Experiential Virtual Scenarios With Real-Time Monitoring (Interreality) for the Management of Psychological Stress: A Block Randomized Controlled Trial

Abstract

Background:
The recent convergence between technology and medicine is offering innovative methods and tools for behavioral health care. Among these, an emerging approach is the use of virtual reality (VR) within exposure-based protocols for anxiety disorders, and in particular posttraumatic stress disorder. However, no systematically tested VR protocols are available for the management of psychological stress.

Objective:
Our goal was to evaluate the efficacy of a new technological paradigm, Interreality, for the management and prevention of psychological stress. The main feature of Interreality is a twofold link between the virtual and the real world achieved through experiential virtual scenarios (fully controlled by the therapist, used to learn coping skills and improve self-efficacy) with real-time monitoring and support (identifying critical situations and assessing clinical change) using advanced technologies (virtual worlds, wearable biosensors, and smartphones).

Methods:
The study was designed as a block randomized controlled trial involving 121 participants recruited from two different worker populations-teachers and nurses-that are highly exposed to psychological stress. Participants were a sample of teachers recruited in Milan (Block 1: n=61) and a sample of nurses recruited in Messina, Italy (Block 2: n=60). Participants within each block were randomly assigned to the (1) Experimental Group (EG): n=40; B1=20, B2=20, which received a 5-week treatment based on the Interreality paradigm; (2) Control Group (CG): n=42; B1=22, B2=20, which received a 5-week traditional stress management training based on cognitive behavioral therapy (CBT); and (3) the Wait-List group (WL): n=39, B1=19, B2=20, which was reassessed and compared with the two other groups 5 weeks after the initial evaluation.

Results:
Although both treatments were able to significantly reduce perceived stress better than WL, only EG participants reported a significant reduction (EG=12% vs. CG=0.5%) in chronic "trait" anxiety. A similar pattern was found for coping skills: both treatments were able to significantly increase most coping skills, but only EG participants reported a significant increase (EG=14% vs CG=0.3%) in the Emotional Support skill.

Conclusions:
Our findings provide initial evidence that the Interreality protocol yields better outcomes than the traditionally accepted gold standard for psychological stress treatment: CBT. Consequently, these findings constitute a sound foundation and rationale for the importance of continuing future research in technology-enhanced protocols for psychological stress management.

Trial registration:
ClinicalTrials.gov: NCT01683617; http://clinicaltrials.gov/show/NCT01683617 (Archived by WebCite at http://www.webcitation.org/6QnziHv3h).

Full text

Original Paper
Experiential Virtual Scenarios With Real-Time Monitoring
(Interreality) for the Management of Psychological Stress: A Block
Randomized Controlled Trial
Andrea Gaggioli1,2, MS(Psycho), PhD(Psych); Federica Pallavicini1, MS(Psycho), PhD(Psych); Luca Morganti1,
MS(Psycho); Silvia Serino1, MS(Psycho); Chiara Scaratti1, MS(Psycho); Marilena Briguglio3, MD, PhD; Giulia
Crifaci3, BBiomedEng; Noemi Vetrano3, MS(Psycho); Annunziata Giulintano3, MS(Psycho); Giuseppe Bernava3, M
Comp Sc, PhD; Gennaro Tartarisco3, MS Eng, PhD; Giovanni Pioggia3, MS Eng, PhD; Simona Raspelli1, MS(Psycho),
PhD; Pietro Cipresso1, MSc Econ, PhD; Cinzia Vigna1, Media Spec; Alessandra Grassi1, MS(Psycho), PhD; Margherita
Baruffi1, MS(Psycho), PsyD; Brenda Wiederhold4, MBA, BCIA, PhD; Giuseppe Riva1,2, MS(Psycho), PhD
1Applied Technology for Neuro-Psychology Lab, Istituto Auxologico Italiano, Milan, Italy
2Department of Psychology, Catholic University of Sacred Heart, Milan, Italy
3Institute of Clinical Physiology (IFC), National Research Council (CNR), Messina, Italy
4Virtual Reality Medical Institute, Brussels, Belgium
Corresponding Author:
Andrea Gaggioli, MS(Psycho), PhD(Psych)
Applied Technology for Neuro-Psychology Lab
Istituto Auxologico Italiano
Via Alessandro Magnasco 2
Milan, 20149
Italy
Phone: 39 0261911 ext 2892
Fax: 39 02619112892
Email: andrea.gaggioli@auxologico.it
Abstract
Background: The recent convergence between technology and medicine is offering innovative methods and tools for behavioral
health care. Among these, an emerging approach is the use of virtual reality (VR) within exposure-based protocols for anxiety
disorders, and in particular posttraumatic stress disorder. However, no systematically tested VR protocols are available for the
management of psychological stress.
Objective: Our goal was to evaluate the efficacy of a new technological paradigm, Interreality, for the management and prevention
of psychological stress. The main feature of Interreality is a twofold link between the virtual and the real world achieved through
experiential virtual scenarios (fully controlled by the therapist, used to learn coping skills and improve self-efficacy) with real-time
monitoring and support (identifying critical situations and assessing clinical change) using advanced technologies (virtual worlds,
wearable biosensors, and smartphones).
Methods: The study was designed as a block randomized controlled trial involving 121 participants recruited from two different
worker populations—teachers and nurses—that are highly exposed to psychological stress. Participants were a sample of teachers
recruited in Milan (Block 1: n=61) and a sample of nurses recruited in Messina, Italy (Block 2: n=60). Participants within each
block were randomly assigned to the (1) Experimental Group (EG): n=40; B1=20, B2=20, which received a 5-week treatment
based on the Interreality paradigm; (2) Control Group (CG): n=42; B1=22, B2=20, which received a 5-week traditional stress
management training based on cognitive behavioral therapy (CBT); and (3) the Wait-List group (WL): n=39, B1=19, B2=20,
which was reassessed and compared with the two other groups 5 weeks after the initial evaluation.
Results: Although both treatments were able to significantly reduce perceived stress better than WL, only EG participants
reported a significant reduction (EG=12% vs CG=0.5%) in chronic “trait” anxiety. A similar pattern was found for coping skills:
both treatments were able to significantly increase most coping skills, but only EG participants reported a significant increase
(EG=14% vs CG=0.3%) in the Emotional Support skill.
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Conclusions: Our findings provide initial evidence that the Interreality protocol yields better outcomes than the traditionally
accepted gold standard for psychological stress treatment: CBT. Consequently, these findings constitute a sound foundation and
rationale for the importance of continuing future research in technology-enhanced protocols for psychological stress management.
