A critical commentary and preliminary re-analysis of the PACE trial

[Cheshire]

https://twitter.com/i/web/status/811276554517020673

 

[slysaint]

https://twitter.com/i/web/status/811276554517020673

How many more times does this need to be pointed out before 'the powers that be' acknowledge it!

 

[Tom Kindlon]

MECVS-patiënten publiceren in wetenschappelijk tijdschrift

2016-12-22 Johan

https://goo.gl/gD4Sx8
i.e.
http://heremiet.pugilator.com/mecvs-patienten-publiceren-wetenschappelijk-tijdschrift/

 

[Tom Kindlon]

Carolyn Wilshire, the lead author for this paper was also lead author for this other paper:

Free full text:
Https://www.researchgate.net/profil...e_evidence/links/564feddd08ae4988a7a877e6.pdf

Phoenix Rising thread:
http://forums.phoenixrising.me/inde...l-illness-time-to-examine-the-evidence.41553/

 

[alex3619]

How many more times does this need to be pointed out before 'the powers that be' acknowledge it!

[Black Hat On, channeling a babbler] Its just some opinions, we trust our experts, and we like the promise of saving money. [Black Hat Off]

 

[Barry53]

There is something regarding CBT and ME that intrigues me, and might lead researchers of the "self-fulfilling prophesy" variety to convince themselves they have found a real cure.

http://www.centreforcbtcounselling.co.uk/stress.php

Clients learn how to 'work smart not hard' and minimise the amount of energy expended on any one task. ... It is this more effective use of energy that is noticeable.

From the above, CBT is commonly used to treat stress, and an aspect of that treatment is to teach more energy-efficient behaviours. If that aspect of CBT was used in PACE, then given that ME sufferers have little spare energy capacity above baseline needs anyway, any energy efficiency improvement, if it happens, will register as "an improvement".

The big faux pas would be to mistake an energy efficiency improvement for an energy availability improvement; in both cases an ME sufferer would likely self-report the same thing - feeling less fatigued.

Could the above have contributed to the very nominal improvements suggested within the PACE trial data?

 

[trishrhymes]

Interesting idea, Barry, but the description of CBT in the particular leaflet you have found is specific to CBT for work based stress.

From what I've read about the CBT used in the PACE trial, the focus was very different. The thought patterns PACE aimed to change were around 'false illness beliefs' not work place stress reduction. I doubt it includes any advice on 'work smart not hard'. More like the opposite aim of increasing physical activity through reduction in 'fear avoidance,'

It seems to me that CBT can be a cover for anything. The overall aim is to change the way a person thinks, or interprets their thoughts.

This can be done:

1. entirely for the benefit of the client by helping them to identify thoughts that are making them unhappy or stressed and helping them see things more rationally.

2. or with mixed benefit for client and employer like the above work based program aimed at having a more efficient, less stressed work force,

3. Or, more sinisterly, with the unacknowledged aims of brainwashing patients to believe their physical illness isn't real and that they are feeling better for long enough to fill in questionnaires in the way the 'therapist' wants, to support their theories, as with PACE.

It is relevant, I think, that the people carrying out the so called CBT for PACE were not psychotherapists trained in CBT, they were nurses given specific training for PACE style CBT. In other words they did not have the wider experience of other more benign CBT and were not made aware that what they were doing was in any way questionable.

 

[Snow Leopard]

Could the above have contributed to the very nominal improvements suggested within the PACE trial data?

It's impossible to say as we don't have blinded control groups, nor objective measures of activity levels and concentration ability before, during and after the trial.

 

[Woolie]

entirely for the benefit of the client by helping them to identify thoughts that are making them unhappy or stressed and helping them see things more rationally.

Actually, this was Beck's original idea - that depressed people are simply not seeing things rationally. Then research in the 80s suggested that it wasn't about being irrational because in fact happy people tend to overestimate their future possibilities, and depressed people actually make assessments that are closer to reality. Turns out being rational is not good for us, its helpful to be a little overoptimistic.

So that's why you don't hear about CBT being designed to correct "irrational" thoughts so much these days, the focus is more on "unhelpful" thoughts.

 

[Hutan]

Could the above have contributed to the very nominal improvements suggested within the PACE trial data?

The very minor differences between the treatments recorded in the trial disappeared at long term followup - and that was only 2.5 years or so after trial commencement.

And, from memory, the more CBT (or GET?) sessions a participant had had over the 2.5 years (regardless of which group they were in during the trial), the worse the outcome at long term followup. There's a very nice analysis of that, with a graph, somewhere here on PR that deserves to be looked at again.

So, I don't think we have to get creative to explain why CBT worked - it just didn't. The differences between treatments along the way to the 2.5 year followup were just random noise, selectively amplified by enthusiastic, persuasive CBT/GET promoters.

