Fifty-four weeks after publishing the “PACE” study, The Lancet published another study of behavioral intervention for CFS that has drawn lots of attention and raised plenty of hackles. The March 1, 2012 early online edition of The Lancet includes an article by Sanne L. Nijhof et al., titled, “Effectiveness of internet-based cognitive behavioural treatment for adolescents with chronic fatigue syndrome (FITNET): A randomized controlled trial.” The paper is accompanied by a commentary, “CFS: Treatment without a cause,” by Peter D. White and Trudie Chalder.
The pair of articles attracted media coverage by BBC, NPR, WebMD, MedPageToday and a slew of other international, regional and local outlets. The headlines provided a sense of déjà vu all over again, thinking back to the mid-February 2011 media blitz following the PACE study. The good news? This time the word “cure” appeared in few headlines. It’s also good news that young people with CFS are a focus of study and that the kids in the FITNET arm of the trial got the benefit of a program that involved orchestrated care from their parent(s), a specially trained therapist and a school mentor. That doesn’t happen often enough. But just as some accused when the results of the rituximab trial were announced last fall, the 66 percent recovery rate reported for FITNET might be more optimistic than warranted.
The FITNET Study Design
The study was conducted by Dr. Nijhof and colleagues at the University Medical Centre in Utrecht, The Netherlands (UMCU). The Expert Centre for Chronic Fatigue in Nijmegen provided consultation. The trial was funded by the Netherlands Organization for Health Research and Development. Screening began in January 2008. FITNET stands for Fatigue in Teenagers on the interNET. The FITNET trial protocol was reported in the open access journal BMC Neurology in February 2011.
FITNET protocol from BMC Neurology
All pediatricians in The Netherlands were informed about the study through the National Surveillance Centre for Children. This network provided referrals of teens aged 12-18 years old whom physicians thought might have CFS based on the 1994 Fukuda definition. Teens and their parent(s) were referred to the UMCU clinic where a single pediatrician familiar with CFS conducted a medical history, a physical examination and laboratory tests. The authors note that the 94 Fukuda definition was used because it was the one physicians in The Netherlands are most familiar with. They also noted that 39 percent (95 of 243) of the individuals referred to the study did not meet CFS criteria upon closer evaluation, suggesting that the referring pediatricians didn’t carefully apply the criteria before making referrals. Individuals were excluded if they had primary depression, anxiety or were at risk for suicide. 135 individuals were enrolled and assigned to either FITNET or “usual care” arms of the study.
There is little description of the “usual care” delivered to 67 individuals in the study. It appears that usual care refers to a continuation of whatever behavioral care the child was receiving before being enrolled in the study, if any. There is no mention of traditional allopathic medical treatment. More than half (38 of 67) of the subjects received more than one form of therapy, usually face-to-face cognitive behavioral therapy (CBT) plus graded exercise therapy (GET). Here are the reported treatments that comprised usual care over the six months of the trial:
|
“Usual Care” Therapy |
|
Number of subjects receiving therapy |
| Cognitive Behavioral Therapy (face-to-face) | 44 | |
| Graded Exercise Therapy | 33 | |
| Alternative Therapy (not described) | 16 | |
| Individual or group rehab (no described) | 15 | |
| No therapy | 7 |
The FITNET arm was designed to test the effectiveness of CBT delivered by five specially trained therapists over the internet to teens and their parents. Sixty-eight teens were assigned to this arm; results are reported on 67 of them. Key features of the program:
- There were 21 interactive modules for the patients and their parents to complete (see below for titles);
- They were able to access the program and send e-consults at any time of the day or night;
- Each participant was assigned to one of the five therapists;
- Therapists responded to messages from patients or parents within a week and were available on an immediate basis for emergencies;
- Parents received the same program as their son or daughter, but were not able to see their son’s or daughter’s communications with the therapist;
- Parents of younger children (under age 15) were advised to “coach” their child through the program; parents of older children (15-18) were to “encourage” their child to take responsibility for her/his participation in the program;
- Subjects agreed that they would not undertake any other medical evaluation or treatment during the six-month trial;
- A school mentor was enlisted to coach, advise and tutor each child as needed;
- The goal was a return to full-time education; and,
- School attendance was reported by the child, the parent(s), the therapist and the school mentor.
