A Three-Armed Randomized Controlled Trial to Evaluate the Effectiveness, Acceptance, and Negative Effects of StudiCare Mindfulness, an Internet- and Mobile-Based Intervention for College Students with No and "On Demand" Guidance.

The college years can be accompanied by mental distress. Internet- and mobile-based interventions (IMIs) have the potential to improve mental health but adherence is problematic. Psychological guidance might promote adherence but is resource intensive. In this three-armed randomized controlled trial, "guidance on demand" (GoD) and unguided (UG) adherence-promoting versions of the seven-module IMI StudiCare Mindfulness were compared with a waitlist control group and each other. The GoD participants could ask for guidance as needed. A total of 387 students with moderate/low mindfulness were recruited. Follow-up assessments took place after 1 (t1), 2 (t2), and 6 (t3) months. Post-intervention (t2), both versions significantly improved the primary outcome of mindfulness ( d = 0.91-1.06, 95% CI 0.66-1.32) and most other mental health outcomes ( d = 0.25-0.69, 95% CI 0.00-0.94) compared with WL, with effects generally persisting after 6 months. Exploratory comparisons between UG and GoD were mostly non-significant. Adherence was low but significantly higher in GoD (39%) vs. UG (28%) at the 6-month follow-up. Across versions, 15% of participants experienced negative effects, which were mostly mild. Both versions effectively promoted mental health in college students. Overall, GoD was not associated with substantial gains in effectiveness or adherence compared with UG. Future studies should investigate persuasive design to improve adherence.