Clinical trial NCT03771300: Efficacy of a MBI Programme With or Without Virtual Reality Support to Reduce Stress in University Students
Official title: Efficacy of a Mindfulness-based Intervention Programme With or Without Virtual Reality Support to Reduce Stress in University Students: Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Keywords: Wellness
University students
Mindfulness
Virtual Reality (VR)
Lead sponsor: Hospital Miguel Servet
Sponsor class: OTHER
First posted: 2018-12-11
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized, controlled, pragmatic trial, involving three assessment time points (baseline, post-intervention and six-month follow-up).
Primary purpose: PREVENTION

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.

Detailed description: Mental health of university students is a noteworthy concern nowadays. Universities are thus challenged to set up effective preventative interventions to help students cope better with university life and improve their mental health. In this regard, it is confirmed that cognitive, behavioral, and mindfulness interventions are effective in reducing symptoms of anxiety in university students.

Mindfulness-based interventions (MBIs) are defined as a type of intervention whose aim is training the mind to adopt a nonjudgmental present-focused awareness. In recent years, these interventions have expanded and have proven to be effective for a variety of clinical and nonclinical populations.This expansion has allowed to study the benefits of mindfulness in university students.

The present study pursue to support this evidence but also to explore the potential benefits of Virtual Reality (VR) around the provision of mindfulness training to university students. VR has showed to be effective for treating several psychological disorders, especially anxiety disorders. However, current research finds promising results when it is incorporated in the third wave of therapy, although the number of studies is still limited yet. A recent study found a high acceptability of VR to practice mindfulness, a significant increase in mindfulness state, and an improved emotional state after one VR mindfulness session.

The main objective of this study is to evaluate the efficacy of a MBI program to reduce stress in university students, in comparison with a relaxation therapy program. The secondary aims are as follows: (1) to analyze the efficacy of a MBI program for improving the psychological well-being and academic functioning of university students, in comparison to the active control group treated with relaxation exercises; (2) to evaluate whether there are differences in the adherence to the mindfulness program, according to the modality in which this mindfulness program has been applied (i.e. with or without VR support); (3) to examine the possible differential effectiveness of each of the sub-groups of mindfulness (i.e. with or without support of the VR) in comparison to the active control group treated with relaxation therapy; (4) to assess the effects of different mindfulness-based VR environments on the emotional and mindfulness states of university students, as well as to evaluate the sensation of immersion caused by each VR environment.

The investigator's main hypothesis is that the provision of mindfulness training will reduce student´s perceived stress of university students in comparison with the university students who have been provided of relaxation training.

This is a randomized, controlled, pragmatic trial, involving three assessment time points (baseline, post-intervention and six-month follow-up). Participants will be randomized into three groups ('mindfulness', 'mindfulness + VR', and 'controls'), considering the secondary objective of evaluating the effectiveness of each mindfulness sub-group separately. Nevertheless, taking into account the primary aim of isolating the common effects of both mindfulness sub-groups, 'mindfulness' and 'mindfulness + VR' will work as an only one group of treatment. 225 participants will be needed: 75 participants in the active control group of relaxation therapy, and 150 participants in the MBI total group. Taking into account all the participants, and assuming a rate of losses of 25%, the total sample has been established in 280 university students.

Several outcomes will be measured and compared between mindfulness (with and without support of VR) and control groups. Three assessment time points will be considered: baseline, post-intervention and six-month follow-up. The investigators will collect data about socio-demographic variables and experience in the use of new technologies, as well as about the primary outcome variable (perceived stress) and secondary outcomes (psychological well-being, academic functioning, mindfulness and compassion).

Socio-demographic data will be described in the baseline by means of frequencies, medians and means, depending on the nature of each of the variables. The treatment conditions will be compared to evaluate the success of randomization by means of Chi-Square test or Fisher test for qualitative variables, Kruskal-Wallis for non-parametric measures and one-way ANOVA for parametric variables. The efficacy of the mindfulness general program compared to the relaxation control group will be analyzed on the main perceived stress variable (PSS), which will be taken continuously. It will be developed by means of a repeated measures design and an intention to treat basis (ITT), using multilevel mixed-effects models,and including time as an independent variable and subjects and presence/absence of VR practices as random effect variables. The efficacy of the general program of mindfulness vs the relaxation control group regarding to psychological well-being, academic functioning, trait mindfulness and self-compassion, will be calculate following the same analytical strategy used for the main analysis. Also the efficacy of the each mindfulness sub-group (with or without VR) vs the control group regarding the main and secondary variables will be estimated - although in this case, the mixed regression model will only include the subjects as a random effects variable.Additionally, possible differences in emotional state, immersion in the VR environment and state mindfulness in the mindfulness + VR sub-group will be explored through each of the VR environments, using the same analytical strategy.

