ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 25 of 246 for:    Recruiting, Not yet recruiting, Available Studies | "Mental Health"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03771300
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Javier Garcia Campayo, Hospital Miguel Servet

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.


Condition or disease Intervention/treatment Phase
Mental Health Wellness 1 Behavioral: Mindfulness Behavioral: Mindfulness condition complemented by VR Behavioral: Relaxation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a randomized, controlled, pragmatic trial, involving three assessment time points (baseline, post-intervention and six-month follow-up).
Masking: Double (Participant, Outcomes Assessor)
Masking Description: 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.
Primary Purpose: Prevention
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
Actual Study Start Date : November 23, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: College Health

Arm Intervention/treatment
Experimental: Mindfulness condition
90-minute group sessions, held once a week over a space of 6 weeks, and is offered as an extra-curricular activity.
Behavioral: Mindfulness
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.

Experimental: Mindfulness condition complemented by VR
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

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.


Active Comparator: Relaxation condition
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
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).




Primary Outcome Measures :
  1. Perceived Stress Scale-10 (PSS) [ Time Frame: Baseline ]
    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.

  2. Perceived Stress Scale-10 (PSS) [ Time Frame: After programme completion at 6 weeks ]
    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.

  3. Perceived Stress Scale-10 (PSS) [ Time Frame: 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.


Secondary Outcome Measures :
  1. State-Trait Anxiety Inventory (STAI) [ Time Frame: Baseline ]
    This inventory is a widely used, validated measure of anxiety and consists of 20 statements that evaluate how the participants feel at the present moment (State Anxiety), and 20 statements that evaluate how the participants feel in general (Trait anxiety). It uses a 0-3 Likert-type rating scale, being that higher scores are positively correlated with higher levels of anxiety.

  2. State-Trait Anxiety Inventory (STAI) [ Time Frame: After programme completion at 6 weeks ]
    This inventory is a widely used, validated measure of anxiety and consists of 20 statements that evaluate how the participants feel at the present moment (State Anxiety), and 20 statements that evaluate how the participants feel in general (Trait anxiety). It uses a 0-3 Likert-type rating scale, being that higher scores are positively correlated with higher levels of anxiety.

  3. State-Trait Anxiety Inventory (STAI) [ Time Frame: 6-month follow-up ]
    This inventory is a widely used, validated measure of anxiety and consists of 20 statements that evaluate how the participants feel at the present moment (State Anxiety), and 20 statements that evaluate how the participants feel in general (Trait anxiety). It uses a 0-3 Likert-type rating scale, being that higher scores are positively correlated with higher levels of anxiety.

  4. Emotional Regulation Questionnaire (ERQ) [ Time Frame: Baseline ]
    It is a 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal, and (2) Expressive Suppression. The scale consists of 10 items and participants respond using a 7-point Likert scale (from 1 = "strongly disagree", to 7= "strongly agree").

  5. Emotional Regulation Questionnaire (ERQ) [ Time Frame: After programme completion at 6 weeks ]
    It is a 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal, and (2) Expressive Suppression. The scale consists of 10 items and participants respond using a 7-point Likert scale (from 1 = "strongly disagree", to 7= "strongly agree").

  6. Emotional Regulation Questionnaire (ERQ) [ Time Frame: 6-month follow-up ]
    It is a 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal, and (2) Expressive Suppression. The scale consists of 10 items and participants respond using a 7-point Likert scale (from 1 = "strongly disagree", to 7= "strongly agree").

  7. Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: Baseline ]
    It is a 39-item self-report measure of mindfulness. The FFMQ is composed of five mindfulness facets: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Respondents indicate on a 5-point Likert scale the degree to which each item is generally true for them, ranging from 1 ("never or very rarely true") to 5 ("very often or always true").

  8. Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: After programme completion at 6 weeks ]
    It is a 39-item self-report measure of mindfulness. The FFMQ is composed of five mindfulness facets: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Respondents indicate on a 5-point Likert scale the degree to which each item is generally true for them, ranging from 1 ("never or very rarely true") to 5 ("very often or always true").

  9. Five Facet Mindfulness Questionnaire (FFMQ) [ Time Frame: 6-month follow-up ]
    It is a 39-item self-report measure of mindfulness. The FFMQ is composed of five mindfulness facets: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Respondents indicate on a 5-point Likert scale the degree to which each item is generally true for them, ranging from 1 ("never or very rarely true") to 5 ("very often or always true").

