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FITNET Trial: Effectiveness of internet-based CBT for CFS: an RCT (Nijhof et al, '12)

Sean

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Primary outcomes were school attendance, fatigue severity, and physical functioning, and were assessed at 6 months with computerised questionnaires.
Looking hard for genuinely objective outcome measures...
 

user9876

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Looking hard for genuinely objective outcome measures...
School attendance is not too bad an objective measure. There is of course a problem that kids with mild ME could be encouraged to use all their energy going to school rather than doing other activities hence an increase in school attendance does not necessarily corrospond to an increase in activity.
 

Enid

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I do not know what the hell is going on here - yes indeed one must try to keep positive though CLINICAL depression (that is in case these idiots cannot diagnose basic BIOLOGICAL pathologies bringing systems to a standstill). Internet BUNK except those here on PR working with understanding and the healing of dysfunctions in many systems.
 

Esther12

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I only had a quack (edit - genuine typo, 'quick') glance - but it looked like they talked of using actometers. That would be great if it got us some real data on how these different groups were responding to treatment.

School attendance is okay-ish... but for most teens, school attendance is a relatively minor part of their energy use. If I had parents to do personal care things, even I could be able to attend school full time (if I had somewhere to rest during breaks), and I'm still seriously ill.

edit: There's lots of measures laid out in that protocol - like with PACE. It's so frustrating to see that all this data is being collected... and we don't get to see it! Why not just put all the raw data on-line? I'm hungry for info.
 
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School attendance is not too bad an objective measure. There is of course a problem that kids with mild ME could be encouraged to use all their energy going to school rather than doing other activities hence an increase in school attendance does not necessarily corrospond to an increase in activity.
Hmm.
School presence Last two weeks school presence expressed in attended hours/obliged hours * 100%[3]
I wonder if they simply wanted to turn up (or say they turned up) for those two weeks so they can be seen as compliant? Remember that children are much more erm, susceptible to suggestion than adults.

Also,

Table 1 Inclusion and exclusion criteria
Inclusion criteria
(1) The participant has given written informed consent
(2) CFS diagnosis according to the CDC criteria [1]
(3) Adolescent between 12-18 years old at inclusion
(4) Fatigue severity subscale (CIS-20) score ?40 (healthy
populations mean plus two SD) [19]
(5) Physical functioning (Child Health Questionnaire) score <85
(healthy populations mean minus two SD) and/or school
participation ?85% (healthy populations mean minus two SD) in
last two weeks [20]
Exclusion criteria
(1) Inadequate control of Dutch language by child or parent
(2) No availability of computer hardware and internet connection
(3) Suicide risk as assessed on the Childrens Depression Inventory
(CDI) [21]
(4) Cognitive retardation (when indicated an IQ-test will be
conducted; IQ <85 will be excluded)
(5) Score greater than or equal to 44 (healthy populations mean
plus two SD) on the State-Trait Anxiety Inventory for Children
(STAIC) [23]
(6) Score greater than or equal to 16 (healthy populations mean
minus two SD) on the Childrens Depression Inventory (CDI) [21]
<85% PF? Many of these patients may be mildly affected at best. Note that after both 'treatments'
, PF was similar across both groups (~85%).

On the whole, this isn't a terrible thing as online CBT is probably more tolerable than other forms, especially the old group therapy.

The key point I have is that CBT only works for 'some' people, they should be working on finding out who those people are (and how their biological markers may differ), rather than pretending that the treatment works for all/should be given to all.

I only had a quack (edit - genuine typo, 'quick') glance - but it looked like they talked of using actometers. That would be great if it got us some real data on how these different groups were responding to treatment.
I missed seeing that, you're right.

And guess what? They've cherry-picked the results so as to not include the actometer results in the Lancet publication. (and we know they've done that before)
 
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Actually, CBT works surprisingly well. It has proven to be very easy with this therapy to brainwash people into thinking they aren't really ill, for instance.

By the same token, the therapy itself can make the patient report that they feel better when the researcher would like them to say that, or to attend school when the researcher would like them to do that. Of course, if they are truly fatigued they may then fall asleep at school, but hey, that's not recorded.
 

alex3619

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Fatigue In Teenagers on the interNET - The FITNET Trial. A randomized clinical trial of web-based cognitive behavioural therapy for adolescents with chronic fatigue syndrome: study protocol: "(d) Physical performance as measured with the actometer. This is a motion-sensing device worn at the ankle that registers and quantifies physical activity. The actometer is worn day and night during a period of twelve consecutive days [27]."

Effectiveness of internet-based cognitive behavioural treatment for adolescents with chronic fatigue syndrome (FITNET): a randomised controlled trial: "Physical functioning was measured with the subscale physical functioning of the CHQ-CF87 (0100%). This assessment method is reported to be reliable and has been validated with a good internal consistency (Cronbachs ?=086)."

