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

Dolphin

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Dolphin said:
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..)
The report is at:
http://www.inami.fgov.be/care/fr/revalidatie/general-information/studies/study-sfc-cvs/index.htm

The main report is at: http://www.inami.fgov.be/care/fr/re...rmation/studies/study-sfc-cvs/pdf/rapport.pdf

Unfortunately the information is in French.
The report is also available in Dutch/Flemish elsewhere if people prefer.
I only have 3 years of German and no Dutch so read the French version.

There are some summaries in English I might report later.

It wasn't a De Meirleir study - not sure if he was involved in these standardised rehab clinics for CFS. Unfortunately, it was an audit and hasn't been published in PubMed that I know of but I have referred to it in a letter and Twisk/Maes also referred to it a bit in one of their papers:

Chronic fatigue syndrome: la bte noire of the Belgian health care system.

Neuro Endocrinol Lett. 2009;30(3):300-11.

Maes M, Twisk FN.

Maes Clinics, Antwerp, Belgium. crc.mh@telenet.be

(I gave every line a paragraph)
Abstract

The World Health Organization acknowledges Myalgic Encephalomyelitis (ME)/Chronic Fatigue Syndrome (CFS) to be a medical illness.

ME/CFS is characterized by disorders in the inflammatory and oxidative and nitrosative stress (IO&NS) pathways.

In 2002, the Belgian government started with the development of CFS "Reference Centers", which implement a "psychosocial" model.

The medical practices of these CFS Centers are defined by the Superior Health Council, e.g. treatment should be based upon Cognitive Behavioral Therapy (CBT) and Graded Exercise Therapy (GET); and biological assessments and treatments of ME/CFS should not be employed.

Recently, the Belgian government has evaluated the outcome of the treatments at the CFS Centers.

They concluded that a "rehabilitation therapy" with CBT/GET yielded no significant efficacy in the treatment of ME/CFS and that CBT/GET cannot be considered to be curative therapies.

In case reports, we have shown that patients who were "treated" at those CFS centers with CBT/GET in fact suffered from IO&NS disorders, including intracellular inflammation, an increased translocation of gram-negative enterobacteria (leaky gut), autoimmune reactions and damage by O&NS.

Considering the fact that these findings are exemplary for ME/CFS patients and that GET may even be harmful, it means that many patients are maltreated by the Belgian CFS Centers.

Notwithstanding the above, the government and the CFS Centers not only continue this unethical and immoral policy, but also reinforce their use of CBT/GET in patients with ME/CFS treated at those Centers.
 
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If you can report the English studies that would be great since this looks pretty important (presumably n is very large).
 

Frank

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This was a study performed by a health control group of the Belgian government. I think it's not public sience.
 
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This was a study performed by a health control group of the Belgian government. I think it's not public sience.
Frank - but it is published, if not strictly public, and potentially the largest follow-up of CBT there is, even if it wouldn't mee the 'rigours' of peer-reviewd research in this field?
 

Dolphin

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Frank - but it is published, if not strictly public, and potentially the largest follow-up of CBT there is, even if it wouldn't mee the 'rigours' of peer-reviewd research in this field?
Yes, it's not a Randomised Controlled Trial (RCT). But it is an audit and can be referred to in the literature (I already have in Brain (a neurology journal)). I'll try to send some more info. in English later - doing something atm. ETA: now started a separate thread: http://www.forums.aboutmecfs.org/sh...f-Belgian-CBT-GET-rehab-clinics-(large-sample)
 

Esther12

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This could be an inappropriate bump, but it's late and I thought these cancer papers could be of interest:

Is increasing physical activity necessary to diminish fatigue during cancer treatment? Comparing cognitive behavior therapy and a brief nursing intervention with usual care in a multicenter randomized controlled trial.

Goedendorp MM, Peters ME, Gielissen MF, Witjes JA, Leer JW, Verhagen CA, Bleijenberg G.
Source

Expert Centre for Chronic Fatigue, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands. m.goedendorp@nkcv.umcn.nl
Abstract

BACKGROUND:

Two interventions for fatigue were given during curative cancer treatment. The aim of this multicenter randomized controlled trial (RCT) with three conditions was to demonstrate the efficacy and to determine the contribution of physical activity.
METHODS:

Recruited from seven hospitals, 220 patients with various malignancies participated in a RCT. The brief nursing intervention (BNI) consisted of two 1-hour sessions, 3 months apart, given by 12 trained nurses, focusing only on physical activity. Cognitive behavior therapy (CBT) consisted of up to ten 1-hour sessions, within 6 months, provided by two therapists, focusing on physical activity and psychosocial elements. The control group received only usual care (UC). Assessments took place before and at least 2 months after cancer treatment, when patients had recovered from acute fatigue. Fatigue was the primary outcome. Efficacy was tested using analyses of covariance. A nonparametric bootstrap approach was used to test whether the effect on fatigue was mediated by physical activity.
RESULTS:

The CBT group was significantly less fatigued than the UC group. Between the BNI and the UC groups, no significant difference was found in fatigue. The mediation hypothesis was rejected.
DISCUSSION:

CBT given during curative cancer treatment proved to be an effective intervention to reduce fatigue at least 2 months after cancer treatment. The BNI was not effective. Contrary to what was expected, physical activity did not mediate the effect of CBT on fatigue. Thus, the reduction in fatigue elicited by CBT was realized without a lasting increase in physical activity.
http://www.ncbi.nlm.nih.gov/pubmed/20930100


Psychosocial interventions for reducing fatigue during cancer treatment in adults.

