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Cognitive behavioural therapy in chronic fatigue syndrome: RCT of group programme (O'Dowd et al, 200

Tom Kindlon

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Can an admin or mod change the heading to:
Cognitive behavioural therapy in chronic fatigue syndrome: RCT of group programme (O'Dowd, 2006)


It doesn't make much sense as it is as the moment in terms of the year.


Free full text: www.cebp.nl/vault_public/filesystem/?ID=3781‎

Cognitive behavioural therapy in chronic fatigue syndrome: a randomised controlled trial of an outpatient group programme.

O'Dowd H1, Gladwell P, Rogers CA, Hollinghurst S, Gregory A.

Health Technol Assess. 2006 Oct;10(37):iii-iv, ix-x, 1-121.

Abstract

OBJECTIVES:

To test the hypothesis that group cognitive behavioural therapy (CBT) will produce an effective and cost-effective management strategy for patients in primary care with chronic fatigue syndrome/myalgic encephalopathy (CFS/ME).

DESIGN:

A double-blind, randomised controlled trial was adopted with three arms.

Outcomes were assessed at baseline and 6 and 12 months after first assessment and results were analysed on an intention-to-treat basis.

SETTING:

A health psychology department for the management of chronic illness in a general hospital in Bristol, UK.

PARTICIPANTS:

Adults with a diagnosis of CFS/ME referred by their GP.

INTERVENTIONS:

The three interventions were group CBT incorporating graded activity scheduling, education and support group (EAS) and standard medical care (SMC).

OUTCOME MEASURES:

The primary outcome measure was the Short Form with 36 Items (SF-36) physical and mental health summary scales.

Other outcome measures included the Chalder fatigue scale, Hospital Anxiety and Depression Scale, General Health Questionnaire, physical function (shuttles walked, walking speed and perceived fatigue), health utilities index and cognitive function (mood, recall and reaction times).

RESULTS:

A total of 153 patients were recruited to the trial and 52 were randomised to receive CBT, 50 to EAS and 51 to SMC.

Twelve patients failed to attend for the 12-month follow-up and 19 patients attended one follow-up, but not both.

The sample was found to be representative of the patient group and the characteristics of the three groups were similar at baseline.

Three outcome measures, SF-36 mental health score, Chalder fatigue scale and walking speed, showed statistically significant differences between the groups.

Patients in the CBT group had significantly higher mental health scores [difference +4.35, 95% confidence interval (CI) +0.72 to +7.97, p = 0.019], less fatigue (difference -2.61, 95% CI -4.92 to -0.30, p = 0.027) and were able to walk faster (difference +2.83 shuttles, 95% CI +1.12 to +5.53, p = 0.0013) than patients in the SMC group.

CBT patients also walked faster and were less fatigued than those randomised to EAS (walking speed: difference +1.77, 95% CI +0.025 to +3.51, p = 0.047;fatigue: difference -3.16, 95% CI -5.59 to -0.74, p = 0.011).

Overall, no other statistically significant difference across the groups was found, although for many measures a trend towards an improved outcome with CBT was seen.

Except for walking speed, which, on average, increased by +0.87 shuttles (95% CI +0.09 to +1.65, p = 0.029) between the 6- and 12-month follow-ups, the scores were similar at 6 and 12 months.

At baseline, 30% of patients had an SF-36 physical score within the normal range and 52% had an SF-36 mental health score in the normal range.

At 12 months, the physical score was in the normal range for 46% of the CBT group, 26% of the EAS group and 44% of SMC patients.

For mental health score the percentages were CBT 74%, EAS 67% and SMC 70%.

Of the CBT group, 32% showed at least a 15% increase in physical function and 64% achieved a similar improvement in their mental health.

For the EAS and SMC groups, this improvement in physical and mental health was achieved for 40 and 60% (EAS) and 49 and 53% (SMC), respectively.

The cost-effectiveness of the intervention proved very difficult to assess and did not yield reliable conclusions.

CONCLUSIONS:

Group CBT did not achieve the expected change in the primary outcome measure as a significant number did not achieve scores within the normal range post-intervention.

The treatment did not return a significant number of subjects to within the normal range on this domain; however, significant improvements were evident in some areas.

Group CBT was effective in treating symptoms of fatigue, mood and physical fitness in CFS/ME.

