Randomized Controlled Trial of Mindfulness - Based Intervention For Student Depression, Anxiety and Stress: Observations on a Disrupted Campus.

BACKGROUND: Background: University students are experiencing higher levels of distress and mental health disorders. In addressing mental health needs, web-based interventions have shown increasing promise to overcome geographic distances and high student-to-counselor ratios, leading to the potential for wider implementation. The Mindfulness Virtual Community (MVC) program, a web based program, guided by mindfulness and cognitive behavioural therapy principles, is among efforts aimed at effectively and efficiently reducing symptoms of depression, anxiety, and perceived stress in students. OBJECTIVE: Objective: This study's aim was to evaluate the efficacy of an 8-week MVC program in reducing depression, anxiety, and perceived stress (primary outcomes), and improving mindfulness (secondary outcome) in undergraduate students at a large Canadian university. Guided by two prior randomized controlled trials (RCTs) that each demonstrated efficacy when conducted during regular university operations, the current study coincided with a university-wide labour strike. Nonetheless, the students' response to an online mental health program on a disrupted campus can provide useful information for anticipating the impact of other disruptions, including those related to COVID-19, currently and in a foreseeable future. METHODS: Methods: In this parallel arm randomized controlled trial (RCT), 154 students were randomly allocated to an 8-week MVC intervention (n= 76) or a waitlist control (WLC) condition (n= 78). The MVC intervention included (1) educational and mindfulness video modules, (2) anonymous peer-peer discussions, and (3) anonymous, group-based, professionally-guided, 20-min videoconferences. Study outcomes were evaluated at baseline and at 8-week follow-up using: Patient Health Questionnaire-9 (PHQ-9), the Beck Anxiety Inventory (BAI), the Perceived Stress Scale (PSS), and the Five Facets Mindfulness Questionnaire Short Form (FFMQ-SF). Generalized estimation equations with an AR(1) covariance structure were used to evaluate the impact of intervention, with outcome evaluations performed on both an intention to treat (ITT) and per protocol (PP) basis. RESULTS: Results: Participants (n= 154) included 35 males and 117 females with a mean age of 23.1 years. There were no statistically significant differences at baseline between MVC and WLC on demographics and psychological characteristics, indicating similar demographic and psychological characteristics across the MVC-WLC groups. Results under both ITT and PP approaches indicated that except for PSS (ITT: s= -2.31, P= .03; PP: s= -2.38, P= .03), there were no statistically significant between group differences in PHQ-9 (ITT: s= -0.44, P= 0.64; PP: s= -0.62, P= .053), BAI (ITT: s= -2.06, P= .31; PP: s= -2.32, P= .27), and FFMQ-SF (ITT: s= 1.33, P= .43; PP: s= 1.44, P= .41) compared to WLC. CONCLUSIONS: Conclusions: During a university labour strike, the MVC program led to statistically significant reductions in PSS compared to WLC, but no other significant between group differences. Comparisons with previous cycles of intervention testing, undertaken during non-disrupted university operations, when efficacy was demonstrated, are discussed. CLINICALTRIAL: Trial Registration: International Standard Randomized Controlled Trial Number ISRCTN92827275; https://www.isrctn.com/ISRCTN92827275.