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

Dolphin

Senior Member
Messages
17,567
Here's some workplace data on CIS norms: Fatigue among working people: validity of a questionnaire measure, see Table 2

White collar worker 20.3 (10.1) mean (SD)

Blue collar: 21.9 (11.4)

After hernia: 32.9 (11.7)

Pregnant: 33.9 (13.0)

Mental: 39.6 (12.1)

On these figures (which are from some of the FITNET co-authors), 30 does look high for a healthy mean. Though maybe adolescents are more fatigued than adults...

A nature paper on bone marrow transplation gives mean fatigue levels under 30 even though around 1/3 of theseare stated as having severe fatigue.

I've also seen >35 as the threshold for severe fatigue eg a Bleijenberg paper on Rheumatoid Arthritis.


Ah, maybe this is it: Is a Full Recovery Possible after Cognitive Behavioural Therapy for Chronic Fatigue Syndrome?
Thanks for digging all that up.

The figure from the full recovery paper is the one I had in mind.
Also note that none of them had SDs close to 5.
 

oceanblue

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using median and range the figures are:
Duration of symptoms at entry (months)
FITNET (n=68) 160 (684)
Usual care (n=67) 190 (6108)
I'd expect adolescents who were ill who were ill for only that length of time to have a relatively good prognosis.
So would I. I'm not convinced the small difference in duration between the two groups would contribute much to the difference in outcomes. Would be very interesting to see the correlation between illness duration and outcomes; some people in both groups had been ill for a very long time.
 

oceanblue

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Thanks, Marco.

That study (abstract here) is closer to what I was looking for in terms of self-report biast, but I'm not sure it quite does what it says the tin. They found looked at patients:
1. pre-treatment
2. at the close of the trial
3. in a completely separate survey (ie not part of the original trial), 8 months later, while patients were still receiving treatment

The self-reported gains were much smaller 8 months on, even though the patients were on the same treatment, than at the end of the trial. The researchers iterpreted this as evidence of the Hawthorne effect, patients reporting better outcomes because they were receiving more attention as part of a clinical trial.

However, one explanation could be that the initial effects diminished. It would have been more convincing if they'd had a control group that had remained part of the original trial for another 8 months, then compared those in the trial with those outside it but still on the same treatment.

It's still probably the best evidence I've seen on self-report bias that's relevant to CFS-type studies. thanks again.
 

oceanblue

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CIS-fatigue data for Dutch adolescents

Severe Fatigue in Adolescents: A Common Phenomenon?


This 2006 study (n=3,454) describes itself as a study of fatigue in a healthy population, though looking at some of the fatigue scores some of them appear to be rather unhealthy. The CIS-fatigue scores are higher than those quoted for adults above:

Girls: 27.54 (12.68) [mean (SD)
Boys: 21.26 (10.44)

Nb mean + 2SD using these data would give an even softer fatigue threshold for 'recovery' than used in the study.

The study also gives a breakdown of the distribution of fatigue scores.

Hope this helps.

ETA: Is this paper the source of their CIS-fatigue data?
Cognitive behaviour therapy for adolescents with chronic fatigue syndrome: randomised controlled trial
Analysis...
We defined patients as having ... and a fatigue score < 35.7 (1 SD above the mean for 420 healthy adolescents, unpublished data) for fatigue severity
 

Guido den Broeder

Senior Member
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Location
Rotterdam, The Netherlands
I'd expect adolescents who were ill for only that length of time to have a relatively good prognosis.
Of course, for purely statistical reasons already, not necessarily because the duration itself has an effect.

It is the same as with unemployment. Those who have been unemployed for a long time have less chances of finding a job. Not because they're not looking that hard anymore (a popular belief among politicians), but because the others, who did have a good chance, are no longer part of the group.

Likewise, a group of patients that have been ill for many years, no longer contains patients with a good chance to quickly recover: those already got better!
 

Dolphin

Senior Member
Messages
17,567
CIS-fatigue data for Dutch adolescents

Severe Fatigue in Adolescents: A Common Phenomenon?


This 2006 study (n=3,454) describes itself as a study of fatigue in a healthy population, though looking at some of the fatigue scores some of them appear to be rather unhealthy. The CIS-fatigue scores are higher than those quoted for adults above:

Girls: 27.54 (12.68) [mean (SD)
Boys: 21.26 (10.44)

Nb mean + 2SD using these data would give an even softer fatigue threshold for 'recovery' than used in the study.

The study also gives a breakdown of the distribution of fatigue scores.

Hope this helps.