  10. Self-Compassion Scale (SCS) [ Time Frame: Baseline ]
    This scale assesses six facets of behaviours towards self (self-Judgment, self-Kindness, isolation, common humanity, mindfulness, over-identification).The SCS uses a 5-point Likert scale, ranging from 1 ("almost never") to 5 ("almost always").

  11. Self-Compassion Scale (SCS) [ Time Frame: After programme completion at 6 weeks ]
    This scale assesses six facets of behaviours towards self (self-Judgment, self-Kindness, isolation, common humanity, mindfulness, over-identification).The SCS uses a 5-point Likert scale, ranging from 1 ("almost never") to 5 ("almost always").

  12. Self-Compassion Scale (SCS) [ Time Frame: 6-month follow-up ]
    This scale assesses six facets of behaviours towards self (self-Judgment, self-Kindness, isolation, common humanity, mindfulness, over-identification).The SCS uses a 5-point Likert scale, ranging from 1 ("almost never") to 5 ("almost always").

  13. Positive and Negative Affect Schedule (PANAS) [ Time Frame: Baseline ]
    This self-report questionnaire consists of 20 affective descriptors. For each descriptor, respondents rated on a 5-point scale from 1 (very slightly or not at all) to 5 (extremely).

  14. Positive and Negative Affect Schedule (PANAS) [ Time Frame: After programme completion at 6 weeks ]
    This self-report questionnaire consists of 20 affective descriptors. For each descriptor, respondents rated on a 5-point scale from 1 (very slightly or not at all) to 5 (extremely).

  15. Positive and Negative Affect Schedule (PANAS) [ Time Frame: 6-month follow-up ]
    This self-report questionnaire consists of 20 affective descriptors. For each descriptor, respondents rated on a 5-point scale from 1 (very slightly or not at all) to 5 (extremely).

  16. Utrecht Work Engagement Survey Scale-Students (UWES-S) [ Time Frame: Baseline ]
    Consist of 17-item which assess academic engagement. It includes three subscales: vigor (6 items), dedication (5 items), and absorption (6 items). The UWES is scored on a seven-point frequency Likert-type rating scale varying from 0 (never) to 6 (always)

  17. Utrecht Work Engagement Survey Scale-Students (UWES-S) [ Time Frame: After programme completion at 6 weeks ]
    Consist of 17-item which assess academic engagement. It includes three subscales: vigor (6 items), dedication (5 items), and absorption (6 items). The UWES is scored on a seven-point frequency Likert-type rating scale varying from 0 (never) to 6 (always)

  18. Utrecht Work Engagement Survey Scale-Students (UWES-S) [ Time Frame: 6-month follow-up ]
    Consist of 17-item which assess academic engagement. It includes three subscales: vigor (6 items), dedication (5 items), and absorption (6 items). The UWES is scored on a seven-point frequency Likert-type rating scale varying from 0 (never) to 6 (always)

  19. Maslach Burnout Inventory Student Survey (MBI-SS) [ Time Frame: Baseline ]
    It consists of 15 items where the references to work are changed for references to study. This questionnaire includes three subscales: exhaustion (5 items), cynicism (4 items) and (lack of) efficacy (EF; 6 items). Participants have to respond on a Likert-type scale with 7 response options ranged from 0 ("never") to 6 ("always"), and the results are presented in scalar scores.

  20. Maslach Burnout Inventory Student Survey (MBI-SS) [ Time Frame: After programme completion at 6 weeks ]
    It consists of 15 items where the references to work are changed for references to study. This questionnaire includes three subscales: exhaustion (5 items), cynicism (4 items) and (lack of) efficacy (EF; 6 items). Participants have to respond on a Likert-type scale with 7 response options ranged from 0 ("never") to 6 ("always"), and the results are presented in scalar scores.

  21. Maslach Burnout Inventory Student Survey (MBI-SS) [ Time Frame: 6-month follow-up ]
    It consists of 15 items where the references to work are changed for references to study. This questionnaire includes three subscales: exhaustion (5 items), cynicism (4 items) and (lack of) efficacy (EF; 6 items). Participants have to respond on a Likert-type scale with 7 response options ranged from 0 ("never") to 6 ("always"), and the results are presented in scalar scores.

