Open Effectiveness of Acceptance Commitment Therapy or Micro Breaks in Patients With Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis

Sly Saint

Sly Saint

Senior Member (Voting Rights)
Not yet recruiting

Sarah Schiebler, University of Zurich

Estimated Study Start Date : January 2022

Brief Summary:
Chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME) is a distinct disease entity with an estimated prevalence of 0.3-0.7% and more common in women (3:1 ratio). It can be diagnosed according to the Institute of Medicine (IOM) 2015 consensus definition using 3 major criteria and one of 2 minor criteria.

Diagnosis requires that the patient have the following three symptoms:

  1. A substantial reduction or impairment in the ability to engage in pre-illness levels of occupational, educational, social, or personal activities that persists for more than 6 months and is accompanied by fatigue, which is often profound, is of new or definite onset (not lifelong), is not the result of ongoing excessive exertion, and is not substantially alleviated by rest,
  2. Post-exertional malaise,* and
  3. Unrefreshing sleep*
At least one of the two following manifestations is also required:

  1. Cognitive impairment* or
  2. Orthostatic intolerance
Note* Frequency and severity of symptoms should be assessed. The diagnosis of ME/CFS should be questioned if patients do not have these symptoms at least half of the time with moderate, substantial, or severe intensity.

Currently, individually tailored therapy with emphasis on cognitive behavioral therapy and graduated activity therapy is considered the therapy of first choice, although their effectiveness has been critically questioned in recent years. There are often frustrating treatment courses, a larger proportion of partial remissions, a significantly smaller proportion of full remissions and return to work.

The study aims to evaluate patients of the outpatient service for chronic fatigue at the Department of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich, Switzerland, in the context of a group therapy for the treatment of CFS/ME in respect to the response to different, non-drug based therapeutic procedures and to gain knowledge about the effects of the therapy.

The study is a clinical comparative study of therapeutic procedures/interventions without the use of drugs or a medical product. The interventions are Acceptance Commitment Therapy (ACT) and Micro Breaks in Everyday Life (MBEL) adapted to CFS/ME. The collection of biological samples (saliva, blood) and health-related personal data (actigraphy, psychometric data from questionnaires) is associated with minimal risks and burdens.

https://www.clinicaltrials.gov/ct2/show/NCT05168124
 
Sly Saint said:
The collection of biological samples (saliva, blood) and health-related personal data (actigraphy, psychometric data from questionnaires) is associated with minimal risks and burdens.
Click to expand...

Funny that they don't assess the risks and burdens associated with their 'therapies', isn't it?

I do hope everyone writes that in red ink all over the bloody questionnaires. In addition, obviously, to enquiring whether all these so-called studies are actually the insurance company equivalent of internet fraudsters' Facebook quizzes, masquerading as medical research.
 
Acceptance and commitment therapy sounds to me like "suck it up and get lost" therapy. Alternatively it also sounds "religious" to me i.e. God gave you these burdens to bear and ACT will help you to do it with a big glowing smile on your face like religious paintings of the saints.
 
By way of running this through a Department of Consultation-Liaison Psychiatry and Psychosomatic Medicine, this study would never get more than a tiny % of ME patients, and only get the mildest cases of chronic fatigue sent their way. Unless they completely hide the association, most ME patients would simply refuse to take part.

In addition to how utterly useless this is to begin with, as if doing this for the 100th time adds anything. Do they not have any self-respect? What is even the point of this? Other, of course, than promoting the mindless nonsense of psychosomatic ideology. Which is of course the only point here. Zero understanding of what they're studying, how could they even interpret anything even if this were useful?
 
This is the description of the micro breaks intervention from the protocol:

Active Comparator:
Micro breaks in everyday life for chronic fatigue
Micro breaks in everyday life (MBEL) includes restructuring the patients' daily routine in terms of how they organize their breaks. A therapy manual is developed for this purpose, which is divided into three phases. In the first phase, patients learn to allow or integrate regular MB of one to five minutes in their daily routine. Appropriate examples are used to show when and where MB can be incorporated and this is practiced at home over the first few weeks until a routine has been established. Patients are encouraged to keep a break diary. In the second phase, the MBs are filled in with content. MB can be designed differently, e.g., with physical activity of moderate or high intensity, with short breathing or relaxation exercises, with nutrition or even with doing nothing. In the third phase, an individual optimization of the design of breaks in everyday life follows and an expansion towards meaningful mental time-out, a combination of relaxation break and mental activation.

Behavioral: Micro breaks in everyday life for chronic fatigue
In terms of break design in the work context, research in recent years has increasingly focused on so-called "micro breaks" (MB) - mini breaks of one to five minutes in length. Transferred to mini breaks in everyday life (MBEL), there have been found fundamentally positive effects in terms of performance, vitality and well-being, which could also have a positive impact on the clinical picture of CFS/ME. However, practically no research results are yet available with regard to the implementation of MB in everyday life of patients with CFS/ME. The effects of MB, on the other hand, have been tested several times in everyday work settings and showed desirable effects on mood, attention, fatigue, vitality, performance, and well-being.
Click to expand...

That seems to be designed for people suffering stress at work, not for sick people.
 
I'm too ill to stick to most treatment programs anyway, even the simplest ones that just require taking a pill every day for months.

Sticking to a plan seems to be a kind of repeated exertion for the brain, and like with physical exertion it becomes harder over time, unless it's very rewarding and interesting. Microbreaks are boring and at best pacing under another name. They don't stand a chance.
 
Last edited:
Jonathan Edwards said:
I seem to have the Omicron this week.

Based on what I have heard and what it is like to have omicron, if it were me with ME I couldn't even cope with working out when my next Mabel was.
Click to expand...

My son seems* to have it, too. Congestion! weird stabbing head pain! Since it's the USA, there's nowhere open *to test, no tests available at less than $200 a pop. Someone in his coterie did test positive/timing is apropos.
 
Yea usual crap (maybe not appropriate on the day that's in it) reminds me of @strategist and @Jonathan Edwards comments here* "system that allows even homeopathy to reach the status of evidence based treatment for almost any condition (if sufficiently subjective endpoints are chosen)". The endpoints here are, of course questionnaires** in an unblinded/inadequately blinded study.
How did this study make it through the University ethics committee i.e. as the endpoints mean that the data is unreliable/unusable and an alternative (reliable) objective outcome indicator is available - Actimetry (FitBit type devices)?

Does anyone know how to make a compliant to the University etc? @Brian Hughes


*
https://www.s4me.info/threads/indep...ed-by-hilda-bastian.13645/page-80#post-390309

**
"Primary Outcome Measures :
  1. Fatigue Severity Scale (FSS) [ Time Frame: The entire duration of the study is 3 years. ]
    The FSS comprises 9 questions, by answering which the patient can assess his limitations due to fatigue of the past week on a 7-point scale. The FSS is considered a well-established assessment tool for surveying subjective fatigue, the resulting limitations in daily, social, as well as occupational life and physical activities. Total score 36-52 is indicative of moderate fatigue ("mild/ no fatigue" at FSS total ≤ 35, "moderate fatigue" at 36 ≤ FSS total ≤ 52), score greater than or equal to 53 is indicative of severe fatigue ("severe fatigue" at FSS total ≥ 53)."
https://www.clinicaltrials.gov/ct2/show/NCT05168124
 
You must log in or register to reply here.
Back
Top Bottom