OFFICIAL UK 'CFS/ME' PACE TRIAL Manuals are NOW ONLINE.

[wdb]

The pacing component of the trial is much more encouraging. All being well this will come out the most successful and massively infuriate the proponents of the psychological model. Probably why they are taking so long to publish it.

Adaptive Pacing Therapy - Aim
To stabilise the symptoms and activity with the anticipated benefit of: (a) maximizing what can be achieved within a limited amount of energy; (b) preventing exacerbation of symptoms and disability; (c) enabling participants to plan activities; (d) providing the best environment for the body to naturally recover; (e) allowing gradual increases in activity as the participant feels able.

Theoretical Model
The assumptions of simple pacing are that it is beneficial to stabilise activity and to balance rest with activity. An analogy of balancing the energy account to avoid overdrawing it is often used. Symptoms are regarded as warning signs to be listened to. It is assumed that the symptoms reflect a pathological disturbance, which is not reversed by undertaking increases in activity. Rather the assumption is that ignoring fatigue and other symptoms risks activity induced exacerbations of the illness and consequently impeding natural recovery, whereas good pacing will maximize the chance of natural recovery and hence improve function in the long term. Activity is therefore planned so as to balance activity and rest. The aim is to maximise what can be done on the one hand but to limit activity related exacerbations of symptoms on the other.

Procedure
The manual includes the following components: (a) the participant is helped to monitor their activity and their energy using simple self-ratings. (b) By learning about the relationship between what they do and how they feel, the participant is more able to plan their pattern of rest and activity; (c) The process is an iterative one whereby level of energy and other symptoms and activity are monitored; activity is planned and then modified in the light of its effect on symptoms. (d) The participant is encouraged to do as much as they are able within the limits imposed by their knowledge of what risks exacerbating symptoms.

 

[Dolphin]

The pacing component of the trial is much more encouraging. All being well this will come out the most successful and massively infuriate the proponents of the psychological model. Probably why they are taking so long to publish it.

I'm afraid I'm not that confident. The authors have used the 2 primary outcome measures (Chalder Fatigue Scale and SF-36 physical functioning subscale) in the past. Many of the people will score 10 or 11 out of 11 on the Chalder Fatigue Scale at the start and can't really get worse (one of the 11 is "do you feel sleepy or drowsy?" which somebody might not mark even if they get worse).

If they had used other symptoms as outcome measures, a pacing-type intervention might come out better.

Various CBT studies have found people saying their fatigue was less but they weren't doing any more activity than the control group.

Similarly, with the regular exercise people who do GET or CBT do, I think people will answer the SF-36 as showing an improvement when asked about ability to walk certain distances, etc (this has also been found with some CBT studies in the past where people weren't doing any more than the control group). The people who are pacing may do more in total but might still say they are restricted in what they can do (because they're more careful not to overdo it).

 

[Snow Leopard]

All being well this will come out the most successful and massively infuriate the proponents of the psychological model. Probably why they are taking so long to publish it.

Such thoughts have crossed my mind too, but then optimism is one of my character flaws.

On the other hand, perhaps they are waiting so long because the initial results were unimpressive. So they were waiting until the results were more differentiated, and or solutions were found with regards to fudging the interpretation of the data to fit their hypothesis.
With regards to the personality attributions, we can and should compare it with astrology and the like.

 

[wdb]

I'm afraid I'm not that confident. The authors have used the 2 primary outcome measures (Chalder Fatigue Scale and SF-36 physical functioning subscale) in the past. Many of the people will score 10 or 11 out of 11 on the Chalder Fatigue Scale at the start and can't really get worse (one of the 11 is "do you feel sleepy or drowsy?" which somebody might not mark even if they get worse).

If they had used other symptoms as outcome measures, a pacing-type intervention might come out better.

Various CBT studies have found people saying their fatigue was less but they weren't doing any more activity than the control group.

Similarly, with the regular exercise people who do GET or CBT do, I think people will answer the SF-36 as showing an improvement when asked about ability to walk certain distances, etc (this has also been found with some CBT studies in the past where people weren't doing any more than the control group). The people who are pacing may do more in total but might still say they are restricted in what they can do (because they're more careful not to overdo it).

Yes that is definitely concerning a very real possibility. I don't know if any other trials to date have included pacing as a treatment option on a roughly equal footing to GET/CBT, but it is possible that attending regular pacing sessions, if done well, could evoke comparable expectations of improvement and positive bias when reporting outcomes.

 

[Snow Leopard]

My guess is they will try to equate the methodology of the "adaptive pacing therapy" to that of GET and overemphasise the need for gradual increases in activity, change in patient beliefs etc.

That said, this is from the participants guide:

[The limit increases with recovery but cannot be increased by increasing activity.
The underlying idea is that if people with CFS/ME use their energy wisely, their limited energy will increase gradually. Pacing can improve coping and provide the conditions for natural recovery but in itself activity does not fundamentally change the course of the disease.

 

[Sean]

There is a possibility that this trial might show that pacing is at least as good as, if not better than CBT/GET. I have no inside info, and have not been closely following the details of it, and I assume they have made it as hard for pacing as they can. But pacing still might just get up.

Even if it doesn't, I will be surprised if they get a clear win from this. The evidence so far clearly says the CBT/GET model is lacking in both explanatory and therapeutic power. I don't expect that to significantly change.

