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

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

• Cite this article
  
• https://doi.org/10.1080/21641846.2024.2306801

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:

• myalgic encephalomyelitis
• chronic fatigue syndrome
• post-exertional malaise
• cognitive behavioral stress management

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.

 

Lies, damned lies, and statistics

 

Hm. Nice try I guess. Curious about the paper though.

 

Abbreviated Introduction —

 

Selected quotes from discussion (from a brief read) —

 

that's what I wondered.

 

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...

 

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

 

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.

 

Trial protocol here:

https://classic.clinicaltrials.gov/ProvidedDocs/36/NCT01650636/Prot_SAP_000.pdf

 

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 —

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

 

That paper analysed baseline data as far as I can tell.

 

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.

 

There was an earlier trial where they tested live and telephone CBSM for ME/CFS.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5270375/

 

No bottle-at-sea cohort? Disappointed.