It was found to be as effective as trials using individual therapy in these domains.

However, it did not bring about improvement in cognitive function or quality of life.

There was also evidence of improvement in the EAS group, which indicates that there is limited value in the non-specific effects of therapy.

Further research is needed to develop better outcome measures, assessments of the broader costs of the illness and a clearer picture of the characteristics best fitted to this type of intervention.

PMID: 17014748 [PubMed - indexed for MEDLINE]
 
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Tom Kindlon

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I've a lot of notes on this so I'm going to post my 2007 Co-Cure post.

--------
I made some notes for myself as I went along - I suspect only a small percentage of the people who might be interested will read it, given it is over 100 pages, so thought I would send these notes/comments out. [My comments aren't all as wordy as the first set!]

Also, Dr. Ellen Goudsmit has pointed out:
"The patients were not diagnosed using research criteria. Those with normal MOS-SF PF scores at baseline would not have met the current CDC criteria for CFS."

---
Results: A total of 153 patients were recruited to the trial and 52 were randomised to receive CBT, 50 to EAS and 51 to SMC.

Twelve patients failed to attend for the 12-month follow-up and 19 patients attended one follow-up, but not both.

The sample was found to be representative of the patient group and the characteristics of the three groups were similar at baseline.

Three outcome measures, SF-36 mental health score, Chalder fatigue scale and walking speed, showed statistically significant differences between the groups.

Patients in the CBT group had significantly higher mental health scores [difference +4.35, 95% confidence interval (CI) +0.72 to +7.97, p = 0.019], less fatigue (difference –2.61, 95% CI –4.92 to –0.30, p = 0.027) and were able to walk faster (difference +2.83 shuttles, 95% CI +1.12 to +5.53, p = 0.0013) than patients in the SMC group.

CBT patients also walked faster and were less fatigued than those randomised to EAS (walking speed: difference +1.77, 95% CI +0.025 to +3.51, p = 0.047; fatigue: difference –3.16, 95% CI –5.59 to –0.74, p = 0.011).

They were still a long long way off a normal group.

"The ISWT, used as a physical performance measure, has normative reference data described by Taylor and colleagues.7 Their sample of 122 healthy subjects (mixed gender and age) walked a mean of 67 × 10-m shuttles."

The CBT group started at: 24.3.
After six months, were at 28.5
and
at 12 months were 28.9 (compared to the 67 shuttles in healthy controls mentioned above i.e. just 10.77% of the gap to the normal)

------
[Aside: And we cannot be sure that this was not just from convincing patients exercise wasn't risky (whether this is true or not of course is a different thing). As they say at one stage part of the aims of the CBT was about "regaining confidence in movement".

They claim that they tested to see whether everyone was exercising as hard by asking them how tired they were after the 6 minutes of walking. It would have been interesting, if they had been followed up for days afterwards like the Staci Stevens and co (University of the Pacific) have been doing, to see if the CBT group had worse postexertional malaise from pushing themselves harder. People with the illness in my opinion can sometimes get a bit of an adrenaline high and actually not feel too bad during or immediately after "over-doing" it - it often only hits many hours or sometimes days later.

O'Dowd et al themselves say (p.11-12):
“One important consideration when choosing a physical outcome measure for CFS/ME is that the patient may be capable of performing during the measure, but may suffer an unacceptable increase in symptoms later as a result. This information is not captured by any outcome measure known to the authors, either for this condition or for the somewhat related clinical area of chronic pain.”

It seems to me it would have been preferable if they had done the SATET (subanaerobic threshold exercise test) (which they had planned to do – see page 11) which seems more objective than a test partly based on how hard patients are willing to push themselves in 6 minutes.
---

They also say at one stage about the shuttle walk:
"Five clear outlying observations were omitted from the analysis of shuttles walked. Three were very low values (0 or 2) and two were amongst the highest values (60 and 75), but were from a patient with a low baseline score (9). **If these outliers were retained, the SEs increased and difference between CBT and SMC was no longer statistically significant (p = 0.17).**

I question in particular excluding the high scores. 60 and 75 are normal scores for healthy people - if somebody recovers, one would expect such scores. It is different from excluding a score like on a blood test that looks like an error. These scores don't look like errors.


