Cognitive behaviour therapy for adolescents with chronic fatigue syndrome: randomised controlled trial
BMJ 2004; 330 doi: https://doi.org/10.1136/bmj.38301.587106.63 (Published 30 December 2004) Cite this as: BMJ 2004;330:14
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It is interesting to note that a review of three Dutch CBT studies has just been released[1] which showed that there was no statistically significant increase in physical activity levels in this trial[2].
The review also found there was no statistically significant increase in physical activity levels in the two other Dutch CBT studies investigated [3,4].
The authors of the review (who include Stulemeijer and Bleijenberg) say that, in the three studies, "treatment was based on the manual of CBT for CFS described in detail by Bleijenberg et al. (2003)"[5]. The review analysed fatigue levels, which were also reduced by CBT in the two other CBT studies. They found that "changes in physical activity were not related to changes in fatigue."
Another research team in the US also found similar results with regard to physical activity[6]. In a study investigating an intervention involving Cognitive Behavior Therapy (CBT) which included encouraging patients for going for longer walks, they found that on the SF-36 Physical Functioning (PF) scale, patients improved from a pre-treatment mean (SD) of 49.44 (25.19) to 58.18 (26.48) post-treatment, equivalent to a Cohen's d value of 0.35. On the Fatigue Severity Scale (FSS), the improvement as measured by the cohen's d value was even great (0.78) from an initial pre- treatment mean (SD) of 5.93 (0.93) to a 5.20 (0.95) post-treatment. However on actigraphy there was actually a numerical decrease from a pre- treatment mean (SD) of 224696.90 (158389.64) to 203916.67 (122585.92) post -treatment (cohen's d: -0.13).
So just because patients report lower fatigue and better scores on the SF-36 PF scale, doesn't mean they're doing more, which is what GET and CBT based on GET claim to bring about.
Further reading shows that another study[7], published over a decade ago, showed the problem of using self-report data in CFS patients. The authors' rationale for the study was: "It is not clear whether subjective accounts of physical activity level adequately reflect the actual level of physical activity. Therefore the primary aims of the present study were to assess actual activity level in patients with CFS to validate claims of lower levels of physical activity and to validate the reported relationship between fatigue and activity level that was found on self- report questionnaires. In addition, we evaluated whether physical activity level adequately can be assessed by self-report measures. An Accelerometer was used as a reference for actual level of physical activity.". The authors reported on the correlations on 7 outcome measures in relation to the actometer readings: "none of the self-report questionnaires had strong correlations with the Actometer. Thus, self-report questionnaires are no perfect parallel tests for the Actometer."
The authors of the 1997 study[7] pointed out that "The subjective instruments do not measure actual behaviour. Responses on these instruments appear to be an expression of the patients' views about activity and may be biased by cognitions concerning illness and disability." This was re-iterated in another paper[8]: "In earlier studies of our research group, actual motor activity has been recorded with an ankle-worn motion-sensing device (actometer) in conjunction with self- report measures of physical activity. The data of these studies suggest that self-report measures of activity reflect the patients' view about their physical activity and may have been biased by cognitions concerning illness and disability."
A corollary of the last statement is that reports of improvement in self-report measures in interventions which change "cognitions concerning illness and disability" may not be reliable. "Improvements" in self-report measures may simply show that patients have changed their cognitions with regard to how they view their illness, disability, symptoms, etc rather than actually representing improvements in activity levels and functional capacity.
Thus, I would suggest that actometers should be used whenever possible in CFS trials where one is investigating whether an intervention has brought about increased activity.
It is also interesting to note that in the large Van der Werf (2000) study[8], which involved 277 CFS patients (and 47 healthy controls), the authors divided the patients up "pervasively passive" (representing 24% of the patients), "moderately active" and "pervasively active". They found that "levels of daily experienced fatigue and psychological distress were equal for the three types of activity patterns". So one can't necessarily tell how active a patient is from the fatigue levels they report.
Incidentally they also said "there were no significant group, gender or interaction effects for the number of absolute large or relatively large day-to-day fluctuations (Table 2 and Table 3)." "The day-to-day fluctuation measures were based on somewhat arbitrary criteria (1 S.D. and 33% activity change). However, when we post hoc tested alternative criteria (50% or 66% activity change), again no significant group differences between controls and CFS patients emerged." Part of the rationale of many behavioural interventions in CFS patients is said to be to reduce "boom and bust" (sample reference,[9]). However, it may be the case that the frequency of this activity pattern in CFS has been exaggerated.