Trial Registration: ClinicalTrials.gov: NCT01683617; http://clinicaltrials.gov/show/NCT01683617 (Archived by WebCite at
http://www.webcitation.org/6QnziHv3h).
(J Med Internet Res 2014;16(7):e167) doi:10.2196/jmir.3235
KEYWORDS
psychological stress; Interreality; virtual reality; biosensors; heart rate; heart rate variability; biofeedback training; relaxation
training; physiological monitoring; smartphones
Introduction
The emerging convergence of technology and health care [1]
is offering new methods and tools for mental health treatments
[2-6]. An emerging trend is the use of virtual reality (VR) within
the exposure-based protocols for anxiety disorders and
posttraumatic stress disorders (PTSD) [7-11]. PTSD is more
difficult to treat than other anxiety disorders. On one hand, in
vivo exposure-based therapy is usually not possible. On the
other, imaginal exposure requires that the patient recounts their
traumatic experience in the present tense to the therapist—a
behavior that patients try to avoid [12]. VR therapy allows
exposure treatment even with patients who fail to improve with
traditional imaginal exposure therapy [13-16]. Since the initial
work by Barbara Rothbaum and her team [17,18], additional
case studies [19-23] and clinical trials [22,24,25], including a
randomized controlled clinical trial [26], have shown the
efficacy of VR therapy in the treatment of PTSD.
One factor that may increase the likelihood of developing the
symptomatology of PTSD is work-related stress. Previous
studies have included stressful life events in the list of risk
factors for PTSD, suggesting that experiencing chronic
psychological stress may increase vulnerability to this anxiety
disorder [27,28]. Indeed, chronic psychological stress may
induce plasticity within the amygdala, which in turn may
increase the risk of developing chronic anxiety states [29]. This
abnormal change in the limbic neural circuitry may provoke a
pathological anxiety response, leading to syndromes such as
PTSD. Other studies have focused on the contribution of
work-related stressors to PTSD [30,31]. For example, Laposa
et al [30] found that interpersonal conflicts, inadequate support
from superiors, and changing jobs were significantly associated
with PTSD symptoms. Different training has been developed
for managing psychological stress at work, both individually
and organizationally focused [32,33]. Specifically, a recent
review showed that individual interventions, like cognitive
behavioral therapy (CBT), can improve individuals’ mental
health, while physical activity as an organizational intervention
is more effective in reducing absenteeism [32]. On the basis of
this evidence, we decided to focus our intervention on the
individual.
However, until now, no systematically tested VR protocols have
been available for the management of psychological stress. A
preliminary attempt, developed by the US Army, was tested for
the training of military medical professionals who are expected
to take care of the wounded in very austere situations. This
protocol included a technology-assisted relaxation training
merging VR exposure sessions with relaxing videos with
embedded English narratives guiding progressive muscle
relaxation and controlled breathing [34].
According to Cohen et al [35], psychological stress occurs when
people perceive that environmental demands tax or exceed their
adaptive capacity. In this view, stressful experiences are
conceptualized as person-environment transactions, whose
results are dependent on the impact of the external stimulus.
This is mediated by:
•The person’s appraisal of the stimulus: when faced with a
stimulus, a person evaluates the potential threat (primary
appraisal). Primary appraisal is a person’s judgment about
the significance of a stimulus as stressful, positive,
controllable, challenging, or irrelevant.
•The personal, social, and cultural resources available: facing
a significant stimulus, a second appraisal follows, which is
an assessment of the individual’s coping resources and
options. Secondary appraisals address what one can do
about the situation.
•The efficacy of the coping efforts: if required by the
appraisal process, the individual starts a problem
management phase aimed at regulation of the external
stimulus.
Stress Management Therapy can help counter effects of
psychological stress. Usually various techniques are used
including relaxation, interaction, biofeedback, and CBT
methods. According to the Cochrane Database of Systematic
Reviews [36-38], the best validated approach covering both
stress management and stress treatment is the CBT approach.
Typically, a CBT protocol (10-15 sessions) includes both
problem-focused (eg, resource optimization and better planning)
and emotion-focused (eg, relaxation training, use of emotional
support) coping strategies. Initially, it includes in-session
didactic materials and experiential exercises and out-of-session
assignments (practicing relaxation exercises and monitoring
stress responses).
The clinical intervention primarily focuses on (1) learning how
to cope better with daily stressors (psychological stress) or
traumatic events (PTSD), and (2) optimizing one’s use of
personal skills and social resources.
The trouble with managing psychological stress is that it is very
personal. So the focus for assessment, prediction, and treatment
has to be the situated experience of the individual. This result
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is difficult to achieve using the available VR protocols for
PTSD. From a clinical viewpoint, in these protocols VR provides
a “closed” experience, separated from the emotions and
behaviors experienced by the patient in the real world. In other
words, VR exposure tries to change cognitive content per se,
rather than changing the context in which cognitions are
experienced [39]. The behavior of the patient in VR has no
direct effects on the real-life experience. The emotions and
problems experienced by the patient in the real world are not
directly addressed in the VR exposure. Moreover, it focuses on
patients’ thoughts and behaviors but does not address social
support and coping skills.
To overcome these issues, Riva et al [40-42] suggested the use
of the “Interreality” paradigm (IR) that integrates assessment
and treatment within a hybrid environment, bridging the physical
and virtual world. The basic idea of the IR intervention is to
bridge virtual experiences (fully controlled by the therapist,
used to learn healthy behaviors and coping skills) with real
experiences (the therapist can identify critical situations and
assess clinical change). In the IR strategy, behavior in the
physical world influences the experience in the virtual one, and
behavior in the virtual world influences the experience in the
real one. The current CBT approach can be described as
imagining evokes emotions and the meaning of the associated
feelings can be changed through reflection and relaxation. In
IR, we introduce an alternative strategy, in which controlled
experiences evoke emotions that result in meaningful new
feelings, which can be reflected on and eventually changed
through reflection and relaxation. This is achieved by using
technology (virtual worlds, advanced sensors, and smartphones)
to create a closed-loop approach for assessment and support.
The assessment is conducted continuously in the virtual and
real worlds through the tracking of individuals’ behavioral and
emotional status over time, in the context of realistic task
challenges. At the same time, the information is constantly used
to improve both the appraisal and the coping skills of the patient
through a conditioned association between effective performance
state and task execution behaviors.