Eligibility criteria: Inclusion criteria:

* 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.

Exclusion criteria:

* 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.

Primary outcomes:
measure: Perceived Stress Scale-10 (PSS)
timeFrame: Baseline
measure: Perceived Stress Scale-10 (PSS)
timeFrame: After programme completion at 6 weeks
measure: Perceived Stress Scale-10 (PSS)
timeFrame: 6-month follow-up
Secondary outcomes:
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: After programme completion at 6 weeks
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: 6-month follow-up
measure: Emotional Regulation Questionnaire (ERQ)
timeFrame: Baseline
measure: Emotional Regulation Questionnaire (ERQ)
timeFrame: After programme completion at 6 weeks
measure: Emotional Regulation Questionnaire (ERQ)
timeFrame: 6-month follow-up
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Baseline
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: After programme completion at 6 weeks
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: 6-month follow-up
measure: Self-Compassion Scale (SCS)
timeFrame: Baseline
measure: Self-Compassion Scale (SCS)
timeFrame: After programme completion at 6 weeks
measure: Self-Compassion Scale (SCS)
timeFrame: 6-month follow-up
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Baseline
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: After programme completion at 6 weeks
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: 6-month follow-up
measure: Utrecht Work Engagement Survey Scale-Students (UWES-S)
timeFrame: Baseline
measure: Utrecht Work Engagement Survey Scale-Students (UWES-S)
timeFrame: After programme completion at 6 weeks
measure: Utrecht Work Engagement Survey Scale-Students (UWES-S)
timeFrame: 6-month follow-up
measure: Maslach Burnout Inventory Student Survey (MBI-SS)
timeFrame: Baseline
measure: Maslach Burnout Inventory Student Survey (MBI-SS)
timeFrame: After programme completion at 6 weeks
measure: Maslach Burnout Inventory Student Survey (MBI-SS)
timeFrame: 6-month follow-up
measure: Burnout Clinical Subtype Questionnaire (BCSQ-36)
timeFrame: Baseline
measure: Burnout Clinical Subtype Questionnaire (BCSQ-36)
timeFrame: After programme completion at 6 weeks
measure: Burnout Clinical Subtype Questionnaire (BCSQ-36)
timeFrame: 6-month follow-up
measure: Visual Analog Scale (VAS)
timeFrame: Week 1 (session 1). 5 minutes before starting the Virtual Reality session 1 (baseline)
measure: Visual Analog Scale (VAS)
timeFrame: Week 1 (session 1). Just after completing the Virtual Reality session 1 (15 minutes from baseline)
measure: Visual Analog Scale (VAS)
timeFrame: Week 2 (session 2). 5 minutes before starting the Virtual Reality session 2 (baseline)
measure: Visual Analog Scale (VAS)
timeFrame: Week 2 (session 2). Just after completing the Virtual Reality session 2 (15 minutes from baseline)
measure: Visual Analog Scale (VAS)
timeFrame: Week 3 (session 3). 5 minutes before starting the Virtual Reality session 3 (baseline)
measure: Visual Analog Scale (VAS)
timeFrame: Week 3 (session 3). Just after completing the Virtual Reality session 3 (15 minutes from baseline)
measure: Visual Analog Scale (VAS)
timeFrame: Week 4 (session 4). 5 minutes before starting the Virtual Reality session 4 (baseline)
measure: Visual Analog Scale (VAS)
timeFrame: Week 4 (session 4). Just after completing the Virtual Reality session 4 (15 minutes from baseline)
measure: Visual Analog Scale (VAS)
timeFrame: Week 5 (session 5). 5 minutes before starting the Virtual Reality session 5 (baseline)
measure: Visual Analog Scale (VAS)
timeFrame: Week 5 (session 5). Just after completing the Virtual Reality session 5 (15 minutes from baseline)
measure: Visual Analog Scale (VAS)
timeFrame: Week 6 (session 6). 5 minutes before starting the Virtual Reality session 6 (baseline)
measure: Visual Analog Scale (VAS)
timeFrame: Week 6 (session 6). Just after completing the Virtual Reality session 6 (15 minutes from baseline)
measure: An adaptation (brief version) of the MAAS (Mindful Attention Awareness Scale) (MAAS-State)
timeFrame: Week 1 (session 1). 5 minutes before starting the Virtual Reality session 1 (baseline)
measure: An adaptation (brief version) of the MAAS (Mindful Attention Awareness Scale) (MAAS-State)