The FITNET program was aimed at changing fatigue-related cognitions and a gradual increase of activities, based on other CBT programs designed to alleviate CFS symptoms and help patients better cope with their illness. As described in the FITNET protocol in BMC Neurology, physical activity patterns were a primary assessment tool for subtyping participants into “relative active” and “relative passive” groups. Use of an actimeter to measure activity patterns is described in the protocol; however, no data is reported in The Lancet study. Five diaries are listed in the protocol; again, no data collected from such diaries is reported with the results. The titles of the 21 internet modules are provided below:
|
21 FITNET Program Modules |
||
|
1. To introduce myself |
8. Changing my attention to fatigue |
15. My social activities |
|
2. How does this treatment work? |
9. Step up my physical activities (passive patients) |
16. To reach goals |
|
3. Assessing my present possibilities |
10. Balance between activity and rest (relative active patients) |
17. My schedule for work |
|
4. My parents |
11. Step up my physical activities (relative active patients) |
18. To have a night out |
|
5. My goals |
12. Recognizable problems with the treatment |
19. Do I still see myself as a patient with CFS |
|
6. My sleep routine |
13. Step up my mental activities |
20. My evaluation |
|
7. My thoughts |
14. My schedule for school |
21. Follow-up |
Subjects in the two arms of the study were similar with an average age of 15.8 years and about 82 percent girls. There were more subjects with acute or postviral onset in the FITNET arm (44%) compared to the usual care arm (36%). The subjects in the usual care arm had been ill longer (19 months on average) compared to the FITNET arm (16 months). School attendance over the past two weeks was roughly similar:
| Frequency of attendance | FITNET | Usual Care | ||
| Continuous | 39.5% | 45.1% | ||
| ≥85% | 4 (6%) | 9 (13%) | ||
| <85% | 64 (94%) | 58 (87%) |
Fatigue was measured by a 20-item instrument called the Checklist Individual Strength (CIS20) and physical functioning was measured by an 87-item instrument called the Child Health Questionnaire (CHQ-CF87). Both are standardized self-report measures. The CIS-20 has been used to measure disability in populations of workers, to measure fatigue in M.S. studies and in other CFS studies. The validity of the CHQ to measure physical functioning has been questioned in at least one study that showed poor test-retest concordance on these measures when testing chronically ill children. (Raat et al., Quality of Life Research, 2002)
Subjects also rated their improvement subjectively. They answered “yes” to one of the following statements: “I have completely recovered,” “I feel much better but still experience some symptoms,” “I still have the same complaints,” or ”I have become much worse” compared to the last evaluation. Either of the first two responses was counted toward recovery totals, even though they may express very different levels of response to the therapy. Self-rating is included in most clinical trials. It carries surprising weight in the U.S. regulatory process when drugs are evaluated by the Food and Drug Administration for possible marketing approval.
Recovery was defined by the authors after the study was complete. They note (accurately) in the paper, “There is no universal definition of recovery in patients with CFS during therapy.” This fact has been a barrier to defining a standard of care, as the results of therapeutic trials have used inconsistent definitions for improvement and/or recovery. The use of dozens of different instruments to measure symptoms and function has also made comparisons difficult. Couple this with different definition or different subtyping criteria, and it is even more challenging for patients and physicians to assess the potential benefit of a particular therapy. It is worth noting that the recovery rate in children with CFS has been reported to be higher than for individuals whose illness begins in adulthood. No non-treatment control group was included for comparison against spontaneous recovery, although 7 teens in the usual care arm received no treatment at all. (Their results are not reported separately within the usual care group.)
For the FITNET study, recovery was defined as less than 10 percent school absence in the prior two weeks (at the end of six months), a fatigue score of less than 40 and physical function score of greater than 85 PLUS a self-rating of feeling improved. The post-hoc and loose nature of the way recovery is defined in this study may be one of its pitfalls. White and Chalder stated in the accompanying commentary,
“The investigators defined recovery post hoc. However, the criteria used to define recovery were not stringent and some individuals who entered the study were already attending school fairly frequently. The investigators used liberal criteria, such as the population mean plus two rather than one standard deviation, as their thresholds for recovery by continuous measures such as fatigue. Therefore, the 63% of patients reported as recovered might have included those who had a significant improvement rather than being fully recovered. This proportion of patients does not detract from the still impressive difference from the 8% of participants who were judged to be recovered after usual care.” — Peter White and Trudie Chalder in accompanying commentary
Results:
After six months of therapy, the authors stated that 63 percent (42 of 67) teens in the FITNET arm met the primary and secondary outcome measures that defined recovery, compared to 8 percent (5 of 64) teens in the usual care arm. The results reported in The Lancet are as follow:
There were no serious adverse events reported in either arm of the study. Four subjects were lost to follow-up; one in the FITNET arm and three in the usual care arm. Two subjects (one in each arm) recovered and two (both receiving usual care) did not wish to return for the post-intervention interview.
