Departments of Epidemiology and General Practice, Maastricht University and Department of Medical Psychology, UMC St Radboud Nijmegen
Department of Epidemiology, Maastricht University
Department of General Practice, Maastricht University
Department of Medical Psychology, UMC St Radboud Nijmegen
Department of General Practice, Maastricht University
Department of General Practice, Maastricht University
Department of Medical Psychology, UMC St Radboud Nijmegen, The Netherlands
Correspondence: M. J. H. Huibers, Department of Medical, Clinical and Experimental Psychology, Maastricht University, PO Box 616, 6200 MD Maastricht, The Netherlands. Tel: +3143 388 1487; fax: +31 43 388 4155; e-mail: m.huibers{at}dmkep.unimaas.nl
Declaration of interest None. Funding detailed in Acknowledgements.
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ABSTRACT |
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Aims To assess the efficacy of cognitive-behavioural therapy by general practitioners for unexplained, persistent fatigue among employees.
Method A randomised controlled trial, using a pre-randomisation design in primary care, investigated 151 employees on sick leave with fatigue. Participants in the experimental group were offered five to seven 30 min sessions of cognitive-behavioural therapy by a general practitioner; those in the control group were offered no treatment. Main outcome measures (fatigue severity, self-reported absenteeism, registered absenteeism and clinical recovery) were assessed at 4 months, 8 months and 12 months.
Results At baseline, 44% ofthe patients already met research criteria for chronic fatigue syndrome. There was no significant difference between the experimental group and the control group on primary or secondary outcomes at any point.
Conclusions Cognitive-behavioural therapy by general practitioners for unexplained, persistent fatigue did not prove to be an effective intervention. Since these doctors were unable to deliver this therapy effectively under ideal circumstances, it is unlikely that doctors in routine practice would be more successful in doing so.
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INTRODUCTION |
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Although persistently fatigued patients tend to rely heavily on the care of their general practitioner, evidence-based treatment options in primary care are few, and referral to secondary care is rarely an option. Studies in secondary care have shown that cognitive-behavioural therapy (CBT) delivered by skilled therapists is effective in the treatment of chronic fatigue syndrome (Prins et al, 2001; Whiting et al, 2001). It has been suggested that some general practitioners might also provide CBT in the treatment of (chronic) fatigue (Sharpe & Wilks, 2002); however, it is unknown whether CBT is effective in less advanced fatigue cases, and whether general practitioners would be able to deliver it.
In this study, we aimed to assess the efficacy of CBT in primary care for unexplained, persistent fatigue. Our hypothesis was that delivering CBT to employees on sick leave for fatigue would reduce the complaints of fatigue and stimulate the resumption of work.
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METHOD |
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Participants
Participants were recruited in collaboration with a local occupational
health service, which monitors a working population of 80 000 employees.
Employees who were on sick leave (irrespective of the reason) were sent
limited study information, including a screening questionnaire, on a monthly
basis by the occupational health service, followed by a reminder 2 weeks
later. Based on the screening questionnaires that were sent back to the
research team, we invited potential candidates who were willing to participate
to visit the university research centre. Eligibility was assessed by the
principal investigator (M.J.H.H.) in a clinical interview. Inclusion criteria
were severe fatigue (a score of 35 or more on the fatigue sub-scale of the
Dutch Checklist Individual Strength (CIS;
Vercoulen et al,
1999; Beurskens et al,
2000) for 4 months or more as one of the main health problems, and
complete absenteeism from work for 6-26 weeks. Patients were excluded from
participation if they had medical conditions that explained fatigue (e.g.
cancer); were receiving another intervention for fatigue (e.g. treatment for
burnout); had a previously classified psychiatric disorder; or were receiving
current psychological treatment (e.g. CBT for major depression). People whose
absenteeism was caused primarily by problems unrelated to health, such as work
conflict, were also excluded.
Interventions
Participants in both groups were asked to agree to being followed up over a
12-month period. Patients allocated to the experimental treatment group were
offered five to seven 30 min sessions of CBT over the course of 4 months. Nine
GPs delivered all interventions at their regular practice but outside usual
office hours. These research GPs were recruited from primary
care doctors in the south-east of the Netherlands, on the basis of their
geographical location. Patients who agreed to receive CBT were assigned to a
research GP near their home address. The intervention was partly based on the
CBT programme for chronic fatigue syndrome developed by members of our group
(Prins et al, 2001).