References:
[1] 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 Jan 5:1 -7. [Epub ahead of print]
[2] Stulemeijer M, de Jong LW, Fiselier TJ, Hoogveld SW, Bleijenberg G (2005). Cognitive behaviour therapy for adolescents with chronic fatigue syndrome: randomised controlled trial. British Medical Journal 330. Published online : 7 December 2004. doi :10.1136/bmj.38301.587106.63.
[3] Knoop H, van der Meer JW, Bleijenberg G (2008). Guided self- instructions for people with chronic fatigue syndrome: randomised controlled trial. British Journal of Psychiatry 193, 340–341.
[4] Prins JB, Bleijenberg G, Bazelmans E, Elving LD, de Boo TM, Severens JL, van der Wilt GJ, Spinhoven P, van der Meer JW (2001). Cognitive behaviour therapy for chronic fatigue syndrome: a multicentre randomised controlled trial. Lancet 357, 841–847.
[5] Bleijenberg G, Prins JB, Bazelmans E (2003). Cognitive-behavioral therapies. In Handbook of Chronic Fatigue Syndrome (ed. L. A. Jason, P. A. Fennell and R. R. Taylor), pp. 493–526. Wiley: New York.
[6] Friedberg F, Sohl S. Cognitive-behavior therapy in chronic fatigue syndrome: is improvement related to increased physical activity? J Clin Psychol. 2009 Feb 11.
[7] Vercoulen JH, Bazelmans E, Swanink CM, Fennis JF, Galama JM, Jongen PJ, Hommes O, Van der Meer JW, Bleijenberg G. Physical activity in chronic fatigue syndrome: assessment and its role in fatigue. J Psychiatr Res. 1997 Nov-Dec;31(6):661-73.
[8] 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. J Psychosom Res. 2000 Nov;49(5):373 -9.
[9] Deary V, Chalder T: Chapter 11, "Conceptualisation in Chronic Fatigue Syndrome" in Formulation and Treatment in Clinical Health Psychology Edited by Ana V. Nikcevic, Andrzej R. Kuczmierczyk, Michael Bruch
Competing interests: None declared
Competing interests: No competing interests
We need to take the results of such clinical research into cfs lightly because it is easy to tear it to bits with rigorous research criteria. If conclusions are drawn from treatment programs which impute the cause of the illness then we do need to tear it to bits. The variables which render such research to be nearly useless are well known:
1. Poor diagnostic criteria (which introduce high levels of error from the start). 2. Highly varied symptomatology add to those errors. 3. Self reporting of symptoms and symptom changes via questionnaires. 4. Control over the variables of treatment protocols. 5. Un-blindedness of clinician/experimenter. etc.
CBT is nothing more than teaching someone to learn how to adapt to adverse circumstances. My experience tells me that with cfs: 1. Some psychosocial and environmental events affect the intensity of symptoms. These seem to be somewhat idiosyncratic. 2. Some thoughts and attitudes are adaptive or maladaptive in the effects of any illness. 3. Some behaviours and habits can exacerbate or moderate some neurological symptoms.
CBT is about understanding and controlling 1-3 in order to reduce symptoms to enable a person to live more effectively. In particular to increase the person's control over their symptoms and the course of the illness. If a CBT programme does that measurably then one can say it was effective, just as you would say a smoking cessation programme was effective if helped 20% of participants to quit smoking for more than 5 years, compared to no programme. Locus of control is inversely proportional to depression so a programme which averted depression could also be said to be effective. Assuming that co-morbid depression would be a worsening consequence of cfs.
I often find myself walking people through the above to avoid an implication that psychological assistance implies psychological cause because people with cfs get touchy about this subject. I must also emphasise that the most effective aids to cfs: selective analgesics, deep relaxation, physical exercise and cognitive behaviour therapy have been no guide to its cause.
I do agree with another reviewer that we don't really need any more research into CBT's effectivenes for cfs. We need some hard research into identifying its causes and some commitment to do that and cease the hurtful and trite psychologising which happens when clinical medicine does not know the cause of an illness or has no bio-markers.
