Cognitive behaviour therapy for the chronic fatigue syndrome: a randomised controlled trial, 1996, Sharpe et al.

Chandelier

Senior Member (Voting Rights)
Cognitive behaviour therapy for the chronic fatigue syndrome: a randomised controlled trial

Sharpe, Michael; Hawton, Keith; Simkin, Sue; Surawy, Christina; Hackmann, Ann; Klimes, Ivana; Peto, Tim; Warrell, David; Seagroatt, Valerie

Abstract​

Objective: To evaluate the acceptability and efficacy of adding cognitive behaviour therapy to the medical care of patients presenting with the chronic fatigue syndrome.

Design: Randomised controlled trial with final assessment at 12 months.

Setting: An infectious diseases outpatient clinic.

Subjects: 60 consecutively referred patients meeting consensus criteria for the chronic fatigue syndrome.

Interventions: Medical care comprised assessment, advice, and follow up in general practice. Patients who received cognitive behaviour therapy were offered 16 individual weekly sessions in addition to their medical care.

Main outcome measures: The proportions of patients (a) who achieved normal daily functioning (Karnofsky score 80 or more) and (b) who achieved a clinically significant improvement in functioning (change in Karnofsky score 10 points or more) by 12 months after randomisation.

Results: Only two eligible patients refused to participate. All randomised patients completed treatment.
An intention to treat analysis showed that 73% (22/30) of recipients of cognitive behaviour therapy achieved a satisfactory outcome as compared with 27% (8/30) of patients who were given only medical care (difference 47 percentage points; 95% confidence interval 24 to 69).
Similar differences were observed in subsidiary outcome measures.
The improvement in disability among patients given cognitive behaviour therapy continued after completion of therapy.
Illness beliefs and coping behaviour previously associated with a poor outcome changed more with cognitive behaviour therapy than with medical care alone.

Conclusion: Adding cognitive behaviour therapy to the medical care of patients with the chronic fatigue syndrome is acceptable to patients and leads to a sustained reduction in functional impairment.

Web | DOI | PMC | PDF | BMJ
 
The study that wet Prof Sharpe‘s appetite for CBT and GET as described by him in this presentation:
 
Seems like yet another case of claiming efficacy based on the intervention group having a larger share of the participants reach an arbitrary threshold.

That will always happen when one group is expected to have a higher score than another, so it’s a way to guarantee a «positive» result from bias alone.

The correct way to look at it is to compare the differences between the means of the groups, and see if that difference is clinically meaningful. Of course this assumes the trial is adequately controlled and therefore not riddled with bias, which is never the case for CBT trials.

Also notice how some of the outcomes like «days spent in bed» simply measure adherence to the intervention, because that’s what they were told to do.
 
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