Objectives: To measure the psychosocial consequences in the Danish lung cancer screening trial (DLCST)and compare those between the computed tomography (CT) group and the control group.

Materials and methods: This study was a single centre randomised controlled trial with five annual screening rounds. Healthy current or former heavy smokers aged 50–70 years (men and women) were randomised 1:1 to a CT group and a control group. Heavy smokers were defined by having smoked ≥20pack years and former smokers by being abstinent ≤10 years. Both groups were invited annually to the screening clinic to complete the validated lung-cancer-specific questionnaire consequences of screening lung cancer (COS-LC). The CT group was also offered a low dose CT scan of the lungs. The COS-LC measures nine scales with psychosocial properties: Anxiety, Behaviour, Dejection, Negative impact on sleep, Self-blame, Focus on Airway Symptoms, Stigmatisation, Introvert, and Harm of Smoking.

Results: 4104 participants were randomised to the DLCST and the COS-LC completion rates for the CT group and the control group were 95.5% and 73.6%, respectively. There was a significant increase in negative psychosocial consequences from baseline through rounds 2–5 for both the CT group and the control group (mean increase >0, p < .0001 for 3 of 4 possible scales). During rounds 2–5 the control group experienced significantly more negative psychosocial consequences in seven of nine scales compared with the CTgroup (mean score >0 and p < .033).

Conclusions: Lung cancer CT-screening trials induced more negative psychosocial reactions in both the CT group and the control group compared with the baseline psychosocial profile. The CT group experienced less negative psychosocial consequences compared with the control group, which might be explained by reassurance among those with normal screening results.

Trial registration: ClinicalTrials.gov: NCT00496977.