The goals of the intervention were to diminish fatigue and other complaints,
establish work resumption and other personal goals, and to establish
self-perceived recovery. The intervention itself consisted of two stages:
The intervention procedure was set out in a treatment manual. The research GPs - none of whom had previous experience with CBT - were trained in delivering the intervention in two 5 h workshops, and were supervised in monthly 2 h sessions throughout the trial by two experienced behavioural therapists (G.B., E.B.). No research intervention was offered to patients in the control group. Patients in either group were free to visit their regular GP for usual care.
Outcome assessment
Researchers and research GPs were not masked to the group allocation. All
self-reported outcomes were assessed using computerised questionnaires at the
research centre (baseline and post-treatment measurement) and postal
questionnaires (8-month and 12-month follow-up). Primary outcomes were fatigue
severity, absenteeism and clinical recovery. Fatigue was
measured with the fatigue sub-scale of the CIS
(Vercoulen et al,
1999; Beurskens et al,
2000), high scores indicating greater severity. Absenteeism was
assessed in two ways, self-reported work resumption or absenteeism (yes/no) at
each measurement, and absenteeism registered by the occupational health
service (number of partial or complete sick days in 365 days). Clinical
recovery was defined as having a CIS fatigue score of 34 or lower in
combination with self-reported work resumption.
Secondary outcomes were global perceived effect, physical functioning and psychological distress. Global perceived effect was rated on a seven-point scale (Feinstein, 1987) and then dichotomised into recovered and not recovered. Physical functioning was measured with the physical functioning sub-scale of the 36-item Short Form Health Survey (SF-36; Ware & Sherbourne, 1992), high scores indicating high levels of functioning. Psychological distress was measured with the Symptom Check-List 90 (SCL-90; Derogatis et al, 1973), high scores indicating high distress.
To assess whether therapy was delivered in accordance with the treatment manual, standardised registration forms were used on which the doctors registered the actions taken in each therapy session and commented on the proceedings. On the basis of these forms and the information gathered in supervision, the CBT supervisors performed a quality check. For each patient in the experimental group, it was assessed whether the CBT received was according to protocol - defined as being exposed to all essential steps of the intervention, something that might have been achieved in less than five sessions. In addition, treatment process indicators from our previous fatigue studies (Vercoulen et al, 1996; Prins et al, 2001; Huibers et al, 2003a) were used to assess the cognitive impact of the intervention: self-efficacy (sense of control in relation to complaints), psychological attributions (beliefs regarding the psychological cause of complaints) and somatic attributions (beliefs regarding the somatic cause of complaints), high scores indicating high self-efficacy or strong attributions.
Additional measures included psychosocial co-interventions, usual care by the persons regular GP and physical activity. Psychosocial co-interventions (defined as treatment by a psychiatrist, a psychologist and/or psychoactive drug treatment) were measured by self-report and expressed in numbers of patients who received such interventions during the first 4 months after the baseline assessment. Usual GP care was expressed as number of visits to the regular GP during the first 4 months after baseline. Physical activity was measured with the actometer, a motion-sensing device attached to the ankle and worn for 12 days continuously (Van der Werf et al, 2000); scores reflect the average number of accelerations per 5 min period. High scores indicate high activity, with a mean of 91 (s.d.=25) for healthy individuals.
Sample size and data analysis
In calculating the sample size we chose the fatigue sub-scale of the CIS as
our main outcome measure. From the baseline data of the affiliated Maastricht
Cohort Study (Kant et al,
2003), we estimated the standard deviation to be 12. To detect a
clinically significant difference of 6 or more on the CIS at a two-sided
significance level of 5% and a power of 80% we would need 63 patients per
group. We extended the sample size to 75 patients per group to take into
account potential withdrawal from the trial. In the main analysis, data were
analysed according to the intention-to-treat principle using all available
data. The t-test for independent samples (continuous data) and the
chi-squared test (dichotomous data) were used to compare the two conditions.
