Efficacy of a MBI Programme With or Without Virtual Reality Support to Reduce Stress in University Students

NCT03771300 | Completed

• 1 other identifier: FPU15/00598
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief Summary

There is a growing concern about mental health problems of university students. Stress, anxiety, and depression are reported to be common in this population. For this reason, mindfulness training is becoming increasingly popular in university contexts. This randomized controlled trial (RCT) pretends to evaluate the efficacy of a mindfulness-based intervention (MBI) to reduce levels of perceived stress and to improve the psychological well-being of university students. Besides, in response to the interest of young people for new technologies, this trial also pretends to explore the capacity of Virtual Reality (VR) to help adherence to the programme. This study protocol presents an RCT, involving the assessment time points of baseline, post-intervention and six-month follow-up. A total of 280 students of the University of Zaragoza or National Distance Education University (UNED), in Spain, will be randomized to joining a mindfulness condition, a mindfulness condition complemented by VR environments, or a relaxation condition (active control group). Perceived stress will be the main outcome and will be measured using the 10-item self-report Perceived Stress Scale (PSS). Other well-being and academic functioning outcomes will also be assessed, as well as variables to explore the impact of VR. Multilevel mixed-effects models will be calculated to estimate the efficacy of the programme, and effect size estimations will be carried out. Effects of VR in adherence to the programme will be evaluated. Some strengths of this study are the RCT study design, which includes a suitable active control group and a 6-month follow up measurement, the large sample size of university students at different stages and degrees, and the incorporation of the VR support to facilitate completion to the programme with the possibility of differential analyses. Potential limitations of this study are the voluntary participation of the students, and the utilization of self-report measures exclusively.

Conditions

Mental Health Wellness 1

Keywords

Wellness; University students; Mindfulness; Virtual Reality (VR)

Outcome Measures

Primary Outcomes (3)

• Perceived Stress Scale-10 (PSS)

  The Spanish PSS short version provides a reliable and valid measure of perceived stress, with adequate psychometric properties (α = 0.82, test-retest, r = 0.77). Through the PSS, participants are asked to rate on a 5-point Likert-type scale (from 0= "never" to 4= "very often"), how unpredictable, uncontrollable and overloaded have found their life over the past month.

  Baseline

• Perceived Stress Scale-10 (PSS)

  The Spanish PSS short version provides a reliable and valid measure of perceived stress, with adequate psychometric properties (α = 0.82, test-retest, r = 0.77). Through the PSS, participants are asked to rate on a 5-point Likert-type scale (from 0= "never" to 4= "very often"), how unpredictable, uncontrollable and overloaded have found their life over the past month.

  After programme completion at 6 weeks

• Perceived Stress Scale-10 (PSS)

  The Spanish PSS short version provides a reliable and valid measure of perceived stress, with adequate psychometric properties (α = 0.82, test-retest, r = 0.77). Through the PSS, participants are asked to rate on a 5-point Likert-type scale (from 0= "never" to 4= "very often"), how unpredictable, uncontrollable and overloaded have found their life over the past month.

  6-month follow-up

Secondary Outcomes (60)

• State-Trait Anxiety Inventory (STAI)

  Baseline

• State-Trait Anxiety Inventory (STAI)

  After programme completion at 6 weeks

• State-Trait Anxiety Inventory (STAI)

  6-month follow-up

• Emotional Regulation Questionnaire (ERQ)

  Baseline

• Emotional Regulation Questionnaire (ERQ)

  After programme completion at 6 weeks

Study Arms (3)

Mindfulness condition

EXPERIMENTAL

90-minute group sessions, held once a week over a space of 6 weeks, and is offered as an extra-curricular activity.

Behavioral: Mindfulness

Mindfulness condition complemented by VR

EXPERIMENTAL

This condition is equivalent to the mindfulness condition (group sessions, held once a week over a space of 6 weeks and offered as an extra-curricular activity), unlike the time of each session, which is reduced from 90 to 75 minutes of duration.

Behavioral: Mindfulness condition complemented by VR

Relaxation condition

ACTIVE COMPARATOR

90-minute group sessions, held once a week over a space of 6 weeks, and will be offered as an extra-curricular activity.

Behavioral: Relaxation

Interventions

Mindfulness BEHAVIORAL

This program is structured around two central elements, mindfulness and compassion. The sessions combine theory and practice components, using a methodology which priorities the reflection and debate among the students. Regarding theory component, mindfulness and compassion concepts will be set out over the length of the program, in addition to others related to time management, stress, anxiety and the balance between personal life and academic/work life. The practical component of the program consists of mindfulness and self-compassion formal and informal practices under the guidance of a specialized instructor.

Mindfulness condition

Mindfulness condition complemented by VR BEHAVIORAL

The VR is comprised of a Samsung VR goggles, a Samsung Galaxy S6 phone and optional headphones. In this condition, the instructor is the same as previously but the implementation of VR will be carried out by a psychologist specially trained for the application of these VR scenarios. Prior to the VR use, the psychologist will make sure about the participants´ health.

Mindfulness condition complemented by VR

Relaxation BEHAVIORAL

This condition is based on the Progressive Muscle Relaxation.The relaxation program include training 16 muscle groups during the initial sessions, 7 muscle groups during the intermediate sessions, 4 muscle groups later and a only recall relaxation in the final session.This program is complemented with visualizations, as it was originally proposed by Jacobson (1938).

