EClinicalMedicine · 2026
Interdisciplinary intervention (GAIN) vs. enhanced usual care for reducing severe post-concussion symptoms in adults 2-4 months post-injury: a stepped wedge cluster randomised controlled trial.
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Hellemose Line Amalie, Thastum Mille Møller, Stabel Henriette Holm, Odgaard Lene, Rask Charlotte Ulrikka, Silverberg Noah D, Skandsen Toril, Rytter Hana Malá, Nygaard Charlotte, Eggertsen Peter Preben, Pedersen Carsten B, Nielsen Jørgen Feldbæk
Аннотация
BACKGROUND: Up to 30% of adults presenting to emergency departments develop persisting post-concussion symptoms (PPCS). Get going After concussIoN (GAIN), has previously shown promising effects in reducing PPCS in adolescents and young adults.
METHODS: This stepped wedge cluster randomised trial tested the effect of GAIN in reducing high levels of PPCS (i.e. a score ≥20 on the Rivermead Post-concussion Symptoms Questionnaire (RPQ)) 2-4 months post-injury in adults (18-60 years). GAIN was delivered in five clusters of municipalities in the Central Denmark Region sequentially allocated to implement the intervention, with one cluster transitioning to deliver GAIN every 3 months over six recruitment periods in the order of a computer-generated randomisation schedule. Participants were allocated to enhanced usual care (EUC) or GAIN + EUC depending on time and their place of residence. Masking of participants and therapists was not feasible. Primary outcome was change in RPQ total score from baseline to 3-month follow-up. Analyses were based on intention to treat using linear-mixed models. The trial is registered with ClinicalTrials.gov, NCT04798885.
FINDINGS: Between May 1, 2021 and November 1, 2022, 310 participants were included. The average difference in change in RPQ score between GAIN + EUC (n = 170) and EUC (n = 140) from baseline to 3-month follow-up was -2.4 points (95% CI -5.4 to 0.4, p = 0.09) in the adjusted model. GAIN reduced maladaptive, symptom-related perceptions and behaviours and patient satisfaction was high. GAIN + EUC was not associated with a greater improvement in psychological distress or physical and mental health than EUC. No serious adverse events were reported.
INTERPRETATION: This study could not confirm the hypothesis that GAIN added to EUC led to a larger long-term reduction in PPCS than EUC alone in adults. However, GAIN may improve long-term prognosis by reducing maladaptive, symptom-related perceptions and behaviours.
FUNDING: The foundation Sygeforsikringen "danmark" and Central Denmark Region.
METHODS: This stepped wedge cluster randomised trial tested the effect of GAIN in reducing high levels of PPCS (i.e. a score ≥20 on the Rivermead Post-concussion Symptoms Questionnaire (RPQ)) 2-4 months post-injury in adults (18-60 years). GAIN was delivered in five clusters of municipalities in the Central Denmark Region sequentially allocated to implement the intervention, with one cluster transitioning to deliver GAIN every 3 months over six recruitment periods in the order of a computer-generated randomisation schedule. Participants were allocated to enhanced usual care (EUC) or GAIN + EUC depending on time and their place of residence. Masking of participants and therapists was not feasible. Primary outcome was change in RPQ total score from baseline to 3-month follow-up. Analyses were based on intention to treat using linear-mixed models. The trial is registered with ClinicalTrials.gov, NCT04798885.
FINDINGS: Between May 1, 2021 and November 1, 2022, 310 participants were included. The average difference in change in RPQ score between GAIN + EUC (n = 170) and EUC (n = 140) from baseline to 3-month follow-up was -2.4 points (95% CI -5.4 to 0.4, p = 0.09) in the adjusted model. GAIN reduced maladaptive, symptom-related perceptions and behaviours and patient satisfaction was high. GAIN + EUC was not associated with a greater improvement in psychological distress or physical and mental health than EUC. No serious adverse events were reported.
INTERPRETATION: This study could not confirm the hypothesis that GAIN added to EUC led to a larger long-term reduction in PPCS than EUC alone in adults. However, GAIN may improve long-term prognosis by reducing maladaptive, symptom-related perceptions and behaviours.
FUNDING: The foundation Sygeforsikringen "danmark" and Central Denmark Region.