JellyBabyKid
Senior Member (Voting Rights)
Maybe they are in need of CBT to deal with their false usefulness beliefs...?
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Effectiveness of psychosomatic therapy for patients with persistent somatic symptoms: Results from the CORPUS... 2023 Wortman et al
- Thread starter Andy
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Maybe they are in need of CBT to deal with their false usefulness beliefs...?
Joan Crawford
Senior Member (Voting Rights)
Ha ha, perhaps but please don’t refer them my way.... I might struggle to provide them with the core conditions
I've put the data into an excel spreadsheet .
There is no relationship between the data in Table 2 and Table 3 for PSC1.
The abstract correctly reports a positive difference between intervention and controls at 12 months for the people classed as moderate of 0.91. (I make it 0.92: change in moderate intervention is -2.09, change in moderate control is -1.17, but that could be rounding).
Importantly, the abstract fails to note that there was a negative difference between intervention and controls at 12 months for the people classed as severe. I make it a negative difference of 0.67: change in severe intervention is 1.18, change in severe control is 1.85. Therefore the severe controls had a bigger improvement in their capacity to do the activity they identified as most important to them than the severe intervention did.
If we combine the data for the intervention group (moderate plus severe) and the control group, the intervention group had a benefit of 1.61 over the 12 months. The controls had a benefit of 1.45 over the 12 months. The difference between the two cohorts for PSC-1 is 0.16. This is a very small difference and was presumably found to be non-significant.
Table 2 should be showing the results of that last calculation - the results at 12 months of a comparison of the changes for the intervention and control groups. But the figure reported is 0.25 (not 0.16). They did some 'adjusted' calculations that made the difference a bit bigger but still pretty small.
Dave, re the figures in the bottom right of Table 3: I don't think they are for the intervention and controls combined, despite the column labels, which look to be a mistake. For the moderates, the -0.91 number reported is the difference in outcomes for intervention and controls. But, for severe, they seem to have done the calculation wrong. They report +0.32, when, as far as I can see, it should be +0.67, as I noted above. That is, the severe intervention had a smaller reduction in the difficulty of function score for PSC1 than the severe controls did.
So, the calculations are either a mess of stuff-ups or they have explained what they did incredibly badly. Or both.
Andy
Retired committee member
Trial By Error: A Crap Study on “Psychosomatic Therapy” for “Persistent Somatic Symptoms”
"Dutch investigators appear to be on a roll—they are producing so much crap that it is hard to keep track. (I have recently written multiple posts about a Dutch study of CBT for fatigue associated with long Covid.) The latest to come to my attention is a real mess called “Effectiveness of psychosomatic therapy for patients with persistent somatic symptoms: Results from the CORPUS randomised controlled trial in primary care,” published in the Journal of Psychosomatic Research."
https://virology.ws/2023/10/26/tria...atic-therapy-for-persistent-somatic-symptoms/
"Dutch investigators appear to be on a roll—they are producing so much crap that it is hard to keep track. (I have recently written multiple posts about a Dutch study of CBT for fatigue associated with long Covid.) The latest to come to my attention is a real mess called “Effectiveness of psychosomatic therapy for patients with persistent somatic symptoms: Results from the CORPUS randomised controlled trial in primary care,” published in the Journal of Psychosomatic Research."
https://virology.ws/2023/10/26/tria...atic-therapy-for-persistent-somatic-symptoms/
Version of a comment posted in response to Dave's article.
The paper said:”Due to our selection procedure we may have included patients who did not always expect a psychosomatic approach.”
@dave30th said: “Are the investigators suggesting that participants were too stupid to read or understand the materials provided to them in the course of enrollment?”
Regarding that comment Dave, there is another interpretation, which is the one I suggested further up the thread.
It is possible that there was a lack of clarity about what the trial was aiming to do, both from the referring GP and the researchers. The authors say that the prospective participants received a pack with extensive information. It would be interesting to see that pack, but, in any case, both the referring GP and the researchers should have checked that the participants understood that this was a trial aiming to fix their psychosomaticism. In that sentence, the researchers seem to be admitting that some of their trial participants were not aware of the nature of the intervention. We know that many practitioners of psychosomatic therapy think concealment is fine, and in fact believe the therapy is more successful when the patient is not aware. See for example Diane O’Leary’s recent You Tube presentation about the ethical problems of this where she quotes Simon Wessely’s ‘To tell or not to tell’ 1999.
