BACKGROUND: Evidence-based treatment of depression continues to grow, but successful treatment and maintenance of treatment response remains limited. AIMS: To compare the effectiveness of exercise, internet-based cognitive-behavioural therapy (ICBT) and usual care for depression. METHOD: A multicentre, three-group parallel, randomised controlled trial was conducted with assessment at 3 months (post-treatment) and 12 months (primary end-point). Outcome assessors were masked to group allocation. Computer-generated allocation was performed externally in blocks of 36 and the ratio of participants per group was 1:1:1. In total, 945 adults with mild to moderate depression aged 18 to 71 years were recruited from primary healthcare centres located throughout Sweden. Participants were randomly assigned to one of three 12-week interventions: supervised group exercise, clinician-supported ICBT or usual care by a physician. The primary outcome was depression severity assessed by the Montgomery-Asberg Depression Rating Scale (MADRS). RESULTS: The response rate at 12-month follow-up was 84%. Depression severity reduced significantly in all three treatment groups in a quadratic trend over time. Mean differences in MADRS score at 12 months were 12.1 (ICBT), 11.4 (exercise) and 9.7 (usual care). At the primary end-point the group x time interaction was significant for both exercise and ICBT. Effect sizes for both interventions were small to moderate. CONCLUSIONS: The long-term treatment effects reported here suggest that prescribed exercise and clinician-supported ICBT should be considered for the treatment of mild to moderate depression in adults.

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