 

[chipmunk1]

Actually, this was Beck's original idea - that depressed people are simply not seeing things rationally. Then research in the 80s suggested that it wasn't about being irrational because in fact happy people tend to overestimate their future possibilities, and depressed people actually make assessments that are closer to reality. Turns out being rational is not good for us, its helpful to be a little overoptimistic.

So that's why you don't hear about CBT being designed to correct "irrational" thoughts so much these days, the focus is more on "unhelpful" thoughts.

so in the past it was: you are irrational and we are experts in rational thinking and will show you how to think.

so today it is: you are too rational, we can help you with this as we are experts in being irrational.

i think the idea that any illness is simply due to the wrong thought patterns is well.. irrational and unhelpful.

 

[Barry53]

I don't think we have to get creative to explain why CBT worked - it just didn't.

I was not trying to get creative @Hutan, it was just a thought that occurred to me.

 

[Jenny TipsforME]

At the IACFSME Conference Madelaine Sunnquist spoke about a large study where activity levels weren't related to illness beliefs. IIRC there was an association between activity levels and case definitions (narrower definition correlated with less activity).

This should be useful when published as it undermines CBT and GET in one blow. Does anyone else know more about it?

 

[Barry53]

Not seen these links posted before (though they probably have), so thought I would (re)post them here:-

https://web.archive.org/web/20150812094244/http://www.pacetrial.org/docs/cbt-therapist-manual.pdf
https://web.archive.org/web/20140712065618/http://www.pacetrial.org/docs/cbt-participant-manual.pdf
https://web.archive.org/web/20120915191244/http://www.pacetrial.org/docs/get-therapist-manual.pdf
https://web.archive.org/web/20110409181936/http://www.pacetrial.org/docs/get-participant-manual.pdf

@trishrhymes: Yes I agree with you. Although stress is mentioned quite a lot in these manuals, the CBT strategy does not seem to actively encourage more efficient energy utilisation. As you say, focuses a lot on supposed false illness beliefs. Also pretty presumptuous on a lot of things.

 

[Tom Kindlon]

Not seen these links posted before (though they probably have), so thought I would (re)post them here:-

https://web.archive.org/web/20150812094244/http://www.pacetrial.org/docs/cbt-therapist-manual.pdf
https://web.archive.org/web/20140712065618/http://www.pacetrial.org/docs/cbt-participant-manual.pdf
https://web.archive.org/web/20120915191244/http://www.pacetrial.org/docs/get-therapist-manual.pdf
https://web.archive.org/web/20110409181936/http://www.pacetrial.org/docs/get-participant-manual.pdf

@trishrhymes: Yes I agree with you. Although stress is mentioned quite a lot in these manuals, the CBT strategy does not seem to actively encourage more efficient energy utilisation. As you say, focuses a lot on supposed false illness beliefs. Also pretty presumptuous on a lot of things.

Most or all of the material from pacetrial.org is now available here:
http://www.wolfson.qmul.ac.uk/current-projects/pace-trial

For example the manuals are here:
http://www.wolfson.qmul.ac.uk/current-projects/pace-trial#trial-information

 

[Jonathan Edwards]

Most or all of the material from pacetrial.org is now available here:
http://www.wolfson.qmul.ac.uk/current-projects/pace-trial

For example the manuals are here:
http://www.wolfson.qmul.ac.uk/current-projects/pace-trial#trial-information

Interesting, Tom, I have not seen these before.

It is remarkable how absurd the second document is. In summary 'Here we provide you with hundreds of pieces of specific advice each known to be helpful in ME. (They include things like 'do not do too much or too little' - obviously correct.) If you follow all these bits of advice in this trial we will be able to see if they are, er, actually helpful in ME.'

It is a bit like writing a book of recipes known to produce the most exquisite food (which have never been tried out), and selling it to people so that they can agree how wonderful the food is. The only thing is that this particular recipe book does not seem to have sold that well with the customers. Maybe like Katherine Whitehorse's Cooking in a Bedsitter it was actually not very tasty.

 

[wdb]

It surprises me that manuals have not seen more attention, a great deal has been written about the newsletter containing participant testimonials that likely influenced expectations and biased the results but the manuals contain even more blatant deliberate attempts to alter expectation. From the GET participant manual

In previous research studies, most people with CFS/ME felt either ‘much better’ or ‘very much better’ with GET.
Exercise has been considered a useful strategy for many years in the rehabilitation of fibromyalgia, Multiple Sclerosis, and many other neurological conditions. Research has now shown that carefully graded exercise (Graded Exercise Therapy) can also be a very helpful therapy for CFS/ME. You may be aware that the Chief Medical Officer’s Report of 2002 recommended GET as one of the most effective therapy strategies currently known.

 

[Snow Leopard]

KNOWLEDGE AND SKILLS REQUIRED

As well as a sound knowledge of the aetiology, epidemiology, consequences and available treatments of CFS/ME, a range of skills will also be necessary in order to help you to engage and work collaboratively.