Relaxation condition

Eligibility Criteria

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

You may qualify if:

• Students of the Universities of Zaragoza or National Distance Education (UNED), in Spain.
• Being \> 18 years of age
• Being in undergraduate or master's degree studies in the referred universities,
• Speaking and writing using the Spanish language and
• Providing written consent form.

You may not qualify if:

• Suffering a disease which affects the Central Nervous System (CNS),
• Presenting some psychiatric diagnosis or serious psychiatric illness,
• Consumption of drugs or medication that could affect the CNS and
• Having a disorder or illness that may affect their mood.

Sponsors & Collaborators

• Javier Garcia Campayo: lead

Study Sites (1)

Department of Psychiatry. Miguel Servet University Hospital

Zaragoza, 50009, Spain

Location

Related Publications (16)

• Neff, K. D. Development and validation of a scale to measure self-compassion. Self and Identity, 2, 223-250, 2003.

  BACKGROUND

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  PMID: 6668417 BACKGROUND

• S. Cohen, G. Williamson, Perceived stress in a probability sample of the United States, in: S. Spacapan, S. Oskamp (Eds.), The Social Psychology of Health, Sage, Newbury Park, CA, 1988.

  BACKGROUND

• Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.

  PMID: 3397865 BACKGROUND

• Schaufeli, W. B., Salanova, M., Gonzàlez-Romá, V., & Bakker, A. B. (2002). The measurement of engagement and burnout: A two sample confirmatory factor analytic approach. Journal of Happiness Studies, 3, 71-92. doi:10.1023/A:1015630930326

  BACKGROUND

• Schaufeli WB, Martínez I, Marqués-Pinto A, Salanova M, Bakker A: Burnout and engagement in university students: A cross-national study. Journal of Cross-Cultural Studies. 2002, 33: 464-481.

  BACKGROUND

• Gross JJ, Levenson RW. Emotion elicitation using films. Cogn Emot. 1995 Jan; 9(1):87-108.

  BACKGROUND

• Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.

  PMID: 12703651 BACKGROUND

• Slater M, Usoh M, Steed A. Depth of Presence in Virtual Environments. Presence Teleoperators Virtual Environ. 1994 Jan; 3(2):130-44.

  BACKGROUND

• Navarro-Haro MV, Lopez-Del-Hoyo Y, Campos D, Linehan MM, Hoffman HG, Garcia-Palacios A, Modrego-Alarcon M, Borao L, Garcia-Campayo J. Meditation experts try Virtual Reality Mindfulness: A pilot study evaluation of the feasibility and acceptability of Virtual Reality to facilitate mindfulness practice in people attending a Mindfulness conference. PLoS One. 2017 Nov 22;12(11):e0187777. doi: 10.1371/journal.pone.0187777. eCollection 2017.

  PMID: 29166665 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

• Conley CS, Shapiro JB, Kirsch AC, Durlak JA. A meta-analysis of indicated mental health prevention programs for at-risk higher education students. J Couns Psychol. 2017 Mar;64(2):121-140. doi: 10.1037/cou0000190.

  PMID: 28277730 BACKGROUND

• Gotink RA, Chu P, Busschbach JJ, Benson H, Fricchione GL, Hunink MG. Standardised mindfulness-based interventions in healthcare: an overview of systematic reviews and meta-analyses of RCTs. PLoS One. 2015 Apr 16;10(4):e0124344. doi: 10.1371/journal.pone.0124344. eCollection 2015.

  PMID: 25881019 BACKGROUND

• Khoury B, Lecomte T, Fortin G, Masse M, Therien P, Bouchard V, Chapleau MA, Paquin K, Hofmann SG. Mindfulness-based therapy: a comprehensive meta-analysis. Clin Psychol Rev. 2013 Aug;33(6):763-71. doi: 10.1016/j.cpr.2013.05.005. Epub 2013 Jun 7.

  PMID: 23796855 BACKGROUND

• Montero-Marin J, Garcia-Campayo J. A newer and broader definition of burnout: validation of the "Burnout Clinical Subtype Questionnaire (BCSQ-36)". BMC Public Health. 2010 Jun 2;10:302. doi: 10.1186/1471-2458-10-302.

  PMID: 20525178 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 DERIVED

MeSH Terms

Interventions

Mindfulness

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Javier García-Campayo, phD

  Miguel Servet University Hospital, Zaragoza, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The assignation of the subjects will be carried out after the evaluation by a member of the research group, who has no knowledge about the study, through a random sequence generated by computer. Participants will be assigned to one of these conditions: 1) Mindfulness condition; 2) Mindfulness condition complemented by VR environments; 3) Relaxation condition.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Model Details: This is a randomized, controlled, pragmatic trial, involving three assessment time points (baseline, post-intervention and six-month follow-up).

Study Record Dates

• First Submitted: December 2, 2018
• First Posted: December 11, 2018
• Study Start: November 23, 2018
• Primary Completion: October 1, 2019
• Study Completion: December 20, 2019
• Last Updated: April 9, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be shared when the study will be published. Length: 5 years.
• Access Criteria: Upon request and reasonable conditions.

Locations

ES (1)