The subjects in the FITNET arm and their parents made heavy use of the internet program. Over 26 weeks, the following activity was recorded:
- Average of 266 log-ons per user (including parents)
- Patients sent an average of 66.6 e-consults (each) to therapists
- Parents sent an average of 22.8 e-consults (each) to therapists
- Therapists sent an average of 28.7 e-consults to each patient
- Therapists sent an average of 19.5 e-consults to each parent or set of parents
There were not significant differences between the five therapists in the results achieved during the study.
Subjects in the FITNET arm were permitted to continue the program for an additional six months and subjects in the usual care arm were invited to start the FITNET program after the six-month point for a period of six months. The follow-up results reported in The Lancet follow:
In the discussion, the authors describe the strengths of the FITNET program:
“First the FITNET rogram involved parents in their children’s treatment. The results of earlier studies have shown the importance of family-focused cognitive behavioural therapy in the successful treatment of adolescents. Furthermore, hardly any loss of follow-up occurred, thus reducing the risk of bias. … The high participation rate is a sign of the low threshold and high acceptance of internet-based health care. A particular strength is that the main outcome (school attendance) was checked and double checked by the investigators, parents, teachers and therapists.
Internet-based treatment has general advantages: it is available at any time, avoids face-to-face treatment barriers (i.e., treatment delay due to poor accessibility, inconvenience of scheduling appointments, missing school or work, travelling to and from a clinician’s office), and reduces treatment time and costs. This unique cognitive behavioral therapy seems to appeal to modern youth, who grow up using the internet as their main source of information.” — Nijhof et al., in The Lancet
While the authors conclude that, “With FITNET effective treatment is within reach for any adolescent with CFS,” White and Chalder note that there are problems with the generalizability of the program. They write, “…only 30 percent of the world’s population have internet access (percentages higher in Europe [58%] and North America [78%]). Patients and parents need to be reasonably literate with no language barriers. The results of the trial cannot be generalised to adults.”
If, as White and Chalder suggest, the authors had used one standard deviation to measure “recovery,” the results would have been less favorable, but would have still supported the benefits of internet-based CBT over usual care (as provided in The Netherlands) — 36 percent of FITNET participants would have met primary and secondary outcomes for recovery, compared to 5 percent in the usual care arm. From the online appendix to the Lancet paper:
Implications
Based on experiences relayed by parents and young people who have endured the first few years of CFS with little support from medical, mental health or education professionals, the benefits arising from a team approach by the young person, her or his parent(s), a dedicated therapist and a school mentor are not surprisingly superior to a hit-or-miss combination of CBT plus graded exercise. Hopefully the students in this study will be followed for a longer period of time, especially after the FITNET program is no longer available to them, to evaluate how well the improvement holds and whether it translates to longer term academic success (versus simply evaluating school attendance) and post-secondary success.
This study makes no suggestion that CFS is a mental health problem or that the positive outcomes achieved have cured or resolved the underlying medical disorder. The authors note that internet-based CBT has been used succesfully to help individuals with depression, anxiety, headache and smoking cessation. News articles also mentioned successful applications in Parkinson’s and cancer.
Even though CBT is (by far) the best-studied intervention for CFS, it’s unlikely this will be the last study of CBT we will see reported. In the U.S., the National Institutes of Health has invested heavily in this form of therapy, nearly to the exclusion of medical approaches. A $1 million study of telephone-based CBT in adult CFS patients led by Michael Antoni of University of Miami has resulted in one publication in April 2011 in the Journal of Psychosomatic Research. Fred Friedberg, PhD, of SUNY-Stonybrook recently secured a second NIH award to continue his studies of self-help programs, with funding totaling $1.15 million. Friedberg’s second award will evaluate whether he can “establish a commercially viable program of illness self- management in people with unexplained chronic fatigue (UCF) and chronic fatigue syndrome (CFS).” So, academic publications are likely to flow from these (and other) awards and business opportunitites may follow as well.
On the other hand, the CFIDS Association has focused its new grant awards organized under a “research institute without walls” on studies that will advance disease-modifying treatment for CFS, including the need for better ways to diagnose and subtype CFS. We know of no other set of projects launched simultaneously with this goal in mind.