The PACE trial started with actometers in the design, but finished without them. Every study with actometers that I have read showed either no improvement in functional capacity or a decline in functional capacity.

This study dropped actometers from their protocol too. I wonder why?

Bye, Alex
 
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Apologies for citing Wessely, but... at least compared to adults, most children recover from CFS anyway.

"Of 26 studies identified, four studied fatigue in children, and found that 54-94% of children recovered over the periods of follow-up. Another five studies operationally defined chronic fatigue syndrome in adults and found that < 10% of subjects return to pre-morbid levels of functioning, and the majority remain significantly impaired."

The prognosis of chronic fatigue and chronic fatigue syndrome: a systematic review
http://qjmed.oxfordjournals.org/content/90/3/223.full.pdf+html

If half to almost all children recover within several years anyway, it's plausible that FITNET could accelerate the recovery period to within 1 year. If over 90% of adults usually don't recover, I wouldn't expect the same effect size.
 

user9876

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Apologies for citing Wessely, but... at least compared to adults, most children recover from CFS anyway.

"Of 26 studies identified, four studied fatigue in children, and found that 54-94% of children recovered over the periods of follow-up. Another five studies operationally defined chronic fatigue syndrome in adults and found that < 10% of subjects return to pre-morbid levels of functioning, and the majority remain significantly impaired."

The prognosis of chronic fatigue and chronic fatigue syndrome: a systematic review
http://qjmed.oxfordjournals.org/content/90/3/223.full.pdf+html

If half to almost all children recover within several years anyway, it's plausible that FITNET could accelerate the recovery period to within 1 year. If over 90% of adults usually don't recover, I wouldn't expect the same effect size.

How many children just get reclassified as having pervasive refusal syndrom when CBT and Get don't work.
 
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<85% PF? Many of these patients may be mildly affected at best. Note that after both 'treatments'
, PF was similar across both groups (~85%).
Nb they didn't use SF-36, but the CHQ scale. I'm not familiar with the scoring system, but they did say the 85% threshold was based on mean-2SD of a healthy population, which would be the equivlaent of about 75 for SF-36, I think.
Physical activity was measured by the Child Health Questionnaire (CHQ-CF87 subscale physical functioning):
...
This is broadly similar to the SF-36 Physical Functioning sub-scale, though it merges walking/stairclimbing, and has the extra questions in italics. This is all I could find on scoring: "Response options also vary from 4-6 levels for the scales"
 

user9876

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I wonder if they simply wanted to turn up (or say they turned up) for those two weeks so they can be seen as compliant? Remember that children are much more erm, susceptible to suggestion than adults.
School attendance records would have been very easy to obtain and analyse. There was a school mentor involved in the FITNET programme as well so I don't know what roll they have taken. I think the question remains as to is this about shifting the focus of what energy some kids have or did there function really improve.

I think the scales that psychiatrists use are not suitable for research since they are not linear and some are not even monotonic. I can see they might be useful diagnostic tools but that doesn't translate into being suitable for having all the values added up as an overall score which can be compared to later scores or across populations. I also feel that they are ignoring a large amount of phycological literature around bias in surveys and ways of asking questions. My initial thought was that school attendance is a good proxy for activity but when thinking about it this is only the case where there are suitable proxies for other activity otherwise you may just see an effect of squeezing effort where energy usage is shifted from one activity to another.

Really the only way to judge is to look at overall activity patterns. Accelorometers are quite cheap and small these days - many people even have them within their phones so I don't see that activity level monitoring should be hughly expensive. I've heard about recent break throughs using nano technology to make very cheap small and accurate accelorometers (and chemical sensors) which will make monitoring even easier in a year or so. I think it would even be interesting just to monitor activity with no intervention to try to get an understanding of activity patterns and things like the time between activity and post exersice malaise and then time to recovery. I assume this type of time information may help in thinking abount underlying mechanisms.
 

Firestormm

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Fatigue In Teenagers on the interNET - The FITNET Trial. A randomized clinical trial of web-based cognitive behavioural therapy for adolescents with chronic fatigue syndrome: study protocol: "(d) Physical performance as measured with the actometer. This is a motion-sensing device worn at the ankle that registers and quantifies physical activity. The actometer is worn day and night during a period of twelve consecutive days [27]."

Effectiveness of internet-based cognitive behavioural treatment for adolescents with chronic fatigue syndrome (FITNET): a randomised controlled trial: "Physical functioning was measured with the subscale physical functioning of the CHQ-CF87 (0100%). This assessment method is reported to be reliable and has been validated with a good internal consistency (Cronbachs ?=086)."

The PACE trial started with actometers in the design, but finished without them. Every study with actometers that I have read showed either no improvement in functional capacity or a decline in functional capacity.

This study dropped actometers from their protocol too. I wonder why?

Bye, Alex
Good spot Alex and Esther.

I think that they could have been better in other ways of recording 'recovery'. School attendance is all right, but what about school performance? Involvement in school activities? Things like that. If the measure of 'recovery' is that before the study they were not able to attend school and after the study they were - then I'd like to see more substance to the claim.