  22. Burnout Clinical Subtype Questionnaire (BCSQ-36) [ Time Frame: Baseline ]
    This scale assesses the three burnout subtypes: frenetic, under-challenged and worn-out. The participants indicate the point to which they agreed with each item using a Likert-type scale with 7 response options ranging from 1 ("never") to 7 ("always").

  23. Burnout Clinical Subtype Questionnaire (BCSQ-36) [ Time Frame: After programme completion at 6 weeks ]
    This scale assesses the three burnout subtypes: frenetic, under-challenged and worn-out. The participants indicate the point to which they agreed with each item using a Likert-type scale with 7 response options ranging from 1 ("never") to 7 ("always").

  24. Burnout Clinical Subtype Questionnaire (BCSQ-36) [ Time Frame: 6-month follow-up ]
    This scale assesses the three burnout subtypes: frenetic, under-challenged and worn-out. The participants indicate the point to which they agreed with each item using a Likert-type scale with 7 response options ranging from 1 ("never") to 7 ("always").

  25. Visual Analog Scale (VAS) [ Time Frame: Week 1 (session 1). 5 minutes before starting the Virtual Reality session 1 (baseline) ]
    This scale assesses the intensity of different emotions before and after the VR intervention. A briefer version of the original measure (16 item emotion) will be used and it will be composed by 7 item emotion (happiness, sadness, anger, surprise, anxiety, relax/calm vigor/energy). Participants can choose responses ranging from 1= "not feeling the emotion at all", to 7 = "feeling the emotion extremely".

  26. Visual Analog Scale (VAS) [ Time Frame: Week 1 (session 1). Just after completing the Virtual Reality session 1 (15 minutes from baseline) ]
    This scale assesses the intensity of different emotions before and after the VR intervention. A briefer version of the original measure (16 item emotion) will be used and it will be composed by 7 item emotion (happiness, sadness, anger, surprise, anxiety, relax/calm vigor/energy). Participants can choose responses ranging from 1= "not feeling the emotion at all", to 7 = "feeling the emotion extremely".

  27. Visual Analog Scale (VAS) [ Time Frame: Week 2 (session 2). 5 minutes before starting the Virtual Reality session 2 (baseline) ]
    This scale assesses the intensity of different emotions before and after the VR intervention. A briefer version of the original measure (16 item emotion) will be used and it will be composed by 7 item emotion (happiness, sadness, anger, surprise, anxiety, relax/calm vigor/energy). Participants can choose responses ranging from 1= "not feeling the emotion at all", to 7 = "feeling the emotion extremely".

  28. Visual Analog Scale (VAS) [ Time Frame: Week 2 (session 2). Just after completing the Virtual Reality session 2 (15 minutes from baseline) ]
    This scale assesses the intensity of different emotions before and after the VR intervention. A briefer version of the original measure (16 item emotion) will be used and it will be composed by 7 item emotion (happiness, sadness, anger, surprise, anxiety, relax/calm vigor/energy). Participants can choose responses ranging from 1= "not feeling the emotion at all", to 7 = "feeling the emotion extremely".

  29. Visual Analog Scale (VAS) [ Time Frame: Week 3 (session 3). 5 minutes before starting the Virtual Reality session 3 (baseline) ]
    This scale assesses the intensity of different emotions before and after the VR intervention. A briefer version of the original measure (16 item emotion) will be used and it will be composed by 7 item emotion (happiness, sadness, anger, surprise, anxiety, relax/calm vigor/energy). Participants can choose responses ranging from 1= "not feeling the emotion at all", to 7 = "feeling the emotion extremely".

  30. Visual Analog Scale (VAS) [ Time Frame: Week 3 (session 3). Just after completing the Virtual Reality session 3 (15 minutes from baseline) ]
    This scale assesses the intensity of different emotions before and after the VR intervention. A briefer version of the original measure (16 item emotion) will be used and it will be composed by 7 item emotion (happiness, sadness, anger, surprise, anxiety, relax/calm vigor/energy). Participants can choose responses ranging from 1= "not feeling the emotion at all", to 7 = "feeling the emotion extremely".