References:
Nijhof SL, Bleijenberg G, Uiterwaal CSPM, Kimpen JLLL, van de Putte EM. Effectiveness of internet-based cognitive behavioural treatment for adolescents with chronic fatigue syndrome (FITNET): a randomised controlled trial.Lancet. March 1, 2012 (epub ahead of print). DOI: doi:10.1016/S0140-6736(12)60025-7
Link to study abstract:
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)60025-7/abstract
Link to full text:
http://press.thelancet.com/FITNET.pdf
White PD, Chalder T. Chronic fatigue syndrome: treatment without a cause. Lancet. March 1, 2012 (e-pub ahead of print). DOI: doi:10.1016/S0140-6736(12)60197-4
Link to summary:
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(12)60197-4/fulltext
Nijhof SL, Bleijenberg G, Uiterwaal CSPM, Kimpen JLLL, van de Putte EM. 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. BMC Neurology. Feb. 11, 2011. DOI: doi:10.1186/1471-2377-11-23
Link to full text: http://www.biomedcentral.com/1471-2377/11/23
Raat H, Landraft JM, Bonsel GJ, Gemke RJ, Essink-Bot ML. Reliability and validity of the child health questionnaire-child form (CHQ-CF87) in a Dutch adolescent population. Quality of Life Research. 2002 Sep;11(6):575-81.
Link to abstract: http://www.ncbi.nlm.nih.gov/pubmed/12206578
K. Kimberly McCleary has been the Association’s chief staff executive since February 1991.
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1. This commentary states that “The FITNET program was aimed at changing fatigue-related cognitions and a gradual increase of activities, based on other CBT programs designed to alleviate CFS symptoms and help patients better cope with their illness” and “This study makes no suggestion that CFS is a mental health problem or that the positive outcomes achieved have cured or resolved the underlying medical disorder. The authors note that internet-based CBT has been used succesfully to help individuals with depression, anxiety, headache and smoking cessation.”
This is a common and damaging misconception about CBT being delivered by the ‘psychosocial school’ in ME/CFS. CBT as practiced by the ‘psychosocial school’ in ME/CFS is explicitly NOT supposed to help a patient ‘cope with their illness’, in fact it is based on the very notion that there is no underlying disease process to begin with. Contrary to ‘helping a patient cope with their illness’, psychosocial CBT for ME/CFS is explicitly intended to CURE the patient of their supposed ‘dysfunctional illness beliefs’, ie the patient’s BELIEF that they are suffering from an organic disease process. That is why these investigators use such pathetic definitions of ‘recovery’ in their studies, because if patients didn’t ‘recover’ as a result of the intervention then the underlying basis for the intervention itself would be unsupported.
From ‘Chronic fatigue syndrome and myalgic encephalomyelitis’, Judith B Prins, Gijs Bleijenberg and Jos WM van der Meer- “We strongly disagree with the statement that no rehabilitation approach is intended to be curative. The intention of cognitive behaviour as practised in our research group is definitely curative… Too often therapists agree to far less concrete and less achievable aims, still within the scope of chronically ill patients. The art of cognitive behaviour therapy is to broaden the patients’ vision to a future life as a well person. After reaching most of the personal goals, one of the last cognitive interventions in cognitive behaviour therapy is for patients to stop labelling themselves as CFS patients… Everyday bodily signs and symptoms were no longer interpreted as indicating CFS.” (1)
From the ‘Manual of cognitive behavioural treatment for CFS’ by Chalder, T, Deale, A, Sharpe, M, Wessely, S, 2002, in conjunction with the PACE trial- “CBT is based on a cognitive behavioural model of CFS. According to the model the symptoms and disability of CFS are perpetuated predominantly by dysfunctional illness beliefs and coping behaviours. These beliefs and behaviours interact with the patient’s emotional and physiological state and interpersonal situation to form self-perpetuating vicious circles of fatigue and disability…The patient is encouraged to think of the illness as ‘real’ but reversible by his or her own efforts’ rather than (as many patients do) as a fixed unalterable disease.” (2)
2. This commentary also states that “As described in the FITNET protocol in BMC Neurology, physical activity patterns were a primary assessment tool for subtyping participants into “relative active” and “relative passive” groups. Use of an actimeter to measure activity patterns is described in the protocol; however, no data is reported in The Lancet study.”
The ‘relatively active’ vs. ‘pervasively passive’ patients in studies by these investigators are another source of concern. The paper says that patients with depression and anxiety disorders were excluded from the study but I don’t know if I believe them.
