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

[Hutan]

The collection of biological samples (saliva, blood) and health-related personal data (actigraphy, psychometric data from questionnaires) is associated with minimal risks and burdens.

So maybe try to get the study protocol modified (to include actimetry) and hope that the next research project they do holds more promise than this one.

Thanks for your efforts on this FMMM1. Just to note though, this trial does seem to have actimetry outputs. Of course that doesn't compensate for the many problems of the trial including its underlying premise, or guarantee that the actimetry results will actually be reported in the resulting paper.

 

[FMMM1]

Thanks for your efforts on this FMMM1. Just to note though, this trial does seem to have actimetry outputs. Of course that doesn't compensate for the many problems of the trial including its underlying premise, or guarantee that the actimetry results will actually be reported in the resulting paper.

Interesting I seem to have missed that. Here's an extract from the study protocol:
"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"


Are there additional (secondary?) outcome measures?

I should have included in my post that I copied my email to one of the Swiss ME/CFS societies "sgme" EDIT - Swiss Society for ME & CFS. Also tried the other Swiss group https://www.mecfs.ch/ but didn't get a reply.

Hi @FMMM1 you are aware that since the trial is recruiting and therefore must have already received ethics board approval, that they cannot deviate from their protocol, right?

Yea I reckoned there was little chance of a change but I thought it might be useful to contact the researchers (and I copied one of the Swiss ME/CFS associations) - so that might help to begin the process of asking for better studies.
EDIT - also, I think it's important to highlight the weakness of the study. That way if the Swiss Government, or anyone else, use this study to develop policy (proposing this as a treatment) then the fact that patient groups have highlighted issues with the protocol might get picked up/raised.
Interesting comment from @Hutan that they may collect actimetry data but not report it!

 

[FMMM1]

Is there a more complete form of the study protocol i.e. including all of the data they propose to collect?

If something isn't listed as a primary outcome (actimetry in this case) then can the (actimetry) data be withheld - if it's listed as a primary outcome then is it expected to be disclosed in a publication?

 

[Hutan]

If something isn't listed as a primary outcome (actimetry in this case) then can the (actimetry) data be withheld - if it's listed as a primary outcome then is it expected to be disclosed in a publication?

I think any identified secondary outcomes should also be reported. But yes, the summary that we have neatly steps around specifying secondary outcomes while implying that there will be objective outcomes.

The collection of biological samples (saliva, blood) and health-related personal data (actigraphy, psychometric data from questionnaires) is associated with minimal risks and burdens.

Also, the microbreak intervention is extraordinarily vague. The microbreaks might be filled with moderate to high intensity exercise, eating, breathing, relaxing or resting. It's not clear from the information we have just how the content of the microbreaks will be selected. Patients 'are encouraged to keep micro break diaries', but it doesn't sound as if those will be generating data for the study, and as others have said, recording every time an activity is broken up by doing another activity is unrealistic. Taking time out to record a microbreak is a microbreak itself. So, we are left with patients potentially performing a sort of pacing but the researchers potentially being able to claim that regular breaks for e.g. exercise is what helps. Worse, if later therapists apply the microbreak technique, they can choose to focus on the bits they like - the exercise, the breathing exercises.

I think it would be very worthwhile getting detail about the study from the researchers:
- what are the secondary outcomes and how will they be measured? If actimetry will be used, how long will measurements be made, and when? What molecules in saliva and blood will be tested for, and when?
- how will the detail of the micro break intervention, as applied by the patient, be recorded? Will actimetry be used to characterise patterns of movement in each of the interventions?

Pinning down the intentions of the researchers now would help a lot to ensure that actimetry data and any other secondary objectives are recorded properly and reported, or at least made available to other researchers.