I have suffered from cfs/fibromyalgia for 13 years, my wife for 2 years and my daughter for 2 years. Why oh Why?
Competing interests: None declared
Competing interests: No competing interests
Apologies: I forgot to include the 95% Confidence Intervals for this study that Malouff et al[1] calculated: -0.16 to 0.79 (as already stated, mean for Cohen's d of 0.31) (See Table 1).
Tom Kindlon
[1] Malouff, J. M., et al.: Efficacy of cognitive behavioral therapy for chronic fatigue syndrome: A meta-analysis. Clinical Psychology Review (2007), doi:10.1016/j.cpr.2007.10.004
Competing interests: Assistant Chairperson, Irish ME/CFS Association - for Information, Support & Research (voluntary position)
Competing interests: No competing interests
Given that the objective of this study was to "evaluate the efficacy of cognitive behaviour therapy for adolescents aged 10-17 years with chronic fatigue syndrome", some people might be interested in the size of an effect measure, the Cohen's d value, which has been calculated by Malouff et al[1].
For a meta-analysis of the efficacy of CBT for CFS patients, they calculated, d, using the following method: "Separate mean effect sizes were calculated for each category of outcome variable (e.g., fatigue self- rating) and for each type of outcome variable (mental, physical, and mixed mental and physical). Studies generally included multiple outcome measures. For all analyses except those that compared different categories or types of outcome variables, we used the mean effect size of all the relevant outcome variables of the study."
The d value for this study (see Table 1) is 0.31. For anyone unfamiliar with Cohen's d values, they are not bounded by 1; also, the higher the score, the bigger the "effect size" i.e. the more "effective" a treatment was found to be. Cohen's d values are considered to be a small effect size at 0.2, a moderate effect size at 0.5, and a large effect size at 0.8[2].
Tom Kindlon
[1] Malouff, J. M., et al., Efficacy of cognitive behavioral therapy for chronic fatigue syndrome: A meta-analysis. Clinical Psychology Review (2007), doi:10.1016/j.cpr.2007.10.004
[2] Cohen J: Statistical power analysis for the behavioural sciences. Edited by: 2. New Jersey: Lawrence Erlbaum; 1988.
Competing interests: Assistant Chairperson, Irish ME/CFS Association - for Information, Support & Research (voluntary position)
Competing interests: No competing interests
90% of the adolescents in this study of the effect of cognitive behaviour therapy on patients with chronic fatigue syndrome were female but the reasons for this were not considered.1 The importance of adequate zinc levels and omega-3 essential fatty acid levels for growth and brain function were not mentioned in the study or in any of the responses. The implications of rises in copper levels at the menarche and the adverse effect of contraceptive hormones were also ignored. Exogenous hormone use further lowers zinc levels and raises copper levels, which increases adverse reactions to common foods and chemicals.
Headache, impaired concentration, impaired memory, sensitive lymph nodes, sore throat, multi-joint pain, tiredness after exercise, unrefreshing sleep are symptoms suggestive of zinc, magnesium, B vitamin and EFA deficiencies. Low copper stores, diagnosable by a red blood cell superoxidase function test, are also a common.2,3
There was also no mention in this study of diet, smoking, alcohol, drug use or dyslexia, in adolescents with a mean age of 15 years. Dyslexic individuals are all likely to be zinc deficient and have higher copper levels as children. Adolescent dyslexic females have particular trouble coping with hormone-induced changes in mineral levels which increase their educational difficulties. They can easily suffer from low self esteem, which can in turn result in eating disorders such as anorexia and bulimia. 4,5
While I am sure good cognitive behaviour therapy can be beneficial to young people who are struggling to cope with abnormal brain chemistry, surely correcting any biochemical deficiencies and advising avoidance of common social poisons should be the first priority?