Overall, no other statistically significant difference across the groups was found, although for many measures a trend towards an improved outcome with CBT was seen. Except for walking speed, which, on average, increased by +0.87 shuttles (95% CI +0.09 >to +1.65, p = 0.029) between the 6- and 12-month follow-ups, the scores were similar at 6 and 12 months.

This means this figure is not likely to continue to improve by very much over time.
 
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Tom Kindlon

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At baseline, 30% of patients had an SF-36 physical score within the normal range and 52% had an SF-36 mental health score in the normal range. At 12 months, the physical score was in the normal range for 46% of the CBT group, 26% of the EAS group and 44% of SMC patients.

What they omit to say in the abstract is that initially the groups were at 37%, 16% and 38% so there is virtually little difference in the increase across groups: 9%, 10% and 6%.

---
Aside in 2014: This is how normal was defined
A subject was assumed to have a score in the ‘normal’ range if the score was on or above the fifth centile for the distribution (estimated as the mean –1.645 × SD for the gender-specific age group). The age and gender-specific means and SDs for the general population were obtained from the SF-36 user manual

It is somewhat interesting to see all those in the normal range at baseline given the definition of recovery in the PACE Trial, etc.
 

Tom Kindlon

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For mental health score the percentages were CBT 74%, EAS 67% and SMC 70%. Of the CBT group, 32% showed at least a 15% increase in physical function and 64% achieved a similar improvement in their mental health. For the EAS and SMC groups, this improvement in physical and mental health was achieved for 40 and 60% (EAS) and 49 and 53% (SMC), respectively.

Because of the way this is written it mightn't be immediately clear that the CBT group does the worst here for +15% increase in physical function
CBT: 32%, EAS: 40% SMC: 49%
 

Tom Kindlon

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The cost-effectiveness of the intervention proved very difficult to assess and did not yield reliable conclusions. Group CBT did not achieve the expected change in the primary outcome measure as a significant number did not achieve scores within the normal range post-intervention. The treatment did not return a significant number of subjects to within the normal range on this domain; however, significant improvements were evident in some areas. Group CBT was effective in treating symptoms of fatigue, mood

That’s debatable

e.g. here’s what they say on the HADS (Depression and Anxiety) results:
“On average, both the anxiety and depression scores for patients in the CBT group were lower (reduced anxiety and depression) than in the EAS and SMC groups. The SMC group reported the highest mean scores for both HADS components (Table 7). Of the six comparisons between groups (three for anxiety and three for depression), one, the difference in mean score between the CBT and SMC groups for anxiety, was of borderline statistical significance (1.27 lower, 95% CI –2.52 to –0.02, p = 0.045). This may be the result of the number of statistical tests carried out, as we have made no adjustment for the multiple tests done and would expect one in 20 to reach statistical significance by chance."

and physical fitness in CFS/ME.

These claims (regarding mood, fatigue and physical fitness) are pretty debatable when one looks at the figures closely and sees the number of measures for which there was not a statistically significant difference. Saying something is "effective" for these measures, given the final values, could be said to be somewhat misleading (although other researchers seem to use this phrase too).
 

Tom Kindlon

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It was found to be as effective as trials using individual therapy in these domains. However, it did not bring about improvement in cognitive function or quality of life.

Or other things such as employment status (the statistics for which they don't discuss in the abstract).

Here's what they say in the executive summary:
"Group CBT did not significantly improve cognitive function, quality of life, **employment status** or **healthcare utility measures**"

There was also evidence of improvement in the EAS group, which indicates that there is limited value in the non-specific effects of therapy. Further research is needed to develop better outcome measures, assessments of the broader costs of the illness and a clearer picture of the characteristics best fitted to this type of intervention.

Overall in the executive summary they say, regarding the (minor) improvement:
"This study is unable to shed any light on the mechanism underlying this change, and it may be possible that patients are feeling more confident and able to manage the condition."
 

Tom Kindlon

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Other bits from the main text:

NICE possibly should take their results on board

“NHS R&D HTA Programme

The research findings from the NHS R&D Health Technology Assessment (HTA) Programme directly influence key decision-making bodies such as the National Institute for Health and Clinical Excellence (NICE) and the National Screening Committee (NSC) who rely on HTA outputs to help raise standards of care. HTA findings also help to improve the quality of the service in the NHS indirectly in that they form a key component of the ‘National Knowledge Service’ that is being developed to improve the evidence of clinical practice throughout the NHS.