Difference scores on continuous outcomes (baseline score minus follow-up
score) were used in the analysis. The influence of baseline differences was
assessed using linear and logistic regression. An analysis of variance was
used to assess the effect of research GP on treatment outcomes. In addition to
intention-to-treat analyses, explanatory subgroup analyses were performed. All
analyses were performed using the Statistical Package for the Social Sciences,
version 11.0.
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RESULTS |
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Baseline demographic and clinical characteristics were fairly similar in both groups, except for physical functioning and psychological distress (Table 1). Adjustment for these two factors did not change the findings. Patients were identified as potentially having chronic fatigue syndrome (CFS-like cases) if they met all of the following research criteria (Fukuda et al, 1994): a CIS score of 40 or higher; a duration of fatigue complaints of 6 months or more; and an SF-36 score on the physical functioning sub-scale of 60 or lower. At baseline, 66 patients (44%) met research criteria for chronic fatigue syndrome, none of whom reported a previous diagnosis of the syndrome. One patient indicated that she believed she suffered from chronic fatigue syndrome.
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Outcomes
Table 2 presents the
clinical outcomes at baseline, 4 months and 12 months. There was no
significant difference between the CBT group and the control group on any
clinical outcome at any point (including the 8-month assessment).
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Treatment received
Five patients allocated to the CBT group immediately refused the treatment
offered to them (Fig. 1). Of
the remaining 71 patients who agreed to receive treatment, 51 patients (72%)
completed the intervention according to protocol. The mean number of CBT
sessions attended was 5.3 (s.d.=1.9), with a mean duration of 33.7 min
(s.d.=9.4). In addition, 13 patients (18% of 74) in the CBT group underwent
psychosocial co-interventions during the first 4 months (intervention period)
compared with 22 patients (31% of 72) in the control group (95% CI for the
difference, -1% to 27%). The mean numbers of visits to the regular GP in the
intervention period were 4.2 (s.d.=4.5) in the CBT group and 3.5 (s.d.=4.3) in
the control group (95% CI for the difference, -0.8 to 2.1). No adverse event
attributable to CBT was reported. Table
3 presents scores on the treatment process indicators assessed at
baseline and follow-up. There was no difference between the CBT and the
control group. Moreover, post-treatment scores remained stable in both groups
compared with baseline.
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Outcomes in CBT completers
We compared the baseline characteristics of those who completed CBT
according to protocol (n=51) with those who refused or withdrew from
CBT (non-completers, n=25) and found that CBT completers were similar
to non-completers at baseline. Clinical outcomes and scores on treatment
process indicators for the completers group were then compared with scores in
the control group (n=75). There was no significant or noticeable
difference between these groups.
Subgroup analyses
Although some differences appeared between individual research GPs in
treatment effect, no overall GP effect on clinical outcomes was found.
Patients were stratified according to fatigue severity (CIS score 35-49,
n=74; CIS score 50-56, n=77), duration of absenteeism (6-12
weeks, n=90; 13 weeks, n=61), duration of fatigue
complaints (4-12 months, n=79;
13 months, n=72),
CFS-like caseness (yes, n=66; no, n=85), gender (men,
n=68; women, n=83), age (
44 years, n=81;
45
years, n=77) and education (low, n=109; high, n=42)
at baseline. There was no significant or noticeable effect of CBT compared
with the control group in any of these categories.
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DISCUSSION |
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Methodological considerations
This is the second study of CBT by GPs for fatigue. In the first,
preliminary study, it was concluded that primary care doctors were unable to
treat chronic fatigue syndrome effectively
(Whitehead & Campion,
2002), but the strength of this study should be questioned because
of poor recruitment and high withdrawal rates. We designed our trial to assess
whether the intervention works under ideal circumstances. Consequently, we
chose to train and deploy a small number of research GPs, instead of a large
sample of GPs who would have had to treat their own patients. Masking is
virtually impossible in this type of research, and therefore we used a
prerandomisation design to control for contamination between groups and to
prevent selective withdrawal from the study
(Knottnerus, 1997). In our
view, the low withdrawal rate (8.6% of 151 patients) outweighs the occasional
refusal of treatment as a result of the design.
