A mindfulness-based intervention to increase resilience to stress in university students (the Mindful Student Study): a pragmatic randomised controlled trial

Background More young people are going to university, but there is concern about an increasing demand for student mental health services. We designed a pragmatic randomised controlled trial to test the hypothesis that providing mindfulness courses to university students would promote their resilience to stress. Methods University of Cambridge students without severe mental illness or crisis (self-assessed) were remotely randomised to join an 8-week mindfulness course adapted for university students (MSS), or to mental health support as usual (SAU). The primary outcome was self-reported psychological distress during the examination period measured using the Clinical Outcomes in Routine Evaluation Outcome Measure. Main outcome intention-to-treat analysis was masked to allocation. Trial registration: ACTRN12615001160527 (complete). Findings In total, 616 students were randomised (circa 3% of all students; 309 to MSS, 307 to SAU); 74% completed the primary outcome measure; 65% of the MSS arm participants completed at least half of the MSS course. MSS reduced distress scores during the exam period compared with SAU (β=-0.44, 95%CI -0.60 to -0.29; p < 0.0001); 57% of SAU participants had distress scores above an accepted clinical threshold level compared with 37% of MSS participants. On average, six students needed to be offered the MSS course to prevent one from experiencing clinical levels of distress (number needed to treat 6, 95%CI 4 to 10). SAU distress worsened over the year whereas MSS scores improved after the course and were maintained during exams. Active monitoring revealed no adverse reactions related to self-harm, suicidality or harm to others. Interpretation The main limitation of this trial is the lack of control for non-specific effects. However, the provision of mindfulness training appears an effective component of a wider student mental health strategy. Funding University of Cambridge and NIHR Collaboration for Leadership in Applied Health Research and Care East of England.University of Cambridge and National Institute for Health Research Collaboration for Leadership in Applied Health Research and Care East of England