ETA: Is this paper the source of their CIS-fatigue data?
Cognitive behaviour therapy for adolescents with chronic fatigue syndrome: randomised controlled trial
Analysis...
We defined patients as having ... and a fatigue score < 35.7 (1 SD above the mean for 420 healthy adolescents, unpublished data) for fatigue severity
Thanks.
That could be it.
In the Lancet paper, it has

Fatigue was measured with the
subscale fatigue severity of the CIS-20 (range 856). The
questionnaire has good reliability and discriminative
validity with good internal consistency (Cronbachs
?=093).12,25

12 Stulemeijer M, de Jong LW, Fiselier TJ, Hoogveld SW, Bleijenberg G.
Cognitive behaviour therapy for adolescents with chronic fatigue
syndrome: randomised controlled trial. BMJ 2005; 330: 14.

25 Vercoulen JH, Swanink CM, Fennis JF, Galama JM,
van der Meer JW, Bleijenberg G. Dimensional assessment of
chronic fatigue syndrome. J Psychosom Res 1994; 38: 38392.

Recovery was defined post hoc, in relation to healthy
peers (2 SD), as having a fatigue severity score of less
than 40,6,12,30

6 Nijhof SL, Maijer K, Bleijenberg G, Uiterwaal CS, Kimpen JL,
van de Putte EM. Adolescent Chronic Fatigue Syndrome:
Prevalence, Incidence, and Morbidity. Pediatrics 2011; 127: e116975.

12 Stulemeijer M, de Jong LW, Fiselier TJ, Hoogveld SW, Bleijenberg G.
Cognitive behaviour therapy for adolescents with chronic fatigue
syndrome: randomised controlled trial. BMJ 2005; 330: 14.

30 van Geelen SM, Bakker RJ, Kuis W, van de Putte EM. Adolescent
chronic fatigue syndrome: a follow-up study. Arch Pediatr Adolesc Med
2010; 164: 81014.
I am more used to adult figures.
Also, I had automatically thought that adolescent/teenage figures would be better.
However, perhaps the figures are worse in that age than adults e.g. not enough sleep, physical demands of growing, pressures of growing up, etc.
 

PhoenixDown

Senior Member
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456
Location
UK
The study also gives a breakdown of the distribution of fatigue scores.
What triggers each individual's fatigue? How long does the fatigue take to settle back to what's baseline fatigue for that individual? How much do various triggers agitate each individual's fatigue? This really is an incomplete picture. The fatigue scales they are using clearly do a great disservice to some patients.
 

oceanblue

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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]."
...

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
As Dolphin said, physical activity as measured by actometers was included as a possible 'predictor' rather than an outcome, but what's a little strange is that the protocol says actometer measurement is carried out at baseline, post-treatment and 6-month follow-up. Obviously you can't use a follow-up measurement as a predictor of treatment response. I wonder if they were collecting this data because they wanted to see if the treatment would improve actometer-measured activity, for once?
 

oceanblue

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Emphasis on school attendance and other goals

I thought it would be worth highlighting some of the protocol appendix about school attendance, and other activites. School attendance seems to have greatest priority but they do consider home and social activity too:

Appendix 1: Overview of FITNET web-based CBT treatment for adolescents with CFS
Cognitive Behavioural Treatment Modules

1. To introduce myself

2. How does this treatment work?

3. Assessing my present possibilities

...

14. My schedule for school

15. My social activities

16. To reach goals

17. My schedule for work

18. To have a night out

...

Typically, treatment involves...(d) gradually increasing activities including home, social and school life, ...

...Return to full time education is always a goal of treatment, and a plan for returning to school will be discussed early with everyone involved.
 

Dolphin

Senior Member
Messages
17,567
Adults: Nijmegen internet-based intervention found no change on actometers

Guided self-instructions for people with chronic fatigue syndrome: randomised controlled trial. Br J Psychiatry. 2008 Oct;193(4):340-1. Knoop H, van der Meer JW, Bleijenberg G.
Free at: http://bjp.rcpsych.org/content/193/4/340.full

This looked like it was helpful based on questionnaire results.

However, actometer data from Wiborg et al (2010):

(CBT (as Wiborg et al call it) =guided self-instructions)
Baseline 63.1 (23.5)
Second assessment 67.3 (22.5)
Change score 4.3 (20.4)

Waiting-list Control group
Baseline: 63.5 (21.8)
Second assessment: 67.8 (21.4)
Change score: 4.3 (21.0)

Information about the intervention:
We assumed that for a subgroup of patients with chronic fatigue syndrome a less intensive treatment sufficed and developed a minimal intervention based on CBT that consisted of self-instructions and email contact.