  31. Visual Analog Scale (VAS) [ Time Frame: Week 4 (session 4). 5 minutes before starting the Virtual Reality session 4 (baseline) ]
    This scale assesses the intensity of different emotions before and after the VR intervention. A briefer version of the original measure (16 item emotion) will be used and it will be composed by 7 item emotion (happiness, sadness, anger, surprise, anxiety, relax/calm vigor/energy). Participants can choose responses ranging from 1= "not feeling the emotion at all", to 7 = "feeling the emotion extremely".

  32. Visual Analog Scale (VAS) [ Time Frame: Week 4 (session 4). Just after completing the Virtual Reality session 4 (15 minutes from baseline) ]
    This scale assesses the intensity of different emotions before and after the VR intervention. A briefer version of the original measure (16 item emotion) will be used and it will be composed by 7 item emotion (happiness, sadness, anger, surprise, anxiety, relax/calm vigor/energy). Participants can choose responses ranging from 1= "not feeling the emotion at all", to 7 = "feeling the emotion extremely".

  33. Visual Analog Scale (VAS) [ Time Frame: Week 5 (session 5). 5 minutes before starting the Virtual Reality session 5 (baseline) ]
    This scale assesses the intensity of different emotions before and after the VR intervention. A briefer version of the original measure (16 item emotion) will be used and it will be composed by 7 item emotion (happiness, sadness, anger, surprise, anxiety, relax/calm vigor/energy). Participants can choose responses ranging from 1= "not feeling the emotion at all", to 7 = "feeling the emotion extremely".

  34. Visual Analog Scale (VAS) [ Time Frame: Week 5 (session 5). Just after completing the Virtual Reality session 5 (15 minutes from baseline) ]
    This scale assesses the intensity of different emotions before and after the VR intervention. A briefer version of the original measure (16 item emotion) will be used and it will be composed by 7 item emotion (happiness, sadness, anger, surprise, anxiety, relax/calm vigor/energy). Participants can choose responses ranging from 1= "not feeling the emotion at all", to 7 = "feeling the emotion extremely".

  35. Visual Analog Scale (VAS) [ Time Frame: Week 6 (session 6). 5 minutes before starting the Virtual Reality session 6 (baseline) ]
    This scale assesses the intensity of different emotions before and after the VR intervention. A briefer version of the original measure (16 item emotion) will be used and it will be composed by 7 item emotion (happiness, sadness, anger, surprise, anxiety, relax/calm vigor/energy). Participants can choose responses ranging from 1= "not feeling the emotion at all", to 7 = "feeling the emotion extremely".

  36. Visual Analog Scale (VAS) [ Time Frame: Week 6 (session 6). Just after completing the Virtual Reality session 6 (15 minutes from baseline) ]
    This scale assesses the intensity of different emotions before and after the VR intervention. A briefer version of the original measure (16 item emotion) will be used and it will be composed by 7 item emotion (happiness, sadness, anger, surprise, anxiety, relax/calm vigor/energy). Participants can choose responses ranging from 1= "not feeling the emotion at all", to 7 = "feeling the emotion extremely".

  37. An adaptation (brief version) of the MAAS (Mindful Attention Awareness Scale) (MAAS-State) [ Time Frame: Week 1 (session 1). 5 minutes before starting the Virtual Reality session 1 (baseline) ]
    Each item will be rated on a 7-point Likert-type scale, ranging from 0 ("not at all"), 3 ("somewhat") and 6 ("very much").

  38. An adaptation (brief version) of the MAAS (Mindful Attention Awareness Scale) (MAAS-State) [ Time Frame: Week 1 (session 1). Just after completing the Virtual Reality session 1 (15 minutes from baseline) ]
    Each item will be rated on a 7-point Likert-type scale, ranging from 0 ("not at all"), 3 ("somewhat") and 6 ("very much").

  39. An adaptation (brief version) of the MAAS (Mindful Attention Awareness Scale) (MAAS-State) [ Time Frame: Week 2 (session 2). 5 minutes before starting the Virtual Reality session 2 (baseline) ]
    Each item will be rated on a 7-point Likert-type scale, ranging from 0 ("not at all"), 3 ("somewhat") and 6 ("very much").

