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Objective: To examine the additional effect of cognitive behavioural therapy for patients with medically unexplained physical symptoms in comparison with optimized medical care. Design: Randomized controlled trial with follow-up assessments. Setting: General Medical Outpatient Clinic, University Hospital, Leiden, the Netherlands. Methods: The study population consisted of an intervention group of 39 and a control group of 40 patients. The treatment group received between 6 and 16 sessions of cognitive behavioural therapy. The control group received optimized general medical care. The main outcome measures involved the degree of change, frequency and intensity of the presenting symptoms, psychological distress, functional impairment, hypochondriac beliefs and attitudes and, 6 months after treatment, number of visits to the general practitioner. Results: After 6 months' intervention, the intervention group reported a higher recovery rate (odds ratio (OR): 0.40; 95% confidence interval (95% CI): 0.16 to 1.00), a lower mean intensity of the physical symptoms (mean difference (MD): -1.2; 95% CI: -2.0 to -0.3) and less impairment of sleep (OR: 0.38; 95% CI: 0.15 to 0.94) than the control group. After adjusting for coincidental baseline differences, the intervention and control groups also differed with regard to frequency of the symptoms (OR: 0.32; 95% CI: 0.13 to 0.77), limitations in social (OR: 0.35: 95% CI: 0.14 to 0.85) and leisure activities (OR: 0.36; 95% CI: 0.14 to 0.93) and illness behaviour (MD: -2.5: 95% CI: -4.6 to -0.5). 6 months later the differences between the intervention group and the control group were largely maintained. Conclusion: Cognitive behavioural therapy appears to be a feasible and effective treatment in general medical patients with unexplained physical symptoms.


Journal article


Nederlands Tijdschrift voor Geneeskunde

Publication Date





1227 - 1232