These features are integrated into two subsystems: the clinical
VR platform (VR inpatient treatment, fully controlled by the
therapist) and the mobile platform (mobile-based real world
support, available to the patient and connected to the therapist).
Combined, these systems are able to provide (1) objective and
quantitative assessment of symptoms using biosensors and
behavioral analysis: monitoring of the patient behavior and of
general and psychological status, early detection of symptoms
of critical evolutions, and timely activation of feedback in a
closed loop approach, and (2) decision support for treatment
planning through data fusion and detection algorithms: the
decision support system allows monitoring stress levels of the
patient both during VR exposure (in the therapist’s office) and
in real-life situations (using the mobile phone), by generating
reports that the therapist can access via a Web-based interface.
The key features of IR are summarized in Figures 1 and 2.
Simply put, patients are continuously assessed in the virtual and
real worlds by tracking their behavioral and emotional status
in the context of challenging tasks (customization of the therapy
according to the characteristics of the patient), and feedback is
continuously provided to improve patients’skills (improvement
of self-efficacy).
The potential clinical advantages of the IR strategy are (1) an
integrated and quantitative assessment of the user’s stress level
using biosensors: the level of stress is continuously assessed in
the virtual and in the real world by recording the participant's
behavioral and emotional status for the decision support system,
and (2) provision of warnings and motivating feedback to
improve self-awareness, compliance, and long-term outcomes:
on the basis of the decision support system, participants
constantly receive feedback to improve their appraisal and
coping skills in an entertaining and motivating manner both in
clinical and mobile settings [40-42].
Starting from the above premise, the main goals of this study
are (1) to define and develop an Interreality protocol for the
management of psychological stress, and (2) to compare, within
a controlled study, its efficacy with a similar non-technological
protocol based on the CBT approach.
We hypothesize that the Interreality protocol is more effective
than both standard CBT and a wait-list condition in (1) reducing
the level of chronic “trait” stress, (2) reducing the perceived
stress and improving quality of life, and (3) improving the
coping skills of the individual.
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Figure 1. Advantages of Interreality.
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Figure 2. The Interreality paradigm for the management of psychological stress.
Methods
Recruitment
The study is designed as a multicentric randomized block
controlled trial involving participants recruited from two
different worker populations (teachers and nurses) that are
highly exposed to psychological stress (the Consort flowchart
is reported in Figure 3and the electronic CONSORT-EHEALTH
questionnaire [43] in Multimedia Appendix 1). Compared to a
completely randomized design, this design reduces variability
within treatment conditions and potential confounding (the
variability within blocks is less than the variability between
blocks), producing a better estimate of treatment effects [44].
A sample of high school teachers recruited in Milan (Block 1:
n=95) and a sample of pediatric nurses recruited in Messina,
Italy (Block 2: n=88) were seen for screening interviews for
admission to the study. Samples were recruited between March
2012 and September 2013. Criteria for participation included
the following: (1) a high level of perceived stress (≥7) as
measured on a 10-item visual-analogue scale, (2) a high level
of relevance of stress for personal health (≥7) as measured on
a 10-item visual-analogue scale, (3) a low level of self-efficacy
related to stress management (≤5) as measured on a 10-item
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visual-analogue scale, (4) no DSM-IV-TR (Diagnostic and
Statistical Manual of Mental Disorders, 4th edition, text revision)
Axis I disorders as assessed by Mini-International
Neuropsychiatric Interview (MINI) [45,46] during the clinical
assessment, (5) aged 25-60 years, (6) no psychotherapy received
for their psychological stress as assessed with a clinical
interview, (7) no current psychiatric medications as assessed
with a clinical interview, (8) no history of neurological diseases,
psychosis, alcohol or drug dependence as assessed with a clinical
interview, and (9) no migraine, headache, or vestibular
abnormalities as assessed with a clinical interview.
Both males and females were included. In order to select
participants, we decided to use only subjective indexes of stress
and coping for this study, without measuring cortisol. The
measures of the concentration of cortisol in blood, saliva, and
urine are established methods for momentary assessments of
the activity in the hypothalamic-pituitary-adrenocortical axis
(HPA). If the cortisol levels become too high or too low for a
longer period, a state of hyper- or hypocortisolism is present,
and both are associated with stress-related disease. However,
two recent studies by Barth [47] and Faresjo [48] suggest that
cortisol levels are not very reliable indicators of stress. The first
study [47] underlined the relevance of subjective evaluations
in producing the negative effects of stress. The author found a
reduced risk of coronary heart disease in stressed individuals
who neglected the subjective relevance of stress on health. The
second study [48] demonstrated the inefficacy of measuring
cortisol levels for assessing stress in subjects living in a stressful
environment. The study found that living in a stressful economic
and social environment produced a down-regulation of the
HPA-axis with a suppression of cortisol levels.
In our study, 62 participants either did not fulfill inclusion
criteria or refused to participate for other reasons (eg, time
constraints). This is an unusual observation. However, it should
be noted that participants experienced a high level of
psychological stress. Chronic psychological stress alters the
psychophysiological processes involved in cognitive appraisals
and coping responses. Several types of coping strategy are
commonly used to face the different demands associated with
stressful events, and their effective use reflects variation in
underlying cognitive appraisal. This refusal may therefore be
read as their inability to appraise and cope with the stressful
events.
All patients meeting the inclusion criteria in each block (B1=61,
B2=60) were randomly assigned to the three groups: (1) the
Experimental Group (EG): n=40, B1=20, B2=20, (2) the Control
Group (CG): n=42, B1=22, B2=20, and (3) the Wait-List group
(WL): n=39, B1=19, B2=20. All the participants signed an
informed consent form before entering the study. The sample
characteristics are shown in Table 1.
Table 1. Demographic parameters and baseline characteristics of the sample (mean and standard deviation).
W-LCGEGVariables
39.6 (9.7)42.9 (10.5)46.3 (7.7)Age
18.3 (1.3)17.3 (1.4)17.9 (1.4)Years of education
92.6 (25.8)86 (19.5)91.4 (25.8)PSMa
19.4 (6.6)18 (5.9)21.1 (7.9)PSSb
40.2 (9.8)42.1 (11.1)43.6 (11.2)STAI-Y2c
26.4 (7.0)24.2 (7.2)23.4 (6.2)SWLSd
COPE-NIVe
29.4 (7.7)29.9 (7.0)27.8 (8.2)Use of emotional support
31.8 (4.5)29.1 (5.1)27.9 (5.5)Positive attitude
31.7 (4.6)29.2 (7.4)28.6 (6.0)Problem focused
23.8 (5.5)21.7 (5.4)19.8 (5.0)Religious coping
22.8 (3.8)21.8 (4.7)24.1 (5.9)Denial
aPsychological Stress Measure.
bPerceived Stress Scale.
cState-Trait Anxiety Inventory Form Y-2.
dSatisfaction With Life Scale.
eCoping Orientation to the Problems Experienced—New Italian Version.
