COGNITIVE-BEHAVIOR THERAPY FOR THE CHRONIC FATIGUE SYNDROME - A RANDOMIZED CONTROLLED TRIAL

Objective-To evaluate the acceptability and efficacy of adding cogniti ve behaviour therapy to the medical care of patients presenting with t he chronic fatigue syndrome. Design-Randomised controlled trial with f inal assessment at 12 months. Setting-An infectious diseases outpatien t clinic. Subjects-60 consecutively referred patients meeting consensu s criteria for the chronic fatigue syndrome. Interventions-Medical car e comprised assessment, advice, and follow up in general practice. Pat ients who received cognitive behaviour therapy were offered 16 individ ual weekly sessions in addition to their medical care. Main outcome me asures-The proportions of patients (a) who achieved normal daily funct ioning (Karnofsky score 80 or more) and (b) who achieved a clinically significant improvement in functioning (change in Karnofsky score 10 p oints or more) by 12 months after randomisation. Results-Only two elig ible patients refused to participate. All randomised patients complete d treatment. An intention to treat analysis showed that 73% (22/30) of recipients of cognitive behaviour therapy achieved a satisfactory out come as compared with 27% (8/30) of patients who were given only medic al care (difference 47 percentage points; 95% confidence interval 24 t o 69). Similar differences were observed in subsidiary outcome measure s. The improvement in disability among patients given cognitive behavi our therapy continued after completion of therapy. illness beliefs and coping behaviour previously associated with a poor outcome changed mo re with cognitive behaviour therapy than with medical care alone. Conc lusion-Adding cognitive behaviour therapy to the medical care of patie nts with the chronic fatigue syndrome is acceptable to patients and le ads to a sustained reduction in functional impairment.