timeFrame: Week 1 (session 1). Just after completing the Virtual Reality session 1 (15 minutes from baseline)
measure: An adaptation (brief version) of the MAAS (Mindful Attention Awareness Scale) (MAAS-State)
timeFrame: Week 2 (session 2). 5 minutes before starting the Virtual Reality session 2 (baseline)
measure: An adaptation (brief version) of the MAAS (Mindful Attention Awareness Scale) (MAAS-State)
timeFrame: Week 2 (session 2). Just after completing the Virtual Reality session 2 (15 minutes from baseline)
measure: An adaptation (brief version) of the MAAS (Mindful Attention Awareness Scale) (MAAS-State)
timeFrame: Week 3 (session 3). 5 minutes before starting the Virtual Reality session 3 (baseline)
measure: An adaptation (brief version) of the MAAS (Mindful Attention Awareness Scale) (MAAS-State)
timeFrame: Week 3 (session 3). Just after completing the Virtual Reality session 3 (15 minutes from baseline)
measure: An adaptation (brief version) of the MAAS (Mindful Attention Awareness Scale) (MAAS-State)
timeFrame: Week 4 (session 4). 5 minutes before starting the Virtual Reality session 4 (baseline)
measure: An adaptation (brief version) of the MAAS (Mindful Attention Awareness Scale) (MAAS-State)
timeFrame: Week 4 (session 4). Just after completing the Virtual Reality session 4 (15 minutes from baseline)
measure: An adaptation (brief version) of the MAAS (Mindful Attention Awareness Scale) (MAAS-State)
timeFrame: Week 5 (session 5). 5 minutes before starting the Virtual Reality session 5 (baseline)
measure: An adaptation (brief version) of the MAAS (Mindful Attention Awareness Scale) (MAAS-State)
timeFrame: Week 5 (session 5). Just after completing the Virtual Reality session 5 (15 minutes from baseline)
measure: An adaptation (brief version) of the MAAS (Mindful Attention Awareness Scale) (MAAS-State)
timeFrame: Week 6 (session 6). 5 minutes before starting the Virtual Reality session 6 (baseline)
measure: An adaptation (brief version) of the MAAS (Mindful Attention Awareness Scale) (MAAS-State)
timeFrame: Week 6 (session 6). Just after completing the Virtual Reality session 6 (15 minutes from baseline)
measure: Slater-Usoh-Steed Questionnaire (SUS)
timeFrame: Week 1 (session 1). 5 minutes before starting the Virtual Reality session 1 (baseline)
measure: Slater-Usoh-Steed Questionnaire (SUS)
timeFrame: Week 1 (session 1). Just after completing the Virtual Reality session 1 (15 minutes from baseline)
measure: Slater-Usoh-Steed Questionnaire (SUS)
timeFrame: Week 2 (session 2). 5 minutes before starting the Virtual Reality session 2 (baseline)
measure: Slater-Usoh-Steed Questionnaire (SUS)
timeFrame: Week 2 (session 2). Just after completing the Virtual Reality session 2 (15 minutes from baseline)
measure: Slater-Usoh-Steed Questionnaire" (SUS)
timeFrame: Week 3 (session 3). 5 minutes before starting the Virtual Reality session 3 (baseline)
measure: Slater-Usoh-Steed Questionnaire (SUS)
timeFrame: Week 3 (session 3). Just after completing the Virtual Reality session 3 (15 minutes from baseline)
measure: Slater-Usoh-Steed Questionnaire (SUS)
timeFrame: Week 4 (session 4). 5 minutes before starting the Virtual Reality session 4 (baseline)
measure: Slater-Usoh-Steed Questionnaire (SUS)
timeFrame: Week 4 (session 4). Just after completing the Virtual Reality session 4 (15 minutes from baseline)
measure: Slater-Usoh-Steed Questionnaire (SUS)
timeFrame: Week 5 (session 5). 5 minutes before starting the Virtual Reality session 5 (baseline)
measure: Slater-Usoh-Steed Questionnaire (SUS)
timeFrame: Week 5 (session 5). Just after completing the Virtual Reality session 5 (15 minutes from baseline)
measure: Slater-Usoh-Steed Questionnaire (SUS)
timeFrame: Week 6 (session 6). 5 minutes before starting the Virtual Reality session 6 (baseline)
measure: Slater-Usoh-Steed Questionnaire (SUS)
timeFrame: Week 6 (session 6). Just after completing the Virtual Reality session 6 (15 minutes from baseline)
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Department of Psychiatry. Miguel Servet University Hospital
Study officials:
affiliation: Miguel Servet University Hospital, Zaragoza, Spain
name: Javier García-Campayo, phD
role: PRINCIPAL_INVESTIGATOR
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