Baseline comparisons among the three groups showed only a
difference in the age of the groups. The age was significantly
higher in the EG and to a lesser extent in the CG than in the
WL group. Of the EG participants, 57.5% were women (23/40)
and 42.5% (17/40) were men, while the CG and WL included,
respectively: 71.4% women (30/42) and 28.6% men (12/42),
and 51.3% (20/39) women and 48.7% men (19/39).
We also assessed participants’ computer literacy at the start of
the trial through a self-assessment scale with three values: “low”,
“medium”, and “high”. Results showed overall a medium level
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of perceived individuals’ technological abilities, and no significant differences were found between groups.
Figure 3. Consort flowchart.
Ethics
The study was approved by ethical review board of Istituto
Auxologico Italiano in Milan, Italy, and by the ethical review
board of Azienda Ospedaliera Universitaria Policlinico “G.
Martino” in Messina. The study was conducted according to
the 1964 Declaration of Helsinki. All the participants signed an
informed consent form that explained the goal of the treatment,
its duration, the involvement of the patients, and for EG
individuals, the possible side effects related to the extended use
of immersive virtual environments (ie, ocular problems,
disorientation and balance disturbances, and nausea).
Treatment Protocols
The treatment protocols were based on 5 weeks of stress
management training (2 sessions per week) following the “stress
management program” by Kaluza [49] and on the “stress
inoculation training” by Meichenbaum [50].
Stress Management Training (SMT) is a short, focused, and
individualized intervention to improve individual coping with
stress at workplace [49]. A meta-analysis of 36 studies showed
the efficacy of SMT in reducing negative mood states (ie,
anxiety, depression) [51]. The Stress Inoculation Training (SIT)
[50,52] is a validated short, semistructured, and active approach
to manage psychological stress (for a review, see [53]). The
effectiveness of SIT has been evaluated in different contexts.
In the clinical setting, SIT has proven an effective means of
helping patients face particularly strenuous conditions [54-56].
In the occupational environment, SIT has been successfully
applied to support employees in managing stressful situations
[57,58] and to help athletes manage anxiety and improve
performance [11,59].
The treatment block for teachers (Block 1: n=61) was offered
by therapists from Istituto Auxologico Italiano both in the
Istituto Scientifico Ospedale San Luca, Milano, Italy and in the
schools where teachers worked. The treatment block for nurses
(Block 2: n=60) was offered by therapists from the Azienda
Ospedaliera Universitaria Policlinico “G. Martino” at the
Pervasive Healthcare Center, a clinical research center of the
Institute of Clinical Physiology.
The IR and CBT treatments were administered by clinical
psychologists with extensive experience in stress management
techniques. Detailed manuals were prepared to facilitate
adherence with the treatment protocols. Clinical reports were
checked for compliance at monthly supervision meetings. A
high level of protocol adherence was reported by therapists.
The difference between the treatment protocols offered by each
block is detailed below (see also [41]).
Experimental Group
Overview
The experimental group used an Interreality protocol based on
the following technologies (see Figure 4 for details).
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Figure 4. Technologies used by the experimental group.
3D Virtual Scenarios (in the Therapist’s Office)
Immersive Role-Playing Scenarios Where the Individual
Interacts With Potentially Stressful Experiences
According to a literature review and the results of a qualitative
analysis, different virtual stressful scenarios were generated for
both teachers and nurses (see Table 2). The stressful scenarios
were played by real actors, video-recorded, and included in the
virtual environments (using the free virtual reality platform
NeuroVR 2 [60-62]) after post-production (for a demonstration
of the procedure, see the video in Multimedia Appendix 2 and
Figure 5).
Figure 5. A Virtual Reality treatment session of the Interreality trial.
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Immersive Natural Scenarios Used to Learn Specific
Relaxation Techniques
In recent years, VR has been used in different clinical protocols
to facilitate relaxation processes in stressed or anxious subjects
[63-65] by visually presenting relaxing scenes [34,66]. The IR
relaxation environments were created on the basis of similar
virtual relaxing environments validated in previous studies
[34,64,67-69]. They included a beach, a lake with a waterfall,
a campfire in a mountain resort, and a desert oasis.
Table 2. The different virtual stressful scenarios.
Virtual scenarios for nursesVirtual scenarios for teachers
Managing the patients’ relativesWorkload
Managing patients’ complaintsClass management
Managing a medical emergency situationCoping with parent’s criticism
Relationship with colleaguesRelationship with boss
Managing relatives’/caregivers anxietyCoping with parents’ handling efforts
Distribution of work tasksRelationship with co-workers
Patient-doctor communicationConflict management
Managing patient’s anxiety
Unsuccessful collaboration/communication with colleagues
Discussions among medical doctors
Biosensors (Personal Biomonitoring System)
Overview
All elements of technology, including smartphone and
biosensors, were loaned to the EG participants free of charge.
Moreover, all the required data connection fees for real-time
stress monitoring were paid for by the trial. All the participants
received 1-week group technology training plus personalized
support sessions if needed.
Biofeedback (in the Therapist’s Office)
Typically, 3D virtual worlds are a closed experience and do not
reflect in any way the real activity and status of the users. In
IR, physiological sensors (heart rate and heart rate variability)
are used to track the emotional/health status of the individual
and to influence their experience in the virtual world. To
improve the efficacy of the relaxing environment, some features
of the experience (eg, the size of the fire or the waterfall flow
rate) were driven by the emotional status of the patient as
measured by biosensors (heart rate or heart rate variability).
Physiological Data Recording (Outside the Therapist’s
Office)
To assess the level of contextual stress, each individual was
provided a body-worn wireless sensor (EMPATICA E3 wrist
sensor) that was able to record and transmit psychophysiological
(heart rate and heart rate variation) and activity data in real time.
Mobile Phone (Outside the Therapist’s Office)
Stress Tracking
The data received from the wireless sensors were assessed in
real time by a decision support system (the description of the
system that was used can be found in [70,71]). This system
provides the user with a graphical representation of the current
stress level experienced and allows them to check the history
of stress levels variations experienced at different timescales
(eg, day, week, month).
