Efficacy of web-based cognitive–behavioural therapy for chronic fatigue syndrome: randomised controlled trial (2018) Knoop

This is fake news Valentijn. This is a great, great therapy. More people have made use of this State of the Nation therapy than ever before in history. It is draining the swamp. After this therapy people increased there ability to fill in on line questionnaires about how able they were to fill in on line questionnaires by 1000 per cent, really incredible. Don't knock it.

Make Psychobabble Great Again! :D

thank you so much for that laugh @Jonathan Edwards & @Valentijn . I was just feeling so demoralised & infuriated, feeling that this tide of bullshit will never end, i needed that giggle so much :laugh:

Dont forget, that PACE was "a great great trial"
 
Its also weird that they are doing CBT in isolation from GET, is this them actually telling people to pace and calling it CBT without the model of "ME is deconditioning".
I think it suggests they daren't try the same thing with GET.
 
It may take less time because, as they are saying the same thing to each victim, it can be a video, so one video, say an hour, for as many victims as they can scam, per session, as opposed to the old model where the time needed was 1 hour per victim per session.

So not less time for the victims, just much, much, much less for the "therapist", and thus cheaper.
 
A total of 240 patients participated in the study. They were consecutively referred to the Expert Center for Chronic Fatigue, a tertiary treatment facility for chronic fatigue at a university hospital. Before referral, consultants at the out-patient clinic of the department of Internal Medicine assessed their medical status to decide whether they had been sufficiently examined to rule out a medical explanation for their fatigue.

If their medical evaluation was deemed insufficient,patients were seen again for anamnesis, full physical examination,
case-history evaluation and laboratory tests following the national CFS guidelines...

able to speak, read, and write Dutch; (e) able to use a computer and having access to the internet. Exclusion criteria
were: (a) being involved in legal procedures concerning disability benefit claims;...

. However, face-to-face CBT is an intensive treatment and treatment capacity is limited. Internet based CBT (iCBT) might help to lower the threshold for seeking help and reduce the burden of the intervention for patients. iCBT
makes treatment easier to access for more patients and might promote self-efficacy. However, iCBT for CFS has only been tested in adolescents, where it was found to be effective. But, as adolescents are more inclined to use e-health, these outcomes cannot automatically be translated to adults. Guided variants of internet treatment are more effective than unguided variants

Even if we assume that the statistics are correct, I have questions.

So patients had to:
  • be well enough to make (and keep) at least one appointment outside the home.
  • able to speak, read, and write
  • be able to do the above in Dutch
  • able to use a computer
  • have access to the internet
  • be able to write e-mails
So the selection criteria weeds out

  • the immobile,
  • the cognitively challenged,
  • the computer illiterate,
  • people too poor to own a computer
  • or have access to the internet,
  • people who cannot use computer programs
  • people who couldn't manage a non-user generated username or password?
  • people who don't speak Dutch as a first language or struggle with it
  • People involved in legal disability claims (people who are willing to challenge authority?)
So, the criteria for being involved probably weeds out people who are probably the sickest and poorest? (and possibly most likely and able to question authority?).

For the patients following the feedback-on-demand condition monitoring was restricted to checking whether each module had been opened

So you didn't check:
  • If the module was read, only opened?
  • Why?
  • No mechanism at the end to show completion of the module?
  • Why?
  • How do we know the patient actually received the treatment then?
An integrity check was performed and for this the content of 5% of all emails the therapists had sent were evaluated

Why 5%? No evidence shown for how this was decided or validated.

Finally, how the web-portal was used was assessed by recording the number of times patients logged in, mean duration of sessions, number of opened treatment modules and number of emails sent.

Again, why? You cannot measure internet activity by recording the number of times patients logged in, mean duration of sessions, number of opened treatment modules, and number of emails sent.
Assuming UX/UI (User eXperience/User Interaction) assumptions are true, i.e that web companies do not spend a lot of money and research on UX/UI for no reason, that the technology for measuring UX/UI are not useless, etc.

  • My current computer session is 8 days, only an idiot would infer that I've been actively using constantly for 8 days without a rest.
  • What were the settings for session time-outs? Where there any?
  • Why do these patients not exhibit the web using trends of general users?

I'm only at the end of pg2 with the questions! :banghead: I'd be interested to hear more from just the technology side.

How do all of these factors constitute a representative(?) sample?

Questions for therapists: How important is non-verbal communication (and/or non-speech language) in assessing a patient? Why isn't it relevant in iCBT?
 
