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QUESTION: In patients with the chronic fatigue syndrome (CFS), how effective is cognitive behaviour therapy (CBT) in reducing fatigue and functional improvement?
3 mental health settings in the Netherlands: 2 based in university medical centres and 1 in a mental health institute.
278 patients between 18 and 60 years of age (mean age 37 y, 79% women) with the US Centers for Disease Control and Prevention criteria for CFS, a score of ≥40 on the fatigue severity subscale of the checklist individual strength (CIS), and a score of ≥800 on the sickness impact profile. Exclusion criteria included pregnancy and previous or current participation in CFS research.
93 patients were allocated to CBT (sixteen 1 h sessions over 8 mo), 94 to guided support groups (eleven 1.5 h meetings over 8 mo), and 91 to the control group (no intervention).
Main outcome measures
The primary outcomes were fatigue severity and functional impairment. Clinical improvement was defined as a reliable change index >1.64 and a fatigue severity score ≤36, showing that the patient had moved to the range of a healthy person.
At 8 months, 241 patients (89%) had complete data. This dropped to 73% at 14 months. At 8 months of follow up and for both primary outcomes, CBT was more effective than both guided support and no treatment with no difference between the latter 2 groups. More patients in the CBT group met the criteria for clinical improvement for CIS fatigue severity and self rated improvement in fatigue (table). Secondary outcomes at various time points were statistically different, but follow up was <80%.
In the chronic fatigue syndrome, cognitive behaviour therapy reduced fatigue and functional impairment.
5 randomised controlled trials (RCTs) of rehabilitative approaches for CFS in secondary care have been previously published. The first trial by Lloyd et al found that brief CBT was no better than medical care.1 Subsequent trials using more intensive treatment found substantial benefits over both usual care and relaxation therapy.2, 3 2 RCTs of supervised simple graded exercise therapy (GET)—both of which showed some, although less, benefit—have also been published.4, 5 These trials were all of intensive therapy given by skilled practitioners in special centres. If therapy was better targeted, could less intensive treatment work? Could less skilled therapists deliver effective treatment? Are patient self help groups as effective as these treatments?
Powell et al addressed the value of better targeted, but briefer, treatment. Although called “educational,” the treatment was similar to CBT and GET but emphasised providing a physiological rationale for rehabilitation. The results were remarkable: although the usual care group changed minimally, all 3 intervention groups, even the minimal one, improved substantially. This trial suggests that a brief intervention can work, perhaps because it used a rationale that was consistent with patients' own understanding of their illness.
Prins et al's well designed study was marred only by limited patient adherence to treatment and attrition in follow up. This study showed that CBT could offer substantial benefit over usual care, even when delivered by non-experts in non-specialist centres. Interestingly, support groups satisfied patients but did not improve outcomes.
What can we conclude? 7 RCTs now exist using rehabilitative approaches for CFS, and 6 have shown benefits. Although the names of the interventions have varied, all are forms of rehabilitation.6 However, important caveats are noted: the total number of patients in these RCTs remains relatively small. Patients who cannot attend outpatient facilities have been excluded. Although most patients achieve improved functioning, they often continue to report excessive fatigue, and some patients do not respond at all. Finally, some patient organisations will not welcome these new findings. The reasons given are (1) the treatments are not a cure; (2) success of psychological treatment implies that CFS is a psychological disorder; and (3) such treatments can be harmful. Adverse effects have rarely been reported in these trials but should be in future trials.
We now need large pragmatic trials that evaluate the utility of rehabilitative approaches in routine practice and explanatory trials to clarify which treatment components are most potent. Finally, we need to establish the place for rehabilitation in the medical care of CFS and related syndromes, and we need to ensure that it is delivered in a form acceptable to patients. These trials are useful steps along that road.