In the CBT chapter of the Handbook of CFS edited by Leonard Jason, Bleijenberg, Prins and one other Dutch psychiatrist include information about actometer data taken from their previous CBT studies. From the information provided in the chapter and from other sources, the ‘pervasively passive’ patients appear to focus more on their symptoms, strongly believe themselves to suffer from organic disease as opposed to psychiatric illness and actually do not respond to CBT, while the ‘relatively active’ patients are more open to psychiatric aetiologies for their fatigue, respond to CBT and don’t focus so much on symptoms (maybe they don’t have as many symptoms, if any?). The implications of the above combined with the stated belief of the investigators involved that ME/CFS is a psychiatric disorder, combined with the longstanding concerns of patient groups that individuals suffering from anxiety disorders and/or depression are being diagnosed by these investigators as having ME/CFS points to an alternate possibility, which would be that the improvements reported by these investigators are actually largely a result of simple diagnostic incompetance, with anxiety disorder and/or depressed patients being misdiagnosed as having ME/CFS. CBT was even originally created for the treatment of such disorders if I’m not mistaken (which I could very well be).
As for actometer data being included in the outcome measures, I doubt we’ll ever be seeing that. Actometer data was taken at the beginning of the trial to determine if it was a predictor of response, not an outcome measure. These investigators have published three seperate trials on CBT however, in which actometer data was taken at the beginning and the end of the trial. In all three studies there were no differences in activity levels in the ‘treatment’ vs. control groups at the end of the trial. Despite the stated intent of the CBT being to increase activity levels, this data was not included in any of the three supposedly ‘successful’ studies but was only published recently in a seperate paper in which the authors try and spin the data to their liking. (3) This is a textbook example of selective reporting of data by the authors. There was also another 2007 study by these investigators which measured cognitive functioning before and after CBT which also showed no improvement following ‘treatment’. (4)
3. One other aspect of this study that hasn’t been reported much was that it actually failed to confirm the earlier CBT studies by this group due to the exceedingly low amount of improvement in the ‘usual care’ group, ie ‘regular’ CBT, GET, etc. That was probably why the authors chose such a low threshold for ‘recovery’, because if they didn’t then their normal and supposedly already ‘successful’ treatments would have looked even worse than they did.
1. Chronic fatigue syndrome and myalgic encephalomyelitis
Judith B Prins, Gijs Bleijenberg, Jos WM van der Meer
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(02)08577-X/fulltext
2. ‘Manual of cognitive behavioural treatment for CFS’ by Chalder, T, Deale, A, Sharpe, M, Wessely, S, 2002, in conjunction with the PACE trial
3. Wiborg JF, Knoop H, Stulemeijer M, Prins JB, Bleijenberg G. How does cognitive behaviour therapy reduce fatigue in patients with chronic fatigue syndrome? The role of physical activity. Psychol Med. 2010 Aug;40(8):1281-7. Epub 2010 Jan 5.
http://www.ncbi.nlm.nih.gov/pubmed/20047707
4. Knoop H, Prins JB, Stulemeijer M, van der Meer JW, Bleijenberg G. The effect of cognitive behaviour therapy for chronic fatigue syndrome on self-reported cognitive impairments and neuropsychological test performance. J Neurol Neurosurg Psychiatry. 2007 Apr;78(4):434-6.
http://www.ncbi.nlm.nih.gov/pubmed/17369597
Thanks, John; all good points as always.
The statement about the objective of the FITNET trial was taken from the BMC Neurology protocol description:
“FITNET is derived from the protocol for CBT that was developed on the basis of a model of perpetuating factors of CFS [2]. It has been tested in several studies [3,17,39] and is aimed at changing fatigue related cognitions and a gradual increase of activities. Typically, treatment involves (a) formulation of treatment goals, (b) establishing a sleep routine, (c) encouraging the participant to achieve a balance between activity and rest, (d) gradually increasing activities including home, social and school life, (e) addressing cognitions about fatigue, (f) gaining independence from surroundings and parents, (g) reducing the focus on fatigue, and (h) paying attention to relapse prevention.” (Nijhof et al., BMC Neurology, 2011, 11:23)
Yes, but just because the investigators don’t go into detail about what the CBT is comprised of doesn’t mean that they have all of the sudden changed their repeatedly stated beliefs about the nature of the ‘illness’ as well as the detailed descriptions of the ‘treatments’ in question which are explicitly based on ME/CFS patients supposedly not suffering from organic disease. That is what the references in the paper are provided for. Also, comparing the CBT used in ME/CFS, as practiced by these and associated investigators, to CBT for Parkinson’s and cancer would be either wholly ignorant of what the intervention comprises (in the case of the media) or disingenuous to the point of deceit (in the case of psychosocial CBT proponents). CBT in Parkinson’s and cancer is not designed with the stated intent of convincing the patient that they are actually not suffering from organic disease to begin with.