  40. An adaptation (brief version) of the MAAS (Mindful Attention Awareness Scale) (MAAS-State) [ Time Frame: Week 2 (session 2). Just after completing the Virtual Reality session 2 (15 minutes from baseline) ]
    Each item will be rated on a 7-point Likert-type scale, ranging from 0 ("not at all"), 3 ("somewhat") and 6 ("very much").

  41. An adaptation (brief version) of the MAAS (Mindful Attention Awareness Scale) (MAAS-State) [ Time Frame: Week 3 (session 3). 5 minutes before starting the Virtual Reality session 3 (baseline) ]
    Each item will be rated on a 7-point Likert-type scale, ranging from 0 ("not at all"), 3 ("somewhat") and 6 ("very much").

  42. An adaptation (brief version) of the MAAS (Mindful Attention Awareness Scale) (MAAS-State) [ Time Frame: Week 3 (session 3). Just after completing the Virtual Reality session 3 (15 minutes from baseline) ]
    Each item will be rated on a 7-point Likert-type scale, ranging from 0 ("not at all"), 3 ("somewhat") and 6 ("very much").

  43. An adaptation (brief version) of the MAAS (Mindful Attention Awareness Scale) (MAAS-State) [ Time Frame: Week 4 (session 4). 5 minutes before starting the Virtual Reality session 4 (baseline) ]
    Each item will be rated on a 7-point Likert-type scale, ranging from 0 ("not at all"), 3 ("somewhat") and 6 ("very much").

  44. An adaptation (brief version) of the MAAS (Mindful Attention Awareness Scale) (MAAS-State) [ Time Frame: Week 4 (session 4). Just after completing the Virtual Reality session 4 (15 minutes from baseline) ]
    Each item will be rated on a 7-point Likert-type scale, ranging from 0 ("not at all"), 3 ("somewhat") and 6 ("very much").

  45. An adaptation (brief version) of the MAAS (Mindful Attention Awareness Scale) (MAAS-State) [ Time Frame: Week 5 (session 5). 5 minutes before starting the Virtual Reality session 5 (baseline) ]
    Each item will be rated on a 7-point Likert-type scale, ranging from 0 ("not at all"), 3 ("somewhat") and 6 ("very much").

  46. An adaptation (brief version) of the MAAS (Mindful Attention Awareness Scale) (MAAS-State) [ Time Frame: Week 5 (session 5). Just after completing the Virtual Reality session 5 (15 minutes from baseline) ]
    Each item will be rated on a 7-point Likert-type scale, ranging from 0 ("not at all"), 3 ("somewhat") and 6 ("very much").

  47. An adaptation (brief version) of the MAAS (Mindful Attention Awareness Scale) (MAAS-State) [ Time Frame: Week 6 (session 6). 5 minutes before starting the Virtual Reality session 6 (baseline) ]
    Each item will be rated on a 7-point Likert-type scale, ranging from 0 ("not at all"), 3 ("somewhat") and 6 ("very much").

  48. An adaptation (brief version) of the MAAS (Mindful Attention Awareness Scale) (MAAS-State) [ Time Frame: Week 6 (session 6). Just after completing the Virtual Reality session 6 (15 minutes from baseline) ]
    Each item will be rated on a 7-point Likert-type scale, ranging from 0 ("not at all"), 3 ("somewhat") and 6 ("very much").

  49. Slater-Usoh-Steed Questionnaire (SUS) [ Time Frame: Week 1 (session 1). 5 minutes before starting the Virtual Reality session 1 (baseline) ]
    Participants response on a 1-7 points Likert scale (1 = "not at all", "at no time" or "something I saw"; 7 = "very much", "almost all of the time" or "some place that I visited") these questions: 1) "Rate your sense of being in the virtual environment"; 2) "To what extent were there times during the experience when the virtual environment was reality for you?"; 3) "To what extent were there times during the experience when the virtual environment became more real or more present for you?";4)"When you think back to the experience, do you think of the virtual environment more as images that you saw or more as some place that you visited?

