CBT found not to increase activity levels in 3 Dutch CFS studies

[Dolphin]

Here is a comment Tate Mitchell posted when posting it on Co-Cure:

This is pretty interesting- The authors state that in three previous
trials of CBT, actometer data was taken. However one of the common
criticisms of CBT studies is that no objective outcome measures, such
as actometer data, have been reported in the literature. This raises
the obvious question of why was this actometer data not reported in
the original results of these studies.

'How does cognitive behaviour therapy reduce fatigue in patients with
chronic fatigue syndrome? The role of physical activity.'

Wiborg JF, Knoop H, Stulemeijer M, Prins JB, Bleijenberg G.

Expert Centre Chronic Fatigue and Department of Medical Psychology,
Radboud University Nijmegen Medical Centre, The Netherlands.

Psychol Med. 2010 Jan 5:1-7. [Epub ahead of print]

http://www.ncbi.nlm.nih.gov/pubmed/20047707


BACKGROUND: Cognitive behaviour therapy (CBT) is known to reduce
fatigue severity in chronic fatigue syndrome (CFS). How this change in
symptomatology is accomplished is not yet understood. The purpose of
the present study was to determine whether the effect of CBT on
fatigue is mediated by an increase in physical activity.

METHOD: Three
randomized controlled trials were reanalysed, previously conducted to
evaluate the efficacy of CBT for CFS. In all samples, actigraphy was
used to assess the level of physical activity prior and subsequent to
treatment or a control group period. The mediation hypothesis was
analysed according to guidelines of Baron & Kenny [Journal of
Personality and Social Psychology (1986)51, 1173-1182]. A
non-parametric bootstrap approach was used to test statistical
significance of the mediation effect.

RESULTS: Although CBT effectively reduced fatigue, it did not change the level of physical
activity. Furthermore, changes in physical activity were not related
to changes in fatigue. Across the samples, the mean mediation effect
of physical activity averaged about 1% of the total treatment effect.
This effect did not yield significance in any of the samples.

CONCLUSIONS: The effect of CBT on fatigue in CFS is not mediated by a
persistent increase in physical activity.

 

[Dolphin]

The actometer data and a few extracts:


The three studies were:

Knoop H, van der Meer JW, Bleijenberg G (2008). Guided
self-instructions for people with chronic fatigue syndrome: randomised
controlled trial. British Journal of Psychiatry 193, 340–341.

Stulemeijer M, de Jong LW, Fiselier TJ, Hoogveld SW, Bleijenberg G
(2005). Cognitive behaviour therapy for adolescents with chronic
fatigue syndrome: randomised controlled trial. British Medical Journal
330. Published online : 7 December 2004. doi
:10.1136/bmj.38301.587106.63.

Prins JB, Bleijenberg G, Bazelmans E, Elving LD, de Boo TM,
Severens JL, van der Wilt GJ, Spinhoven P, van der Meer JW (2001).
Cognitive behaviour therapy for chronic fatigue syndrome: a
multicentre randomised controlled trial. Lancet 357, 841–847.

================

The approaches were all based on CBT manual:

"Treatment was based on the manual of CBT for
CFS described in detail by Bleijenberg et al. (2003)
and effectively reduced fatigue severity in all trials."

Bleijenberg G, Prins JB, Bazelmans E (2003). Cognitivebehavioral
therapies. In Handbook of Chronic Fatigue
Syndrome (ed. L. A. Jason, P. A. Fennell and R. R. Taylor),
pp. 493–526. Wiley: New York.

