Trial Report Videoconference-delivered group cognitive behavioral stress management for ME/CFS patients who present with severe PEM: a RCT, 2023, May

Dolphin

Dolphin

Senior Member (Voting Rights)
https://www.tandfonline.com/doi/full/10.1080/21641846.2024.2306801

Videoconference-delivered group cognitive behavioral stress management for ME/CFS patients who present with severe PEM: a randomized controlled trial

Marcella May
Sara F. Milrad
Dolores M. Perdomo
Sara J. Czaja
Devika R. Jutagir
Daniel L. Hall
Nancy Klimas
&
Michael H. Antoni
show less
Received 03 Aug 2023, Accepted 15 Jan 2024, Published online: 25 Jan 2024


ABSTRACT
Background
In Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), post-exertional malaise (PEM) is associated with greater distress and symptoms. Cognitive Behavioral Stress Management (CBSM) has demonstrated beneficial effects for ME/CFS and may mitigate stress-related triggers of PEM. We tested a virtual CBSM intervention to increase access, and we report on its effects on stress and symptoms in ME/CFS patients with severe PEM.

Methods
Data were from a randomized controlled trial (NCT01650636) comparing 10-week videoconference-delivered group CBSM (V-CBSM, n = 75) to a 10-week Health Information active control (V-HI, n = 75) in Fukuda criteria ME/CFS patients (71 classified as highPEM, 79 lowPEM). Linear regression explored PEM-by-Treatment interactions on overall symptom frequency and intensity, perceived stress, and fatigue-specific interference and intensity, at 5-month follow-up. Logistic regression tested V-CBSM effects on 5-month PEM status. Analyses controlled for age, gender, race/ethnicity, mode of symptom onset, and time since diagnosis.

Results
The sample was middle-aged (47.96 ± 10.89 years), mostly women (87%) and non-Hispanic White (65%), with no group differences on these variables or baseline PEM. For highPEM patients, V-CBSM (versus V-HI) demonstrated medium to large effects on follow-up symptom frequency, symptom intensity, fatigue interference, and fatigue intensity (p’s < .05) and trending to significant reductions in perceived stress (p = .07). Differences were not evident for lowPEM patients. Treatment predicted follow-up PEM status at a trend (p = .058), with patients receiving V-CBSM demonstrating half the risk of highPEM classification versus V-HI.

Conclusions
V-CBSM demonstrates benefits for ME/CFS patients presenting with severe PEM and may reduce the expression of PEM over time.

Trial registration: ClinicalTrials.gov identifier: NCT01650636..

KEYWORDS:


Disclosure of interest
Michael H. Antoni discloses that he is a paid consultant for Blue Note Therapeutics and Atlantic Healthcare, two digital health software companies. He is also an inventor of cognitive behavioral stress management (UMIP-483) and receives royalties for books, treatment manuals and other products associated with this intervention. The other authors declare no conflicts of interest.

https://twitter.com/user/status/1750519421104459938
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I don't have access to the full paper. The abstract is very confusing.What do they mean by highPEM and lowPEM patients? And still using Fukuda criteria...
If by high PEM they mean people who actually experience PEM, then only half the participants have ME/CFS by current research definitions.
If they mean severe patients, then how can they cope with weekly group online training sessions without crashing?

They also seem to be clutching at straws in claiming benefits, with fudged reporting of p values and no mention of correcting for multiple comparisons and all the usual problems of unblinded and subjective outcomes.

Huge conflict of interest in a study run by someone who invented and makes money from the therapy.

What on earth is Nancy Klimas doing putting her name to this rubbish.
 