So the selection criteria weeds out

  • the immobile,
  • the cognitively challenged,
  • the computer illiterate,
  • people too poor to own a computer
  • or have access to the internet,
  • people who cannot use computer programs
  • people who couldn't manage a non-user generated username or password?
  • people who don't speak Dutch as a first language or struggle with it
  • People involved in legal disability claims (people who are willing to challenge authority?)
So, the criteria for being involved probably weeds out people who are probably the sickest and poorest? (and possibly most likely and able to question authority?).

The disability claims exclusion criteria is odd, and that seems worth querying, but given the nature of the intervention there were always going to be limitations on who can take part. I don't think that most of them are a real problem with the trial. In a trial of iCBT, providing a computer and computer training to those who would need them is quite an extra task (and one unlikely to be taken up in clinical care outside the trial).
 
The disability claims exclusion criteria is odd, and that seems worth querying, but given the nature of the intervention there were always going to be limitations on who can take part. I don't think that most of them are a real problem with the trial. In a trial of iCBT, providing a computer and computer training to those who would need them is quite an extra task (and one unlikely to be taken up in clinical care outside the trial).

How do we even know that the patients received some or all of the treatment? We know that they started 'treatment modules', but there is no proof that they completed them. What if they felt an obligation to say they completed modules because they wanted to please or look like they tried?

Technically we don't even know the contents of the e-mails, just that they exist?
 
A wait list control is pretty poor. I read this paper really only interested in their actimeter results, but not much info was given on them. I think that they may have messed up their supplementary files. They also mentioned doing a range of analyses, but I couldn't see the results for a lot of them. It is past my bed-time though, so I may have just missed them in my rush.

I pulled out some bits that I thought were of interest, but this was only a quick read through:

I feel like they should have explained that this related to depression and anxiety, not CFS.

Guided variants of internet treatment are more effective than unguided variants,8

8 Spek V, Cuijpers P, Nyklicek I, Riper H, Keyzer J, Pop V. Internet-based cognitive
behaviour therapy for symptoms of depression and anxiety: a meta-analysis.
Psychol Med 2007; 37: 319–28

This was part of their entry criteria:

(c) being severely disabled, operationalised
as a score of 700 or higher on the Sickness Impact Profile 8
(SIP8);

The average SF36-PF score for all three groups was 62 at baseline. ie the average participant fulfilled the PACE trials SF36-PF recovery criteria (although this is also under the PACE trial's entry criteria for severe and disabling fatigue, which required and SF36-PF of 65 or under). Presumably many of the participants had scores significantly higher than this too.

I've not looked at the reference for this, but it's from 1988 and it doesn't mention CFS in the preview page that was available:

The SF-36 is a reliable and valid instrument to assess
self-reported health status in patients with CFS.19

19
Stewart A, Hays R, Ware J. The MOS short-form general health survey. Reliability
and validity in a patient population.
Med Care 1988; 26: 724–35.

Interesting that they gave no justification for this cut off:

Fatigue scores in the normal range were defined as a score of <35
on the CIS fatigue severity subscale at second assessment, together
with a reliable change index (RCI) >1.96.

They mentioned these changes from their protocol (protocol is here, I've not read it: https://bmcneurol.biomedcentral.com/articles/10.1186/s12883-015-0392-3 ):

After trial registration but before the start of the study, we added
the Chalder Fatigue Questionnaire (CFQ)24 and Work and Social
Adjustment Scale (WSAS)25 to the assessment battery as both
instruments are often used in CFS intervention studies. Adding
them aids comparison of treatment effects between studies (see
also Worm-Smeitink et al)26 Another deviation of the original
study protocol was the decision not to determine quality-adjusted
life-years; because of limited resources we were unable to perform
a cost-effectiveness study. The quality of life questionnaire (the
EQ-6D)27 was, however, still part of the assessment battery.

I thought it was a bit fun that they took such care with this, but then had a wait-list control:

Patients were not informed about the existence of the two iCBT
treatments to avoid contamination between the two treatment arms.

I wonder why this was?

Six patients were included with less than four CDC symptoms
(one being randomised to the waiting list and five to the ondemand
treatment).

Maybe this is where the 40% recovery claim came from? I wonder if there was a press release for this paper:

Significantly more patients had
fatigue scores in the normal range following protocol-driven iCBT
than controls (protocol-driven 29/80 (36%) v. waiting list 12/80
(15%): χ2(1,n = 160) = 9.5, P = 0.0021; number needed to treat
(NNT) = 4.7) (supplementary Fig. 1).

Significantly more patients
had fatigue scores in the normal range following treatment than
the controls (on demand 34/80 (43%) v. waiting list 12/80 (15%):
χ2(1,n = 160) = 14.8, P = 0.0001; NNT = 3.6) (supplementary Fig. 1).