The reason why I posted material from the PACE trial is because the PACE trial itself states that it was based on Bleijenberg’s 2001 Lancet study and in his CBT chapter in Leonard Jason’s Handbook of CFS Bleijenberg states that “The first treatment protocol developed by our own research group has much in common and can best be compared with the programs by Sharpe and Deale…The initial sessions deal with impeding cognitions…The main goal of the treatment is full recovery, the supplementary objective being return to the workplace.” Michael Sharpe was Co-PI of the PACE trial.
From the ‘Summary of Treatments to be Compared in the PACE Trial’-
“Essence
The essence of cognitive behavioural therapy is helping the patients to change their interpretation of symptoms and associated fear, symptom focussing and avoidance. Patients are encouraged to see symptoms as a reflection of reversible psychological and physiological processes rather than as evidence of fixed disease.
Aim
The aim of this treatment is to change the behavioural and cognitive factors, which are assumed to perpetuate the person’s symptoms and disability. It is anticipated that by reversing these, physiological changes will follow and the person will be able to make a gradual improvement in both symptoms and functioning.
Theoretical model
The theoretical model assumes that symptoms and disability are perpetuated by psychological and behavioural factors (and their physiological consequences). These are assumed reversible. The model emphasises the importance of the patients understanding of their illness and interpretation of symptoms as “warning signs” as understandable but incorrect. Fear of symptoms and consequence avoidance of activity associated with symptoms is emphasized. It also acknowledges that the patients concerns and beliefs are related to the wider social context and addresses the information available to the patients and the attitudes and views of family.
Procedure
There are detailed manuals for delivery of cognitive behavioural therapy. It includes stabilization of activity and sleep, graded increases in activity and actively addressing the patients understanding of their symptoms and functioning.
Delivery
The administration of cognitive behavioural therapy requires a highly skilled therapist, usually a mental health professional who has had training in cognitive behavioural therapy and specific experience and training in applying cognitive behavioural therapy to chronic fatigue syndrome.”
This is the CBT practiced by Sharpe, Wessely, Bleijenberg, White, etc.
“Wessely, Sharpe, and others have suggested a cognitive behavioral model of CFS: it is well known within the field that dysfunctional illness beliefs and avoidant coping perpetuate both the symptoms and disability of CFS. One of the beliefs of CFS patients that predicts outcome is that exercise is dangerous or damaging.” (1)
1. Peter D. White, M.D.- CNS and ANS Responses to Exercise in Patients with CFS
Neuroimmune Mechanisms and Chronic Fatigue Syndrome: Will Understanding Central Mechanisms Enhance the Search for the Causes, Consequences, and Treatment of CFS?
June 12–13, 2003
http://orwh.od.nih.gov/cfs_june03report.pdf
John, I wasn’t contesting your view. I just wanted to clarify where that description came from since it wasn’t cited in the post.
I’m concerned that the FITNET study is highlighted on the HHS Office of Women’s Health website. I hope the CAA and others share this concern.
http://www.womenshealth.gov/news/headlines/662235.cfm
One can read the manual for adults on which it is based at: https://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind1009C&L=CO-CURE&P=R1774&I=-3 (unfortunately it’s very long).
Here is what I’m basing this on. A lot of reading of course:
——-
“We developed Fatigue In Teenagers on the interNET (FITNET), a comprehensive internet-based application based on existing protocols and a theoretical model of effective face-to-face cognitive behavioural therapy for adolescents, 12,22,23 specifically for those with chronic fatigue syndrome and their parents.”
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. Free full text: http://www.bmj.com/content/330/7481/14?view=long&pmid=15585538
22 Prins JB, Bleijenberg G, Bazelmans E, et al. Cognitive behaviour therapy for chronic fatigue syndrome: a multicentre randomised controlled trial. Lancet 2001; 357: 841–47. Free full text:
http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(00)04198-2/fulltext
23 Bleijenberg G, Prins J, Bazelmans E. Cognitive behavioral therapies. In: Jason LA, Fennel PA, Taylor RR, eds. Handbook of chronic fatigue syndrome. Hoboken: Wiley and Sons, 2003: 493–526.