Abbreviated Introduction —

Cognitive restructuring (i.e. modifying unhelpful thoughts) and behavioral activation (i.e. engaging in pleasant activities) are commonly utilized CBT techniques; however, the manner of their application can vary widely. For instance in the PACE trial, the largest clinical trial on therapies for ME/CFS, CBT was explicitly based on a fear-avoidance theory and designed to increase activity levels by promoting physical/mental engagement and restructuring related thoughts. In contrast, cognitive behavioral stress management (CBSM) is based on a neuroimmune model of ME/CFS and aims to increase stress management skills to improve quality of life and functioning, with cognitive restructuring broadly applied to stressors rather than with the specific intent of increasing activity levels.
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Studies included in the previously cited systematic review of CFS interventions also varied in their CBT approach. Four appeared to use a fear-avoidance model whereas one took a strengths-based approach that emphasized tolerance of illness limitations. Another occupied a middle ground of addressing negative fatigue-related beliefs and promoting consistent, realistic activity levels. Despite distinctions, all were classified as CBT obfuscating effects specific to any particular approach.
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Variations in case definitions for ME/CFS yield a heterogeneous patient group, and thus subgroups may also respond differently to treatment. Post-exertional malaise (PEM), for example, is an exacerbation of symptom burden following mental or physical exertion. However, it is not a necessary symptom for diagnosis according to the Fukuda criteria for CFS which are polythetic and require the presence of four of eight symptoms (e.g. PEM lasting more than 24 h, unrefreshing sleep) in addition to fatigue. The Fukuda criteria were at one time frequently used in research and practice but are now applied less often as they do not reflect current understanding of ME/CFS. In 2015, the National Academy of Sciences published an updated case definition for ME/CFS which does require PEM which was then adopted by the Centers for Disease Control and Prevention. More recently, PEM has been identified as among the three most frequently reported symptoms of ME/CFS along with sleep dysfunction and cognitive dysfunction and these are seen as cardinal features of the disorder. Further, the phenomenology of PEM is now more flexibly defined in order to recognize PEM that may be more brief or delayed.
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PEM is a uniquely distressing symptom of ME/CFS, with higher levels of distress potentially reflecting the challenges of managing a more severe disease. Therefore, PEM may be used to characterize a vulnerable CFS patient subgroup that demonstrates greater need for psychological intervention.
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The neuroimmune model of ME/CFS holds that immunological/hormonal dysregulation is aggravated by stress, with symptoms prompting distress reactions and cyclically intensifying future symptoms. CBSM draws from this model and seeks to interrupt the cycle by increasing adaptive coping skills (e.g. relaxation, coping effectiveness, interpersonal skills) and reducing distress in a supportive group environment.
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If the CBSM intervention is efficacious, then its virtual modalities deserve particular attention for the population of ME/CFS patients. Travel is often physically and mentally demanding, and this is especially relevant to individuals with fatigue-related concerns. Further, some ME/CFS patients are home-bound or bed-ridden and thus entirely unable to access the benefits of in-person treatment.
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Recruitment for the V-CBSM trial, which took place prior to the National Academy of Sciences publication, utilized the Fukuda criteria for CFS to determine eligibility. Therefore, although PEM is now considered a cardinal feature of ME/CFS some of the VCBSM trial participants did not report notable experience of PEM. Given that PEM has been linked to higher levels of circulating pro-inflammatory cytokines the neuroimmune approach of CBSM may be particularly relevant to patients with ME/CFS and those diagnosed with CFS who experience PEM. Further, PEM is likely to inhibit patients from engaging in physically/mentally exerting tasks, thereby compromising quality of life and resulting in feelings of low agency and hopelessness; stress management skills could intervene on these latter domains. Lastly, previous research suggests that emotional experiences may trigger PEM, and as such, emotion regulation skills (e.g. relaxation, coping effectiveness) comprise a large component of the CBSM protocol. Given the importance of PEM in more updated conceptualizations of ME/CFS and the potential fit between the experience of PEM and a CBSM intervention, we sought to reanalyze V-CBSM data separately for patients with and without notable experience of PEM.
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Selected quotes from discussion (from a brief read) —

