No evidence of increased gaming-related problems with long-term use of a video game therapeutic: Exploratory endpoint findings from a randomized controlled trial.

Digital therapeutics for mental health often face low patient engagement, which limits their clinical impact. Interventions that deliver treatment using a video game medium may improve engagement and therapeutic efficacy, but the potential emergence of gaming-related problems remains a safety question and a concern among clinical stakeholders. We examined whether long-term adjunctive use of the video game therapeutic Meliora was associated with changes in gaming-related problems in a three-arm randomized controlled trial. Participants were adults with interview-confirmed major depressive disorder without significant gaming or gambling problems at baseline. The intention-to-treat cohort (n = 1001) had a mean age of 33.4 years (SD 9.3), and 64% were female. From baseline to post-intervention (week 12), Game Addiction Scale (GAS-7) scores decreased in the Meliora group (mean change, -0.63 points; 95% CI, -0.91 to -0.34; dz = -0.24; Holm-adjusted p < 0.001), whereas no change was observed in the Sham group, which used a highly similar video game therapeutic (mean change, -0.02 points; 95% CI, -0.25 to 0.28; dz = -0.01; Holm-adjusted p = 0.900). Between-group analyses showed more negative GAS-7 change in the Meliora group than in the Sham group (adjusted mean difference, -0.19 points; 95% CI, -0.30 to -0.08; d = -0.13; Holm-adjusted p = 0.001), indicating a relatively greater reduction with Meliora, whereas changes were similar between the Meliora and TAU groups (adjusted mean difference = 0.04 points; 95% CI, -0.08 to 0.15; d = 0.03; Holm-adjusted p = 0.509). Intervention usage time, experienced immersion, and their interaction were not significantly associated with changes in GAS-7 scores in either the Meliora or Sham group. Using a ≥ 25% deterioration threshold, deterioration occurred in 10.4% of participants in the Meliora group, 15.3% in the Sham group, and 9.8% in the TAU group, with no statistically significant between-group differences. Complementary per-protocol analyses among participants with greater intervention exposure were consistent with the ITT findings. These findings provide no evidence that long-term use of a video game therapeutic was associated with increased gaming-related problems in appropriately screened patients using interventions with safeguards against excessive use.