Contextualized Homework
According to the performance achieved in the therapist’s office
and level of stress assessed by the decision support system, the
individual was able to experience on the smartphone different
guided relaxation and biofeedback virtual experiences
(non-immersive) similar to the ones experienced in the
therapist’s office.
Schema
Assessment Session (Session 1)
The session started with a discussion with the clinician about
the assessment week. Then, after a brief introduction to the
specific content of this session, the psychometric questionnaires
were administered for the first time (see below), and the
physiological baseline of the participant was recorded for 3
minutes. To measure the psychological variations occurring
during the different stressful virtual scenarios, subjects
completed the Visual Analogue Scale for Anxiety (VAS-A) and
the State-Trait Anxiety Inventory Form Y-1 (STAI-Y1) at the
baseline and after each scenario. During stressful exposition,
participant physiological parameters were also recorded. Besides
the stressful scenarios (see Table 2), each participant was
assessed in a neutral virtual environment and in one where they
completed a cognitive task in front of a virtual audience. This
allowed the therapist to identify the situations inducing the
highest level of stress. At the end of this session, the clinician
explained to the participant how to use the smartphone and the
body-worn wireless sensor.
Training Session (Sessions 2-9)
The following sessions were dedicated to teaching participants
how to cope with stress, through cognitive restructuring
techniques and relaxation exercises. Each session lasted about
1 hour and was divided into four parts: homework checking,
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exposure to a stressful VR environment, relaxation exercises
(with or without biofeedback), and a homework assignment.
The clinician decided with the participant the specific stress
scenarios to work on in the exposure (cognitive restructuring)
during at least two consecutive sessions. Cognitive restructuring
was used to help patients identify and challenge their erroneous
beliefs and interpretations. Specifically, patients were taught to
look at their negative beliefs, look for possible alternative
explanations and ways of thinking, and evaluate the pros and
cons of maintaining them. Relaxation was induced through the
immersion in a natural scenario selected by the subject, where
they could move and interact. The experience also integrated
different pre-recorded audio narratives describing the specific
setting and guiding the execution of different progressive muscle
relaxation/deep breathing exercises. The scenario was
experienced with or without VR biofeedback, in alternate ways
during sessions. At the end of the sessions, the clinician
explained to the participant how to use the smartphone and the
body-worn wireless sensor to check the level of contextual stress
and do the contextualized homework.
Follow-up Session (Session 10)
To verify the efficacy of the training, during the final session
participants were reassessed through the administration of
psychometric questionnaires. Moreover, participants were
re-exposed to the different stressful virtual scenarios, following
the same procedure of the assessment session (Session 1). At
the end of this assessment, the clinician discussed with the
participant the protocol and its perceived efficacy/usefulness.
Control Group
The control group used a protocol based on traditional cognitive
behavioral techniques, following the same structure (10 one-hour
sessions in 5 weeks) and the same assessment points of the EG,
but without the use of any technological tool. Exposure therapy
designed for the control group involved imaginal exposure to
the same stressful situations reproduced in virtual reality (see
Table 2). Patients were instructed to close their eyes and
experience the stressful situation by imagining that it was
currently happening. An audio recording provided a detailed
description of the context, the participants, the physical
sensations, and emotional reactions.
Guided imagery was also used to teach relaxation exercises.
Like in the EG, the imagery experience was supported by the
same pre-recorded audio narratives describing the specific
scenario and guiding the execution of different progressive
muscle relaxation relaxation/deep breathing exercises.
CG participants did not use the mobile phone for stress
assessment, but a traditional diary in which they recorded every
relevant stressful event. Moreover, participants’homework was
a self-help book about stress management. Topics included
identifying and fully understanding what stress is, how stress
affects our performance, the importance of becoming aware of
stress, and simple strategies to make desired changes to reduce
stress. See Multimedia Appendix 3 for the EG and CG study
protocols.
Wait-List Group
The wait-list group did not receive treatment. They completed
all facets of the pre-test and post-test (after 5 weeks), similar to
those individuals included in the other groups.
Assessment
Questionnaires
To assess the effects of the stress management protocols, several
questionnaires were used at different points of time.
Clinical Assessment
To exclude participants suffering from DSM-IV-TR Axis I
disorders, the recruited sample was assessed before the start of
the training using the MINI semistructured interview [45,46].
The MINI is a short diagnostic, structured interview that enables
researchers to make diagnoses of psychiatric disorders according
to DSM-IV or the International Statistical Classification of
Diseases and Related Health Problems, 10th revision (ICD-10).
The administration time of the interview is approximately 15
minutes and was designed for epidemiological studies and
multicentered clinical trials.
Primary Outcome Measures
Overview
The following questionnaires were administered offline under
a therapist’s supervision to each participant at pre-treatment,
and upon completion of the trial (after 5 weeks).
State-Trait Anxiety Inventory Form
State-Trait Anxiety Inventory form (STAI) [72,73] consists of
two scales containing 20 items each that measure anxiety in
adults. The STAI clearly differentiates between the temporary
condition of “state anxiety” (STAI Form Y-1, also known as
STAI-Y1) and the more general and long-standing quality of
“trait anxiety” (STAI Form Y-2, also known as STAI-Y2). For
the initial and the final assessment in the trial, we used the STAI
Y2, that is, the trait version of the STAI, which measures
characteristic tendencies to be anxious.
Coping Orientation to the Problems Experienced—New
Italian Version
Coping Orientation to the Problems Experienced (COPE)
Inventory was originally developed to assess a broad range of
coping responses [74]. COPE-NIV represents a useful and
validated tool to assess different coping dimensions in an Italian
context [75]. It consist of five scales, for a total of 60 items
altogether: use of emotional support, denial, positive attitude,
problem focused, and religious coping. This inventory can be
used to assess trait coping (the usual way people cope with
stress in everyday life) and state coping (the particular way
people cope with a specific stressful situation).
Perceived Stress Scale
The Perceived Stress Scale (PSS) [76] is a 10-item self-reported
measure designed to deal with the degree to which situations
in an individual’s life are appraised as stressful. It was originally
developed as a 14-item scale that assessed the perception of
stressful experiences over the previous month using a 5-point
Likert scale. Later, the authors reported that the 10-item version
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(PSS-10) showed stronger psychometric characteristics in
comparison to the 14-item scale [77].
Psychological Stress Measure
The Psychological Stress Measure (PSM) [78,79] consists of
49 items based on the various individual perceptions of the
cognitive, physiological, and behavioral state of subjects. PSM
provides a global score of stress and some partial subscores.
