NCT05929430

Mindfulness in University Students. ATENEU Program

Effects of a Mindfulness Program on the Occupational Balance and Mental Health of University Students. Protocol for a Randomized Controlled Trial Study. ATENEU Program (Mindfulness in University Students)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 174 (estimated)
• Sponsor: Universidad Miguel Hernandez de Elche · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study aims to examine the effects of a mindfulness-based intervention and a mindfulness-based intervention with virtual reality on occupational balance and on the reduction of psychological distress in university students (i.e. stress, anxiety and depression). The specific objectives will be to examine the effects of the intervention on other variables related to mental health, psychological functioning and occupations, and their maintenance at three months.

Detailed description

The college student population is considered at high risk for developing mental health problems with the prevalence of depression being 34%, anxiety 32%, and sleep disorders 33% post-pandemic. This psychological distress affects students worldwide and is linked to poor academic performance and the presence of health risk behaviors such as substance use or suicide. Addressing student mental health is an urgent research priority. As such, a growing number of universities are offering interventions aimed at students, including MBI or mindfulness which is defined as the ability to pay attention to present moment experience with interest, curiosity, and acceptance MBI has been shown to have beneficial effects in students but the level of adherence to the program is low. One of the possible solutions could be the incorporation of virtual reality (VR) due to the high affinity of this population with new technologies and the increase in its frequency of use in neurorehabilitation and clinical psychology. Objectives: The study aims to examine the effects of a mindfulness-based intervention and a mindfulness-based intervention with virtual reality on occupational balance and on the reduction of psychological distress in university students (i.e. stress, anxiety and depression). The specific objectives will be to examine the effects of the intervention on other variables related to mental health, psychological functioning and occupations, and their maintenance at three months. Methodology: Single-blind, 3-arm randomized clinical trial (RCT): traditional MBI, MBI with VR, passive control group (waiting list), with 4 evaluation moments: pre-intervention, inter-session, post-intervention and follow-up. Participants will be undergraduate, master and doctoral students of the Miguel Hernández University of Elche, Alicante. Intervention: Mindfulness-Based Intervention, Mindfulness-Based Intervention with virtual reality and Control group. Variables and instruments: This study will be carried out with mixed methodology. The quantitative part will be carried out by means of ad hoc questionnaires and measurement instruments adapted and validated in Spain, and by means of EMA (Ecological Momentary Assessment). The qualitative part will be conducted through Focus Groups.

Conditions

• Occupational Balance
• Mental Health Wellness
• University Students
• Burnout, Student

Interventions

Type	Name	Description
BEHAVIORAL	Mindfulness program	Six weeks mindfulness program. The program is explained in arm descriptions.
BEHAVIORAL	Mindfulness program with Virtual Reality	Six weeks mindfulness program. The program is explained in arm descriptions.

Timeline

• Start date: 2023-11-02
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2023-07-03
• Last updated: 2024-12-24

Locations

1 site across 1 country: Spain