1 Stulemeijer M, de Jong L W A M, Fiselie T J W, et al. Cognitive behaviour therapy for adolescents with chronic fatigue syndrome: randomised controlled trial. BMJ 2005; 330: 14
2 Grant ECG. Nutritional deficiencies found in ME/CFS patients. http://bmj.com/cgi/eletters/330/7498/1012#106029, 6 May 2005
3 Grant ECG. Nutritional deficiencies and food and chemical allergies in ME/CFS patients. http://bmj.com/cgi/eletters/330/7498/1012#106241, 9 May 2005
4 Grant ECG. Psychologists ignore treatable biochemical abnormalities in dyslexia. http://bmj.com/cgi/eletters/313/7065/1096#102157, 31 Mar 2005
5 Grant ECG. Children with psychiatric disorders and learning disabilities have biochemical abnormalities. http://bmj.com/cgi/eletters/330/7494/742#102754, 5 Apr 2005
Competing interests: None declared
Competing interests: No competing interests
The statistical relevance of the children in terms of developing an "Effective Therapy" is as meaningless as being taken to the hospital after an accident and having medical staff attempt to determine your statistical propensity for accidents instead of tending to your injuries.
Ever seen someone respond to a television that flickers out by pounding on it? If it doesn't start working again, they pound harder. Of course they know that this is unlikely to actually fix the television but are quick to tell you that there is nothing to be lost by trying. If it works, there you have it: Evidence Based Therapy.
This strategy of Pound and Check Effectiveness: PACE, is being touted as an "Effective" simply because researchers had a few instances where the subject flickered a bit and showed some signs of life. Even if there was any statistical improvement observed after applying PACE, this still wouldn't mean that it could be construed as scientific or methodical means to construct a therapy any more than having a repairman shake and pound on a broken television and consider it a job well done if it happened to start working again.
ME/CFS sufferers must remove the "environment of validation" from researchers that allows them to persist in their work avoidance behaviors and phobias against researching physiological dysfunctions. I suggest that this lack of motivation on the part of researchers may be corrected by the judicious application of PACE. If it works, there you have it: Evidence Based Therapy.
-Erik Johnson
Competing interests: None declared
Competing interests: No competing interests
We would like to respond to the issue raised by dr. Stouten about the analysis of the primary outcome "school attendance". This analysis deviated from the 'last observation carried forward' approach applied for the other variables in the way that two participants in the Cognitive Behaviour Therapy condition were left out of that analysis because they did not require to attend school anymore at time of the post assessment. In his response, dr. Stouten questioned this approach, and suggested that the preferred way to deal with this situation is to treat these values as missing data instead of excluding the patients. Like dr Stouten, we too have thoroughly reflected on this matter, but come to a different conclusion. We believe that including these two patients, and assuming "no change' in the analyses would unjustly reflect reality which is that these youngsters did a fantastic job by passing their examinations. Furthermore, they both reported great decrease in fatigue severity as well as functional limitations. Before analysing the data we have consulted an experienced statistician in our hospital to discuss this approach and he, as well as the reviewers from BMJ later on, supported this analysis.
Competing interests: None declared
Competing interests: No competing interests
If a patient went to the hospital complaining of chest pains, with numbness and tingling in the left arm, they would be checked for heart problems, not given a series of therapy "pep talks". Operant conditioning is not used to treat a blocked artery. If a group of psychologists recomended such an approach they would be laughed at. cardiac events have a verifable biocehmical imprint that they leave on the body. So does CFS/FM/MPS. So does all chronic pain.
Yet here we are, after all this time spent on the hard science of these conditions, still in the realm of physicians and shrinks who don't believe in serious science (or their own governing bodies) but do believe in the idea that widespread endocrine disruption and immune problems in a patient (which happen to result in pain and exhaustion) can be "talked away" by instilling a positive attitide in the patient.
This makes about as much sense as replacing a hospital trauma center with a new age seminar on the power of positive thinking.
I would like very much to see a form of psychiatric therapy that could kill the mycoplasm and ricketsia infections in my body, increase my DHEA and testosterone levels (which are almost non-existent), fix my nonfunctional endocrine system, right my immune system, decrease my substance P level and make my liver chemisry, lipids, thyroid and cardiac function go back to normal. It is obvious that no form of motovational therapy can do this, any more than it can sucessfully treat a blocked artery or a broken leg. So why is this hokum being recomended?