=================

Table 2. Baseline, second assessment and change scores on fatigue
severity and physical activity in the group of included patients per
treatment condition

Prins et al. (2001) (n=211)
Treatment condition … CBT Control
(n=70) (n=141)

Fatigue severity:
----------------

Baseline
52.4 (4.0) 51.7 (4.1)

Second assessment
40.3 (10.5) 45.8 (8.7)

Change score
-12.1 (10.3) -6.0 (9.2)

Physical activity:
-----------------

Baseline
67.4 (21.8) 64.5 (19.7)

Second assessment
68.8 (25.2) 64.9 (21.7)

Change score
1.4 (18.5) 0.4 (16.4)

=========================

Knoop et al. (2008) (n=132)
CBT Control
(n=58) (n=74)

Fatigue severity:
----------------

Baseline
49.5 (5.1) 49.6 (5.7)

Second assessment
38.9 (10.8) 45.7 (8.9)

Change score
-10.6 (11.1) -3.9 (8.4)


Physical activity:
-----------------

Baseline
63.1 (23.5) 63.5 (21.8)

Second assessment
67.3 (22.5) 67.8 (21.4)

Change score
4.3 (20.4) 4.3 (21.0)

==============================

Stulemeijer et al. (2005) (n=58)

CBT Control
(n=28) (n=30)

Fatigue severity:
----------------

Baseline
52.3 (4.1) 51.3 (4.4)

Second assessment
24.8 (14.1) 42.9 (13.9)

Change score
-27.5 (14.2) -8.4 (13.4)


Physical activity:
-----------------

Baseline
65.6 (22.4) 65.0 (20.1)

Second assessment
75.8 (21.7) 67.7 (23.8)

Change score
10.3 (21.7) 2.7 (28.1)

CBT, Cognitive behaviour therapy.
Values are given as mean (standard deviation).

=========
Information on the outcome measures/instruments:

"Instruments:

Fatigue
The subscale fatigue severity of the Checklist Individual
Strength (CIS) was used to indicate the severity
of fatigue experienced by patients. It consists
of eight items which are scored on a seven-point
Likert scale. The sum score varies between 8, no fatigue,
and 56, severe fatigue. The CIS is a reliable and
valid instrument for the assessment of fatigue in CFS
(Vercoulen et al. 1994; Dittner et al. 2004). A common
cut-off score for severe fatigue is 35 (or higher), which
is about two standard deviations above the norm score
for healthy patients.

Physical activity

Actigraphy was used to assess physical activity in all
trials. The Actometer is a motion-sensing device
which is worn around the ankle for 12 consecutive
days. An average daily level of physical activity is
computed over this period, with higher scores indicating
more physical activity. The Actometer is described
in more detail by van der Werf et al. (2000).
They found a significant difference between the mean
Actometer score of CFS patients which was 66 (S.D.=
22) and healthy controls who had a mean Actometer
score of 91 (S.D.=25). They also identified a group of
patients who scored below the mean score of CFS
patients on 11 out of 12 days and labelled this group
as pervasively passive. We excluded all patients from
our study who missed actigraphy at second assessment."

[TK: My guess is the Actometer score for healthy adolescents (relevant
for Stulemeijer et al. (2005) study) would be higher than 91 (25)m
which was calculated from adult controls as I recall]

=========

Discussion
The data did not support a treatment model in which
the effect of CBT on fatigue is mediated by an increase
in physical activity. CBT did neither cause an increase
in physical activity at the end of treatment (path a) nor
was an increase in physical activity associated with a
reduction in fatigue (path b). A formal test of the mediation
effect confirmed that CBT yielded its effect independent
of a persistent change in physical activity.

These results are in line with the study of Moss-
Morris et al. (2005) in which it was demonstrated that
not an increase in fitness but a change in preoccupation
with symptoms mediated the effect of GET on
fatigue. The results are also consistent with earlier research
on CBT for CFS in which a reduction in fatigue
was associated with a change in illness beliefs (Deale
et al.1998). In the light of these findings, changing illness-
related cognitions seems to play a more crucial
role in CBT for CFS than an increase in physical activity.

========
[Tom: My chief observation is most people would believe that actometer data
is more objective than outcome measures from questionnaires like fatigue
scores. And as they shown, CBT wasn't increasing activity levels. These
studies reported improvements in the SF-36 physical functioning subscale,
while again many people might be more impressed by improvements in actual
physical functioning (as measure by a pedometer) not a change in how people
respond to questionnaires!]

