Clinical trial NCT05929430: Mindfulness in University Students. ATENEU Program
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Occupational Balance
Mental Health Wellness
University Students
Burnout, Student
Keywords: Mindfulness
Occupational Balance
Mental Health
University Students
Burnout Student
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
Collaborators: name: Universidad Complutense de Madrid
First posted: 2023-07-03
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled clinical trial (RCT) with three arms
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Occupational Balance
timeFrame: Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
measure: Change in Anxiety, Depression and Stress
timeFrame: Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
measure: Change in Academic stress
timeFrame: Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
measure: Change in Burnout
timeFrame: Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Secondary outcomes:
measure: Change in Emotional dysregulation
timeFrame: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
measure: Change in Psychological flexibility
timeFrame: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
measure: Change in Mindfulness
timeFrame: Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
measure: Change in Self-compassion
timeFrame: Baseline (1 day), inter-session (one time per day over 42 days, from 1 week until 6 week), immediately post-intervention (6 weeks) and follow-up (18 weeks).
measure: Change in Life Satisfaction
timeFrame: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
measure: Change in Adherence to the Mediterranean Diet
timeFrame: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
measure: Change in Sleep
timeFrame: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
measure: Change in Physical Activity
timeFrame: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
measure: Change in Mental representations
timeFrame: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Other outcomes:
Locations:
city: San Juan De Alicante
country: Spain
facility: Alicia Sánchez Pérez
state: Alicante
Study officials:
affiliation: Universidad Miguel Hernández- Facultad de Medicina
name: Alicia Sánchez Pérez, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Sanchez-Perez A, Mendialdua-Canales D, Hurtado-Pomares M, Peral-Gomez P, Juarez-Leal I, Espinosa-Sempere C, Fernandez-Pires P, Zango-Martin I, Abellan-Miralles I, Lopez-Gonzalez P, Valera-Gran D, Navarrete-Munoz EM. The ATENcion Plena en Enfermedad de Alzheimer (ATENEA-Mindfulness in Alzheimer's Disease) Program for Caregivers: Study Protocol for a Randomized Controlled Trial. Healthcare (Basel). 2022 Mar 15;10(3):542. doi: 10.3390/healthcare10030542.