Off now to read the full published paper and the initial one too. I may never return :D
 
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School attendance records would have been very easy to obtain and analyse. There was a school mentor involved in the FITNET programme as well so I don't know what roll they have taken. I think the question remains as to is this about shifting the focus of what energy some kids have or did there function really improve.

... I also feel that they are ignoring a large amount of phycological literature around bias in surveys and ways of asking questions. My initial thought was that school attendance is a good proxy for activity but when thinking about it this is only the case where there are suitable proxies for other activity otherwise you may just see an effect of squeezing effort where energy usage is shifted from one activity to another.

Really the only way to judge is to look at overall activity patterns. Accelorometers are quite cheap and small these days - many people even have them within their phones so I don't see that activity level monitoring should be hughly expensive. I've heard about recent break throughs using nano technology to make very cheap small and accurate accelorometers (and chemical sensors)
Measurement of School attendance
School attendance was
measured as the proportion of classes attended, expressed
as a percentage of the normal school schedule. It was
recorded daily on a 24 h timetable of the self-observation
list 12 days before testing.29 On the day of testing, the past
2 weeks of school attendance were validated with a
general questionnaire and checked with the parents.
During FITNET treatment, the therapist and school
mentor were in contact about the school plan and
attendance when needed.
I agree we need to be aware of activity displacement to ensure overall activity levels have increased. However, I would caution against assuming actometers are a gold standard of measuring activity in 'free-living' humans - they are not. They are very accurate at measuring activity on a lab treadmill, so long as the treadmill isn't inclined up or down, in which case they are clueless as they measure acceleration not force/load. For example, an actometer can't tell the difference between strolling across the living room and climbing a flight of steps - wheras the difference is critical to a patient. The manufacturers of these devices have hyped the accuracy and this has largely been uncritically accepted by researchers. You can see an intermittent debate about this starting here.

Actometers are a valuable tool, and don't suffer from self-report bias, but we shouldn't assume they give a definitive value for activity levels. In particular, I have seen no evidence on their ability to accurately measure differences in activity levels pre/post intervention (and I haven't seen such evidence for SF-36 etc either).

Do you know of any specific references re survey bias? I know there's a lot of literature but never managed to find a particular killer paper; all the stuff I saw was tangential.
 

Marco

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Measurement of School attendance

Do you know of any specific references re survey bias? I know there's a lot of literature but never managed to find a particular killer paper; all the stuff I saw was tangential.
I'd need to search for the reference but I was reading one paper recently on the use of a particular questionnaire the review included the point that different responses are obtained when the questionnaire is adminstered by telephone compared to 'on site'. Perhaps there is a similar distance effect here?
 
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I'd need to search for the reference but I was reading one paper recently on the use of a particular questionnaire the review included the point that different responses are obtained when the questionnaire is adminstered by telephone compared to 'on site'. Perhaps there is a similar distance effect here?
That would be interesting, but what I was really hoping for was something that looked at possible bias where trial participants had a strong relationship with a therapist, and might be, subconsciously or otherwise, boosting their score a little. I've not seen anything like that to date.
 

Dolphin

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Recovery percentage in Appendix 1 is 36%

[STRIKE]Has anyone got the appendix? I think I should really read it before I start writing the letter I have in mind. PM me and I can send e-mail address. Thanks.[/STRIKE]
Got it.

In case anyone is interested, it's mentioned here:
"Analysis at other cutoff points for recovery (1 SD) did not change our findings with respect to treatment effects (appendix)."
Using a stricter (& better) definition of recovery (Appendix 1) causes drop from 63% to 36%!
 

Marco

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That would be interesting, but what I was really hoping for was something that looked at possible bias where trial participants had a strong relationship with a therapist, and might be, subconsciously or otherwise, boosting their score a little. I've not seen anything like that to date.
Sounds like acquiesence/social desirability bias in this case in a professional setting.


Anecdotally I was referred for CBT for a problem unrelated to ME/CFS.

It had no impact whatsoever.

However I did like the therapist. We had both graduated in psychology from the same university and are both guitar players. I found the therapy sessions (which included rational emotive therapy and EMDR as well as CBT) interesting (the only reason I studied psychology) but ultimately useless.

When I read the discharge report back to my GP my psychologist had reported some useful progress. Which is probably what I told him rather than appear ungrateful.

If the CBT had been for ME/CFS I would now be thoroughly ashamed of my white lies.
 

Esther12

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When I read the discharge report back to my GP my psychologist had reported some useful progress. Which is probably what I told him rather than appear ungrateful.
I think that this is a really big part in the faith clinicians have in their treatments for CFS.

Anecdotally - I had a somewhat heated and condemning final exchange at a CFS centre, and their letter to my GP still claimed that I was pleased with how helpful I had found their advice. Self-interested dishonesty probably plays a role too!