Mindfulness in University Students. ATENEU Program

Miguel Hernández University of Elche

Status: Enrolling

Conditions: Burnout, Student; Occupational Balance; Mental Health Wellness; University Students

Treatments: Behavioral: Mindfulness program; Behavioral: Mindfulness program with Virtual Reality

Study type: Interventional

Funder types: Other

Identifiers

NCT05929430

Mind02UMH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 174 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• being 18 years old or older
• being a degree, master or doctorate student at Miguel Hernández University
• speaking fluent Spanish
• signing the informed consent form
• having attended at least 4 of the 6 sessions (66% of the program)
• internet access from a computer or smartphone to complete the online assessments and formal practices during the program.

Exclusion criteria

• miss more than 2 out of 6 sessions (33% of the program)
• present a severe mental disorder in active phase diagnosed by a health professional (e.g., schizophrenia, bipolar disorder)
• are under the influence of alcohol or other drugs during sessions and/or assessments (determined by the program instructor)
• participate in another standardized meditation program during the study period
• withdrew before starting the intervention.
• Additionally, should any participants require psychological or psychiatric treatment during the study, they will be excluded and referred to specialized care services.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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174 participants in 3 patient groups

Mindfulness-Based Health Care Program (MBHC).

Experimental group

Description:

Mindfulness skills will take over a 6-week period. Mindfulness skills will deliver in a weekly group format. Participants will be instructed to follow mindfulness practice at home. The program is focused on cultivating mindfulness of present-moment, cultivating a nonreactive, nonjudgmental attitude toward the experience, and includes specific formal and informal practices aimed at cultivating healthy habits and lifestyle (e.g., activities of daily living such as feeding, bathing, or showering and other occupations such as communication management, health management, etc.; and prosocial components (e.g., kindness and compassion).

Treatment:

Behavioral: Mindfulness program

Mindfulness-Based Health Care program with virtual reality (MBHC-VR).

Experimental group

Description:

This program combines mindfulness practice with immersion in a virtual environment. The content and objectives of MBHC-VR program are the same that MBHC, with the main difference being that all formal practices of each session will be performed using VR.

Treatment:

Behavioral: Mindfulness program with Virtual Reality

Waiting list control group (WL).

No Intervention group

Description:

Participants in the WL control group will not receive any intervention during the study. However, for ethical reasons, at the end of the 3-month follow-up assessment, participants of this WL control group will be invited to participate in the MBHC program free of charge.