Despite many years of trying to prove the effectiveness of CBT in the treatment of chronic pain and various other chronic illnesses, there has never been a scientific peer reviewed paper that demonstrated any statisitaclly significant positive outcome from CBT in the actual reduction of pain or in the curing of an illness or even the reduction of physical symptoms. Yet, those dedicated to its use coninue to believe that if they do the same thing again and again (CBT in a CFS patient) they will get a different result. This is known as "Magical Thinking".
There are a number of government and medical bodies who have stated their official position on CBT. Here is one such example .
- "Because the available, published evidence either does not support or denies any demonstrable benefit, formal behavioural therapy cannot be recommended for acute back pain, other than as an experimental therapy."
Yet, despite the fact that there is no no evidence that it works, CBT is still regularly recomended for people with chronic pain conditions. Why? Simply put, it is the same reason that NSAIDS are given to pain patients (destroying their livers). Because the doctor does not have to prescribe any opiates. Doctors are frightened to prescibe pain relief out of fear of legal ramifications. and they are frightened to do so. Yet it is well document that failure to prescribe opiod pain relief for chronic pain (including FMS/CFS) patients, often results in "central senstisation" which means that the body of the abandonded patient changes in reponse to their untreated pain. These changes are very painful and permanent.
Competing interests: None declared
Competing interests: No competing interests
Have psychologizers ever once apologized for the damage they have done? Did psychologizers ever say to an AIDS patient "I'm sorry I blamed your illness on you because of your lifestyle"? To a woman with PMS "I'm sorry I said you were a hysterical female"? Someone with ulcers from H - Pylori, "I'm sorry I kept telling you it was stress when it was really a bacterial infection"? Tuberculosis; "I'm sorry I told you that you brought this illness upon yourself by having a nervous disposition"? Thyroid; "I'm sorry that I said your weight problem was from a lack of discipline in your diet"? ADD/ADHD: "I'm sorry that I told you that this was from your bad choice of sugar laden foods"? Autism; "I'm sorry that I slapped your child and tried to shake him out of it"? SIDS/Cot Death; "I'm sorrry that I accused you of killing your own child"? Munchausen: "I'm sorry that I wrongly took your children away forever"?
What do psychologizers plan to say to CFS/MS sufferers when psychologizers finally realize that they were wrong again and that CFS/ME is exactly what sufferers say it is?
Is there any illness in history that didn't have psychologizers standing in the way of sick people seeking medical help by saying "They don't need that kind of help. They just need to change their attitude". When the etiology of any illness was finally found to be "Not Psychological", did psychologizers ever make the slightest attempt to undo the damage they created? Did psychologizers ever try to restore the credibility they stole from those they falsely told "It's All In Your Head"? Or did they scamper off to concentrate their "help" on the next "unexplained medical illness" they could find? How many more examples of this process do we need to go through before society prevents psychologizers from pronouncing their victims "Guilty! - until proven innocent of mental illness?
-Erik Johnson
Competing interests: None declared
Competing interests: No competing interests
Data on the other SF-36 subscales has been released
This trial used the SF-36 physical functioning subscale as one of its three primary outcome measures[1].
There are eight subscales of the SF-36 and the data from these were released to a team looking at the use of the SF-36 in randomised trials[2].
I thought I would highlight this information here as most people who are interested in the Stulemeijer et al. trial are probably not aware of it [it isn't, for example, listed in the above list, "This article has been cited by other articles"]:
As well as the SF-36 physical functioning subscale, one can see from the table at http://www.bmj.com/cgi/data/338/jan12_1/a3006/DC1/2 (legend at: http://www.bmj.com/cgi/data/338/jan12_1/a3006/DC1/4) that:
- Statistically significant results in favour of the experimental interpretation were found for: Role Physical, General Health, Vitality and Social Functioning.
- There were non-statistically significant difference between groups (which seems to include no numerical difference as opposed to just those where there are numerical differences): Bodily Pain, Role Emotional and Mental Health.
References:
[1] 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 Jan 1;330(7481):14. Epub 2004 Dec 7.
[2] Contopoulos-Ioannidis DG, Karvouni A, Kouri I, Ioannidis JP. Reporting and interpretation of SF-36 outcomes in randomised trials: systematic review. BMJ. 2009 Jan 12;338:a3006. doi: 10.1136/bmj.a3006.
Competing interests: None declared
Competing interests: No competing interests