Available at: https://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind1009C&L=CO-CURE&P=R1774&I=-3
There’s just something really fishy about this study. I bet what might have had a good chance of happening is in relation to the parents being so involved in the study.
These investigators are notorious for their belief that ME/CFS is simply the result of abnormal illness beliefs and subsequent deconditioning and is not an organic disease process, I bet what might have happened in this study relates to what the investigators told the parents of the teens in the study and the parents of the teenagers leaned hard on their kids to claim that they were better than they really were, ie to get off this ‘ME/CFS’ business. These poor kids, if they were actually accurately diagnosed, are probably still sick as anything but their parents have been told that there’s nothing wrong with them so the teens are probably under a tremendous amount of pressure to act as if they are better. I bet the chat logs of what questions were asked by the parents as well as what kinds of answers they received would be extremely telling and probably could be used as evidence of misconduct if governmental and/or regulatory bodies ever get involved in actually providing some kind of oversight in ME/CFS, which hopefully might happen if the Rituximab findings get replicated. That’s the main thing I can think of besides misdiagnosis to explain the results; I don’t believe for one second that accurately diagnosed ME/CFS patients became ‘cured’ as a result of typing crap on their computer. If that were the case we’d all be cured!
I SO agree with you, John! (Been living with very severe ME since 1979)
Additional points:
It would have been interesting to know how many of this cohort would have been diagnosed with ME and CFS using the Pediatric definition as the Fukuda criteria are for adults. According to Jason et al 2009 the pediatric criteria not only differentiate between children without ME and CFS, but also between those with moderate vs severe ME and CFS. Would the therapy have been equally effective in both the moderate and severe groups?
Interestingly, parents were asked to fill out the same survey instruments as the children, but the study doesn’t say whether the parent or parents also met the Fukuda criteria. Common sense tells us that parents do influence thinking, at least in younger children, but this may stray a bit close to controversial Munchausen syndrome by proxy for the comfort of some.
Another issue with self-report in CFS studies in general is that CFS has a well known remitting/relapsing pattern which may possibly influence self-report.
You also stated, “The good news? This time the word “cure” appeared in few headlines.”
I believe you meant to say “fewer” headlines.
Why are the CAA, a research and advocacy group, giving so much space to this abusive rubbish? Just looking at the programme modules shows that this was indeed based on a CBT that denies the reality of ME/CFS. This has been shown, time and time again, to actually make people worse.
Throw the study in the trash, where it belongs.
@Jane if you look through the rest of the site you will find that Research 1st publishes analysis of research so readers can better understand what the research does and doesn’t cover. As you can see from reading the analysis above, there were a number of specific problems with this particular study.
Well, this is like 0 steps forward and 2 steps back. I hope there is good analysis of this “study.”
What about CFS sufferers who do have therapy but whose physical illness does not improve and, in fact, as one ages, worsens? Does anyone discuss this or analyze this phenomenon?
I do not care what any study says, but if one has severe exhaustion and muscle pain, and the myriad of symptoms which we with CFS have, and which get worse with activity, and much worse if one pushes oneself, then how does this jibe?
This raises the queestion, Who do you believe, people doing studies, who are in labs, universities, and other hallowed halls, but do not have the disease or live with or know anyone who has it or those who have it or know people with it who struggle through every single day, one step at a time?
And it is worrisome that it’s up at the HHS Office of Women’s Health. Who needs to be told to pace oneself? To try to move?
That is so condescending. Everyone has to pace themselves to survive this and if they can, to move as much as they can without getting bad muscle pain.
I hope some voices of sanity and reason, perhaps with a few MD’s or PHD’s after their names, will answer this study. Those of us with the disease who are able to respond, to write and speak, will do so.
Morning Kim,
I would like to hear your take on this study if you are able.
This also brings up the question regarding a Belgian Government report from 2006 about setting up 4 reference centers to try and see if CBT/GET for ME/CFS really worked. Unsurprisingly, this report never gets mentioned by psychosocial CBT proponents despite the fact that it had over twice the number of patients than were in the PACE Trial’s CBT and GET arms. Results from the report? 862 patients in total, 0 cures, patients’ physical capacity did not change between start and end of the treatment, patients’ employment status decreased and the number of patients living on sickness allowance increased.
CBT for ME/CFS is a bad joke.
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6 BELGIAN DATA
6.2 SUMMARY OF THE RIZIV/INAMI REPORT (2006)
6.2.3 Reference centres for adults: evaluation of results.
“The four reference centres were evaluated for the period of April 1st, 2002 till December 31st, 2004.”
