Qualitative study of the acceptability and feasibility of acceptance and commitment therapy for adolescents with [CFS], 2021, Crawley et al

[Hutan]

@Ravn, you expressed the feelings I share about ACT for ME/CFS very well. And @Robert 1973's letter is great.

I think this study is a reaction to the realisation, expressed in the draft NICE guidelines, that CBT is not a treatment for ME/CFS. So here is this new thing that can be rolled out by all of the existing infrastructure. It is promoted as a treatment, not just psychological support, and yet at the same time it's suggested that it isn't going to change symptoms.

Within that fuzziness is an awful lot of room for misrepresentation, and for therapists themselves to get confused about what they actually can achieve. We can see that happening here.

From the paper:

They felt therapy options were lacking, therefore an alternative treatment provided hope. HCPs welcomed ACT, agreeing “it’d be great to offer something else”

HCPs had concerns that parents might think ACT means “you’ve just got to deal with it” (ID11a) and misunderstand ACT to be about “where you’re at now” (ID08), whereas it is “more about where you’re going, it’s still about moving things forward just through a slightly different approach.”

@adambeyoncelowe, @Keela Too , it's worth reading this paper to get a sense of what clinic staff might be offering and thinking about. Crawley et al appear to be wrestling with how they will deliver all of CBT, GET, Activity Management and now ACT to exhausted children who, as part of these therapies are being told to do more, and change their values so that they be all that they can be. If ACT is the next new thing, it may need to be covered in reasonable detail in the NICE guidelines, acknowledging that it is not a treatment, and giving some guidance on how to deliver it safely.

Studies of ACT in CFS/ME have focussed on adults. One feasibility study in 40 adults with CFS/ME showed ACT resulted in sustained improvements in CFS/ME-related disability at six months(13).

This is the paper:
Jonsjö M, Wicksell R, Holmström L, et al. Acceptance & Commitment Therapy for ME/CFS (Chronic Fatigue Syndrome) – A feasibility study. J Contextual Behav Sci. 2019;12:89–97 doi: 10.1016/j.jcbs.2019.02.008
It's discussed here by @Michiel Tack:
Discussing acceptance and commitment therapy in ME/CFS.

From Michiel's letter to the editors and their reply defending ACT, it looks like, in the wrong hands, there is a lot of scope for harm. Coming from a chronic pain paradigm, it looks as though it can be used to encourage people to accept higher levels of pain, in order to increase functionality. That, of course, is only sustainable to a point with any health condition, and is particularly unsuited to the reality of ME/CFS.

In Jonsjö et al. ‘s feasibility trial, for example, ME/CFS patients were encouraged to “decrease behaviors aimed at avoiding or reducing discomfort”.

The authors present a model based on psychological flexibility, of which acceptance is a single component. In the psychological flexibility model, as explained by the authors, acceptance is a vehicle specifically for values-based behavior change

According to Jonsjo et al., in ACT “strategies to avoid or reduce experiences of symptoms and distress (i.e. experiential avoidance) restrict activities and thereby reduce the possibility to live a broad and satisfactory life.”

 

[Trish]

There is absolutely no evidence that any psychological therapy is an effective treatment for ME/CFS. So if the NICE guidelines committee do decide to name ACT, it should be on the list of unevidenced therapies that shouldn't be offered as treatments.

Personally I find the idea of a healthy therapist instructing me on accepting my symptoms and disability demeaning, insulting and more like some of the aspects of religion I find most unacceptable, than health care.

Sure, any named therapy in the hands of an empathic and skilled therapist may help some people who want them to cope with various distressing situations, but they should not be first line treatments for physical diseases.

 

[mango]

This is the paper:
Jonsjö M, Wicksell R, Holmström L, et al. Acceptance & Commitment Therapy for ME/CFS (Chronic Fatigue Syndrome) – A feasibility study. J Contextual Behav Sci. 2019;12:89–97 doi: 10.1016/j.jcbs.2019.02.008
It's discussed here by @Michiel Tack:
Discussing acceptance and commitment therapy in ME/CFS.

Jonsjö's supervisor Gunnar Olsson talked about ACT for ME in a webinar recently, mentioned briefly that they have realised along the way that their usual ACT model isn't suitable for pwME(!):

https://www.s4me.info/threads/swede...-act-for-me-hosted-by-bragée-me-center.20149/

My impression of what Olsson said in the webinar is that the ACT for ME model they are using today is very different from the one described in their study protocols (see threads linked in the webinar post for more details about them).

