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Recruiting NCT05929430

Mindfulness in University Students. ATENEU Program

No phase Interventional Occupational Balance Mental Health Wellness University Students Burnout, Student

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mindfulness program, Mindfulness program with Virtual Reality.
Who it may be relevant to
Registry conditions: Occupational Balance, Mental Health Wellness, University Students, Burnout, Student. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Change in Occupational Balance [Time frame: 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).]
  • Change in Anxiety, Depression and Stress [Time frame: 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).]
  • Change in Academic stress [Time frame: 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).]
  • Change in Burnout [Time frame: 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 outcome measures (9)
  • Change in Emotional dysregulation [Time frame: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).]
  • Change in Psychological flexibility [Time frame: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).]
  • Change in Mindfulness [Time frame: 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).]
  • Change in Self-compassion [Time frame: 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).]
  • Change in Life Satisfaction [Time frame: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).]
  • Change in Adherence to the Mediterranean Diet [Time frame: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).]
  • Change in Sleep [Time frame: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).]
  • Change in Physical Activity [Time frame: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).]
  • Change in Mental representations [Time frame: Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Prevention

Study locations

Spain · 1 center
  • Alicia Sánchez Pérez — Sant Joan d'Alacant

Publications

  • Sheldon E, Simmonds-Buckley M, Bone C, Mascarenhas T, Chan N, Wincott M, Gleeson H, Sow K, Hind D, Barkham M. Prevalence and risk factors for mental health problems in university undergraduate students: A systematic review with meta-analysis. J Affect Disord. 2021 May 15;287:282-292. doi: 10.1016/j.jad.2021.03.054. Epub 2021 Mar 26. PMID 33812241
  • Yusoff MS, Abdul Rahim AF, Yaacob MJ. Prevalence and Sources of Stress among Universiti Sains Malaysia Medical Students. Malays J Med Sci. 2010 Jan;17(1):30-7. PMID 22135523
  • Modrego-Alarcon M, Lopez-Del-Hoyo Y, Garcia-Campayo J, Perez-Aranda A, Navarro-Gil M, Beltran-Ruiz M, Morillo H, Delgado-Suarez I, Olivan-Arevalo R, Montero-Marin J. Efficacy of a mindfulness-based programme with and without virtual reality support to reduce stress in university students: A randomized controlled trial. Behav Res Ther. 2021 Jul;142:103866. doi: 10.1016/j.brat.2021.103866. Epub 2021 PMID 33957506
  • Dhas BN, Wagman P. Occupational balance from a clinical perspective. Scand J Occup Ther. 2022 Jul;29(5):373-379. doi: 10.1080/11038128.2020.1865450. Epub 2020 Dec 31. PMID 33382004
  • Regehr C, Glancy D, Pitts A. Interventions to reduce stress in university students: a review and meta-analysis. J Affect Disord. 2013 May 15;148(1):1-11. doi: 10.1016/j.jad.2012.11.026. Epub 2012 Dec 13. PMID 23246209
  • Levit-Binnun N, Arbel K, Dorjee D. The Mindfulness Map: A Practical Classification Framework of Mindfulness Practices, Associated Intentions, and Experiential Understandings. Front Psychol. 2021 Oct 12;12:727857. doi: 10.3389/fpsyg.2021.727857. eCollection 2021. PMID 34712178
  • Shapiro SL, Carlson LE, Astin JA, Freedman B. Mechanisms of mindfulness. J Clin Psychol. 2006 Mar;62(3):373-86. doi: 10.1002/jclp.20237. PMID 16385481
  • Dawson AF, Brown WW, Anderson J, Datta B, Donald JN, Hong K, Allan S, Mole TB, Jones PB, Galante J. Mindfulness-Based Interventions for University Students: A Systematic Review and Meta-Analysis of Randomised Controlled Trials. Appl Psychol Health Well Being. 2020 Jul;12(2):384-410. doi: 10.1111/aphw.12188. Epub 2019 Nov 19. PMID 31743957

Identifiers

NCT: NCT05929430 · Mind02UMH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