The possibility of a lack of clarity about the nature of the intervention raises questions about the study’s approval process, and about the level of respect the GPs who participated in the recruitment and the investigators had for the participants’ autonomy.
The paper said:”Due to our selection procedure we may have included patients who did not always expect a psychosomatic approach.”
@dave30th said: “Are the investigators suggesting that participants were too stupid to read or understand the materials provided to them in the course of enrollment?”
Regarding that comment Dave, there is another interpretation, which is the one I suggested further up the thread.
It is possible that there was a lack of clarity about what the trial was aiming to do, both from the referring GP and the researchers. The authors say that the prospective participants received a pack with extensive information. It would be interesting to see that pack, but, in any case, both the referring GP and the researchers should have checked that the participants understood that this was a trial aiming to fix their psychosomaticism. In that sentence, the researchers seem to be admitting that some of their trial participants were not aware of the nature of the intervention. We know that many practitioners of psychosomatic therapy think concealment is fine, and in fact believe the therapy is more successful when the patient is not aware. See for example Diane O’Leary’s recent You Tube presentation about the ethical problems of this where she quotes Simon Wessely’s ‘To tell or not to tell’ 1999.
The possibility of a lack of clarity about the nature of the intervention raises questions about the study’s approval process, and about the level of respect the GPs who participated in the recruitment and the investigators had for the participants’ autonomy.
good points! thanks for pointing this out. I read it as straining for an explanation. I can't remember another paper in which the authors have offered lack of participant understanding as a reason for a trial's failure to generate positive results. Since this was the entire premise of the trial, it's hard for me to see how the participants could not have been aware of it. But who knows??
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As Andy said, the treatment is pretty much CBT and GET. I think, there have been a lot of BPS trials, perhaps even most, where it is not made clear to the participants that such treatments are aiming to correct psychosomaticism.
It would be great to get hold of the information pack and hear from the participants what they were told by their GPs and the investigators.
How can they not discuss this in the paper and be precise about whether the death was related to the PSS ( IE problem that was ignored or misdiagnosed as psychosomatic) or was related to suicide? in both cases, the treatment and diagnosis presents safety issues
Ash
Senior Member (Voting Rights)
I favour this explanation.
Though I haven’t read this study so perhaps it wasn’t the case there.
I can imagine patients talking and thinking about their illnesses a bit differently to how we generally do in my country. But still I cant imagine the researchers being fully honest with their participants and still getting numbers in.
What I am imagining is some countries put more pressure on to their sick than others to participate in harmful treatment.
There is a lot of pressure here in the UK and it seems one of the few places to be even more obnoxious to their sick than here is the Netherlands.
From my own experience, and other people I’ve known with ‘contested’ illnesses or biomedically neglected diseases, including ME, whenever we involve ourselves with the medical system and find ourselves having either to or desperate enough to engage the surrounding branches of healthcare where you might be passed about, physio, respiratory physio, occupational health and psychologists through Fatigue Clinics etc, they never ever lay out up front that they think you’re mentally deficient, dysfunctional emotionally broken or whatever else they choose to view you as.
Any healthcare practitioner will always start acknowledging your physical limitations and explaining that they understand how difficult it is to live with (they don’t do this well it’s usually obvious they don’t but sometimes they put more effort in than others and that because of this burden you’re saddled with, that as a patient your bound to be more stressed than usual (read than other people who manage stress well and properly) and possibly feel somewhat ‘overwhelmed’. That you’re overwhelmed is of course likely true. Being disabled and forced into interaction with these people and this system, as well as being in pain and or poverty due to untreated conditions and loss of income opportunities.
At no point even after model participation did they say ‘are you see now, you were fully mental but now you’re a bit less mental!’
They always frame it as supporting you because you physical health is a burden. You know the old ‘People with cancer can benefit from CBT!’(I doubt that myself but you get the idea)
Because I engaged with these clinics and showed willing to turn up and listen to their warped perceptions, I was able to claim benefits and stay alive. Unfortunately did me serious lasting psychological damage to be exposed to this manipulation and exploitation, while these people had such power over my material life.
I can imagine it’s a small step to recruit unserved patients into a study so they feel some hope at least temporarily.
Maybe the authors of this study were less sly more bold but, their admission that their participants had some confusion over the direction of the research makes me doubt it.
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Ash
Senior Member (Voting Rights)
Thanks!