Patients are asked to answer on the basis of how they have been
feeling in the last 4-5 days. The global score of the PSM is
compared with ground truth scores, which give threshold
cut-offs on the basis of the gender (103 for male and 110 for
female subjects).
Satisfaction With Life Scale
The Satisfaction with Life Scale (SWLS) [80,81] is a measure
of life satisfaction (subjective well-being). The 5-item
questionnaire is designed to measure global cognitive judgments
of satisfaction with one’s own life. Qualitative feedback was
also obtained using a semistructured questionnaire at
pre-treatment, and upon completion of the trial.
Secondary Outcome Measures
Overview
Individuals were also assessed at the beginning and at the end
of each of the 8 training sessions using the following
questionnaires.
State-Trait Anxiety Inventory Form Y-1
STAI Y1 [72,73] addresses state anxiety, which could be defined
as a temporary emotional condition characterized by
apprehension, tension, and fear about a particular situation or
activity. This inventory consists a of a 20-item scale, like the
STAI Y2.
Visual Analogue Scale for Anxiety
Visual Analogue Scale for Anxiety (VAS-A) is an instrument
that measures anxiety across a continuum. It is a horizontal line,
100 millimeters in length, anchored by word descriptors at each
end (No anxiety; Very severe anxiety). Individuals mark on the
line the point that they feel represents their perception of their
own current state. The VAS-A score is determined by measuring
in millimeters from the left end of the line to the point that the
person marks.
Power Analysis
A power analysis was conducted to determine the appropriate
number of participants needed for the current study. With an
established alpha level of .05, 0.80 power, and a preliminary
research based effect size of 0.272 (n=15, treatment vs
non-treatment using the STAI Y2 score), a sample size of 30
participants for the group was enough to test the hypothesis of
significant differences between groups. Using the trial sample
size of 40 participants for groups, we achieved a power of more
than 0.9.
Statistical Analysis
Our primary end points are the change of the level of chronic
“trait” stress, perceived stress, and coping skills from baseline
(pre) to the end of intervention (post). Secondary outcomes
included the change in situational “state” stress scores from
start (pre) to the end of intervention (post) in each treatment
session.
For primary analyses, stress and coping scores were assessed
by analysis of covariance (ANCOVA), with post-treatment
scores as the baseline variable, while the pre-treatment scores
served as covariates. This approach allowed us to “adjust”
posttest scores for the variability on the pretest ones produced
by the block design [82]. Several assumptions were met to use
these techniques: (1) the use of interval or ratio data, (2) equally
and normally distributed deviations in scores, (3) existence of
a linear relationship between the dependent variable and the
covariate (pretest scores), and (4) random assignment to groups.
A two-sided Pvalue of .05 or less was considered to be
statistically significant. For secondary analyses, the experimental
and control groups were simultaneously taken into the analysis
of variance model for repeated measures (T=8). Differential
effects of the treatments were determined using post-hoc
analyses. In particular, to reduce the risk of type I errors, we
used the Bonferroni post-hoc procedure with an adjusted
Experiment-wise Error Rate (EER): 0.05 for each variable in a
three-group analysis and 0.025 for each variable in a four-group
analysis [83]. Prior to analysis, the distributions for the outcome
variables were examined. We detected univariate outliers using
boxplots.
Results
Primary Outcome Variables
Outcome data were available for all the participants at the end
of treatment (see Table 2). The one-way ANCOVA on the
pre-post-treatment scores showed a significant group effect
(F2,107=4.42; P<.014; effect size=0.74) on the primary outcome
variable of chronic “trait” anxiety (STAI Y2). While no
significant differences were found in either the WL group or
the CG between pre- and post-measurements, the EG was able
to obtain a significant decrease in anxiety (1.2%). These data
were confirmed by post-hoc analyses: they revealed significant
differences between the EG and the CG (P<.05), and between
the EG and the WL (P<.01).
We then used ANCOVA to analyze the pre-post changes in the
level of coping skills. On one side, no significant differences
were found in WL between the pre- and post-measurements.
On the other, the two treatment groups were able to obtain
significant coping skill improvement in four subscales (see
Table 2) with a significant greater improvement for the EG
(P<.05) in the Emotional Support skill. The analysis on the
other stress scales (PSS, PSM) revealed a significant reduction
in both treatments groups (see Table 3).
Post-hoc analyses did not reveal significant differences among
the treatments, although the percentage of decrease in stress
scales for the EG was higher (PSS: EG=21%, CG=16%; PSM:
EG=13%, CG=5%). No differences were found in the WL
group. Finally, we did not find difference between the three
groups in the pre-post quality of life (SWLS) scores.
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We also compared the two blocks (teachers and nurses) to check
for differences. In general, nurses obtained slightly better values
than teachers in most of the outcome variables for both
treatments. We also found limited but significant differences
in the STAI Y2 reduction (Teachers: -0.44+/-8.9; Nurses:
-3.2+/-5.3; P=.44, effect size=0.04), in the COPE-NIV
Emotional Support skill increase (Teachers: -0.3+/-6.3; Nurses:
2.3+/-5.4; P=.20, effect size=0.05) and in the SWLS quality of
life increase (Teachers: -0.6+/-5.58; Nurses: 1.8+/-3.3; P=.005,
effect size=0.07).
Table 3. ANCOVA results.
ANCOVAGroupVariables
η2
PdfFWaiting ListControlExperimental
STAI Y2
.74.0142, 1074.4239.8 (8.71)42.1 (11.1)43.6 (11.2)Time 1
40.2 (8.82)41.8 (10.8)38.2 (8.09)Time 2
COPE-NIV
Use of emotional support
.237.0002, 11117.229.4 (7.17)29.9 (7.04)27.8 (8.23)Time 1
28.8 (7.59)29.5 (6.82)31.7 (7.62)Time 2
Positive attitude
.234.0002, 10916.731.7 (4.08)29.1 (4.69)27.9 (5.54)Time 1
30.9 (4.01)29.4 (5.86)31.4 (5.16)Time 2
Problem focused
.104.0022, 1096.3431.3 (3.78)29.2 (7.36)28.6 (5.96)Time 1
29.6 (6.02)29.5 (6.48)31.7 (7.62)Time 2
Religious coping
.048.0642, 1112.8123.8 (5.63)21.7 (5.39)19.8 (5.01)Time 1
23.2 (6.1)21.3 (5.63)21.1 (6.65)Time 2
Denial
.082.0092, 11618.623.1 (3.69)21.8 (4.69)24.1 (5.91)Time 1
24 (5.27)20.9 (4.28)22.3 (5.13)Time 2
PSS
.155.0002, 11110.119.5 (6.64)18 (5.94)21.1 (7.95)Time 1
19.8 (7.24)15 (5.55)16. 6 (4.75)Time 2
PSM
.39.1152, 1112.292.3 (26.1)86.1 (19.5)91.4 (25.8)Time 1
92.4 (23.2)81.6 (19.8)79.2 (18.3)Time 2
SWLS
.058.0362, 1113.4326.5 (6.95)24.2 (7.18)23.4 (6.22)Time 1
23.2 (6.1)24.5 (7.53)25.5 (6.57)Time 2
Secondary Outcome Variables
To better understand the differences between the EG and CG,
we used a repeated measures analysis of variance (ANOVA)
(T=8) to analyze the changes in the situational “state” stress
scores (STAI Y1 and VAS-A) before and after each treatment.