Yeah - this was from later on:

Comparing iCBT outcomes with
those of patients allocated to the waiting list, we found a significantly
larger reduction of fatigue severity, overall impairment and
psychological distress in the treatment groups, with approximately
40% of completers reporting fatigue scores within the normal range.

They said:

Patients who received iCBT were asked if they had experienced
negative side-effects of the therapy.

This is mentioned here, but I can't see supplementary Table 2 in the supplementary files.

No serious adverse events were reported. Some patients indicated
adverse events: 4 of 38 (11%) patients in the protocol-driven
condition, 7 of 39 (18%) in the on-demand condition, and 12 of
46 (26%) in the control condition (see supplementary Table 2 for
details and the patients’ perception of iCBT side-effects). The chisquared
analysis revealed no significant differences for the three
conditions in the proportion of patients reporting an exacerbation
of symptoms and/or functional impairments.

I don't really understand what was happening with their actigraphy, why they were not planning to assess results, and why they then did. The mentions it gets:

We conducted post
hoc ANCOVAs for the CFQ, the WSAS and the assessment of physical
activity using actigraphy to determine the effects of the intervention.

Finally, the post
hoc analyses revealed that CFQ scores and social impairment
(WSAS) were significantly reduced and objectively assessed activity
was significantly increased following the iCBT conditions compared
with the waiting list (supplementary Table 1).

I can't see supplementary Table 1 either. I've got table three, but it looks like they may not have uploaded the final file:

upload_2018-2-3_5-23-58.png


I think that this is as close as they come to addressing criticisms (ref 32 is PACE recovery, 34 is PACE Lancet):

There is an
ongoing debate in the literature and among patient advocacy groups
that challenge the efficacy and safety of CBT for CFS. [No references for
that... wouldn't want readers to be aware of the details of the debate!]
First, in line
with previous studies this study has shown that a subgroup of patients
with CFS were able to reduce their fatigue severity to healthy proportions
and reduce their overall impairment and improve psychological
well-being.18,32 Second, this study has shown, in line with previous
research, that CBT is a safe intervention.33,34 Unfortunately, only
half of the patients in our trial were asked to report on the occurrence
of adverse events as this evaluation was not added until a portal update
halfway through the study. Still, the available data did not show more
patientswith adverse events in the iCBT conditions comparedwith the
waiting-list condition and none of the adverse events reported were
serious. Furthermore, we found no evidence of a higher prevalence
of clinically significant exacerbation in fatigue and other outcomes
in the treatment conditions.

One could argue that the use of a waiting-list control does not
control for non-specific therapy factors and limits the external validity.
However, a meta-analysis that studied active placebo conditions for
CFS did show low responses,35 as was also true for standardised specialistmedical
care.34

This is what they say on physical functioning:

Impact of iCBT on physical functioning

One iCBT condition did not result in a significant increase in physical
functioning. This seems remarkable as previous studies did find positive
effects of face-to-face CBT on physical functioning (for example
White et al).34 Previous studies, however, often used compromised
physical functioning as an inclusion criterion, excluding patients
who score within the ‘normal range’ on physical functioning. In
our study these patients could be included if they reported severe
impairments in other domains of functioning, like work or social
functioning, as assessed with the SIP8. The fact that our study did
not select on the level of physical functioning will make it more difficult
to find an effect of iCBT on physical functioning. It would be
interesting to directly compare iCBT and face-to-face CBT in a
sample of patients with CFS with a compromised physical functioning
scoring below a cut-off on the SF-36 to determine if the interventions
differ in their effect on physical functioning. A post hoc analysis
showed that objectively assessed physical activity significantly
increased after iCBT. However, this might be an accidental finding,
taking the amount ofmissing data into account and previous research
that did not find an increase in physical activity following CBT.36

Limitations

The effects of iCBT were only assessed 6 months post-randomisation
as the medical ethical committee considered it unethical to
let patients wait longer than the regular waiting period for start of
treatment in usual care. Moreover, step two of our (stepped care)
study consisted of face-to-face therapy if patients were still fatigued
at the second assessment, therefore ruling out a controlled followup.
More men participated in this study as compared with other
CBT for CFS trials. This can be explained by the inclusion criteria

How do we even know that the patients received some or all of the treatment? We know that they started 'treatment modules', but there is no proof that they completed them. What if they felt an obligation to say they completed modules because they wanted to please or look like they tried?