Goedendorp MM, Gielissen MF, Verhagen CA, Bleijenberg G.
Source

Expert Centre for Chronic Fatigue, Radboud University Nijmegen Medical Centre, Mercator 1, Toernooiveld 214, 6525 EC, Nijmegen, HB, Netherlands, Postbus 9101/6500. m.goedendorp@nkcv.umcn.nl
Abstract

BACKGROUND:

Fatigue is a common symptom in cancer patients receiving active treatment. There are a limited number of reviews evaluating interventions for fatigue during active treatment, and they are restricted to patients with advanced cancer, or to patients during radiotherapy. To date there is no systematic review on psychosocial interventions for fatigue during cancer treatment.
OBJECTIVES:

To evaluate if psychosocial interventions are effective in reducing fatigue in cancer patients receiving active treatment for cancer, and which types of psychosocial interventions are the most effective.
SEARCH STRATEGY:

In September 2008 we searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), PUBMED, MEDLINE, EMBASE, CINAHL and PsycINFO, and checked the reference lists.
SELECTION CRITERIA:

Randomised controlled trials (RCTs) were included which evaluated psychosocial interventions in adult cancer patients during treatment, with fatigue as an outcome measure.
DATA COLLECTION AND ANALYSIS:

Three review authors independently extracted data from the selected studies, and assessed the methodological quality using several quality rating scales and additional criteria.
MAIN RESULTS:

Twenty-seven studies met the inclusion criteria with a total of 3324 participants, and seven studies reported significant effects of the psychosocial intervention on fatigue. In three studies the effect was maintained at follow-up. The quality of the studies was generally moderate. Effect sizes varied between 0.17 to 1.07.The effectiveness of interventions specific for fatigue was significantly higher (80%) compared to interventions not specific for fatigue (14%). In five studies the interventions were specifically focused on fatigue, with four being effective. The five interventions were brief, consisting of three individual sessions, provided by (oncology) nurses. In general, during these interventions participants were educated about fatigue, were taught in self-care or coping techniques, and learned activity management.Of the remaining 22 studies only three were effective in reducing fatigue, and these interventions had a more general approach. These interventions were aimed at psychological distress, mood and physical symptoms, and varied strongly in duration and content.
AUTHORS' CONCLUSIONS:

There is limited evidence that psychosocial interventions during cancer treatment are effective in reducing fatigue. At present, psychosocial interventions specifically for fatigue are a promising type of intervention. However, there is no solid evidence for the effectiveness of interventions not specific for fatigue. Most aspects of the included studies were heterogeneous, and therefore it could not be established which other types of interventions, or elements were essential in reducing fatigue.
http://www.ncbi.nlm.nih.gov/pubmed/19160308
 

Dolphin

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This could be an inappropriate bump, but it's late and I thought these cancer papers could be of interest:


http://www.ncbi.nlm.nih.gov/pubmed/20930100




http://www.ncbi.nlm.nih.gov/pubmed/19160308
Thanks. I find the first one more interesting: I had got the impression that post-exertional symptoms wasn't as big a problem with Cancer fatigue so might have hypothesised that for a CBT intervention focusing on physical activity and psychosocial elements, that reductions in fatigue might be related to increases in activity. It makes me even less excited by fatigue as an outcome measure for such interventions that the reduction in fatigue wasn't mediated by activity increase.

Full text of both are in Goedendorp PhD thesis: http://dare.ubn.kun.nl/bitstream/2066/89943/1/89943.pdf
 
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Just a few comments on this trial. Aside from the the fact that CBT fatigue gains were not matched by physical activity ones, it's worth pointing out:

Lack of controls properly matched for therapist attention
  • CBT consisted of up to ten 1-hour sessions, within 6 months, provided by two therapists
  • brief nursing intervention (BNI) consisted of two 1-hour sessions, 3 months apart, given by trained nurses, focusing only on physical activity. Cognitive behavior therapy
  • The control group received only usual care (UC)
Modest gains of -5.6 (on 8-56 point CIS scale)

Modest self-reported gains and lack of proper controls in unblinded study = doubtful findings.
Not sure this tells us much. Normally Cochrane reviews provide full analysis of studies eg forest plots of effect size, checking for heterogeneity (ie are they comparing apples with plums?) but this one did not. Studies were only of 'moderate' quality, just one study used an intention to treat analysis and in some positive studies the sole therapist was the main author. Effect sizes were all over the place from 0.17 - >1. The review also points out there may be publication bias due to negative studies not being reported.

Finally:
Several methodological elements of the psychosocial intervention studies could be improved. For example, avoiding the risk of contamination, and testing the adherence of participants
Interesting acknowldgement of the importance of adherence there, but what's contamination?
 

Dolphin

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Several methodological elements of the psychosocial intervention studies could be improved. For example, avoiding the risk of contamination, and testing the adherence of participants
Finally:Interesting acknowldgement of the importance of adherence there, but what's contamination?
Contamination in this context can mean that the therapist introduces elements of another therapy including one in another trial arm rather than sticking to the one therapy they are supposed to be testing.
 

biophile

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In another context, contamination seemingly began and ended the XMRV saga. When referring to response bias and suggestibility affecting questionnaire-taking behaviour, "contamination" also began and will help end the CBT/GET saga.