Efficacy of a mindfulness-based intervention programme with and without virtual reality support to reduce stress in university students: protocol for a randomized controlled pragmatic trial

Abstract Background There is growing concern about mental health problems in university students. For this reason, mindfulness training is becoming increasingly popular in university settings. However, mindfulness-based interventions (MBIs) usually present high attrition rates. This trial aims to evaluate the efficacy of a MBI to reduce perceived stress and to improve the psychological well-being of university students, as well as to explore the capacity of virtual reality (VR) to enhance adherence to the intervention. Methods This study protocol presents a randomized controlled trial (RCT) involving assessment time points of baseline, posttreatment and 6-month follow-up. A total of 280 students from the Spanish National Distance Education University (UNED) or the University of Zaragoza will be randomly assigned to a mindfulness condition, a mindfulness condition complemented by VR, and a relaxation condition to serve as a control group. Stress will be the main outcome and will be measured using the 10-item self-report Perceived Stress Scale (PSS). Other well-being and academic functioning outcomes will be assessed, as well as variables that explore the impact of VR. Multilevel mixed-effects models will be calculated to estimate the efficacy of the programme, and effect size estimations will be carried out. Effects of VR in adherence to programme will be evaluated. Discussion Some strengths of this study are the RCT design, which includes a suitable active control group and a 6-month follow-up assessment; a large sample size of university students at different stages of their courses and a variety of degrees; and the incorporation of the VR support to facilitate completion of the MBI programme. Potential limitations are the voluntary participation of the students and the utilization of self-report measures. Trial registration number ClinicalTrials.gov NCT03771300.