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

[Bob]

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

 

[Esther12]

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:

Pauline Powell (who wrote the main booklet I have from Liverpool) was also part of the research team associated with Alison Weardon of Manchester University, who is the lead on the MRC funded FINE (Fatigue Intervention by Nurses Evaluation) trials. Some information on FINE here

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.

 

[Bob]

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?

 

[Dolphin]

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

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:

Castell, B. D., Kazantzis, N. and Moss-Morris, R. E. (2011), Cognitive Behavioral Therapy and Graded Exercise for Chronic Fatigue Syndrome: A Meta-Analysis. Clinical Psychology: Science and Practice, 18: 311–324. doi: 10.1111/j.1468-2850.2011.01262.x

A summary of interventions and theoretical assumptions, used
to guide the classification of trials as CBT or GET, is
available from the corresponding author. Categorization
of treatment type was straightforward in the
majority of cases. However, where trials employed elements
from both or other treatments, the trial protocol
was designated according to the treatment most closely
matching the actual interventions employed. For this

reason, two trials published as patient education with

graded exercise and pragmatic rehabilitation (Powell,

Bentall, Nye, & Edwards, 2001; Wearden et al., 2010)

were included in the CBT analysis on the basis that

the intervention incorporated key aspects of the cognitive

behavioral model of CFS, including targeting

beliefs regarding symptoms using alternative, evidencebased

explanations.

 

[Esther12]

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?

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).

 

[Bob]

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.

 

[biophile]

[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).

 

[Bob]

[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).

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.

 

[Bob]

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."

 

[Dolphin]

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. 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."

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

 

[Esther12]

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.

 

[oceanblue]

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

In 2001, we reported a new educational self help treatment for CFS/ME called pragmatic rehabilitation. This treatment had proved successful in a hospital based trial, with 57% of patients who received pragmatic rehabilitation recovering after 12 months compared with 6% of patients in a waiting list control group.[13 Powell study]

Pragmatic rehabilitation has elements in common with cognitive behavioural therapy and graded exercise therapy, but does not require delivery by cognitive behavioural therapists or physiotherapists.

Whereas cognitive behavioural therapy usually starts with an individualised formulation of the patient’s problem( s), pragmatic rehabilitation starts with the more didactic presentation of an explanatory model of CFS/ ME, which provides the rationale for a graded increase in activity. The pragmatic rehabilitation activity programme is devised collaboratively with the patient rather than prescribed on the basis of exercise testing, as in graded exercise therapy.

 

[Bob]

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.

 

[Bob]

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

In 2001, we reported a new educational self help treatment for CFS/ME called pragmatic rehabilitation. This treatment had proved successful in a hospital based trial, with 57% of patients who received pragmatic rehabilitation recovering after 12 months compared with 6% of patients in a waiting list control group.[13 Powell study]

Pragmatic rehabilitation has elements in common with cognitive behavioural therapy and graded exercise therapy, but does not require delivery by cognitive behavioural therapists or physiotherapists.

Whereas cognitive behavioural therapy usually starts with an individualised formulation of the patient’s problem( s), pragmatic rehabilitation starts with the more didactic presentation of an explanatory model of CFS/ ME, which provides the rationale for a graded increase in activity. The pragmatic rehabilitation activity programme is devised collaboratively with the patient rather than prescribed on the basis of exercise testing, as in graded exercise therapy.

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!

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

 

[Dolphin]

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.

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

 

[Bob]

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

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.

 

[Dolphin]

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 they still recommend CBT and GET?

My money would be on "yes".

 

[Bob]

My money would be on "yes".

Yes, why do I have a horrible feeling that you are definitely right!!!

 

[alex3619]

My money would be on "yes".

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

 

[Dolphin]

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

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.