 

[Adrian]

Background Paediatric Chronic Fatigue Syndrome/Myalgic Encephalomyelitis (CFS/ME) is disabling and relatively common. Although evidenced based treatments are available, at least 15% of children remain symptomatic after one year of treatment. Acceptance and Commitment Therapy (ACT) is an alternative therapy option; however, little is known about whether it is an acceptable treatment approach. Our aim was to find out if children who are still disabled by CFS/ME after 12 months of treatment would find ACT acceptable, to inform a randomised controlled trial (RCT) of ACT.

Methods We recruited children (diagnosed with CFS/ME; not recovered after one year of treatment; aged 11-17 years), their parent/carer, and healthcare professionals (HCPs) from one specialist UK paediatric CFS/ME service. We conducted semi-structured interviews to explore barriers to recovery; views on current treatments; acceptability of ACT; and feasibility of using an RCT to test effectiveness. Thematic analysis was used to identify patterns in data.

I suspect if you promote a potential treatment to patients where there are none you will get a relatively positive result from many. Hence I was wondering if you really want to know if patients find a potential therapy acceptable how you describe it is critical but also you could do a comparison with other made up or alternative therapies and this may help show the underlying thing of people will try anything or anything that seems remotely feasible.

 

[FMMM1]

Not to mention that the philosophy underlying ACT is the complete opposite of that for CBT (as applied to ME, at least).

The bare faced gall of these people doing such an about face with nary a backward glance, let alone a grovelling apology and resignation for getting it so utterly wrong for 30 years, is disgusting beyond words.

And the world wonders why we are so angry at these people?

I think this is @Jonathan Edwards comment - the (dud) meal ticket lovingly polished -- how much money have they got certainly £millions - £10 million in total? Plus that provides the Government with an excuse/response - funded £xmillion -- children --- all the usual buzz words.

I wonder if we could link the outcome of the NICE review, which considered the evidence to be poor, and the fact that this research is publicly funded - I'm in te UK and I for 1 object.

@Trish maybe worth writing to the public accounts committee outlining that NICE have labelled these studies as poor and asking is this just jobs for the boys (in-folks getting public money). Also, have a go at the sponsoring body [anyone know who this is?] MRC or Government Departments are likely the funders.

An MP has offered to write a question so may try to link all of this to the wider public perception of sleaze (in-folks getting public money for poor quality studies) - in my view at least it is.

 

[It's M.E. Linda]

@Trish maybe worth writing to the public accounts committee outlining that NICE have labelled these studies as poor and asking is this just jobs for the boys (in-folks getting public money). Also, have a go at the sponsoring body [anyone know who this is?] MRC or Government Departments are likely the funders.

An MP has offered to write a question so may try to link all of this to the wider public perception of sleaze (in-folks getting public money for poor quality studies) - in my view at least it is.

From memory, I think 3 MPs in the Committee for Science and Technology in the last Parliament tried something when discussing ‘Research Integrity’. (Supportive MPs were Norman Lamb (Chair), Carol Monaghan & Darren Jones)


Also from memory, Meg Hillier, Chair of the Public Accounts Committee was sympathetic when GET was previously raised at Committee level, but was hampered by lack of evidence?

Something could gain more traction now that NICE can be quoted that the studies were ‘poor or very poor’.

 

[It's M.E. Linda]

Oral Evidence 8 May 2018

Questions raised by Carol Monaghan with Sir Patrick Vallance about the release of data on the PACE trial

http://data.parliament.uk/writtenev...-committee/research-integrity/oral/82537.html

Then, another member of the Committee asks (my bolding):

“ Vicky Ford: Again, this is just an observation. When Dr Goldacre was here, he was very focused on the point that all trials needed to report their results —not necessarily the raw, granular data, but the results—especially if trials had not shown positive benefits from treatments, so that that was known. I want to hear from the Minister whether he is backing the campaign to make sure that all trialresults become known. The suggestion was that, at a minimum, people who routinely do not publish their trial results should find it more challenging to receive public funding for future trials.”