The HTA Programme was set up in 1993. Its role is to ensure that high-quality research information on the costs, effectiveness and broader impact of health technologies is produced in the most efficient way for those who use, manage and provide care in the NHS.

.. The HTA Programme commissions research only on topics where it has identified key gaps in the evidence needed by the NHS.”

-----------------------
 

Tom Kindlon

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If people want to get an idea of Hazel O'Dowd and her team's views and where they are coming from, Chapter One gives a background to their views (not much if any biomedical research mentioned there)
 

Tom Kindlon

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P.4-5 – What CBT is (might help settle some debates?)


The rehabilitation and symptom management approach

There has been a steady increase in the number of services dedicated to the rehabilitation and management of the symptoms associated with CFS. This is, most likely, a result of the success of this approach with other chronic conditions, for example chronic pain.20 The approach is based on CBT and addresses a range of areas implicated in the biopsychosocial model of disease and disability.

The role of cognitions in health

It is increasingly recognised that individuals can make major contributions to their own health and well-being through the adoption of healthenhancing coping strategies. The identification of the underlying factors that lead to the adoption of helpful coping has been the focus of much research in psychology.21 Effective rehabilitation should be based on the cognitive processes that influence an individual’s health behaviour. There are many health behaviours relevant to CFS/ME that can improve self-management, delay progression of the illness or improve an individual’s general sense of well-being. The underlying premise of using CBT in rehabilitation is that a change in an individual’s cognitions or thoughts will have a direct effect on their behaviour. This can be used to promote the use of adaptive coping strategies, for example exercise. Given the heterogeneity of both the condition and the treatment, one would expect individuals to respond differentially.

Although CBT covers a wide variety of interventions provided in diverse clinical environments, all CBT interventions share a common set of theoretical assumptions regarding the interaction between environmental events, cognitions, behaviours and feelings that determine patients’ actions and experiences.

CBT developed from an early form of the therapy used for behavioural and psychiatric disorders in the early 1970s. It has since been successfully applied to a range of other health problems, such as chronic pain and rheumatoid arthritis. The frequency of a behaviour can be linked to the consequential frequency of positive or aversive consequences.22 The approach also posits that a change in the cognitive and affective factors within patients will lead to a change in behaviour. For patients with a chronic illness to manage, this means the adoption and enhancement of appropriate coping behaviours and adherence to rehabilitation regimes.

There are five underlying assumptions to CBT:

1. Individuals actively process information from the environment. Their beliefs and subsequent behaviours are shaped by their analysis of the consequence of these events. The analysis is influenced by both internal and external factors and especially previous experience. For example, if an individual experiences a severe increase in symptoms following increased activity, they may conclude that activity is unhelpful and avoid it.

2. Individuals’ cognitions affect their behaviour and affective state. In this client group, beliefs about the causation of the illness and how best to manage rest and activity play a key role in determining the coping strategy selected.

3. The relationship between environmental events, cognitions and affective state is reciprocal.

4. Treatment strategies aim to bring about change. In order to do this, cognitive, affective and behavioural dimensions of the individual must be addressed.

5. Individuals must be active participants in the change process.

The CBT used in this trial was designed to do two things:

1. attempted modification of thoughts and beliefs about symptoms and illness

2. attempted modification of behavioural responses to symptoms and illness, such as rest, sleep and activity.
 
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Tom Kindlon

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Dropouts:

Page 12:

They say:

“Drop-out rates

Previously reported drop-out rates have varied. In Whiting and colleagues’ review,17 the overall dropout rate was 15%. The highest drop-out was observed in the CBT trial and reached 19%. No reasons were given for this, but clearly if CBT is considered an effective treatment, the reasons for high drop-out in this area will be pertinent. Several authors have reported difficulties with patient drop-out,17 but there have been no trials reporting drop-out rate from a treatment delivered in a group setting.”

