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

Noticed this:
"Sponsors and Collaborators
Sarah Schiebler
University of Zurich"

Here's Sarah Schiebler's biop (not confidence building):
https://www.usz.ch/team/sarah-lavinia-florence-schiebler/

 

Here's a comment, on this trial, I came across:
"This sounds like a bad study, indeed.

IMHO, questionnaires are fine (preferably in combination with other measures) in a blinded study. Which this is not. They compare two treatment groups and a control group, which is just "waiting for treatment". This is as bad as it gets and repeats all the mistakes of the PACE trial (hopefully treatment is less harmful since they don't have the GET part). The main problem is not that patients are not good at estimating their activity, but a simple (strong) placebo effect. It is a shame that such studies are still considered "scientific"."

The reference to "simple (strong) placebo effect" reminded me of @Jonathan Edwards expert testimony to the NICE Committee.

@Michiel Tack

 

I think there was one trial of exercise (Dutch study?) which used actimetry to measure the outcome - does anyone remember what it was? Thanks.

EDIT - I've found a reference to the study via NICE evidence review:
"Friedberg "Efficacy of two delivery modes of behavioral self-management in severe chronic fatigue syndrome"*
"Actigraphs were worn 24/7 for 1 week at baseline, and at 3 month and 12 month follow-ups. Actigraphs were used for research purposes, and not to assist the intervention."
I've requested the paper from the authors (via ResearchGate) if anyone has a copy then I'd be interested in the actimetry outcomes. Maybe there's a thread on this site?




*Friedberg F, Adamowicz J, Caikauskaite I, Seva V, Napoli A. Efficacy of two delivery modes of behavioral self-management in severe chronic fatigue syndrome. Fatigue: Biomedicine, Health and Behavior. 2016; 4(3):158-174

 

https://www.sci-hub.ee/10.1080/21641846.2016.1205876

 

Thanks @Sly Saint I couldn't open the webpage.

 

Grateful for views here. Here's an extract:
"Primary outcome measure
Primary outcome measure Results (Table 2 and Figure 2) at baseline indicated that the three conditions were not statistically different on the FSS (all p-values were > .24). Results at 3-month follow-up revealed that the FSM:CTR group had significantly improved (t(127) = −2.18; p = .03) FSS scores in comparison to the UC (Cohen’s d = .58). However, at 3-month follow-up, differences in FSS means between FSM:ACT and UC were not significant t(127) = −1.65; p = .10; d = .40). FSM:ACT and FSM:CTR subjects did not statistically differ on FSS scores at the 3-month follow-up visit."
FSM:ACT = Active Treatment (‘high tech’): Fatigue Self-Management with Web Diaries and Actigraphs
FSM:CTR = Active Treatment (‘low tech’): Fatigue Self-Management with Paper Diaries and Step Counters
UC = Usual Medical Care/No-Treatment Control

So basically the scores for the test group [FSM:ACT] and the control group [UC] were not significantly different at the three month follow up.

Not sure where I'm going with this but Friedberg (2016) shows you can use actimetry. This thread relates to an unblinded (Swiss) trial which doesn't use actimetry/actigraphy meaning that the study will likely indicate a small positive effect from the intervention [EDIT - based on questionnaires] due to placebo. The fact that the results are entirely unreliable will be lost on most people including policy makers; so people with ME/CFS will be offered
"Acceptance Commitment Therapy or Micro Breaks" as a treatment. The pits.

@Brian Hughes

 

Does anyone have any ideas, is there anything that can be done to put pressure on the NIH to STOP funding stupid, useless research that is just money wasted when they are always saying there is so little to go round? I'd rather one very good expensive study than hundreds of pointless ones.

And of course I'm talking biomedical research not this endless round of studies that have predetermined positive outcomes based on an uninterpretable study design.

I truly feel that there has to be an argument for a lack of cost benefit in doing this over and over. I don't mean that as hyperbole.

And I am frustrated that the bureaucracies holding the purse strings don't see this for the futility that it is.

 

Come on now, just acceptance therapy it!

 

I might be mistaking your direction of argument but if you mean the current study - then there's no indication it is funded by the NIH. The clinicaltrials.gov website lists trials internationally https://clinicaltrials.gov/ct2/search/map and only a fraction are US funded. There is a requirement for certain US based trials to be listed on clinicaltrials.gov.

I don't have much of a grasp of what the NIH is actually doing with ME/CFS at present but a quick look at https://www.nih.gov/mecfs/funding seems to suggest an overall biomed direction.

Apologies if I have misunderstood your post.

 

I just had a look. I see that the research of the thread title is based at Zurich and doesn't indicate NIH funding.

I have extreme memory problems and confused the sci-hub link:
https://www.sci-hub.ee/10.1080/21641846.2016.1205876
with the research of the thread title.

Whenever I read a post I only have any memory of however many I've just read (I have only a vague grasp of my own life in terms of memories). I struggle. Anything read previously is mostly forgotten unless I am really familiar with the information or have reread it multiple times.