In that case do you think it’s more a case that they got at least reasonable (although as you say we don’t know what proportion) numbers of subjects who were super invested in this ideology and even then the study fell short of the positive results that this ideology had primed both these and researchers for?
…And they are trying to blame this on the subset of participants who weren’t sufficiently primed?
It's a good question, and without knowing more details I think it's not really possible to know. It's also very possible that people didn't really realize what they were getting into. Or it could be a mix of both. But it's really an own goal to suggest that people didn't have enough knowledge about what the study was about and that's why it failed to produce good results. As Hutan suggests, it is of course the responsibility of researchers to ensure that participants have a clear understanding of the study and its approach and goals. If participants did not, it certainly speaks poorly of the ethics and methodology of the investigators.
ME/CFS Skeptic
Senior Member (Voting Rights)
Yes really misleading. Supplementary material C shows that PSC-2 and PSC-3 showed no statistically significant difference between the group. Makes me think the result was also not significant if the three questions were combined. And if they corrected for multiple comparisons, none of the difference was probably significant.
ME/CFS Skeptic
Senior Member (Voting Rights)
I don't interpret it as that the participants weren't properly informed ('lack of clarity about what the trial was aiming to do') or that they think patients were too stupid to understand the materials.
It feels more like a criticism that patients weren't willing enough to go along with the researchers' psychosomatic view (similar to what the Norwegian LP proponents have argued for their trial). Apparently, you have to be willing to become a true believer in order for the treatment to work properly. It seems that the researchers were disappointed by the lack of response bias of their participants.
ME/CFS Skeptic
Senior Member (Voting Rights)
The authors write:
Effectiveness of a cognitive behavioural intervention for patients with undifferentiated somatoform disorder - 2019 Sitnikova et al. (CIPRUS trial) | Science for ME (s4me.info)
"For patients with moderate PSS, psychosomatic therapy seems to be effective compared with patients with severe PSS. This is in agreement with a previous study with an individual, nurse-led CBT-based intervention for patients with PSS [28] that was particularly suitable for patients with symptoms that had been present for a limited number of years and with few comorbid physical diseases."
Reference 28 is another Dutch study with similar null results that received a positive spin by looking at subgroups, small effect sizes and by not correcting for multiple comparisons. I've made a thread about it here:
Effectiveness of a cognitive behavioural intervention for patients with undifferentiated somatoform disorder - 2019 Sitnikova et al. (CIPRUS trial) | Science for ME (s4me.info)
ME/CFS Skeptic
Senior Member (Voting Rights)
The description of the treatment is so vague, it is hard to know what exactly it entailed. I wish it was common standard to include the treatment manual or a link to it. It must exist as the paper writes: "The therapists received an intervention manual describing the sessions"
he he
Peter T
Senior Member (Voting Rights)
I have not read the full paper, but suspect that @ME/CFS Skeptic is on the right track.
Many years ago I was the subject of a research trial looking at the effects of specific food supplements (I think fish oil) on our condition. I went into the trial with no preconceptions about whether it would work or not, and I have no idea if I was in a control arm or a placebo arm, and went into the study happy to go along with the idea that ME was a result of both biological and psychological issues. I was seen by the lead researcher who was a psychiatrist who started each visit with the standard endless questionnaires, but also with a discussion of my health. It quickly became apparent that it was very important to her that I acknowledge my ME was primarily psychological. Her entrenched position stimulated me to examine my experience more critically and lead me to the conclusion that my symptoms better fitted a biomedical model.
Following the questionnaires and the researcher’s evangelism slot a blood sample was taken. The first time a sample was taken from my arm, it was done with me sitting and my sleeve rolled up; the next time the researcher insisted I strip to the waist; it felt that she was deliberately asserting her power because I would not accept her understanding of my condition. On the third visit she insisted I strip to the waist and lie down, I argued that this was unnecessary and citing that previous occasions, but she denied that she had ever taken blood other than with me stripped to the waist lying down and asserted that no alternative was possible.
Given the ongoing unpleasantness and that her obsession with me adopting her understanding of ME which was irrelevant to the stated objectives of the study (also creating scope for significant researcher bias effects), I did not bother to complete the study. I was never contacted to ask why I had dropped out
I suspect the subjects in the current study were told that the set of interventions would?may help with their condition, that they might not even have thought much about any theory behind the intervention, just willing to try anything that might possibly help. So for some subjects, they might only have strengthened their view point as to a biomedical aetiology when they thought about their experience in the context of the researchers seeking to impose their understanding on them in the course of the experiment.