Mindfulness in University Students. ATENEU Program

Mental Health Wellness Clinical Trial

— ATENEU  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05929430
• Other study ID #: Mind02UMH
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2023
• Est. completion date: December 2027

Study information

• Verified date: November 2023
• Source: Universidad Miguel Hernandez de Elche
• Contact: Alicia Sánchez Pérez, Ph.D
• Phone: 654486081
• Email: alicia.sanchez[@]umh.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 174
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Burnout, Psychological
• Burnout, Student
• Mental Health Wellness
• Occupational Balance
• University Students

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Spain	Alicia Sánchez Pérez	San Juan De Alicante	Alicante

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Miguel Hernandez de Elche	Universidad Complutense de Madrid

Country where clinical trial is conducted

Spain, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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).
Primary	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	Change in Emotional dysregulation	Difficulties in Emotional Regulation Scale (DERS) contains 28 items grouped into 5 subscales: Attention-Inattention, Clarity-Confusion, Acceptance-Rejection, Functioning-Interference, and Regulation-Discontrol. These items are scored on a Likert-type scale from 1 (almost never) to 5 (almost always). Higher scores indicate greater difficulties in emotion regulation.	Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Secondary	Change in Psychological flexibility	Acceptance and Action Questionnaire II (AAQ-II) consists of 7 items to which participants respond on a 7-point Likert-type scale from 1 (never true) to 7 (always true). Scores range from 7 to 49. Higher scores indicate a tendency to act on the need to control or avoid aversive thoughts, memories, or feelings.	Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Secondary	Change in Mindfulness	Five Facets of Mindfulness Questionnaire Short-Form (FFMQ-SF) contains 24 items that assess the five facets of mindfulness: observing, describing, acting with awareness, non-judgement of inner experience, and non-reactivity to inner experience. It is scored on a Likert-type scale from 1 (never or very rarely true) to 5 (very often or always true). Higher scores indicate a greater capacity for mindfulness. 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	Change in Self-compassion	Self-Compassion Scale short form (SCS-SF) consists of 12 items assessing 6 factors: Self-Kindness, Self-Judgment, Common Humanity, Isolation, Mindfulness, and Over-identification. Each item can be rated on a Likert-type scale from 1 (almost never) to 5 (almost always). Higher scores indicate greater self-compassion. 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	Change in Life Satisfaction	Satisfaction with Life Scale (SLS) is composed of 5 items with a 7-point Likert-type scale (from 1, strongly disagree; to 7, strongly agree). The score ranges from 5 to 35, with higher scores indicating greater satisfaction.	Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Secondary	Change in Adherence to the Mediterranean Diet	Mediterranean Diet Adherence Test is a brief dietary assessment instrument consisting of a set of 14 short questions whose evaluation is intended to provide information on adherence to the Mediterranean Diet pattern. This questionnaire scores one point per question, with a score of <9 meaning low adherence and a score of >=9 meaning good adherence.	Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Secondary	Change in Sleep	Insomnia Severity Index (ISI) is a 5-item self-report instrument that assesses the severity of the sleep problem, the degree of dissatisfaction and the impact on quality of life. Scores range from 0 (best score) to 28 (worst score).	Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Secondary	Change in Physical Activity	International Physical Activity Questionnaire (IPAQ-SF) is a self-administered questionnaire consisting of 7 items that assesses the time spent being physically active in the last 7 days.	Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).
Secondary	Change in Mental representations	Plymouth Sensory Imagery Questionnaire (Psi-Q) consists of 21 items measuring 7 sensory modalities: vision, sound, smell, taste, touch, bodily sensation and emotions. The questionnaire has a Likert-type scale between 1 (no imagery) and 7 (perfectly clear and as vivid as the actual experience).	Baseline (1 day), immediately post-intervention (6 weeks) and follow-up (18 weeks).