But they don’t seem to comment much if at all on the higher drop-outs in the CBT in this trial


Dropouts (Appendix 9) At 6 months:
SMC: 5
EAS: 5
CBT: 9

At 12 months:
SMC: 7
EAS: 4
CBT: 13
 

Tom Kindlon

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Chapter 2:

Aims of CBT described: page 16

Condition 1 – description of the CBT intervention

The CBT used in this trial was designed to do two things: first to attempt to modify thoughts and beliefs about symptoms and illness, and second to attempt to modify behavioural responses to symptoms and illness, such as rest, sleep and activity.

The ultimate goal of the treatment was to increase adaptive coping strategies and therefore reduce the distress and disability.

The content of the programme included:
● Elucidation of core beliefs regarding their illness and its management.
● Monitoring of activity levels and introduction of appropriate timetable.
● Introduction to exercises designed to increase general level of fitness, balance and confidence in exercise. A range of aerobic, strength, balance and stretching exercises were taught.
● Behavioural modification of sleep patterns.
● Mood management advice.
● Goal setting.

The CBT groups were introduced to a structured incremental exercise programme following a group discussion about the unhelpful nature of activity cycling, following CBT principles. The calculation of a deliberately low ‘baseline’ for exercise as a means of counteracting activity cycling was taught, and instructions were given about pacing up by small increments once the exercise level had been achieved successfully for several days (flexibility was allowed for patients to choose their own frequency of increments). Advice was given to patients to reduce the level of exercise considerably should a significant increase in symptoms be experienced at some stage in the future, and the balance between the risks and the benefits of prolonged rest during such a setback was explored. The management of setbacks was a specific subject included in the CBT group syllabus.
 

Tom Kindlon

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Appendix 8:
“This appendix summarises the content of the CBT sessions.”
(Trudie Chalder’s book "coping with chronic fatigue" was lent to the CBT patients)


CBT sessions

This appendix summarises the content of the CBT sessions. Each session lasted from 12 am until 2 pm, with a short comfort break at 1 pm. Exercise sessions were normally before the break to allow a period of recovery after the journey to hospital and prior to the journey home. Meetings were held on alternate weeks, that is, the eight sessions were delivered over a 16-week period.

Slight variations in the content and the order of presentation occurred owing to staff annual leave. The majority of the talks lasted between 20 and 30 minutes. The following is a typical outline:

Session one

● Introduction to staff and other participants and housekeeping rules.
● Outline of CFS/ME as a syndrome with clear symptoms and psychosocial consequences but with unknown organic pathology. As a result, the course was being directed at best management of the symptoms, and their consequences.
● Group exercise following the impact of the condition upon a typical sufferer, along a timeline from onset to 2 years post-onset. The wide range of symptoms was explored, in addition to the impact of symptoms upon psychological and social functioning.
● Impact of symptom-contingent over- and underactivity cycling explored.
● Introduction to setting baselines for activity and exercise to avoid activity cycling.
● Introduction to graded exercise as a means of regaining fitness and confidence in movement.

Session two

● Introduction to using an activity diary to analyse pacing skills.
● Review of baselines set for first exercises.
● Further exercises taught.
● Introduction to goalsetting.
● Small group work focusing upon individual goalsetting.

Session three

● Review of activity diary use and pacing skills.
● Obstacles to progress; session focusing upon behaviours that may prevent benefit being gained from the programme.
● Disease model analysis; analysis of usual expectation that identification of an illness leads to treatment and then to recovery. Redirection of participant’s attention away from seeking a cure towards a ‘best management strategy’ that involves enhanced coping, and may lead to increased chances of recovery.
● Exercise review and ‘troubleshooting’ session.
● Small group work focusing upon individual goalsetting.

Session four

● Introduction to stress management.
● Slow diaphragmatic breathing taught.
● Relaxation practice, recordings of relaxation protocol lent for home practice.
● Small group work focusing upon individual goalsetting.

Session five

● Assertiveness and communication with others, particularly with regard to the importance of paced activity.
● Dealing with setbacks; setting up a recovery plan.
● Feedback regarding relaxation practice and ‘troubleshooting’.
● Exercise programme progressed.
● Small group work focusing upon individual goalsetting.

Session six

● Dealing with depression.
● Exercise programme progressed.
● Relaxation practice (imagery).
● Feedback regarding the books lent to patients (Coping with chronic fatigue by Trudie Chalder).76
● Small group work focusing upon individual goalsetting.

