跳至主要内容
临床试验/NCT03771300
NCT03771300已完成不适用

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

Javier Garcia Campayo2 个研究点 分布在 1 个国家目标入组 280 人开始时间: 2018年11月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
280
试验地点
2
主要终点
Perceived Stress Scale-10 (PSS)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Perceived Stress Scale-10 (PSS)

时间窗: 6-month follow-up

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.

次要结局

  • State-Trait Anxiety Inventory (STAI)(6-month follow-up)
  • Emotional Regulation Questionnaire (ERQ)(6-month follow-up)
  • Self-Compassion Scale (SCS)(6-month follow-up)
  • Utrecht Work Engagement Survey Scale-Students (UWES-S)(6-month follow-up)
  • Maslach Burnout Inventory Student Survey (MBI-SS)(6-month follow-up)
  • Burnout Clinical Subtype Questionnaire (BCSQ-36)(6-month follow-up)
  • Five Facet Mindfulness Questionnaire (FFMQ)(6-month follow-up)
  • Positive and Negative Affect Schedule (PANAS)(6-month follow-up)
  • Visual Analog Scale (VAS)(Week 6 (session 6). Just after completing the Virtual Reality session 6 (15 minutes from baseline))
  • An adaptation (brief version) of the MAAS (Mindful Attention Awareness Scale) (MAAS-State)(Week 6 (session 6). Just after completing the Virtual Reality session 6 (15 minutes from baseline))
  • Slater-Usoh-Steed Questionnaire (SUS)(Week 6 (session 6). Just after completing the Virtual Reality session 6 (15 minutes from baseline))
  • Slater-Usoh-Steed Questionnaire" (SUS)(Week 3 (session 3). 5 minutes before starting the Virtual Reality session 3 (baseline))

研究者

发起方
Javier Garcia Campayo
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Javier Garcia Campayo

Principal investigator

Hospital Miguel Servet

研究点 (2)

Loading locations...

相似试验

Efficacy of a MBI Programme With or Without Virtual... | 临床试验