6.2.3.1 Adults: Diagnostic phase
“Between April 1st, 2002 and December 31st, 2004, 1,655 patients entered the reference centres for the first outpatient consultation. After this first consultation, 94% of the patients seen were considered to be a possible CFS-patienti. In 96% of these patients (N=1,087), the diagnosis was confirmed after the multidisciplinary evaluation.”
“Of the patients with confirmed diagnosis of CFS (N=862), 79% were considered to be candidates for an interdisciplinary rehabilitation program in the reference centre.”
6.2.3.2 Interdisciplinary treatment of adults: characteristics and outcome
“89% of the rehabilitation interventions in the centres were stopped because of “end of the RIZIV/INAMI reimbursement period”; for 71% of the patients the team estimated that the maximal result for the patient had been reached, although no patient was considered to be totally cured. Only 2.8% of the treatments were stopped by the patient, who generally speaking seemed very motivated to follow the therapy.”
“Results concerning the patients’ quality of life were conflicting: for one group of patients there was a significant improvement as compared to the start of the therapy, for another group of patients this could not be confirmed. However, for all patients the average quality of life was still below the level of healthy adults.”
“Physical capacity (maximal or sub-maximal according to the patient’s possibilities) did not change between start and end of the treatment.”
“Employment status decreased at the end of the therapy, from an average of 18.3% of a 38h- working week, to 14.9%. However, it should be noticed that this was not one of the preset goals of the interdisciplinary treatment, and that no specific occupational rehabilitation was foreseen. The percentage of patients living from a sickness allowance increased slightly from 54 to 57%.”
6.2.5 Belgian CFS reference centres: conclusions and discussion
6.2.5.1 Adults
“Between April 1st, 2002 and December, 31st 2004, 1,655 patients entered the reference centres, but in three centres, long waiting lists exist. For more than 90% of the patients, the diagnosis of CFS was confirmed… Approximately 80% of the CFS patients followed an interdisciplinary program in the centre; the time between initial outpatient consultation and start of the rehabilitation was on average 4 to 5 months.”
“Treatment was ended in only 2.8% of the cases by the patient himself, so the motivation of the patients for the treatment seemed to be high. In 71% the team considered the patient to have reached his maximal capacity — although no patient had been cured. Therapy provided systematically included CBT and GET. After treatment duration of 41 to 62 hours of rehabilitation per patient of which 83% group based, spread over 6 to 12 months, patients’ subjective feelings of fatigue were improved, but results concerning quality of life were equivocal. Psychological problems or psychiatric co-morbidities improved, but still fell outside the range of healthy adults. Physical capacity did not change; employment status decreased at the end of the therapy. It is difficult however, to judge these results, since no control group had been included.”
webpage- https://kce.fgov.be/nl/publication/report/chronisch-vermoeidheidssyndroom-diagnose-behandeling-en-zorgorganisatie
report- https://kce.fgov.be/sites/default/files/page_documents/d20081027358.pdf
supplement- https://kce.fgov.be/sites/default/files/page_documents/d20081027360.pdf
The question CAA should be asking is why did they withold the actigraph data yet again?
Simply put, it is scientifically dishonest to withold this data, since it is the most indicative of whether patients have actually improved or not, or merely temporarily reporting improvements on questionnaires.
Thank you, John. Very nice and very useful critique.
I’m a little late on this, due to Me/CFS symptoms.
Thanks for your terrific, realistic, critique, John.
One thing none of theCBT/GET studies mention is how patients who suffer from ‘Impaired memory or concentration’ which form part of the CDC criteria are supposed to effectively participate in CBT treatment. Or someone talking them out of their symptoms which seems to be part of CBT. (This is a little easier to understand in computer based contact.) None of the CBT studies mention just which individual criteria were met. It makes it so much easier to fudge the whole exercise.
The whole exercise seems to be rubbish.
Yet another idiot ,that doesn’t seem to realise this is a desease.
I don’t personally give a damn about my fatigue………..that isnt the issue.
The desease is the issue. And that I want treated.
Before getting ill I could run plus 30 miles at 17.5 stones over mountains.
There is absolutely no way that this idiot could do the same with determination or cognitive dribble.Or any other trumped up idea.
I could………before being ill. Now I cant reach the shop 300 yards away.
What has it done for the muscular pain,the constant malise,the headaches, the damage to the heart, the liver,the kidneys. The loss of memory………etc etc etc. Id like to meet just one of these idiots face to face to illucidate them to the facts.