exhaustion.

Conclusions
Our study applies a biopsychosocial perspective to bothersome somatic symptoms during the COVID-19 pandemic and contributes to the identification of potential risk factors as a starting point for future interventions that could support the handling of symptoms.


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Those bothersome somatic symptoms again. And just to re-iterate: seronegativity means nothing.

Clinical And Serological Predictors Of Post Covid-19 Condition: Findings From A Canadian Prospective Cohort Study (2023, Preprint: MedRxiv)

Pre-existing polymerase-specific T cells expand in abortive seronegative SARS-CoV-2 (2021, Nature)

Divergent adaptive immune responses define two types of long COVID (2023, Frontiers in Immunology)

Distinct T cell functional profiles in SARS-CoV-2 seropositive and seronegative children associated with endemic human coronavirus cross-reactivity (2023, Preprint: MedRxiv)

Memory SARS-CoV-2 T-cell response in convalescent COVID-19 patients with undetectable specific IgG antibodies: a comparative study (2023, Frontiers in Immunology)

Evidence of previous SARS-CoV-2 infection in seronegative patients with long COVID (2022, Lancet: eBioMedicine)
 
Hutan said:
I wonder at what stage this study is at. Long covid and ME/CFS patient organisations need to get the message out that this study should be boycotted. When the investigators approach the whole issue with such certainty (e.g. the lead author comes from the Department of Psychosomatic Medicine and Psychotherapy; the misinterpretation of the (ME/)CFS literature) then there is no chance of sound science being done.

In theory, we could stop a lot of this rubbish by educating people that the answer to post-infection diseases is not in psychosomatic theory and cutting off the supply of participants for their nonsense studies and treatment programmes.
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Yeah at this point it’s very rare for people to have no access to patient advocacy information at all so in theory we should be able to organise a full boycott of all BPS related research. An indefinite boycott. I’ve long thought this is the way forward to protect individual would be participants from harm and the wider patient population from harm.

Having said that there would be significant obstacles to implementing this particular health and safety practice.

New patients are all gonna be desperate for release from the prison of relentless symptoms and restrictions on their abilities. Terrified of continuing suffering. Scared and scarred by the dominant ideology that tells them that it is their individual responsibility to heal, and drives societal punishments of poverty and reduced social status for all those who fail to meet this requirement.

If previously in good health and insulated from the attitudes within healthcare systems towards patients, there is a decent chance that such new patients will believe medical and physiological professionals are only there to help and always, at least in the collective, have their best interests at heart. That checks and balances actually exist. That ‘evidence based’ means something. Something related to the scientific method. That pseudoscience is something only that exists outside of the realms of trusted institutions.

But even if new patients don’t believe any of this, recruiters for these studies will usually do sufficiently decent marketing as to make a study seem at least somewhat plausibly helpful. Patients want to help themselves and to help others usually.

Also new patients may want, and definitely need to appear compliant with their own healthcare providers. Most patients would be as cooperative as possible with their healthcare providers. This disadvantage and good faith can easily be exploited.

But then I am going to guess that some patients perhaps a decent number may either strongly want to believe, in lieu of other options at least, that they can indeed think themselves better if only someone with experience and expertise could show them how it’s done, or actually believe having already bought into this belief system before becoming unwell.

But also new patients usually won’t know much about this whole landscape, so there will be many ways that researchers can exploit this lack of background knowledge. And it’s really hard to catch up on all this knowledge for sick persons who probably has a hard time absorbing new information or been able to read and listen thanks to their symptoms.
 
Ash said:
If previously in good health and insulated from the attitudes within healthcare systems towards patients, there is a decent chance that such new patients will believe medical and physiological professionals are only there to help and always, at least in the collective, have their best interests at heart. That checks and balances actually exist. That ‘evidence based’ means something. Something related to the scientific method. That pseudoscience is something only that exists outside of the realms of trusted institutions.
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And you can pretty much guarantee papers will be written about such a boycott, which proves that this is clearly due to abnormal psychology and "the bastards don't want to get better".
 
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