Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
174 participants
INTERVENTIONAL
2023-11-02
2027-12-31
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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Mindfulness-Based Health Care Program (MBHC).
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).
Mindfulness program
Six weeks mindfulness program. The program is explained in arm descriptions.
Mindfulness-Based Health Care program with virtual reality (MBHC-VR).
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.
Mindfulness program with Virtual Reality
Six weeks mindfulness program. The program is explained in arm descriptions.
Waiting list control group (WL).
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.
No interventions assigned to this group
Interventions
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Mindfulness program
Six weeks mindfulness program. The program is explained in arm descriptions.
Mindfulness program with Virtual Reality
Six weeks mindfulness program. The program is explained in arm descriptions.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Universidad Complutense de Madrid
OTHER
Universidad Miguel Hernandez de Elche
OTHER
Responsible Party
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ALICIA SANCHEZ PEREZ
Associate Professor of Occupational Therapy
Principal Investigators
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Alicia Sánchez Pérez, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Universidad Miguel Hernández- Facultad de Medicina
Locations
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Alicia Sánchez Pérez
Sant Joan d'Alacant, Alicante, Spain
Countries
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Central Contacts
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Facility Contacts
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Alicia Sánchez Pérez, PhD
Role: primary
References
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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.
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.
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 Apr 26.
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.
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.
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.
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.
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.
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.
Lillo-Navarro C, Fernandez-Pires P, Benavides Gil G, Martinez-Zaragoza F, Chaves C, Roca P, Peral-Gomez P, Gonzalez Valero ME, Mendialdua Canales D, Poveda Alfaro JL, Goldin PR, Sanchez-Perez A. Effects of a mindfulness-based program on the occupational balance and mental health of university students. Protocol for a randomized controlled trial. PLoS One. 2024 May 2;19(5):e0302018. doi: 10.1371/journal.pone.0302018. eCollection 2024.
Other Identifiers
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Mind02UMH
Identifier Type: -
Identifier Source: org_study_id