Mindfulness in University Students. ATENEU Program

NCT05929430 | Recruiting

• 1 other identifier: Mind02UMH
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Mindfulness; Occupational Balance; Mental Health; University Students; Burnout Student

Outcome Measures

Primary Outcomes (4)

• Change in Occupational Balance

  Occupational Balance Questionnaire (OBQ) is a brief 13-item tool scored on a 6-point Likert-type response scale, ranging from 0 (strongly disagree) to 5 (strongly agree), with a total score ranging from 0 to 65, where a higher score indicates greater occupational balance. A question from the Ecological Momentary Assessment questionnaire will also be used to evaluate this variable in the inter-session 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

  Anxiety, Depression and Stress Scale (DASS 21) consists of 21 items, 7 items for each subscale: DASS-D (depression), DASS-A (anxiety) and DASS-S (stress). Participants are asked to rate the degree to which this statement has happened to them in the past week on a scale from 0 (has not happened to me) to 3 (has happened to me a lot or most of the time). A question from the Ecological Momentary Assessment questionnaire will also be used to evaluate this variable in the inter-session 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

  SISCO Inventory which consists of 31 items distributed into: 1 filter item (yes-no), 1 item on a Likert-type scale from 1 (a little) to 5 (a lot), 8 items on a Likert-type scale from 1 (never) to 5 (always) that allow identifying stressful stimuli, 15 items on a Likert-type scale from 1 (never) to 5 (always) allowing to identify stressful stimuli divided into physical, psychological and behavioural reactions and 6 items on a Likert-type scale from 1 (never) to 5 (always) allowing to identify the frequency of use of coping strategies. A question from the Ecological Momentary Assessment questionnaire will also be used to evaluate this variable in the inter-session 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

  Maslach Burnout Inventory-Student Survey Questionnaire (MBI-SS). The MBI-SS contains 15 items grouped into 3 subscales: Emotional Exhaustion (5 items), Cynicism (4 items), and Academic Efficacy (6 items). These items are scored on a scale from 0 (never/never) to 6 (always/every day). High scores on burnout and cynicism and low scores on academic efficacy are indicative of burnout. A question from the Ecological Momentary Assessment questionnaire will also be used to evaluate this variable in the inter-session 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 Outcomes (9)

• Change in Emotional dysregulation

  Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).

• Change in Psychological flexibility

  Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).

• Change in Mindfulness

  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

  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

  Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).

Study Arms (3)

Mindfulness-Based Health Care Program (MBHC).

EXPERIMENTAL

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).

Behavioral: Mindfulness program

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

EXPERIMENTAL

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.

Behavioral: Mindfulness program with Virtual Reality

Waiting list control group (WL).

NO INTERVENTION

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.

Interventions

Mindfulness program BEHAVIORAL

Six weeks mindfulness program. The program is explained in arm descriptions.

Mindfulness-Based Health Care Program (MBHC).

Mindfulness program with Virtual Reality BEHAVIORAL

Six weeks mindfulness program. The program is explained in arm descriptions.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead
• Universidad Complutense de Madrid: collaborator

Study Sites (1)

Alicia Sánchez Pérez

Sant Joan d'Alacant, Alicante, 03550, Spain

RECRUITING

Related Publications (10)

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 33957506 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 35327020 BACKGROUND

• 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.

  PMID: 38696406 DERIVED

MeSH Terms

Conditions

Burnout, Psychological; Psychological Well-Being

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Personal Satisfaction

Study Officials

• Alicia Sánchez Pérez, Ph.D

  Universidad Miguel Hernández- Facultad de Medicina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alicia Sánchez Pérez, Ph.D

CONTACT

654486081; alicia.sanchez@umh.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Members of the research team who are not involved in the assessments and implementation of the intervention will be responsible for the random sequence and data analysis.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Occupational Therapy

Model Details: A randomized controlled clinical trial (RCT) with three arms

Study Record Dates

• First Submitted: May 26, 2023
• First Posted: July 3, 2023
• Study Start: November 2, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)