  50. Slater-Usoh-Steed Questionnaire (SUS) [ Time Frame: Week 1 (session 1). Just after completing the Virtual Reality session 1 (15 minutes from baseline) ]
    Participants response on a 1-7 points Likert scale (1 = "not at all", "at no time" or "something I saw"; 7 = "very much", "almost all of the time" or "some place that I visited") these questions: 1) "Rate your sense of being in the virtual environment"; 2) "To what extent were there times during the experience when the virtual environment was reality for you?"; 3) "To what extent were there times during the experience when the virtual environment became more real or more present for you?";4)"When you think back to the experience, do you think of the virtual environment more as images that you saw or more as some place that you visited?

  51. Slater-Usoh-Steed Questionnaire (SUS) [ Time Frame: Week 2 (session 2). 5 minutes before starting the Virtual Reality session 2 (baseline) ]
    Participants response on a 1-7 points Likert scale (1 = "not at all", "at no time" or "something I saw"; 7 = "very much", "almost all of the time" or "some place that I visited") these questions: 1) "Rate your sense of being in the virtual environment"; 2) "To what extent were there times during the experience when the virtual environment was reality for you?"; 3) "To what extent were there times during the experience when the virtual environment became more real or more present for you?";4)"When you think back to the experience, do you think of the virtual environment more as images that you saw or more as some place that you visited?

  52. Slater-Usoh-Steed Questionnaire (SUS) [ Time Frame: Week 2 (session 2). Just after completing the Virtual Reality session 2 (15 minutes from baseline) ]
    Participants response on a 1-7 points Likert scale (1 = "not at all", "at no time" or "something I saw"; 7 = "very much", "almost all of the time" or "some place that I visited") these questions: 1) "Rate your sense of being in the virtual environment"; 2) "To what extent were there times during the experience when the virtual environment was reality for you?"; 3) "To what extent were there times during the experience when the virtual environment became more real or more present for you?";4)"When you think back to the experience, do you think of the virtual environment more as images that you saw or more as some place that you visited?

  53. Slater-Usoh-Steed Questionnaire" (SUS) [ Time Frame: Week 3 (session 3). 5 minutes before starting the Virtual Reality session 3 (baseline) ]
    Participants response on a 1-7 points Likert scale (1 = "not at all", "at no time" or "something I saw"; 7 = "very much", "almost all of the time" or "some place that I visited") these questions: 1) "Rate your sense of being in the virtual environment"; 2) "To what extent were there times during the experience when the virtual environment was reality for you?"; 3) "To what extent were there times during the experience when the virtual environment became more real or more present for you?";4)"When you think back to the experience, do you think of the virtual environment more as images that you saw or more as some place that you visited?

  54. Slater-Usoh-Steed Questionnaire (SUS) [ Time Frame: Week 3 (session 3). Just after completing the Virtual Reality session 3 (15 minutes from baseline) ]
    Participants response on a 1-7 points Likert scale (1 = "not at all", "at no time" or "something I saw"; 7 = "very much", "almost all of the time" or "some place that I visited") these questions: 1) "Rate your sense of being in the virtual environment"; 2) "To what extent were there times during the experience when the virtual environment was reality for you?"; 3) "To what extent were there times during the experience when the virtual environment became more real or more present for you?";4)"When you think back to the experience, do you think of the virtual environment more as images that you saw or more as some place that you visited?

  55. Slater-Usoh-Steed Questionnaire (SUS) [ Time Frame: Week 4 (session 4). 5 minutes before starting the Virtual Reality session 4 (baseline) ]
    Participants response on a 1-7 points Likert scale (1 = "not at all", "at no time" or "something I saw"; 7 = "very much", "almost all of the time" or "some place that I visited") these questions: 1) "Rate your sense of being in the virtual environment"; 2) "To what extent were there times during the experience when the virtual environment was reality for you?"; 3) "To what extent were there times during the experience when the virtual environment became more real or more present for you?";4)"When you think back to the experience, do you think of the virtual environment more as images that you saw or more as some place that you visited?

  56. Slater-Usoh-Steed Questionnaire (SUS) [ Time Frame: Week 4 (session 4). Just after completing the Virtual Reality session 4 (15 minutes from baseline) ]
    Participants response on a 1-7 points Likert scale (1 = "not at all", "at no time" or "something I saw"; 7 = "very much", "almost all of the time" or "some place that I visited") these questions: 1) "Rate your sense of being in the virtual environment"; 2) "To what extent were there times during the experience when the virtual environment was reality for you?"; 3) "To what extent were there times during the experience when the virtual environment became more real or more present for you?";4)"When you think back to the experience, do you think of the virtual environment more as images that you saw or more as some place that you visited?