As could be expected, patients in the control group received more co-interventions, which might have led to an underestimation of the effect of CBT. A limitation of this study is the nature of our quality check: we used registration forms instead of audiovisual recordings to assess the quality of the CBT that was delivered and, as a result, we cannot be certain that the research GPs actually did what they claimed to have done.
Previous studies
This is the first study on CBT for fatigue in primary care that adequately
controlled for usual care. Treatment of chronic fatigue by skilled
cognitive-behavioural therapists was no more effective than counselling in a
study by Ridsdale et al
(2001), but these
interventions were not compared with either no treatment or usual care. It is
interesting to find that the proportion of patients who failed to complete CBT
in our study (33%) is comparable with rates of withdrawal from therapy in
primary care (Ridsdale et al,
2001) and secondary care
(Prins et al, 2001)
studies investigating CBT for chronic fatigue.
Few earlier studies have addressed the effectiveness of CBT provided by GPs. In a recent study by King et al (2002), teaching CBT skills to GPs proved ineffective. However, the extent to which GPs actually applied their skills was not assessed in that study. In a review for the Cochrane Collaboration (Huibers et al, 2003b), we found little evidence for the effectiveness of psychosocial interventions by GPs, except for a favourable effect of problem-solving treatment by a small number of experienced GPs on major depression (Mynors-Wallis et al, 1995, 2000). In general, positive effects of psychosocial interventions seemed to be associated with a small number of GPs (10 or fewer) treating many patients (Huibers et al, 2003b).
Can the lack of efficacy be explained?
The lack of efficacy in this study cannot be attributed to clear
methodological flaws: interventions were delivered under ideal
circumstances as opposed to routine care evaluations, study conditions
were highly contrasted, and the majority of patients and GPs appeared
compliant with the protocol. Rather, the lack of efficacy is likely to result
from a disturbance in the interaction between the patient, the doctor and the
intervention. Our study was not designed to reveal the source of the
disturbance in this triad. However, a plausible explanation for our findings
would be that research GPs did not treat enough patients to gain the necessary
experience in delivering the complex intervention. Also, since many patients
were characterised at baseline by an advanced degree of impairment in terms of
fatigue, psychological distress and physical functioning, they might have had
better chances for improvement in secondary mental health care
(Prins et al, 2001). This might be particularly true for those who met the research criteria for
chronic fatigue syndrome. On the other hand, one might claim that the
substantial (natural) recovery in both groups is partly accountable for the
lack of difference in effect between the conditions, leading to the
possibility that the brief intervention was not adequate, specific or
intensive enough for those who did not recover in the course of time. An
additional difficulty might have been that the intervention was targeted not
only at fatigue but also at the resumption of work, a complex process that is
determined by a wide variety of factors.
How do our findings reflect on the evidence for the effectiveness of CBT in patients with chronic fatigue syndrome? We should keep in mind that our study differs from those of Prins et al (2001) and Whiting et al (2001) in important ways. We did not deploy experienced CBT therapists but relatively inexperienced GPs; our study population consisted of individuals with a different profile (e.g. impairment, attitudes, illness beliefs, prognosis) from that of patients with classic chronic fatigue syndrome in secondary care; and our CBT intervention consisted of only half the number of sessions administered in other studies. Apparently, these factors have to be matched appropriately for CBT to be successful in patients with chronic fatigue syndrome.
Implications for treatment
A recent review concluded that it cannot be assumed that psychosocial
treatments in secondary care will produce the same magnitude of effect in
primary care (Raine et al,
2002), owing to differences in prognostic spectrum, treatment
regimen and treatment provision. Effective CBT for chronic fatigue syndrome in
secondary care consisted of approximately 16 sessions given by skilled and
supervised specialists (Prins et
al, 2001). In primary care, however, more treatment sessions
or more training (King et al,
2002) seem not to be a feasible option. Even under ideal
circumstances, our research GPs were unable to deliver CBT effectively. In our
opinion, it is unlikely that GPs in routine practice would be any more
successful in delivering a complex psychosocial treatment such as CBT.
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Clinical Implications and Limitations |
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LIMITATIONS
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ACKNOWLEDGMENTS |
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Received for publication June 16, 2003. Revision received September 25, 2003. Accepted for publication October 15, 2003.
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