 

[Robert 1973]

apparently you can edit comments for up to 7 days after they appear so I will try to remember to do that

I managed to edit my comment which has now been published below the preprint: https://www.medrxiv.org/content/10.1101/2021.04.20.21255804v1

Clery and colleagues state that “evidenced based treatments are available” for chronic fatigue syndrome. These are listed as Cognitive Behavioural Therapy-for-fatigue (CBT-f), Activity Management (AM) and Graded Exercise Therapy (GET).

In 2017 the US Centers for Disease Control and Prevention concluded that there are no effective treatments for CFS, after it re-examined the scientific evidence and removed CBT and GET as recommended treatments [1].

Similarly, the 2020 draft NICE guideline for ME/CFS specifically warns against the prescription of CBT and GET as treatments due to the evidence that they are ineffective and potentially harmful [2]. 89% of outcomes in studies of non-pharmacological interventions for ME/CFS have been graded as “very low quality” with a high or very high risk of bias by NICE’s independent experts. And no outcomes in any studies of CBT or GET are graded as better than “low quality” [3].

Clery and colleagues cite Nijhof et al (FITNET) [4] for their claim that “at least 15% of children with CFS/ME [sic] remain symptomatic after one year of treatment”. It should be noted that Nijhof et al used the 1994 CDC Fukada diagnostic criteria [5], which is less specific than other criteria as it does not require post-exertion malaise (PEM) as a symptom.

Evidence suggests that most people with fatigue and other persistent symptoms following viral infection will recover within 2 years with no treatment, but a minority with ME/CFS will not recover [6,7]. There is no reliable evidence to suggest that long term outcomes are any better for those who have been prescribed CBT or GET and there is good evidence to suggest that these interventions are harmful [8].

There is undoubtedly a need for children and adults with post-viral fatigue syndromes and ME/CFS to be given appropriate advice and support to manage and cope with the effects of their illnesses. However, acknowledgement of the very low quality of past studies and the evidence that CBT and GET are neither safe nor effective treatments for ME/CFS should be considered a prerequisite for any research pertaining to the provision of such services.

References:

1. https://meassociation.org.u...

2. https://www.nice.org.uk/gui...

3. https://www.nice.org.uk/gui...

4. https://www.thelancet.com/j...

5. https://pubmed.ncbi.nlm.nih...

6. https://pubmed.ncbi.nlm.nih...

7. https://pubmed.ncbi.nlm.nih...

8. https://www.bmj.com/content...

I’m minded to submit something similar to the journal when the final paper is published, assuming it’s much the same. If someone could tag me when it’s published that would be helpful in case I miss it.

 

[Andy]

I've submitted the following comment in haste (awaiting approval):


Clery and colleagues state that “evidenced based treatments are available” for chronic fatigue syndrome. These are listed as Cognitive Behavioural Therapy-for-fatigue (CBT-f), Activity Management (AM) and Graded Exercise therapy (GET).

In 2017 the US Centers for Disease Control and Prevention concluded that there are no effective treatments for CFS, after it re-examined the scientific evidence and scientific removed CBT and GET as recommended treatments [1].

Similarly, the 2020 draft NICE guideline for ME/CFS specifically warns again the prescription of CBT and GET due to the evidence that these therapies are ineffective and potentially harmful [2]. 89% of outcomes in studies of non-pharmacological interventions for ME/CFS have been graded as “very low quality” with a high or very high risk of bias by NICE’s independent experts. No outcomes in any studies of CBT or GET are graded as better than “low quality” [3].

Clery and colleagues cite Nijhof et al (FITNET) [4] for their claim that “at least 15% of children with CFS/ME [sic] remain symptomatic after one year of treatment”. It should be noted that Nijhof et al used the 1994 CDC Fukada diagnostic criteria [5], which is less specific than other criteria as it does not require post-exertion malaise (PEM) as a symptom.

Evidence suggests that most people with fatigue following viral infection will recover within 2 years with no treatment, but a minority with ME/CFS will not recover [6,7]. There is no reliable evidence to suggest that long term outcomes are any better for those who have been prescribed CBT or GET and good evidence to suggest that these integrations are harmful [8].

There is undoubtedly a need for children and adults with post-viral fatigue syndromes and ME/CFS to be given appropriate advice and support to manage and cope with the effects of their illnesses. However, acknowledgement of the very low quality of past studies and the evidence that CBT and GET are neither safe nor effective treatments for ME/CFS should be considered a prerequisite for any research pertaining to the provision of such services.