  57. Slater-Usoh-Steed Questionnaire (SUS) [ Time Frame: Week 5 (session 5). 5 minutes before starting the Virtual Reality session 5 (baseline) ]
    Participants response on a 1-7 points Likert scale (1 = "not at all", "at no time" or "something I saw"; 7 = "very much", "almost all of the time" or "some place that I visited") these questions: 1) "Rate your sense of being in the virtual environment"; 2) "To what extent were there times during the experience when the virtual environment was reality for you?"; 3) "To what extent were there times during the experience when the virtual environment became more real or more present for you?";4)"When you think back to the experience, do you think of the virtual environment more as images that you saw or more as some place that you visited?

  58. Slater-Usoh-Steed Questionnaire (SUS) [ Time Frame: Week 5 (session 5). Just after completing the Virtual Reality session 5 (15 minutes from baseline) ]
    Participants response on a 1-7 points Likert scale (1 = "not at all", "at no time" or "something I saw"; 7 = "very much", "almost all of the time" or "some place that I visited") these questions: 1) "Rate your sense of being in the virtual environment"; 2) "To what extent were there times during the experience when the virtual environment was reality for you?"; 3) "To what extent were there times during the experience when the virtual environment became more real or more present for you?";4)"When you think back to the experience, do you think of the virtual environment more as images that you saw or more as some place that you visited?

  59. Slater-Usoh-Steed Questionnaire (SUS) [ Time Frame: Week 6 (session 6). 5 minutes before starting the Virtual Reality session 6 (baseline) ]
    Participants response on a 1-7 points Likert scale (1 = "not at all", "at no time" or "something I saw"; 7 = "very much", "almost all of the time" or "some place that I visited") these questions: 1) "Rate your sense of being in the virtual environment"; 2) "To what extent were there times during the experience when the virtual environment was reality for you?"; 3) "To what extent were there times during the experience when the virtual environment became more real or more present for you?";4)"When you think back to the experience, do you think of the virtual environment more as images that you saw or more as some place that you visited?

  60. Slater-Usoh-Steed Questionnaire (SUS) [ Time Frame: Week 6 (session 6). Just after completing the Virtual Reality session 6 (15 minutes from baseline) ]
    Participants response on a 1-7 points Likert scale (1 = "not at all", "at no time" or "something I saw"; 7 = "very much", "almost all of the time" or "some place that I visited") these questions: 1) "Rate your sense of being in the virtual environment"; 2) "To what extent were there times during the experience when the virtual environment was reality for you?"; 3) "To what extent were there times during the experience when the virtual environment became more real or more present for you?";4)"When you think back to the experience, do you think of the virtual environment more as images that you saw or more as some place that you visited?



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03771300


Contacts
Contact: Javier García-Campayo, phD +34696082630 jgarcamp@gmail.com

Locations
Spain
Department of Psychiatry. Miguel Servet University Hospital Recruiting
Zaragoza, Spain, 50009
Contact: Javier García Campayo, pHd         
Sponsors and Collaborators
Javier Garcia Campayo
Investigators
Principal Investigator: Javier García-Campayo, phD Miguel Servet University Hospital, Zaragoza, Spain

Publications:
Neff, K. D. Development and validation of a scale to measure self-compassion. Self and Identity, 2, 223-250, 2003.
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.
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
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.
Gross JJ, Levenson RW. Emotion elicitation using films. Cogn Emot. 1995 Jan; 9(1):87-108.
Slater M, Usoh M, Steed A. Depth of Presence in Virtual Environments. Presence Teleoperators Virtual Environ. 1994 Jan; 3(2):130-44.

Responsible Party: Javier Garcia Campayo, Principal investigator, Hospital Miguel Servet
ClinicalTrials.gov Identifier: NCT03771300     History of Changes
Other Study ID Numbers: FPU15/00598
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Databases will be shared for replication studies upon request and reasonable conditions.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data will be shared when the study will be published. Length: 5 years.
Access Criteria: Upon request and reasonable conditions.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Javier Garcia Campayo, Hospital Miguel Servet:
Wellness
University students
Mindfulness
Virtual Reality (VR)