 

[Dolphin]

As one person on another list I'm on said:

These results are very close to a fatal blow to their model, the major stated aim of which was to increase physical activity. That is all that ultimately counts. Getting very modest changes to scores on totally subjective tests is meaningless without strong correlations to objective changes in activity patterns. To describe these modest subjectively reported changes as an "effective" treatment in reducing fatigue, is stretching the meaning of effective to the point where it has little value, particularly if there is no correlation between subjectively reported reductions in fatigue, and objective measures of activity levels.

 

[Mithriel]

This is pretty interesting- The authors state that in three previous trials of CBT, actometer data was taken. However one of the common criticisms of CBT studies is that no objective outcome measures, such as actometer data, have been eported in the literature. This raises the obvious question of why was this actometer data not reported in the original results of these studies.

Does this mean that actometer data was taken but it was left out of the published papers or does is it asking why it isn't done in all trials if it can be done in a few?

I do feel that "CBT and GET are very effective treatments for CFS" is one of those myths that are only true because people keep saying it.

I have never seen these "effective" results in any papers.

Mithriel

 

[Dolphin]

This is pretty interesting- The authors state that in three previous trials of CBT, actometer data was taken. However one of the common criticisms of CBT studies is that no objective outcome measures, such as actometer data, have been eported in the literature. This raises the obvious question of why was this actometer data not reported in the original results of these studies.

Does this mean that actometer data was taken but it was left out of the published papers or does is it asking why it isn't done in all trials if it can be done in a few?

Yes, that is true. I have checked the papers in recent days. It's shocking.

I do feel that "CBT and GET are very effective treatments for CFS" is one of those myths that are only true because people keep saying it.

I have never seen these "effective" results in any papers.

Mithriel

Good point.

 

[leelaplay]

'CBT Proven to NOT Work' or 'CBT Struck Fatal Blow'

Hi Tom

I had 3 major reactions to this post:

1. You do have restrained titles sometimes. Think I might have gone for something more BBCish - "CBT proven to NOT work" or "CBT Sruck Fatal Blow".

The stated aim of the CBT was to increase physical activity. They say that CBT did not increase physical activity = DEATH BLOW

2. It seems criminal almost for the 3 studies to have collected actometer data and then to have not included it in their studies.

Is there a protocol for inquiring as to why they did not include the data? Something that clearly shows any scientist reading the papers that this is a significant problem?

Wanted to add "and shoddy 'science'?", but realized that might be construed as being inflammatory

3.Their discussion of the results states (with my bolds and spacing):

Discussion

The data did not support a treatment model in which the effect of CBT on fatigue is mediated by an increase in physical activity. CBT did neither cause an increase in physical activity at the end of treatment (path a) nor was an increase in physical activity associated with a reduction in fatigue (path b). A formal test of the mediation effect confirmed that CBT yielded its effect independent of a persistent change in physical activity.

In my layman's opinion - nice clear statement of results

These results are in line with the study of Moss-Morris et al. (2005) in which it was demonstrated that not an increase in fitness but a change in preoccupation with symptoms mediated the effect of GET on fatigue.

The results are also consistent with earlier research on CBT for CFS in which a reduction in fatigue was associated with a change in illness beliefs (Deale et al.1998).

In the light of these findings, changing illness-related cognitions seems to play a more crucial role in CBT for CFS than an increase in physical activity.

I am suspicious that they try to bring in other studies that toe the party line and bring in GET as well.

And the final sentence says that CBT seems to have something to do with changing 'illness-related cognitions' (although that was NOT proven here), MORE THAN?????? it increases physical activity (they have just proven that it DOES NOT increase physical activity) - very bizarre wording

Fortunately the Results and Conclusion in the abstract are clear:

RESULTS: Although CBT effectively reduced fatigue, it did not change the level of physical activity. Furthermore, changes in physical activity were not related to changes in fatigue. Across the samples, the mean mediation effect of physical activity averaged about 1% of the total treatment effect. This effect did not yield significance in any of the samples.

