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The FINE Trial. BMJ ARTICLE. Nurse led, home based self help treatment for patients in primary care

Discussion in 'Latest ME/CFS Research' started by pollycbr125, Apr 23, 2010.

  1. Bob

    Bob

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    Hi folks,

    I'm trying to establish whether the FINE Trial's 'pragmatic rehabilitation' treatment program was based on CBT, or if it involved elements of CBT, and I can't find any info about it. Neither the protocol or the paper itself say that CBT was involved, as far as I can see (The paper says that there is a GET 'component' to the treatment.)

    Has anyone got any insight, or info, about this please?

    I'm sure i've missed something obvious.

    Thanks,
    Bob
     
  2. Esther12

    Esther12 Senior Member

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    There are some good reasons to believe that the leaflet mentioned in FINE is the same way Orla details here: http://forums.phoenixrising.me/inde...liverpool-cf-cfs-clinic-patient-handout.3066/

    (It's by P Powell who was involved in the trial, from the right time, and fits the description in the paper).

    Orla said, prior to FINE coming out:

    I don't think that this material has ever been officially released though, so it would be difficult to mention it in an academic letter, or something similar.
     
  3. Bob

    Bob

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    Ah, OK, thanks Esther... So you think it may well have had elements of CBT, but we don't actually know?
    Do you know if the training notes, nurses' info, or patient info, were ever made public?
     
  4. Dolphin

    Dolphin Senior Member

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    In the past, Powell et al (2001) which used a similar intervention has been put in GET rather than CBT meta-analyses.

    There haven't been many meta-analyses papers since Wearden et al (2010) came out.

    In:
     
  5. Esther12

    Esther12 Senior Member

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    I don't think that they have been. But they could have been before I started following this stuff so closely (or I could have missed it since). There was that paper where they explained that their conception of CFS led to nurses viewing patients as "ungrateful bastards who don't want to get better" (that wasn't their intent in writing the paper, but it's what I took from it, and is not a surprising psychosocial outcome for those of us who have had to engage with the NHS over the last couple of decades), but it doesn't go in to much detail about what the treatment actually was, (or take the time to explain to new readers how ineffective the treatment was found to be).

    To me, the information in that leaflet seemed written up in a bad-CBT type manner intended to manipulate patients in to adopting particular views about their illness.

    (This is all from memory, and I looked far less closely at FINE than PACE, as far less work had been put in to spinning the results in a misleading way).
     
  6. Bob

    Bob

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    Thank you Esther and Dolphin.

    That citation is very helpful thanks Dolphin.
    That's probably all the evidence I need in order to be able to say that pragmatic rehabilitation used elements of CBT.
    Or I can say pragmatic rehabilitation: " incorporated key aspects of the cognitive behavioral model of CFS".
    Very useful.
     
  7. biophile

    biophile Places I'd rather be.

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    [How to exercise people with chronic fatigue syndrome: evidence-based practice guidelines] (Van Cauwenbergh et al 2012) also refers to the FINE Trial as involving sessions of CBT/GET but later uses the phrase "pragmatic rehabilitation" too. Then it goes on to apparently misrepresent the results, which questions their understanding of the FINE Trial, so it may not be CBT/GET afterall (but from what we know, pragmatic rehabilitation is very close to CBT/GET, sort of a simpler version that can be taught to people with less qualifications).
     
  8. Bob

    Bob

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    Thanks biophile.

    Yes, I've seen nothing to suggest that 'pragmatic rehabilitation' included actual "sessions of CBT" although it may have included sessions of 'education' that included CBT elements, or were based on the CBT model. Maybe a subtle difference?

    Pragmatic rehabilitiation did include GET 'components', which I think means the same as GET 'sessions'.

    The protocol says:
    "Patients are then encouraged to embark upon a series of treatment components, including graded exercise (starting at a very low level and increased very gradually), a return to more regular sleep patterns, and relaxation exercises."

    About pragmatic rehabilitation, the protocol also says:
    "The first intervention session is taken up with providing
    patients with a detailed explanation of their symptoms in
    terms of such physiological explanations as circadian
    rhythm desynchronisation, disrupted sleep patterns,
    neuro-endocrinological disturbances, and cardiovascular
    and muscular deconditioning. The somatic manifestations
    of anxiety are also explained to the patient."

    This doesn't look particularly CBT-based to me, except maybe the bit about anxiety.
     
  9. Bob

    Bob

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    Someone has pointed out to me that, in the protocol, 'pragmatic rehabilitation' is described using the following phrases:

    "[CFS is] often maintained by illness beliefs that lead to exercise avoidance."

    "The essential feature of the treatment is the provision of a detailed explanation for patients' symptoms, couched in terms of the physiological dysregulation model, from which flows the rationale for a graded return to activity."