References:

1. https://meassociation.org.uk/2017/0...ecommended-treatments-for-mecfs-11-july-2017/

2. https://www.nice.org.uk/guidance/indevelopment/gid-ng10091/documents

3. https://www.nice.org.uk/guidance/gid-ng10091/documents/evidence-review-7

4. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)60025-7/fulltext

5. https://pubmed.ncbi.nlm.nih.gov/7978722/

6. https://pubmed.ncbi.nlm.nih.gov/16950834/

7. https://pubmed.ncbi.nlm.nih.gov/23263024/

8. https://www.bmj.com/content/371/bmj.m4356/rr-0

----

Lot of other points that could be raised, which I hope others will make.

[Edit to add - annoying to spot the typos after submitting. Hopefully still makes sense. Trouble with submitting in haste on the ipad in bed. Don't think i can edit after submitting unfortunately.]

[Update: apparently you can edit comments for up to 7 days after they appear so I will try to remember to do that.]

Just checked, no public response from the authors so far.

 

[Sly Saint]

now published
Qualitative study of the acceptability and feasibility of acceptance and commitment therapy for adolescents with chronic fatigue syndrome

https://pubmed.ncbi.nlm.nih.gov/34660913/

https://bmjpaedsopen.bmj.com/content/5/1/e001139

 

[NelliePledge]

Is it time? No it is NOT.

 

[Denise]

Is it time? No it is NOT.

And it never (!) will be!

 

[dave30th]

We will see many papers in progress that will be immediately out-of-date the minute they're published because of their references to "evidence-based" treatments (ie GET and CBT). Peer reviewers should immediately flag this issue, although most of them won't because they all mostly believe the exact same thing as the authors of these nonsensical papers. (Added): What will be most interesting to see is if anything changes assuming NICE publishes the guideline--will this bullshit still receive funding from UK agencies?

 

[adambeyoncelowe]

Reading the abstract, it seems randomisation would be a problem because children didn't want to be randomised.

So, once again, that suggests people are a) either desperate for any treatment or b) desperate for the treatment that is currently being hyped because it's being hyped.

 

[Arnie Pye]

acceptance and commitment therapy

ACT always sounds to me like "suck it up and go away" therapy.

 

[rvallee]

Better do this 28x more times just to be sure, how can we really know if something commonly used is feasible? After all, this exact study has only been done many dozens of times so far.

What we really need to find out, though, is whether it is feasible for participants to drink a glass of water and evaluate how fresh it is. Maybe it's unfeasible and this would revolutionize our understanding of the relationship between the body and water. Better try it no less than 44 times.

In my working days I worked a lot on BS marketing stuff, websites built specifically for a campaign that just gets thrown away once the date has passed. And it felt pointless, unproductive, but compared to this, I was basically doing something massively productive and rewarding.

 

[Jonathan Edwards]

An RCT needs to solve issues around randomisation and timing of the intervention.

Has anyone any idea what this sentence is supposed to mean and how an intelligent professor can allow their name to be put on a paper that includes it?

I cannot think of any particular issues around randomisation, other than needing a randomised set of allocations. And what has it to do with the actual treatment?

 

[rvallee]

Has anyone any idea what this sentence is supposed to mean and how an intelligent professor can allow their name to be put on a paper that includes it?

I usually defer to the famous Watergate quote, it fully applies: "the truth is, these guys are not very bright guys and things got out of hand". So far it works 100% of the time.

I don't think memorizing textbooks fully qualifies as intelligence, though it can mimic it convincingly. It takes especially dull minds to mindlessly repeat the same nonsense for decades, anyone actually smart would be bored to death right away. That's the giveaway, that they aren't even bored of this yet.

 

[dave30th]

What on earth do they mean by solving issues around randomisation? The wording strongly suggests that they haven't a clue.
What is the point of investigating timing without whether it works?

When i asked questions about Professor Crawley's questionable work, the Bristol University vice chancellor filed multiple complaints with Berkeley's chancellor about my "behaviour." So ask questions about her work at your peril!

 

[Jonathan Edwards]

When i asked questions about Professor Crawley's questionable work, the Bristol University vice chancellor filed multiple complaints with Berkeley's chancellor about my "behaviour." So ask questions about her work at your peril!

They know about my behaviour at UCL.
And Crawley was once one of our trainees!
But I realise that two premises don't necessarily make a syllogism.