CONCLUSIONS: The effect of CBT on fatigue in CFS is not mediated by a persistent increase in physical activity.

 

[Dolphin]

Hi Tom

I had 3 major reactions to this post:

1. You do have restrained titles sometimes. Think I might have gone for something more BBCish - "CBT proven to NOT work" or "CBT Sruck Fatal Blow".

The stated aim of the CBT was to increase physical activity. They say that CBT did not increase physical activity = DEATH BLOW

You are probably right. I am used to writing to Co-Cure where one is encouraged to be factual so I have just been using the titles of the papers.

If a mod sees this, I'd be grateful if they changed it to: CBT found not to increase activity levels in 3 Dutch CFS studies (if that's just a little too long, knock off the "CFS" and if necessary "Dutch" also or if necessary just finish after levels)

 

[acer2000]

It seems like if they were testing to see if CBT actually increased functional capacity in CFS patients, v.02 Max and Anaerobic Threshold (basically exercise test data) would have been a better marker than actometer data.

 

[Mithriel]

That would be far too sensible and objective thus far too likely to give the wrong result - proving the disease is physical and their theories are just plain wrong.

Studies which use actimeters all show the same effect, no extra activity. The strong suspicion is that the data was not published because that was the result, I doubt it would go unpublished if it supported their case.

It is also the reason why the multimillion pound PACE trial which is due out soon used actimeters for baseline but not for outcome - very scientific.

Objective results are the best science but is not what is being used in CFS research. If their theories were sound they would not have to manipulate the data in this way.

Mithriel

 

[_Kim_]

If a mod sees this, I'd be grateful if they changed it to: CBT found not to increase activity levels in 3 Dutch CFS studies (if that's just a little too long, knock off the "CFS" and if necessary "Dutch" also or if necessary just finish after levels)

All done :Retro smile:

 

[Dolphin]

It seems like if they were testing to see if CBT actually increased functional capacity in CFS patients, v.02 Max and Anaerobic Threshold (basically exercise test data) would have been a better marker than actometer data.

The authors never said that they tested for functional capacity using the actometer data. They said in the studies this was done using questionnaires.
However, these were CBT programs designed to encourage greater activity. Going for walks and the like are encouraged. But there was no increase in activity (in the Stulemeijer, adolescents, there was a numerical increase over the controls but not in the other two) which means they didn't do what they are supposed to do. Friedberg found that a similar thing in some studies he did and found that people must be giving up other activities to do the walk. While if their functional capacity improved, they most likely wouldn't need to do this - they'd be able to do the walk plus what they were already doing (plus one might expect more given the improved "physical functioning", fatigue and "functional capacity" they reported in questions).

There can also be problems with using VO2Max, etc.
(i) People can have set-backs from doing the exercise test itself
(ii) It might not be a good way of measuring functional capacity in ME/CFS - people with ME/CFS may be able to achieve a result that is not too bad on one test but in reality, they wouldn't be able to do the number of steps a comparable non-ME/CFS case could do across a day. In the same way that some people with ME/CFS can't achieve the same results on a second day of exercise testing. Or other studies that have found exercise abnormalities.
In the Belgium CFS rehabilitiation clinics, which involved patients doing on average 41 sessions (exercise and CBT) there was neglible difference between the VO2 max scores at the start and at the end. They did find that lots of people didn't do it the second time as they had a bad reaction the first time.

 

[Dolphin]

Studies which use actimeters all show the same effect, no extra activity. The strong suspicion is that the data was not published because that was the result, I doubt it would go unpublished if it supported their case.

I think so too.

 

[acer2000]

There can also be problems with using VO2Max, etc.
(i) People can have set-backs from doing the exercise test itself
(ii) It might not be a good way of measuring functional capacity in ME/CFS - people with ME/CFS may be able to achieve a result that is not too bad on one test but in reality, they wouldn't be able to do the number of steps a comparable non-ME/CFS case could do across a day. In the same way that some people with ME/CFS can't achieve the same results on a second day of exercise testing. Or other studies that have found exercise abnormalities.
In the Belgium CFS rehabilitiation clinics, which involved patients doing on average 41 sessions (exercise and CBT) there was neglible difference between the VO2 max scores at the start and at the end. They did find that lots of people didn't do it the second time as they had a bad reaction the first time.