The intervention consisted of a self-instruction booklet containing
information about chronic fatigue syndrome and weekly
assignments. The programme took at least 16 weeks, but often
more if patients formulated long-term goals such as returning
to work. Patients were asked to email (or telephone if they did
not have email) at least once every 2 weeks to report their
progress. A cognitivebehavioural therapist, trained in regular
CBT for chronic fatigue syndrome, responded to this email or call
.
If patients did not respond every 2 weeks, a reminder was sent by
email or patients were telephoned.

It was already known that individual CBT is an effective treatment
for chronic fatigue syndrome.1 Our study showed that a less
intensive intervention based on the same principles
 

oceanblue

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I'm confused. Is the Wiborg actometer data from the Knoop email study? And where does Nijmegen fit in?
 
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I'm confused. Is the Wiborg actometer data from the Knoop email study? And where does Nijmegen fit in?

I think prior actometer data from Nijmegen has been included in this discussion to show that Nijmegen hasn't been able to produce objective improvement in the past.

In several studies (a few years ago?) they reported a spectacular improvement in how people feel after CBT. In those studies, they deliberately left out any mention of the actometers until several years after they were published, then used that actometer data to publish an additional paper discussed here.

In that paper, they explain how perceived fatigue and physical activity are not related in ME/CFS, with the implication that treating perceived fatigue is more important than increasing physical activity.

In another paper discussed here, the same group explains poor cognitive performance after being treated with CBT by concluding that actual cognitive importance must therefore be less important in ME/CFS than perceived cognitive performance.

They have repeatedly created studies based on a "proven" CBT theory, and they will work backward to warp any findings to fit their theory. So it is extremely relevant to know when an ME/CFS study involves researchers from the Nijmegen CFS clinic.
 

oceanblue

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Take a look at Table 4. In the last two rows, they have practically the same physical functioning score but a 25% difference in school attendance. Rows 3 and 7 have practically the same fatigue severity score but almost a 30% difference in school attendance.
That's a really interesting point.

I've tried to bring the data together, below. One measure is A/F, the ratio of school Attendance to physical Function. This is arround 0.75 for baseline and both 'Usual Care' follow-ups, but around 1.0 for FITNET patients at follow-up - suggesting that FITNET patients attend a lot more school for their levels of physical functioning. This could be a 'smoking gun' in terms of showing disproportionate energy being directed into school attendance rather than, say, social or home activity.

However, I noticed that the ratio for reference healthy group is also around 1.0 (ie same as FITNET), so I'm not sure if this gets us anywhere.

Fatigue scores transformed to 'Energy' scores
I've transformed the 8-56 fatigue scale (56=max fatigue) into a 0-100 Energy scale for easier comparison with 0-100 scores for attendance and function. 0-100 Energy scale: 100=no fatigue [CIS=8], 0 = max fatigue [CIS=56]. This makes all 3 scales (Attendance, Function and Energy) 0-100 where 100 is best.

Seemed like a good idea at the time, though now I'm not sure if it helps. Comments welcome.

AttendFunctionFatigueEnergyA/F
Reference
'Healthy' population98%9530541.03
Recovery (weak, -2SD)>=90%>=854033
Recovery (stronger, -1SD)>=94%>=903544
Baseline
FITNET39.5%60.751.210.00.65
Usual Care45.1%56.851.69.20.79
Post-treatment
FITNET84.3%88.524.066.70.95
Usual care51.7%70.042.328.50.74
12 months
Usual care to 6 months
Not recovered >FITNET (n=31)85.7%84.228.457.51.02
Not recovered, more usual care (27)60.6%83.132.948.10.73
 

oceanblue

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I think prior actometer data from Nijmegen has been included in this discussion to show that Nijmegen hasn't been able to produce objective improvement in the past.
...
They have repeatedly created studies based on a "proven" CBT theory, and they will work backward to warp any findings to fit their theory. So it is extremely relevant to know when an ME/CFS study involves researchers from the Nijmegen CFS clinic.
Oh, I see, I think. This latest Nijhof paper was from work based on the same Nijmegen clinic where the studies for the Wiborg actometer paper were carried out? I was confusing people with clinics.
 

Dolphin

Senior Member
Messages
17,567
Calculated using the means derived from the appendix for recovery scores, as detailed in 'reference' above. Have I made a mistake.
Ok, get it now. I hadn't associated the attendance figures with population norms but of course that makes sense.

---
Could you do Attendance/Fatigue. Thanks.
 

charityfundraiser

Senior Member
Messages
140
Location
SF Bay Area
Ah thanks, oceanblue, for typing and formatting all that out, and coming up with the ratio to look at it. I guess if one were assuming that school attendance and fatigue levels should have a linear relationship, then it would look like the CFS patients were underallocating their energy to school before FITNET. I suppose though that even at the same energy level, if one were able to increase school attendance at the cost of something else, one might feel more accomplished.