This study was a secondary analysis of a trial testing the effects of a videoconference-delivered group cognitive behavioral stress management intervention (V-CBSM) on symptoms in patients diagnosed with ME/CFS, considering the moderating role of post-exertional malaise (PEM).
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Patients in our sample were diagnosed with CFS per the Fukuda criteria. Despite that this case definition does not require PEM, 71 of 150 participants (47.3%) reported elevated PEM symptoms (i.e. severe or very severe PEM) at study entry
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Considering all CBT-based treatment approaches to ME/CFS, including those based on fear-avoidance models, equivalent likely obfuscates heterogeneity that would be of consequence to ME/CFS patients. Given the degree of patient mistrust surrounding CBT, facilitating stakeholders’ awareness of differences is vital to ensuring that patients are able to utilize the resources at their disposal.
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PEM is associated with a greater degree of psychological concerns and biophysiological dysregulation in ME/CFS, and the neuroimmune model of CBSM appears well-suited to the vulnerable highPEM patient subgroup. Our results suggest that CBSM may intervene on this vulnerability factor, with patients who received V-CBSM demonstrating less than half the risk of follow-up highPEM classification versus those who received V-HI. Although the present study was limited in terms of characterizing PEM status with a single item, the fact that effects of PEM status were found with our rudimentary measure suggests promising results for future work.
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A stress-related mechanism for latent virus reactivation may underlie both long-COVID and ME/CFS, and may explain some of our findings. Up to 67% of long-COVID patients have shown re-activation of Epstein–Barr Virus (EBV) versus 10% of control participants. We previously found that CBSM decreases EBV viral re-activation markers, as well as other herpes virus re-activation markers, in patients with HIV. Future studies could examine whether CBSM-associated effects on stress and viral re-activation are related to CBSM-associated symptom improvement in patients with ME/CFS and those with long-COVID, particularly as the needs of long-COVID patients are likely to overwhelm healthcare resources.
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OK, so it's a badly written abstract that caused my confusion and rejection out of hand of this research. But I don't think there's evidence that learning to handle stress is the solution to ME/CFS. It may help some people to cope better, but it's not going to cure what I have. Even in my least stressed times, physical activity still makes me crash just as badly.
 
Thanks dit sharing the bits from the paper. It's what I suspected. It's obviously not as harmful as CFS PACE CBT. For some it might be helpful in regards of coping but other than that it seems they're also overstating what it can achieve. I guess it could be a lot worse...
 
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fwiw - A sampling of other publications Klimas has done with Antoni.

Perceived Fatigue Interference and Depressed Mood: Comparison of Chronic Fatigue Syndrome/Myalgic Encephalomyelitis Patients with Fatigued Breast Cancer Survivors
https://pubmed.ncbi.nlm.nih.gov/26180660/

Stress management skills, neuroimmune processes and fatigue levels in persons with chronic fatigue syndrome
https://pubmed.ncbi.nlm.nih.gov/22417946/

Cognitive-behavioral stress management intervention buffers distress responses and immunologic changes following notification of HIV-1 seropositivity.
https://psycnet.apa.org/doiLanding?doi=10.1037/0022-006X.59.6.906

Stress management interventions and psychosocial predictors of progression in HIV-1 infections
Stress and immune function in HIV-1 disease
 
This study was a secondary analysis of a trial testing the effects of a videoconference-delivered group cognitive behavioral stress management intervention (V-CBSM) on symptoms in patients diagnosed with ME/CFS
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If this is a secondary analysis, is there a paper describing the analysis of primary endpoint? The way they’re slicing and dicing the sample in an arbitrary way and looking at interactions makes me think the primary endpoint was negative.
 
Sid said:
If this is a secondary analysis, is there a paper describing the analysis of primary endpoint? The way they’re slicing and dicing the sample in an arbitrary way and looking at interactions makes me think the primary endpoint was negative.
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This paper said:
In the present study, we consider data from a third trial of videoconference-delivered CBSM (V-CBSM) for which results reported on the NIH funding database indicated no overall pre–post intervention effects on change in symptom intensity, symptom frequency, or perceived stress (see ClinicalTrials.gov, NCT01650636). We re-analyze these data from the perspective of a PEM subgroup analysis.
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That trial protocol relates to the published Relationship satisfaction, communication self-efficacy, and chronic fatigue syndrome-related fatigue (2019, Social Science & Medicine)

The results are in the trial registration page. There are no publications listed currently, despite the 2019 paper above which states —

The 2019 paper said:
This study was funded by the National Institutes of Health National Institute of Neurological Disorders and Stroke (NIH/NINDS R01NS072599) and registered under ClinicalTrials.gov (NCT01650636).
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Perhaps they didn't "feel the need" to publish those null primary outcome results in a paper that people might read in J Psychosom Res :whistle:
 
WTH is NINDS funding crap like this? They go around telling us they don't have money but then what little they do have they waste some of it on useless nonsense like this.

And doing a secondary analysis on a null result, about a long-debunked pseudoscientific approach no less, reeks of excessive bias, trying to salvage a result they expected and will find a way to promote no matter what.
 
Sid said:
If this is a secondary analysis, is there a paper describing the analysis of primary endpoint? The way they’re slicing and dicing the sample in an arbitrary way and looking at interactions makes me think the primary endpoint was negative.
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There was an earlier trial where they tested live and telephone CBSM for ME/CFS.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5270375/
 
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