I agree no measure is perfect, but even if it caused the patients to feel bad doing exercise testing at the beginning and end of the studies - the data is still relevant. The fact that you state the Belgian studies show basically what I was curious about - that CBT didn't increase exercise capacity clearly shows the limitation of CBT as a therapy for actually improving CFS patients.

 

[Esther12]

This all looks really interesting, so I'm just adding a comment to remind myself to look back at this thread when I have more time. Ta.

 

[starryeyes]

CONCLUSION: The effect of CBT on fatigue in CFS is not mediated by a persistent increase in physical activity.

Epic Fail! :sofa:



xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx

 

[Adam]

Lol You must be an Equals 3 subscriber on You Tube. Love it.

PS. In 2001 spent 22 hellish days in Oldchurch Hospital Romford London. 6 CFS beds. A real eye opener that made me stick my head in the sand for nine years until, you've guessed it, XMRV popped up on BBC text one day and my wife said "seen this, a study in US about a virus for CFS" and my world will never be the same again. Death to CBT. My thought processes are no more crazy than the next citizens. And as for GET. I'd love some therapist to try and cross a busy road with me. No love, you go right ahead and cross on your own. You'll be fine. Just wave to the motorists a bit and get them to slow down once the lights have changed to green. I'll stay here. I'm just fine. I don't want to get mashed up by a motor vehicle.

 

[Advocate]

There can also be problems with using VO2Max, etc.

Hi Tom,

I can see that you are interested in ways of measuring fatigue. I hope you will go to the draft of our survey and take a look at the section on "other" tests. What words do you think we should use in asking if people have had VO2Max testing, actometer tests, etc.

 

[Dolphin]

Hi Tom,

I can see that you are interested in ways of measuring fatigue. I hope you will go to the draft of our survey and take a look at the section on "other" tests. What words do you think we should use in asking if people have had VO2Max testing, actometer tests, etc.

Thanks for asking, Advocate.

I filled in the questionnaire there. I have to say I like things to be thorough but did find it a bit tiring.

My point about actometers is with regard to treatment claims - so somebody would need before and after data. Similarly for VO2 max.

If you collect just one set of numbers, that tells you less. But you could look for correlations e.g. see how well VO2max or actometer scores correlate with symptoms or disability scores.

One of my objections is when "cause and effect" is read into them e.g. if people exercise, this will solve they're problems. Just because there may be a correlation between a particular outcome measure and disability, doesn't mean the person necessarily "deserves praise" or are at that higher level because they exercised. I functioned at a high level for years (pre-diagnosis) then I got stuck at a low level (probably from late diagnosis and advice to exercise).
If you had tested my VO2 max level or measured my actometer readings when I was mildly affected, they would have been good. But it doesn't mean that now I can exercise myself up to those levels now.

Also when I was mildly affected, my VO2 max might have been better than some people in the population but I still had specific problems and would have felt worse than healthy people the next day after the test.

 

[Snow Leopard]

In the Belgium CFS rehabilitiation clinics, which involved patients doing on average 41 sessions (exercise and CBT) there was neglible difference between the VO2 max scores at the start and at the end. They did find that lots of people didn't do it the second time as they had a bad reaction the first time.

Is the data on that published? I assume it would be a DeMeirlier study?
(I haven't done a revew of related articles so..)

 

[Sunshine]

Supporting the findings in this post of Dutch CFS patients, similar findings from the UK are shown.

Cognitive behavioural therapy for ME/CFS sufferers: How strong is the evidence?
http://www.meresearch.org.uk/research/reviews/cbt.html

Question marks over evidential basis of claims for psychosocial therapies
http://www.meresearch.org.uk/research/reviews/psychosocial.html