The analysis revealed significant TIME (F7,511=3.8; P<.01;
effect size=0.05) and TIME x GROUP (Quadratic contrast:
F1,73=4.23; P<.05; effect size=0.05) effects in the VAS-A scores.
First, both groups progressively increased the relaxation level
achieved in a session during the protocol. Second, the pattern
of this increase is curvilinear (ie, is represented by a curve with
one bend) with a difference between the two groups (see Figure
6). EG showed a marked (>15%) early increase in the relaxation
level (from Session 3) and a further improvement (>20%) in
the next sessions; CG instead showed an initial increase of the
relaxation level (>10%) from the first session, with a marked
(>15%) increase in the relaxation level only in the last sessions
(7-8). The visible peaks experienced by EG in Figure 6
correspond to the introduction of a new stress scenario used by
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the clinician for VR exposure (see description of the training
sessions).
The analysis of STAI scores revealed a similar pattern but with
a lack of significant values due to the low statistical power
(0.23). We then compared the two blocks (teachers and nurses)
to check for differences. Again, nurses obtained higher, but not
significant, relaxation values than teachers in all the sessions.
Figure 6. Mean VAS-A reduction (pre-post) in the 8 treatment sessions for both treatment groups.
Discussion
Principal Results
Although both treatments (CBT and IR) were able to
significantly reduce perceived stress (with a better outcome for
IR), only participants who received IR reported a significant
reduction (12% vs 0.5%) in chronic “trait” anxiety. This
outcome is also better than that (11% reduction) obtained in a
previous trial by a 5-week stress management meditation
program where self-selected teachers were instructed to use
meditation twice daily for 20-minute periods, both at school
and at home [84]. In the IR protocol, no compulsory relaxation
exercises were required outside the therapist’s office, which is
an obvious advantage for both unmotivated individuals and for
individuals who are unable to understand the meditation
technique or to apply it properly.
A similar pattern was found for coping skills. Both treatments
were able to significantly increase most coping skills, but
participants who received IR reported a significantly greater
increase (14% vs 0.3%) in the Emotional Support skill than
CBT. It is interesting to note that meditation/mindfulness stress
management programs, unlike CBT ones, do not address coping
skills in their protocol. However, different clinical trials showed
long-term efficacy of coping skill training for better emotional
control [85], quality of life [86,87], and resiliency enhancement
[88].
In sum, the obtained data suggested both the clinical efficacy
of IR and its enhanced efficacy over CBT and other existing
protocols in the management of psychological stress.
Interreality as an Effective Clinical Protocol for Stress
Management
Although different studies in the past may have evaluated the
use of VR in the treatment of posttraumatic stress disorder, this
is, to our knowledge, the first randomized controlled trial
evaluating a technology-enhanced treatment program with active
therapeutic involvement for the management of psychological
stress.
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The main issue in dealing with stress is that it is very personal.
Thus, stress-related disorders cannot be explained simply on
the basis of the adverse situations experienced by people. These
disorders depend a great deal on how the person experiencing
a stressor is put together psychologically and physically. So the
focus for assessment, prediction, and treatment should be the
situated experience of the person. And this is difficult to achieve
using both CBT and the available VR protocols. The emotions
and problems experienced by the patient in the real world are
not directly assessed and/or addressed in real time by CBT; VR
is a “closed” experience, separate from the emotions and
behaviors experienced by the patient in the real world.
In this study, we provided initial evidence that a possible
approach to overcome these issues is the use of the “Interreality”
paradigm, which combines assessment and treatment within a
hybrid environment, bridging physical and virtual worlds
[40-42]. Specifically, the proposed protocol bridged experiential
virtual scenarios (fully controlled by the therapist, used to learn
coping skills and improve self-efficacy) with real-time
monitoring and support (identifying critical situations and
assessing clinical change), using advanced technologies (virtual
worlds, wearable biosensors, and smartphones).
Possible explanations for the higher efficacy of the proposed
approach are:
1. The added value offered to individuals by VR over guided
imagery for the acquisition of behavioral and coping skills:
As the findings indicate, VR is able to help individuals
obtain a marked increase in the relaxation levels early in
the therapy (from Session 3), while guided imagery is able
to obtain the same relaxation levels only later on (from
Session 7).
2. The added value offered to the individuals by real-time
stress monitoring and support over traditional diary
reporting: As suggested by qualitative reports, the IR sample
strongly appreciated the possibility of having real-time
stress monitoring and, if needed, use of the smartphone to
experience the same relaxation protocols learned in the
therapist’s office in real-life settings.
3. The added value offered to the therapists by real-time stress
monitoring over traditional diary reporting: In the early part
of each session, IR therapists used the recorded real-time
stress data to identify critical situations to be addressed in
virtual scenarios. CBT therapists were not able to obtain
similar detailed information from the diaries compiled by
their subjects.
Strengths and Limitations
This study had several strengths as a direct test of the effects of
an IR technology-enhanced protocol in the context of
psychological stress management. The first strength of this study
is that IR was compared with the best validated approach for
stress management, CBT, as identified by the Cochrane
Database of Systematic Reviews [36-38], demonstrating the
added value offered by IR technology for psychological stress
problems. Another important strength is the use, as primary
outcome variables, of reliable theory-based measures of
situational state and chronic trait anxiety. The third strength of
IR is the use of VR to enhance the efficacy of biofeedback
intervention. Biofeedback training is regarded as a useful
technique to reduce anxiety symptoms (eg, [89]). The most
common limitation of biofeedback and relaxation training is
that it requires time commitment and implementation effort on
behalf of the patient, who can rely only on very simple audio
and visual cues provided by the system to learn about body
responses to stress. In VR-based biofeedback, elements of the
virtual environment are directly modified by the patient’s
physiological parameters recorded in real time (eg, in the
“Campfire” scenario, physiological parameters control the fire
intensity, so that the reduction of the patient’s physiological
activation results in a reduction of the fire until it goes out).
