NCT03771300

Efficacy of a MBI Programme With or Without Virtual Reality Support to Reduce Stress in University Students

Completed NA Last updated 9 April 2020

What this trial tests

NA trial testing Mindfulness in Mental Health Wellness 1 in 280 participants. Completed in 20 December 2019.

Timeline

23 November 2018

Primary endpoint
1 October 2019

20 December 2019

Quick facts

Lead sponsor	Javier Garcia Campayo
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	prevention
Enrollment	280
Start date	23 November 2018
Primary completion	1 October 2019
Estimated completion	20 December 2019
Sites	1 location across Spain

Drugs / interventions tested

• Mindfulness
• Mindfulness condition complemented by VR
• Relaxation

Conditions studied

• Mental Health Wellness 1 — all drugs for Mental Health Wellness 1 →

Sponsor

Javier Garcia Campayo

Who can join

18 and older, any sex, with Mental Health Wellness 1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

There is a growing concern about mental health problems of university students. Stress, anxiety, and depression are reported to be common in this population. For this reason, mindfulness training is becoming increasingly popular in university contexts. This randomized controlled trial (RCT) pretends to evaluate the efficacy of a mindfulness-based intervention (MBI) to reduce levels of perceived stress and to improve the psychological well-being of university students. Besides, in response to the interest of young people for new technologies, this trial also pretends to explore the capacity of Virtual Reality (VR) to help adherence to the programme.

This study protocol presents an RCT, involving the assessment time points of baseline, post-intervention and six-month follow-up. A total of 280 students of the University of Zaragoza or National Distance Education University (UNED), in Spain, will be randomized to joining a mindfulness condition, a mindfulness condition complemented by VR environments, or a relaxation condition (active control group). Perceived 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 also be assessed, as well as variables to 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 the programme will be evaluated.

Some strengths of this study are the RCT study design, which includes a suitable active control group and a 6-month follow up measurement, the large sample size of university students at different stages and degrees, and the incorporation of the VR support to facilitate completion to the programme with the possibility of differential analyses. Potential limitations of this study are the voluntary participation of the students, and the utilization of self-report measures exclusively.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Efficacy of a mindfulness-based programme with and without virtual reality support to reduce stress in university students: A randomized controlled trial.
   Modrego-Alarcón M, López-Del-Hoyo Y, García-Campayo J, Pérez-Aranda A, et al · · 2021 · cited 25× · PMID 33957506 · DOI 10.1016/j.brat.2021.103866
2. 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
   Modrego-Alarcón M, Navarro-Gil MT, Beltrán-Ruiz M, Monreal-Bartolomé A, et al · · 2021 · DOI 10.21203/rs.2.12892/v2