    "The explanations for various symptoms of CFS/ME highlight the interaction between psychological and biological factors."

    "Having taken control of their symptoms through a programme of graded activity, normalisation of sleep patterns, and simple anxiety and stress-reducing procedures, patients are better able to consider the role of psychological and social factors in their condition."

    So I think this pretty much makes it clear that they are trying to correct 'maladaptive cognition', etc. In which case it suggests the use of 'CBT', because 'GET' is designed only to increase exertion, and not to address maladaptive cognition.

    So I think that answers the question, and I can safely say that elements of CBT were used, or similar.


    The above passages were a description of 'pragmatic rehabilitation' specifically in reference to the Liverpool study, which some of the FINE Trial authors also authored.

    But the FINE Trial does not indicate that the version of 'pragmatic rehabilitation' used was any different to the Liverpool study. Immediately after the Liverpool 'pragmatic rehabilitation' description, the FINE protocol just says the following, suggesting that there was no change in protocol:

    "The treatment trial protocol reported here was designed to determine whether pragmatic rehabilitation is effective in
    primary care settings, when delivered by non-specialist nursing staff who have received brief training."
     
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  10. Dolphin

    Dolphin Senior Member

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    Just in case anyone is confused by a reference to a Liverpool study, it's this study:

     
    Bob likes this.
  11. Esther12

    Esther12 Senior Member

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    I've not read the protocol for this (and won't have time to for a while yet), but thought I'd add in the link in case others were interested.

    Ta for pulling out those bits Bob:

    http://www.biomedcentral.com/1741-7015/4/9

    The claims made in the leaflet are so utterly absurd given how ineffective this approach has been shown to be.
     
  12. oceanblue

    oceanblue Senior Member

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    This is from the FINE study - not sure if it has been posted yet:
     
  13. Bob

    Bob

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    Interestingly, and worryingly, the protocol makes this claim about the Liverpool study:

    "In the Liverpool trial, three treatment groups received the
    manual and varying amounts of contact with a therapist
    over a three-month period; either nine face-to-face sessions
    (maximum treatment), two face-to-face sessions
    and seven telephone calls, or two face-to-face sessions
    only (minimum treatment). Results showed that all of
    these treatments were very effective when compared with
    medical assessment and advice: 57% of patients in the
    treatment groups no longer fulfilled case criteria for CFS
    12 months after starting treatment, as compared with 6%
    of patients in the control condition [26]."
    http://www.biomedcentral.com/1741-7015/4/9

    Liverpool study:
    Powell P, Bentall R, Nye F, Edwards R: Randomised controlled trial of patient education to encourage graded exercise in chronic fatigue syndrome. BMJ 2001, 322:387-390.
     
  14. Bob

    Bob

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    Ah! Thank you Ocean! I'm not sure how I missed that!
    Except that I searched the paper for 'CBT', but not 'cognitive behavioural therapy'! Doh! :cool: :whistle: :oops:

    So that really does answer my question then doesn't it!!!
     
  15. Dolphin

    Dolphin Senior Member

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    The Powell et al (2001) study is one of the reasons why GET is seen as "evidence-based" and "effective" e.g. by NICE.
     
  16. Bob

    Bob

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    That's interesting... I think I'd only recently become ill at the last NICE review, so I missed it all.
    The Powell at al 2001 study only investigated tertiary care (hospital) patients, and the FINE Trial only investigated primary care (GP) patients, so I wonder how will NICE work out which carries more weight at the next review.

    And then the PACE Trial looked at secondary care patients who were not house-bound, and found CBT to be ineffective at reducing physical disability, but moderately effective at reducing subjective levels of fatigue. And CBT and GET only benefited approx 13% of patients, leaving 87% without any benefit from GET or CBT.

    Will NICE still recommend CBT and GET at the next review, I wonder?

    Edit:
    Hopefully we'll be able to bring in all the reviews, including Tom's harms paper, as evidence for the next review, which will all help.
     
  17. Dolphin

    Dolphin Senior Member

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    My money would be on "yes".
     
  18. Bob

    Bob

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    Yes, why do I have a horrible feeling that you are definitely right!!! :cry: :( :confused:
     
  19. alex3619

    alex3619 Senior Member

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    Hi Dolphin, even were I an insane gambler I wouldn't want to take that bet against you. CBT/GET fits their agenda and view of medicine, and evidence has never had much to do with psychosomatic medicine. Bye, Alex
     
  20. Dolphin

    Dolphin Senior Member

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    I'm not sure NICE should necessarily have an agenda. However, there is a strong and influential CBT/GET-type lobby in the UK who earn a living, etc. from these treatments. Also, unfortunately I'm not sure there are many competing treatments at the moment that have the sort of evidence (at least two positive RCTs) NICE are looking for.
     

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