BACKGROUND: Evidence for effective interventions to prevent long-term sequelae after concussion is sparse. This study aimed to test the efficacy of Get going After concussIoN (GAIN), an interdisciplinary, individually-tailored intervention of 8 weeks duration based on gradual return to activities and principles from cognitive behavioural therapy. METHOD(S): We conducted an open-label, parallel-group randomised trial in a hospital setting in Central Denmark Region. Participants were 15 to 30-year-old patients with high levels of post-concussion symptoms (PCS) 2 to 6 months post-concussion (ie, a score >= 20 on the Rivermead Post-concussion Symptoms Questionnaire (RPQ)). They were randomly assigned (1:1) to either enhanced usual care (EUC) or GAIN+EUC. Masking of participants and therapists was not possible. The primary outcome was change in RPQ-score from baseline to 3-month FU. All analyses were done on an intention-to-treat basis using linear mixed-effects models. This trial is registered with ClinicalTrials.gov number NCT02337101. FINDING(S): Between March 1, 2015, and September 1, 2017, we included 112 patients. Patients allocated to GAIN+EUC (n = 57) reported a significantly larger reduction of PCS than patients allocated to EUC (n = 55) with a mean adjusted difference in improvement of 7.6 points (95% confidence interval (CI) 2.0 to 13.1, p = 0.008), Cohen's d = 0.5 (95% CI 0.1 to 0.9). Number needed to treat for prevention of one additional patient with RPQ >= 20 at 3-month FU was 3.6 (95%CI 2.2 to 11.3). No adverse events were observed. INTERPRETATION(S): Compared with EUC, GAIN+EUC was associated with a larger reduction of post-concussion symptoms at 3-month FU. FUNDING(S): Central Denmark Region and the foundation "Public Health in Central Denmark Region -- a collaboration between municipalities and the region".

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