I let Unrest run on Netflix while I was doing something else, just to indicate an interest. It's hard to check on some of this stuff. They gave some more details on this here:

Our integrity check showed that 90.3% of the interventions were
delivered according to protocol with an interrater reliability
(Cohen’s Kappa) of 0.96. A total of, 4 of 80 (5%) patients in the
protocol-driven condition and 6 of 80 (8%) in the on-demand condition
did not start the intervention. Without taking the relapse
module into account, 39 (49%) patients in the protocol-driven condition
were adherent to following our criteria of emailing fortnightly
and having opened all modules. Of the patients in the on-demand
condition, 74 (93%) were adherent to following our criterion of
having opened all modules. When the relapse module was taken
into account, this percentage dropped considerably to 16 and
19%, respectively (see supplementary Table 3). Finally, the post
hoc analyses revealed that CFQ scores and social impairment
(WSAS) were significantly reduced and objectively assessed activity
was significantly increased following the iCBT conditions compared
with the waiting list (supplementary Table 1).
 
Oh - and in their third supplementary material, they did describe their CBT as having graded activity - I saw discussion of that somewhere:

Treatment content of iCBT for CFS

Cognitive behaviour therapy (CBT) is based on a model of perpetuating factors(1). This model assumes that fatigue and disability are maintained by fatigue related beliefs and behaviour. CBT is aimed to change these cognitive-behavioural factors with recovery as highest attainable goal(2, 3).

ICBT for CFS is adapted from the face-to-face CBT protocol(4). ICBT for CFS consists of several modules. After general information about how to progress with iCBT the cognitive behavioural model of CFS is explained. Thereafter, patients first start to formulate treatment goals aimed at recovery that contains future activities assuming a patient is no longer severely fatigued and impaired. Secondly, patients start to regulate their sleep-wake pattern with fixed bedtimes and without sleeping or lying down during the daytime. Information is provided on how to reduce ‘catastrophizing’ and non-accepting fatigue beliefs’, and patients formulate more helpful beliefs in response to fatigue. Furthermore, patients learn how to shift their attention away from fatigue towards other activities or the environment to reduce the focus on fatigue. The next module addresses the perceived lack of social support and how to communicate about CFS with significant others.



Dependent on the activity pattern of patients(5) that was assessed at basseline, tailored information was provided on how to proceed with a graded activity program. Two patterns can be discerned: a low active and a relative active pattern. Patients with a low active activity pattern, characterized by an extremely low level of physical activity, immediately start to gradually increase their activity with walking or cycling. Relative active patients, characterized by an ‘all-or-nothing pattern’ of activity, first have to learn to divide their activities more evenly accross the day before they start with graded activity. For patients with a high impact of pain, information was provided on how to deal with pain by formulating helpful beliefs. All patients learn how to solve problems with the graded activity program. The graded activity was followed by a step by step realisation of goals. This included work or study resumption, increasing mental and social activities and other goals.



The last CBT module was on how to learn to ‘deregulate’ oneself again, e.g. by having peaks of activity or going to bed late at night again. In this phase patients determine if they are recovered from CFS and how they can maintain the gains they have made.

References

1. Vercoulen JH, Swanink CM, Galama JM, Fennis JF, Jongen PJ, Hommes OR, et al. The persistence of fatigue in chronic fatigue syndrome and multiple sclerosis: development of a model. J Psychosom Res. 1998;45(6):507-17.

2. Knoop H, Bleijenberg G, Gielissen MF, van der Meer JW, White PD. Is a full recovery possible after cognitive behavioural therapy for chronic fatigue syndrome? Psychother Psychosom. 2007;76(3):171-6.

3. White PD, Goldsmith K, Johnson AL, Chalder T, Sharpe M. Recovery from chronic fatigue syndrome after treatments given in the PACE trial. Psychol Med. 2013;43(10):2227-35.

4. Knoop H, Bleijenberg G. Het chronisch vermoeidheidssyndroom. Behandelprotocol cognitieve gedragstherapie voor CVS. [Chronic fatigue syndrome. Treatment protocol for cognitive behavioural therapy with CFS-patients] Bohn Stafleu Van Loghum; 2010.

5. van der Werf SP, Prins JB, Vercoulen JH, van der Meer JW, Bleijenberg G. Identifying physical activity patterns in chronic fatigue syndrome using actigraphic assessment. Journal of Psychosomatic Research. 2000;49(5):373-9.
 
People involved in legal disability claims (people who are willing to challenge authority?)
It's important to filter out people who think and fight for themselves - which is one mission of psychiatry. Furthermore, people who are involved in legal disability cases probably know they have a physical illness, and that CBT is useless. It's harder to convince them of the efficacy of CBT.

  • If the module was read, only opened
  • Why?
  • No mechanism at the end to show completion of the module?
  • Why?
  • How do we know the patient actually received the treatment then?
Again, why? You cannot measure internet activity by recording the number of times patients logged in, mean duration of sessions, number of opened treatment modules, and number of emails sent.
To me, you rise good points, and they make this publication a low-quality study in my opinion. On top of subjective outcomes you have these issues.
 
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