Mind Body Intervention for COVID-19 Long Haul Syndrome

From Clinical Trials
Detailed Description:
This study is a pilot and feasibility study to determine if a mind-body program that we have previously developed for chronic back pain can improve the multiple somatic complaints associated with the COVID Long Haul Syndrome in patients without evidence of ongoing tissue injury. We will perform a 12-week intervention consisting of a series of classes which will focus on knowledge therapy, desensitization, emotional expression, and stress reduction.
Open label, tick
No active control arm, not even a wait list group to give some idea about the impact of natural recovery and disease fluctuation, tick
A primary measure and long list of secondary measures, all subjective, all ready for cherry picking, tick
Selective Inclusion criteria: "Willingness to consider mind-body intervention", "The participants will receive an initial one-on-one interview", tick

BPS trial design ready to produce spurious results? Tick. Indeed, the job is done.
 
From their previous paper Psychophysiologic symptom relief therapy for chronic back pain: a pilot randomized controlled trial (2021) [PDF] —

Psychophysiologic symptom relief therapy is based on the hypothesis that nonspecific back pain is the symptomatic manifestation of a psychophysiological process that is substantively driven by stress, negative emotions, and other psychological processes. This intervention addresses underlying stressors and psychological contributors to persistent pain (including underlying stressful conflicts and aversive affective states), as well as conditioned pain responses and fear-avoidant behaviors. Treatment strategies in the first 4 weeks include psychophysiologic pain education, desensitization, and emotional expression. Given this focus during the first 4 weeks, our data collection and analysis plan allowed for assessment both at this juncture and beyond. The last 8 weeks of this program focused on mindfulness meditation (MBSR) whose goal is to provide the tools to better process current and future stressors while allowing for time to practice techniques learned earlier in the program.
 
Cutting edge stuff. As it has been for forty years. This was where Waddell came in.

Some people who report being disabled by "low back problems" may rarely suffer pain because they are so successful at avoiding activities believed to cause it. In such cases pain is believed to indicate "harm". there is little evidencet hat such is the case (Nachemson 1979, 1982, Hall 1980, Flor and Turk1984)....

As a result many self imposedl imitations in work related and leisure activities can occur, not because the level of discomfort is intolerable or even uncomfortable, but rather because of mistaken beliefs and related unnecessarry fear about what that pain indicates. In addition the natural healing processes of the body are retarded by disuse and promoted by use (Bortz 1984)


That was Arthur Cott in 1986 from his paper to the 1985 International Conference on Illness Behaviour in Toronto. With no particular evidence base the theory was transported into ME.

The only thing we learn from history is that we learn nothing from history. As Hegel probably almost said.
 
I’ve tried reaching out to this guy on Twitter a multitude of times. I suggested he contact David Systrom and a plethora of other Boston researchers as this is where Donnino is located.

From what I can tell, and I believe it’s been touched on elsewhere, Donnino suffered some low back pain and now considers himself a luminary in post-viral illness. Always disappointing that nobody pushes back on this publicly. I hope some of our researchers illuminate the myriad flaws when the positive results are inevitably shared.

{Edited to add}: Beth Israel in Boston, where this is taking place, is an eminent institution. I fear this will be taken far more seriously than it should, which is not seriously at all of course. Might be best to try and highlight the deficiencies beforehand, but aside from this forum I’m unsure as to the best mechanism for doing so.
 
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This dude actually replied somewhere on twitter that their thing is novel and special and whatever. It's literally the exact same crap as always. Everything biopsychosocial is branding and labels, there is no substance to it at all. Nothing but applying transparent stickers onto hot air.

Seriously, though, this is exactly the same process as homeopathy in that the substance is completely irrelevant. Only labels and sales pitches.
 
Here is the clinical trials entry for his study, https://clinicaltrials.gov/ct2/show/NCT04854772

"Detailed Description:
This study is a pilot and feasibility study to determine if a mind-body program that we have previously developed for chronic back pain can improve the multiple somatic complaints associated with the COVID Long Haul Syndrome in patients without evidence of ongoing tissue injury. We will perform a 12-week intervention consisting of a series of classes which will focus on knowledge therapy, desensitization, emotional expression, and stress reduction."
 
I guess the success of BPS for back pain provides a lot of the motivation for the belief that it should also work for fatigue. Is the research showing that it works for back pain on a good footing? Does anyone know of threads here anywhere discussing that?
 
I would strongly suspect that any trials for back pain from BPS would be just as bad as the trials they do on CFS. The stunning results for fatigue in the PACE trial are used to promote CBT and GET for MS, rheumatoid arthritis and others so building on a false foundation is common in mind/body proponents.
 
I recall a few studies looking at exercise for backpain which showed no real effect in the short term but longer term had better outcomes (people who exercise regularly are healthier than those that dont!). I haven't yet seen anything that is actually effective for backpain really, surgery has a terrible history and can often make things much worse. I would go as far as saying we don't know what causes chronic backpain, its no different to all the other chronic pain we can't explain and currently put into the BPS model that so far has managed to cure nothing.
 
https://www.medrxiv.org/content/10.1101/2022.10.07.22280732v1

Donnino strikes with incredible ineptitude. No control group, open label, selection bias with participants, sample size of 23, and subjective, self reported outcomes. I’m sure further funding will emerge for this nonsense. What a disappointing state of affairs. Long Covid has only emboldened the psychosomatic nonsense. It’s yet to reach the summit
 
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