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A prospective study was conducted to identify the psychological impact of labelling middle-aged men as having above average risk for coronary heart disease. A second aim was to find out the psychological effect of participation in a subsequent clinical trial.5813 men attended nine special screening clinics in England and Scotland for baseline measurement of psychological symptoms and coronary disease risk factors. Each man was later informed of his risk status by letter as either above average risk (high-risk) or no special risk (low-risk). In three clinics some men also received an intermediate risk (moderate-risk) between high-risk and low-risk. Follow-up psychological measurements were made after labelling and 3 months later.Men who received either the high-risk label (n=838) or the low-risk label (n=3114) showed a decrease in reported psychological symptoms after labelling. Men receiving the unexpected intermediate risk (moderate-risk) label, which communicated specific test abnormalities, increased their psychological symptoms to 'case' levels on the General Health Questionnaire; relative risk (compared with low-risk) was 1.80 (95% confidence interval 1.19-2,71) after adjustment for confounding factors. Compliers with a subsequent clinical trial decreased their risk of becoming cases and, if ill at trial entry, increased their case remission rate.The ascription of an 'above average risk' label for coronary disease to middle-aged men does not adversely affect the psychological state of those who receive it if they have received preparation for risk labelling. However, communicating abnormal coronary disease test results without adequate preparation confers short-term psychological harm. Nonspecific support from familiar general practice professionals received by participants in a clinical trial reduces the risk of psychological ill-health. All coronary disease screening programmes should include adequate pre-labelling preparation for all risk labels and abnormal results.