Cognitive behavioural therapy in chronic fatigue syndrome: a randomised controlled trial of an outpatient group programme, 2006, O'Dowd et al

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NICE Health topics: Tiredness/Fatigue in adults (includes CFS).
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The NHS seems to consider GET and CBT as Health Technologies (HTs), as there was a long HTA (HT Assessment) produced by O'Dowd and Gladwell, Bristol, in 2006.

https://www.researchgate.net/public...rolled_trial_of_an_outpatient_group_programme

So, presumably NICE should consider harms from CBT and GET alongside those from other "Health Technologies". Although the title refers to Group CBT, it incorporates "graded activity scheduling":

"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).

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."


This "tome" was published 15 years ago, in 2006 and they still haven't worked out "better outcome measures"!!

The whole report runs to 140 pages: https://www.journalslibrary.nihr.ac.uk/hta/hta10370/#/abstract

 

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Some extracts from the same HTA "Executive Summary"


"The economic impact appears substantial, with
over 60% of patients citing the onset of CFS/ME as
the main reason why they cannot work.

Limitations
The trial had a number of limitations: patients
were referred from the GP, without a specialist
diagnosis, and the individuals’ suitability for group
treatment was not assessed prior to randomisation.
One patient was withdrawn because an alternative
diagnosis was made and several patients would
not, in clinical practice, have been considered
psychologically appropriate for group treatment.
Also, some subjects were already using good
management techniques and could not, therefore,
be expected to show a significant improvement.
On average, the patients in the study population
were more fatigued, had been ill for longer and
were more distressed than samples used in
previous research, although they were able to
attend an outpatient programme, which implies a
certain level of ability. It is not possible to assess
from this trial whether the interventions
investigated would be effective, ineffective or
even hazardous for more severely disabled
individuals.
Conclusions
Group CBT did not significantly improve
cognitive function, quality of life, employment
status or healthcare utility measures, although
such changes have been demonstrated in the
literature for individual CBT. The increased
measures of mood and fitness and decreased
symptoms of fatigue seen with CBT are
comparable to the changes seen in the individual
research literature.

The similarity of the Borg perceived fatigue scores across each condition,
both initially and at follow-up, indicates that each
cohort reported exercising to a similar level of
fatigue.

This indicates that the significant increase
in shuttle walking found in the CBT group was
not an artificial gain achieved by ‘pushing
through’ fatigue. It appears to be more substantial.

These subjects reported increases in their normal
walking pace. It seems that the gain is for both
speed and endurance. This is of great functional
significance for CFS/ME sufferers.

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."


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.