Sweden: Acceptance & Commitment Therapy for ME/CFS – A feasibility study, 2019, Jonsjö et al

I don't think it is unreasonable to test ACT in a randomised trial, only we need objective measures of improved functioning as the primary outcome and to not conclude that it is beneficial simply because patients answered some subjective questionnaires slightly more positively after the therapy concluded.

I don't believe that simply conducting trials of these therapies inherently imply anything about what causes the illness, though its certainly possible that practitioners (or researchers) of such therapies might have such beliefs.

 

This reference provides a good overview of what ACT is: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3635495/

Hayes seems convinced that all our 'psychological' problems arise from our development of language. Apparently this is the reason why dogs don't get depressed. So how any of this could be any possible use in ME is beyond me.

 

But dogs can shows signs of being depressed!?!

https://www.petmd.com/dog/behavior/can-dogs-get-depressed

 

They must have acquired language then! (you can see where this is going...)

 

And proper understanding and reporting of harms and deterioration! They really must start to recognize PEM and the risks involved when increasing activity regardless of symptoms/worsening of symptoms etc. This is a massive problem

They even used a PACE article as a reference in the ethics approval application, to support their claim that increasing activity is totally safe and no risks involved whatsoever etc...

 

https://twitter.com/user/status/1102976037867212804

 

I don't agree with some of the criticism.

The diagnostic criteria seem alright: patients had to meet the Fukuda criteria and Canadian criteria. Almost all patients were unable to work or study full-time and a majority was on 100% sick leave. So they were more than mildly affected.

The lack of a control group is probably because this is a feasibility trial. ACT hasn't been trialed before in ME/CFS so the authors first had to check whether this therapy is feasible and acceptable in this patient population. As I see it, the trial wasn't run to determine the efficacy of ACT but to check if it is safe, practically doable etc. So I don't think that using subjective outcomes and the lack of a control group are the major problems with this trial.

The major issue, in my opinion, is the treatment manual. After all the controversy around CBT and GET, the authors do not come with an alternative, but with more of the same. Instead of collaboratively working with ME/CFS patients to identify some of the issues where psychotherapy might help, they simply copy-pasted the treatments they know from the chronic pain literature and changed the word pain into fatigue. That's exactly the approach that has failed in the past.

My experience in the ME/CFS community tells me that psychotherapy might help some patients to accept their illness and the limitations that come with it. It might help patients to accept that this illness prevents them from being the person that thought they were or hoped to become. It might tell them that there is not guilt into doing less and saying no because ME/CFS can cause relapses when overdoing it. It might help to recognize that ME/CFS patients aren't able to change or overcome their limitations and that they have to find ways to make the most of it by focusing on the things that are still possible.

These are issues that come up in in-depth interviews of patients following CBT. The authors could have used this or started with an investigation of the psychological problems ME/CFS patients face. Instead, they assumed that ME/CFS patients show inadaptive avoidance behavior and an unwillingness to experience discomfort. No evidence is given for this assumption, and the authors seem unaware that there is a whole literature (pacing and the energy envelope theory) on why symptom avoidance might be adaptive in ME/CFS. Their form of ACT doesn't help to accept the illness or disability, but the experience of having symptoms and discomfort. That is not the problem in ME/CFS.... This is all very frustrating. It seems like a lost opportunity. There finally was some money to research an alternative form of CBT than the fear-avoidance model that has been proven to be unsuccessful. And now that opportunity is wasted for more of the same...

 

This whole "ACT hasn't been trialed before in ME/CFS" thing bothers me. Per Fink has been involved in a study (albeit FSS rather than CFS) - https://www.ncbi.nlm.nih.gov/pubmed/27633643 and, as I said above, the Pain and Fatigue Management Centre in Bronllys have been using this approach for at least 5 years on patients, some of whom will have CFS or similar.

The problem is that these therapies fly under the radar and are not regulated in any way - because they don't have to.

 

Even though this is a feasibility study, the lack of control group, blinding, and objective outcomes is a major problem. It is clearly stated in the text that the intention was to evaluate adaptation, acceptability, safety, and preliminary efficacy. The design means that there is no way to eliminate systematic bias from the estimated efficacy. It is difficult to evaluate efficacy across studies, but Cohen’s delta in the ACT study was 1.2 for psychological flexibility, and less than 0.7 for all other outcomes in Table 1.

Cohen’s delta for subjective fatigue in PACE was 1.2 for the CBT group and 1.3 for the GET group, although both these groups virtually had null results in secondary objective outcomes. There was a study on homeopathy for ME/CFS in 2004, and I estimated Cohen’s delta for general fatigue in this study to about 1.0. These numbers give a hint of the magnitude of systematic bias in studies.

The problem with the ACT study is that it is used to estimate the efficacy and to determine whether more resources should be spent on follow up studies. However, the numbers above suggest that the improvement in the study wasn’t larger than what could reasonably be expected from systematic bias. With this design—where systematic bias is included in the efficacy estimate—the conclusion will always be that the results are promising and that the researchers should be awarded more money for future research. This is an unacceptable, self-serving design error of a feasibility study.

 

So sorry for the split thread, guys! This is so confusing...

In the published article it says that the participants were recruited between 2013 and 2016.

In the comments I made earlier (now moved to the new thread) I was referring to an ethical approval application document which I thought was for this trial, based on the fact that its reference number is listed on the clinicaltrials.gov project page linked in post #1. However, that ethical approval is from 2015... and it says that the data would be collected between 2015-2018.

Also, the title of the trial in the published article is very different than the title in the ethical approval document. Many other important details are different too, such as aim and tests etc.

What makes it even more confusing is the fact that the documents sent by Olsson's team to the participants gave me and others the impression that the currently active trial was simply a continuation or part of the previous one.

So, I'm really confused now... Are these two separate trials or one? @Obermann, do you know?

To be on the safe side, I asked the mods to split them for now, in an attempt to minimize the risk of wrongly conflating things, until we can be sure either way. Or what do you guys think? (I should have asked for your opinion before I asked the mods to split the thread, sorry...)

I'll keep digging for more info.

 

@mango you probably did the right thing, and in any case no harm done if they turn out to be the same after all

Be careful and take care of yourself, health comes first.

 

But that is not the focus of ACT at all. From the trial write up:

Behavioral: Acceptance and Commitment Therapy (ACT)
The main target in ACT for ME/CFS (as for Fibromyalgia and Chronic pain in previous studies by our group) is to promote a shift of perspective in life from symptom reduction (when it does not work) to a valued life. As such it entails acceptance and exposure to discomfort, in order to lessen the effects of negative experiences (symptoms, emotions, thoughts) on behaviours in everyday life.

I would think that the kind of acceptance with regards to limitations etc would come from going through the grieving process.