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Therapeutics

Cognitive behavior therapy reduced fatigue severity and functional impairment in the chronic fatigue syndrome

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ACP J Club. 2001 Sep-Oct;135:47. doi:10.7326/ACPJC-2001-135-2-047

Related Content in this Issue
• Companion Abstract and Commentary: Patient education to encourage graded exercise improved physical functioning in the chronic fatigue syndrome


Source Citation

Prins JB, Bleijenberg G, Bazelmans E, et al. Cognitive behaviour therapy for chronic fatigue syndrome: a multicentre randomised controlled trial. Lancet. 2001 Mar 17;357:841-7. [PubMed ID: 11265953] (All 2001 articles were reviewed for relevancy, and abstracts were last revised in 2007.)


Abstract

Question

In patients with the chronic fatigue syndrome (CFS), how effective is cognitive behavior therapy (CBT) in reducing fatigue and functional improvement?

Design

Multicenter, randomized {allocation concealed*}†, unblinded,* controlled trial with 8-month follow-up (follow-up at 14 mo was < 80%).

Setting

3 mental health settings in the Netherlands: 2 based in university medical centers and 1 in a mental health institute.

Patients

278 patients between 18 and 60 years of age (mean age 37 y, 79% women) with the U.S. 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.

Intervention

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.

Main results

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%.

Conclusion

In the chronic fatigue syndrome, cognitive behavior therapy reduced fatigue and functional impairment.

*See Glossary.

†Information provided by the author.

Source of funding: Health Insurance Council.

For correspondence: Ms. J.B. Prins, Department of Medical Psychology, University Medical Centre Nijmegen, P.O. Box 9101, 6500 HB Nijmegen, The Netherlands. FAX 31-24-3613425.


Table. Improvement at 8 months for cognitive behavior therapy (CBT), guided support (GS), and control treatment (C) in the chronic fatigue syndrome‡

Outcomes Comparison Improvement RBI (95% CI) NNT (CI)
CIS fatigue severity CBT vs GS 33% vs 13% 160% (38 to 402) 5 (4 to 14)
CBT vs C 33% vs 13% 154% (35 to 389) 6 (4 to 15)
Self-rated improvement in fatigue CBT vs GS 57% vs 17% 236% (99 to 489) 3 (2 to 5)
CBT vs C 57% vs 30% 93% (31 to 189) 4 (3 to 9)

‡CIS = checklist individual strength. Other abbreviations defined in Glossary; RBI, NNT, and CI calculated from data in article.


Commentary

5 randomized controlled trials (RCTs) of rehabilitative approaches for CFS in secondary care have been previously published. The first trial by Lloyd and colleagues (1) found that brief CBT was no better than medical care. 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 centers. 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 and colleagues addressed the value of better targeted, but briefer, treatment. Although called “educational,” the treatment was similar to CBT and GET but emphasized providing a physiologic 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 and colleagues' 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 nonexperts in nonspecialist centers. 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 organizations will not welcome these new findings. The reasons given are 1) the treatments are not a cure; 2) success of psychological therapy implies that CFS is psychological 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.

Michael Sharpe, MA
University of Edinburgh
Edinburgh, Scotland, UK


References

1. Lloyd AR, Hickie I, Brockman A, et al. Immunologic and psychologic therapy for patients with chronic fatigue syndrome: a double-blind, placebo-controlled trial. Am J Med. 1993;94:197-203. [PubMed ID: 8430715]

2. Deale A, Chalder T, Marks I, Wessely S. Cognitive behavior therapy for chronic fatigue syndrome: a randomized controlled trial. Am J Psychiatry. 1997;154:408-14. [PubMed ID: 9054791]

3. Sharpe M, Hawton K, Simkin S, et al. Cognitive behaviour therapy for the chronic fatigue syndrome: a randomized controlled trial. BMJ. 1996;312:22-6. [PubMed ID: 8555852]

4. Fulcher KY, White PD. Randomised controlled trial of graded exercise in patients with the chronic fatigue syndrome. BMJ. 1997;314:1647-52. [PubMed ID: 9180065]

5. Wearden AJ, Morriss RK, Mullis R, et al. Randomised double-blind, placebo-controlled treatment trial of fluoxetine and graded exercise for chronic fatigue syndrome. Br J Psychiatry. 1998;172:485-90. [PubMed ID: 9828987]

6. Sharpe M. Rehabilitative treatments for CFS: cognitive behavioural and graded exercise therapies. Baillieres Clinical Psychiatry. 1997;3:511-536. [No PMID]

7. Chambers D, Bagnall AM, Hempel S, Forbes C.Interventions for the treatment, management and rehabilitation of patients with chronic fatigue syndrome/myalgic encephalomyelitis: an updated systematic review. J R Soc Med. 2006;99:506-20. [PubMed ID: 17021301]

8. Whiting P, Bagnall AM, Sowden AJ, et al.Interventoins for the treatment and management of chornic fatigue syndrome: a systematic review. JAMA. 2001;286:1360-8. [PubMed ID: 11569542]

9. Stulemeijer M, de Jong LW, Fiselier TJ, Hoogveld SW, Bleijenberg G. Cognitive behaviour therapy for adolescents with chornic fatigue syndrome: randomised controlled trial. BMJ . 2005;330:14. [PubMed ID: 15585538]