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Cognitive behavioural therapy
in chronic fatigue syndrome:
a randomised controlled trial
of an outpatient group programme
H O’Dowd,
1*
P Gladwell,
1
CA Rogers,
2
S Hollinghurst
3
and A Gregory
1
1
Pain Management Centre, Frenchay Hospital, Bristol, UK
2
Bristol Heart Institute, Bristol Royal Infirmary, UK
3
Department of Community Based Medicine, University of Bristol, UK
* Corresponding author
HTA
Health Technology Assessment
NHS R&D HTA Programme
Health Technology Assessment 2006; Vol. 10: No. 37
Executive summary
Cognitive behavioural therapy in chronic fatigue
syndrome
Background and objectives
This report describes the conduct and results of a
double-blind randomised controlled trial to
compare group cognitive behavioural therapy (CBT)
with education and support (EAS) and with
standard medical care (SMC) for the treatment of
patients with chronic fatigue syndrome/myalgic
encephalopathy (CFS/ME). The research hypothesis
was that group CBT would provide an effective and
cost-effective management strategy for patients in
primary care with CFS/ME and that treatment gains
in these areas would be found even when controlling
for the non-specific effects of therapist exposure.
Methods
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
The study was set in 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 were referred by
their GP. Over a 2-year period (August 2000–July
2002), 153 eligible patients were recruited and
consented to participate; 52 were randomised to
receive CBT, 50 to EAS and 51 to SMC. The target
sample size for the trial, set at 43 per condition,
was met. Seven patients did not receive the
treatment assigned for clinical or ethical reasons
and fear of contamination but all analyses were
carried out on an intention-to-treat basis. 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.
Interventions
The primary analyses compared the outcome scores
between the three treatment interventions.
Differences between the treatment cohorts are
reported with 95% confidence intervals (CIs). For
the primary outcome measures, the SF-36 physical
and mental summary scales, the numbers of patients
reporting a 15% increase over the baseline score
(defined as a successful outcome) and the numbers
returning to the normal range are also reported.
Outcome measures
A range of generic outcome measures were used as
validated disease-specific outcome measures were
not available for this condition. 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 (HADS), General Health Questionnaire,
measures of physical function (shuttles walked,
walking speed and perceived fatigue), health
utilities index, cognitive function (mood, recall and
reaction times) and resource use. Outcomes were
measured as baseline (before randomisation) and at
6 and 12 months after the initial assessment.
Results
Three outcome measures, SF-36 mental health
score, Chalder fatigue scale and walking speed,
showed statistically significant differences between
the groups. The CBT group had significantly
higher SF-36 mental health scores (difference
+4.35, 95% 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 was 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; fatigues, 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.
Excepting 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.
Executive summary: Cognitive behavioural therapy in chronic fatigue syndrome
Executive summary
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, but these changes were not
statistically significant.
There were multiple difficulties in completing the
economic evaluation. A cost–utility (or cost-
effectiveness) analysis was planned, but the quality
of the data prevented this objective being realised.
The intention was to use data from participating
primary and secondary care centres and patient
questionnaires. However, owing to the unexpected
departure of the health economist early in the
trial, the study was almost complete before it was
realised that patient records would need to be
scrutinised for resource use data. This meant that
limited resources were available for this exercise,
and minimal data were obtained. Also, the patient
questionnaire was inadequate. It asked patients
about treatments and medication use but failed to
ascertain the cost involved. Data on direct patient
costs and indirect societal costs was sought but the
response was too poor for the data to be of much
value, with a great deal of missing data. As a
result, the quality of the health economic data was
poor; the evaluation was limited to the perspective
of the healthcare provider (NHS) and the
reporting of results was descriptive only. The
descriptive data tentatively suggest that most of
the cost of CFS/ME is borne by family and friends.
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.
Recommendations for future
research
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.
Publication
O’Dowd H, Gladwell P, Rogers CA, Hollinghurst S,
Gregory A. Cognitive behavioural therapy in
chronic fatigue syndrome: a randomised
controlled trial of an outpatient group
programme. Health Technol Assess 2006;10(37).
Health Technology Assessment 2006; Vol. 10: No. 37 (Executive summary)
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