Session seven

● The influences of positive and negative thinking upon coping, and how to deal with negative automatic thoughts. ● Exercise review; focus upon exercise habits for the future.
● Moving from illness identity into ‘well’ thinking.
● Small group work focusing upon individual goalsetting.

Session eight

● Strategies for keeping going with selfmanagement.
● Risks for a setback in the future: how to avoid the risks and review of recovery planning.
● Summary of the benefits and disappointments of the programme.
● Information about the research programme and the importance of the reassessments.
 

Tom Kindlon

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Appendix 9

Reasons for drop-out

Intervention

SMC


6 months

3 withdrew from study (84, 123, 143)
1 on holiday (66)
1 unable to attend (99)

12 months
3 withdrew from study (84, 123, 143)
2 were not contactable (99, 152)
1 transport problems (98)
1 unknown (7)

-----

EAS




6 months


1 moved away (153)
1 CFS too severe (140)
1 wrote and said did not find approach helpful (17)
2 unknown (56, 73)

12 months
1 CFS too severe (140)
1 too ill to attend (138)
1 not contactable (96)
1 unknown (56)

-----

CBT


6 months


2 moved away (20, 76)
1 dropped out following an argument (31)
1 dropped out owing to work pressures (154)
1 transport problems (137)
2 unable to attend owing to a bereavement (132, 142)
2 unknown (23, 119)


12 months
4 moved away (14, 20, 28, 76)
1 dropped out following an argument (31)
1 dropped out owing to work pressures (65)
1 dropped out (137)
1 said she could not see the point (132)
1 could not be contacted (145)
1 declined to make further appointment (154)
2 unknown (34, 37)
 

Tom Kindlon

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Employment status

Appendix 12:

Page 106 lists their employment status at the end:

For the groups CBT, EAS and SMC, the figures for not working are: 49%, 41% and 43%. Also "not specified" is 10%, 7% and 7%.

It is somewhat awkward to see if there was any improvement for this improvement as at baseline so many people had "not specified": 42%, 34% and 39%. The figures for "no job" at baseline were: 38%, 44% and 31%.

The authors do admit:
“Group CBT did not significantly improve cognitive function, quality of life, employment status or healthcare utility measures”.
 

Tom Kindlon

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Final comment
(remember this is copied from a 2007 Co-Cure post)

[End of commentary on O'Dowd in particular] Given the extremely modest improvements found in this study (amongst those who were willing and able to take part and finish it) as well as the extremely modest improvements found in the adults in the various Belgian clinics:

(ref: http://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind0701D&L=CO-CURE&P=R3379&I=-3& m=16601 or http://tinyurl.com/2uqoqs

http://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind0701E&L=CO-CURE&P=R427&I=-3&m =16601 or http://tinyurl.com/366v5l

http://listserv.nodak.edu/cgi-bin/wa.exe?A2=ind0702C&L=CO-CURE&P=R4161&I=-3& m=16601 or http://tinyurl.com/yvjlwx )

it seems patients should be on the lookout for any suggestions that CBT based on Graded Activity or Graded Exercise is anywhere near sufficient for this illness.

There seems to be a lot of hype by certain individuals of these treatments. When one looks closely at the studies [especially those not simply involving the very vague Oxford CFS criteria (basically unexplained chronic fatigue for 6+ months) (or where Prins (2001) used CDC 94 but didn't require the patients to have any of the 8 CDC criteria!)], the results generally seem modest at best.
 

WillowJ

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At 12 months, the physical score was in the normal range for 46% of the CBT group, 26% of the EAS group and 44% of SMC patients.

For mental health score the percentages were CBT 74%, EAS 67% and SMC 70%.

Of the CBT group, 32% showed at least a 15% increase in physical function and 64% achieved a similar improvement in their mental health.

For the EAS and SMC groups, this improvement in physical and mental health was achieved for 40 and 60% (EAS) and 49 and 53% (SMC), respectively.

it seems they've gone out of their way to put a "better" figure from CBT next to a lower figure from some other treatment (even if the two don't compare, e.g. 64% mental health CBT...next figure one reads is 40% physical health EAS, although they should be comparing 32% physical health from CBT with that 40 figure from EAS)

Many people speed read and could get the wrong impression.
 
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