Thus, patients receives immediate feedback on their level of
activation (as in the traditional biofeedback techniques), but
with richer and more engaging 3D visual cues [90].
Unfortunately, our experimental design does not allow
determination of the relative benefits of VR experiences and
VR-based biofeedback intervention in reducing stress and
anxiety, which is a future research goal.
However, the present findings should not be considered
definitive. First, the study did not include a follow-up assessment
of behavior maintenance in the long term. We have planned a
follow-up research study to assess the participant samples again
at 6-month and 12-month intervals.
A further limitation is that the study did not include any measure
of physiological stress (eg, cortisol levels in blood, saliva, or
urine samples). However, we justified this choice in the Methods
following the results of a recent study demonstrating the low
sensitivity of cortisol levels for individuals under long-term
stress exposure [48].
Third, while our study design provided a strong test of the
efficacy of the IR protocol, it did not allow an evaluation of the
specific effectiveness of the different technological tools
included in it. Further research is needed to identify the effective
elements of the IR protocol and the optimal amount of
technological intervention needed. As underlined clearly by
qualitative reports, the usability, invasiveness, and complexity
of the provided technology are the main barriers for a wide use
of the proposed protocol: 2 out of 3 teachers and 1 out of 4
nurses involved in the EG evaluated as “high” or “very high”
the amount of technological effort required by the protocol. In
particular, the main issues indicated by the participants are the
duration/charging of the batteries for both smartphone and
biosensors, the Bluetooth pairing of the smartphone with the
biosensors, the invasiveness of the biosensors, and the difficulty
in consulting real-time stress data in some working situations
(eg, teaching for teachers, consulting for nurses).
Finally, the IR technology–enhanced treatment is more
expensive for both therapists (VR hardware including computer:
€2200; biosensors: €2500) and patients (smartphone: €650;
biosensor: €1000). Nevertheless, the rapid technological
development is reducing the cost of the required technology.
For example, at the end of the trial, the cost of a comparable
body-worn wireless sensor decreased from €1000 (Empatica
E3 Wrist Sensor) to €150 (Angel Health Monitor).
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Conclusions
Our findings provide initial evidence that a technology-enhanced
IR protocol provides better outcomes than the traditionally
accepted gold standard for psychological stress treatment, CBT.
However, a follow-up study assessing behavior maintenance in
the long term is needed in order to provide additional evidence
of the effectiveness of IR. In particular, unlike CBT, IR was
able to significantly reduce chronic trait anxiety and better
improve emotion-related coping skills. Consequently, these
findings constitute a sound foundation and rationale for future
research in technology-enhanced protocols for psychological
stress management. In particular, our study provides the
evidence required to justify carrying out much larger follow-up
trials to identify the most effective technological interventions
and the optimal amount of technological support needed.
Acknowledgments
This study was funded by European Union INTERSTRESS project (ICT Grant Number: FP7-247685).
Authors' Contributions
RG, GAnd, PF, RS, GAl, WB, and PG contributed to the design of the study. RG prepared the initial drafts of the paper. RG,
GAnd, PF, SS, and WB critically discussed and reviewed the initial drafts of the paper. PG, BG, TG, and VC designed and
developed some of the technologies used in the studies. PF, ML, SC, BMari, RS, Bmarg, CG, VN, and GAnn were involved in
the treatment and in data collection CP, SS, PF, and RG carried out the analysis and interpretation of data. All authors contributed
to the final draft of the paper and approved the final version for publication.
Conflicts of Interest
None declared.
Multimedia Appendix 1
CONSORT-EHEALTH checklist V1.6.2 [43].
[PDF File (Adobe PDF File), 2MB - jmir_v16i7e167_app1.pdf ]
Multimedia Appendix 2
Stressful scenarios for the project.
[MP4 File (MP4 Video), 11MB - jmir_v16i7e167_app2.mp4 ]
Multimedia Appendix 3
EG and CG study protocols.
[PDF File (Adobe PDF File), 28KB - jmir_v16i7e167_app3.pdf ]
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Abbreviations
ANCOVA: analysis of covariance
CBT: cognitive behavioral therapy
CG: control group
COPE: Coping Orientation to Problems Experienced inventory
COPE-NIV: Coping Orientation to the Problems Experienced—New Italian Version
DSM-IV: Diagnostic and Statistical Manual of Mental Disorders, 4th edition
EG: experimental group
IR: Interreality
MINI: Mini-International Neuropsychiatric Interview
PSM: Psychological Stress Measure
PSS: Perceived Stress Scale
PTSD: posttraumatic stress disorders
STAI: State-Trait Anxiety Inventory
SWLS: Satisfaction With Life Scale
WL: wait-list group
VAS-A: Visual Analogue Scale for Anxiety
VR: virtual reality
Edited by G Eysenbach; submitted 10.01.14; peer-reviewed by M Wolters, R Mclay; comments to author 31.01.14; revised version
received 05.03.14; accepted 26.04.14; published 10.07.14
Please cite as:
Gaggioli A, Pallavicini F, Morganti L, Serino S, Scaratti C, Briguglio M, Crifaci G, Vetrano N, Giulintano A, Bernava G, Tartarisco
G, Pioggia G, Raspelli S, Cipresso P, Vigna C, Grassi A, Baruffi M, Wiederhold B, Riva G
Experiential Virtual Scenarios With Real-Time Monitoring (Interreality) for the Management of Psychological Stress: A Block
Randomized Controlled Trial
J Med Internet Res 2014;16(7):e167
URL: http://www.jmir.org/2014/7/e167/
doi:10.2196/jmir.3235
PMID:
©Andrea Gaggioli, Federica Pallavicini, Luca Morganti, Silvia Serino, Chiara Scaratti, Marilena Briguglio, Giulia Crifaci, Noemi
Vetrano, Annunziata Giulintano, Giuseppe Bernava, Gennaro Tartarisco, Giovanni Pioggia, Simona Raspelli, Pietro Cipresso,
Cinzia Vigna, Alessandra Grassi, Margherita Baruffi, Brenda Wiederhold, Giuseppe Riva. Originally published in the Journal of
Medical Internet Research (http://www.jmir.org), 10.07.2014. This is an open-access article distributed under the terms of the
Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution,
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copyright and license information must be included.
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