So, essentially . . . my bad. My comment I suppose would have been valid until recently if in fact the NIH are in the process of doing things differently to their usual MO.

 

You do make the important point @Snowdrop that research so poorly designed that it is never going to produce any meaningfully interpretable results can never be cost effective in terms of science or medicine, despite many researchers and clinicians building their careers on the back of it.

What might be in the short interests of individual researchers and university departments is not necessarily to the benefit of patients or of society as a whole.

 

Certainly true in the UK. I think @Trish has highlighted that some researchers receive funding for research on teenagers which has no objective outcome criteria - something that still continues and has done for a decade (+?).

 

I decided to contact the "ME/CFS Association Switzerland" to see if they wish to make a formal complaint*, to the University of Zurich, regarding this trial. I suppose other actions are possible e.g. encouraging people not to participate unless the protocol is revised to include objective outcome criteria (actimetry).

If anyone has contacts in Switzerland then I'd be interested.


*"Hi,
I'm contacting you regarding this trial at the University of Zurich "Effectiveness of Acceptance Commitment Therapy or Micro Breaks in Patients With Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis" [https://www.clinicaltrials.gov/ct2/show/NCT05168124].

The trial is unblinded and uses subjective outcome criteria i.e. questionnaires. Unblinded studies require objective outcome criteria e.g. actigraphs (FitBit type devices). Actigraphs have been used in similar studies e.g. Friedberg 2016*. In its current form this trial, by the University of Zurich, will simply demonstrate a placebo effect and will provide no reliable data.

As a group representing Swiss people with ME/CFS, I'm interested in whether you wish to make a complaint to the University of Zurich?

Thank you in advance and happy to discuss
Xxxx

*Friedberg F, Adamowicz J, Caikauskaite I, Seva V, Napoli A. Efficacy of two delivery modes of behavioral self-management in severe chronic fatigue syndrome. Fatigue: Biomedicine, Health and Behavior. 2016; 4(3):158-174

 

Or indeed wholly accurate if an "R" is added to NIH to indicate the UK National Institute of Health Research which is institutionally wedded to psych approaches across the board and despite the NIHR part funding to the Decode ME study, it remains a bastion of support for rubbish psych.

 

European ME Alliance
Website:http://www.euro-me.org/

"The Alliance now has representatives from Belgium, Croatia, Denmark, Finland, France, Germany, Iceland, Ireland, Italy, Netherlands, Norway, Serbia, Slovenia, Spain, Sweden, Switzerland and the UK.."

 

Thanks @CRG
Err I've had some problems with European ME Alliance - the masonic(?) term blackballed comes to mind (don't worry I'm smiling as I type). Thanks for the laugh!

I've posted on the ME Action Global site (one reply tagging someone who might have contacts) and the ME Action European Union site.

 

It's interesting that we're between a rock and a hard place. I've had some feedback, from a person with ME/CFS in Switzerland, and the (psychiatrist) Doctor (Sarah Schiebler) is very supportive of people with ME/CFS ---- benefits, ---.

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.

 

Yes reminds me of the annoying (even the OH person said that) computer programme that shut your screen down every 15mins for a short time period 'to give you a break'. You can imagine the scenarios where you are mid-email or something and you end up having to re-read the whole thing to get back into it. At best people spend the time getting annoyed trying to use a mnemonic to remember where they were. And that is people without ME. Covered backs on things like carpal tunnel or eye strain or whatever they were for

I can't imagine how on earht there is positive data for them though.

 

Just emailed the trial lead "Sarah" [https://www.usz.ch/team/sarah-lavinia-florence-schiebler/]. I've suggested that Sarah might wish to check out this site - can't recall how you join though.

*Sarah,
[my story/background] ---I noticed a trial you are leading "Effectiveness of Acceptance Commitment Therapy or Micro Breaks in Patients With Chronic Fatigue Syndrome/ Myalgic Encephalomyelitis".

I am aware, e.g. from Professor Brian Hughes blog "The Science Bit", that it is difficult to run blinded trials on non-drug interventions. However, there are examples of studies which used objective outcome criteria "actimetry" (FitBit type devices in layperson's terms) i.e. to ensure that the results are not due to reporting bias and/or placebo effect [Friedberg 2016*].

I'd also like to highlight that there is some discussion on pacing-type management on the Science for ME forum**. This is a potential research area and one likely to be supported by people with ME/CFS. The discussion, on Science for ME, may only be visible to members; however, it is relatively simple to join the forum [https://www.s4me.info/].

Regards and happy to discuss
Xxxx


*Friedberg F, Adamowicz J, Caikauskaite I, Seva V, Napoli A. Efficacy of two delivery modes of behavioral self-management in severe chronic fatigue syndrome. Fatigue: Biomedicine, Health and Behavior. 2016; 4(3):158-174
**https://www.s4me.info/threads/if-and-how-to-research-pacing-discussion-thread.22860/

 

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?