Statistical power cuts both ways, and there is a limit to how far they can spin the raw numbers. Don't want to get anybody's hopes up, but the results from this trial might actually be unfavourable for the CBT/GET school.

 

[Dolphin]

I feel the Pacing-type intervention would have had a better chance if they hadn't dropped actometers as an outcome measure. When Action for M.E. wrote a letter of support for the trial in 2001 when they were applying for funding, they had them as an outcome measure but dropped them somewhere along the way. Peter White has confirmed this in comments: http://www.biomedcentral.com/1471-2377/7/6/comments#306608 . The two exercise tests are short. I think the pacing-type group won't push themselves as much as the CBT and GET groups in the tests. The exercise tests don't use objective measures like VO2.

 

[Dolphin]

All the PACE manual stuff in one zip file

<Link I was suggesting no longer works>

I hope people will read the manuals. They're not that difficult to read in terms of the amount of science in them, etc. They will help people understand what CBT and GET are.

 

[Dolphin]

Blocks to recovery

I'm sure people want to know why they're not recovering:

CBT Manual

Opinions/attitudes of important others, e.g. family, colleagues, friends (too
much/too little)
Ask about the opinion and attitudes of people that are close to them. Find out about
their friends attitudes, have they lost friends? Are friends supportive? What are work
colleagues/employers like? How about family members? Establish the level of support
they get (too much/too little). For example, sometimes relatives and friends do more
than may be required, e.g. all of their shopping, cleaning, cooking resulting in increased
dependence of the person with CFS/ME. On the other hand they may be struggling to
keep their head above water in a household where no-one helps.

BLOCKS TO RECOVERY

6) The "wrong" kind of social support

. If you have a very supportive family member (partner, parent or child) who
is used to doing everything for you, it may be difficult for you to increase
your activity levels. Your relative may feel that they have your best interest at
heart and discourage you from doing more. They may have difficulty accepting that
in order to make progress, you need to do things at regular times even if
you are feeling very fatigued. If family members have been your "carer' during
your illness, they can sometimes feel that they no longer have a role when you
are getting better which can sometimes lead them to be critical of your CBT
programme or suggest that you are making yourself worse. This may then lead
you to question the validity of the programme and deter you from persevering
with it particularly when you have a lot of symptoms.

Also:

5) Conflicting advice or being in receipt of different kinds of therapy/diets

• Although there is a lot of information to support CBT for CFS/ME, there are
health professionals who would suggest that you need other tests or should try
different types of treatments, this can lead to confusion.
• Starting new treatments or diets for your CFS/ME while you are doing CBT can
make it difficult for you to fully concentrate on your programme.

Also a whole section:

INFORMATION FOR RELATIVES, PARTNERS AND FRIENDS

 

[Snow Leopard]

So instead of just blaming the patients, they can also blame our family and friends too!

 

[Sean]

So instead of just blaming the patients, they can also blame our family and friends too!

Yes. Everyone and everything, except them and their model.

Problem is they start from the (unproven) assumption that our perceptions and behaviour are the cause of our physical symptoms, and then they premise their interpretation and discussion of the evidence on that assumption. So, surprise surprise, they conclude that whatever our perceptions and behaviour are they must be pathological, and hence in need of 'correction' by experts, despite no evidence that makes any real difference.

Circular logic, methinks?

 

[Angela Kennedy]

Yes. Everyone and everything, except them and their model.

Problem is they start from the (unproven) assumption that our perceptions and behaviour are the cause of our physical symptoms, and then they premise their interpretation and discussion of the evidence on that assumption. So, surprise surprise, they conclude that whatever our perceptions and behaviour are they must be pathological, and hence in need of 'correction' by experts, despite no evidence that makes any real difference.

Circular logic, methinks?

Yep. A massive, un-maintenanced, dangerous merry-go-round in a dodgy fair-type circular!

 

[Dolphin]

For my sins, I'm reading through the APT manual(s). I thought I might as well as I have read the two CBT and two GET manuals a few weeks ago along with the SSMC manual. APT is the one the PIs hope don't work I think it's fair to say (e.g. Peter White and Trudie Chalder walked out of the CMO Working Group because pacing was put on the same level as GET and CBT).

From what I've seen so far, I don't recall much talk about abnormalities that have been found in research e.g. in response to exercise, cognitive abnormalities, etc.

In the CBT and/or GET manuals (can't remember all the details), they were often talking about research which supposedly backed up their point (this research having been done on healthy people so I really debate how relevant it is).

So I'm not sure how convinced people will be of the APT program compared to the CBT and GET programs.

Also, I think if people were given idea of the sort of things that are a bit unusual in ME, they could be more assertive with friends, family, work colleagues, etc to allow them pace.

But then I suppose when one of the authors of the PACE manual is Michael Sharpe, it might influence what is in it!

 

[Sean]

But then I suppose when one of the authors of the PACE manual is Michael Sharpe, it might influence what is in it!

Can we all say 'conflict of interest'?

 

[Dolphin]

FWIW, Number of references in reference list:
CBT therapists’ manual: 16
GET therapists’ manual: 51
APT therapists’ manual: 11

But the CBT one looks convincing (to somebody who doesn't know much) as it talks about the effects of lack of exercise (exercise is something people would think is good for them anyway), stress, etc.

It’s not really explained from any sort of biological point of view (from what I have read so far) why one might want to stay within limits for the pacing-type intervention, that response to exercise in the illness is abnormal, etc.