Engagement
In order to engage the participant in therapy, it is important that the therapist conveys to the participant their belief in the reality of their symptoms, distress and disability. The therapist should be able to demonstrate a sound knowledge of CFS/ME as participants will generally be well informed about their illness and may have had “difficult” experiences with other professionals who may have not taken their problems seriously. People with CFS/ME are often sensitive to the over-emphasis of psychological factors. It is therefore important right from the start that an integrative model that incorporates biological factors, e.g. initiating infection, is used. It is important that you show respect for their beliefs on the cause(s) of their illness and avoid challenging them as this is likely to provoke strong emotion and will reduce the likelihood of a good therapeutic relationship being established. In order to maintain participant’s engagement throughout treatment, it will be important that you continue to use an integrative model and avoid promoting a rigidly dichotomous view of physical and psychological illness.

Warmth and Empathy
Empathy is something that we will hopefully tend to do with all patients without thinking about it. However, with this client group it is particularly important. Often they have had their health problems for a long time. Many of them will report at least one upsetting incident relating to a health professional, whether it is not being believed, not being taken seriously or being told it is all in their mind. Often participants will have been given conflicting advice about how to deal with their problems, leading them to a state of confusion and frustration. Some participants will feel guilty about being ill and blame themselves for their predicament. Some participants will have had trauma in their background that may still provoke emotion.
It is therefore very important that you convey warmth and empathy at your first meeting. The assessment provides a wonderful opportunity for participants to tell their story. Often it is the first time that they will have been able to go into detail about their problems. Allowing participants to elaborate on their illness often gives them the feeling that their illness is being taken seriously, often for the first time. Acknowledging the difficulties they have encountered along the way in terms of their illness, whether related to its impact on their life or response from other health professionals, etc., is important.
Throughout your treatment sessions, it will be important that you continue to show warmth and empathise with your participant. There is no doubt that getting people to change previous routines can be difficult in a number of ways. The participant may be very fearful of changing the way they do things, fearing worsening of the symptoms. They may find that their symptoms initially worsen when starting their GET programme. Acknowledging the challenges associated with the programme is important if you are to win their trust.

Sensitivity
Participants may not have had their illness taken seriously by previous professionals and may be concerned that you will be no different. They may think that you will be another “professional” who will tell them “to pull themselves together” etc. Participants may feel sensitive about the use of particular words, such as asking them how often they feel tired which can provoke anger in someone who differentiates strongly between the word fatigue and tiredness. Although you cannot forever be thinking about whether or not you are going to offend them, it is worthwhile listening to and trying to use language that is not going to be alienating. In general, it is best to use the language that the participant does to describe their symptoms.

Collaboration
Collaboration is an essential skill in working with people with CFS/ME. Up to the point of meeting you, many participants will not have been included in the management of their illness. They may not have been asked their opinion about what is wrong with them and may feel rather helpless and out of control. Collaborating throughout treatment will help participants to feel more involved in their treatment and will help them to regain some sense of control.
You will be demonstrating a collaborative style at your first meeting when you individualise the GET model to their illness. By this we mean drawing a model together, examining factors they think have been responsible for triggering as well as maintaining the illness.
Agreeing an agenda for each treatment session, asking for their input in making suggestions for their activity programme and evaluating previous sessions will help participants to feel valued and included in the treatment process.

Positive reinforcement
It is essential that you demonstrate positive reinforcement when you work with people with CFS/ME. Often, they will be very good at pointing out what they haven’t achieved. It is therefore important that you emphasise and are very positive about what they have achieved. Every session you should positively reinforce all of their achievements, however small they may seem, whether it is managing to walk for a minute longer than the previous session, read for 5 minutes longer or get up 5 minutes earlier. Establishing confidence in you as a therapist Establishing the participant’s confidence in you as a therapist is important. This is likely to occur if you utilise the skills in the sections listed above. One cautionary note, if you do not know the answer to a question, you are more likely to be respected for saying that you don’t know the answer, rather than trying to answer it in a muddled way.

Encouraging optimism
Although it is important that you are realistic about the treatment targets that you set with participants, it is important that you encourage optimism about the progress that they may make with this approach. You can explain the previous positive research findings of GET and show in the way you discuss goals and use language that you believe they can get better.

The therapist manual goes into great depth about how it is about reversing deconditioning... But as we know from the objective measures, levels of fitness did not change. It is clear the "effect" of GET was on cognitive factors, that led to a change in questionnaire answering behaviour, despite a lack of change in underlying activity levels in most patients. "Positive reinforcement" "Encouraging optimism" shows you what they were really aiming for (a change in how patients respond to questionnaires).

 

[A.B.]

Positive psychology or hypomanic psychology?

 

[Cheshire]

Positive psychology or hypomanic psychology?

Salesmanship?