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Randomized Controlled Trial
. 2013 Jun 28:14:191.
doi: 10.1186/1745-6215-14-191.

Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial

Affiliations
Randomized Controlled Trial

Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial

Federica Pallavicini et al. Trials. .

Abstract

Background: Psychological stress occurs when an individual perceives that environmental demands tax or exceed his or her adaptive capacity. Its association with severe health and emotional diseases, points out the necessity to find new efficient strategies to treat it. Moreover, psychological stress is a very personal problem and requires training focused on the specific needs of individuals. To overcome the above limitations, the INTERSTRESS project suggests the adoption of a new paradigm for e-health--Interreality--that integrates contextualized assessment and treatment within a hybrid environment, bridging the physical and the virtual worlds. According to this premise, the aim of this study is to investigate the advantages of using advanced technologies, in combination with cognitive behavioral therapy (CBT), based on a protocol for reducing psychological stress.

Methods/design: The study is designed as a randomized controlled trial. It includes three groups of approximately 50 subjects each who suffer from psychological stress: (1) the experimental group, (2) the control group, (3) the waiting list group. Participants included in the experimental group will receive a treatment based on cognitive behavioral techniques combined with virtual reality, biofeedback and mobile phone, while the control group will receive traditional stress management CBT-based training, without the use of new technologies. The wait-list group will be reassessed and compared with the two other groups five weeks after the initial evaluation. After the reassessment, the wait-list patients will randomly receive one of the two other treatments. Psychometric and physiological outcomes will serve as quantitative dependent variables, while subjective reports of participants will be used as the qualitative dependent variable.

Discussion: What we would like to show with the present trial is that bridging virtual experiences, used to learn coping skills and emotional regulation, with real experiences using advanced technologies (virtual reality, advanced sensors and smartphones) is a feasible way to address actual limitations of existing protocols for psychological stress.

Trial registration: http://clinicaltrials.gov/ct2/show/NCT01683617.

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Figures

Figure 1
Figure 1
CONSORT Flow diagram.
Figure 2
Figure 2
Clinical setting hardware units. a) the head-mounted display (Vuzix VR Bundle with twin high-resolution 640 × 480 LCD displays, iWear® 3D-compliant); b) the joypad (Xbox controller); c) the portable computer (ACER ASPIRE with Intel® Core™i5, graphic processor Nvidia GeForce GT 540M and Bluetooth support); d) the cardiovascular belt (Pisa National Centre of Research).
Figure 3
Figure 3
Mobile setting hardware units. a) the smartphone (iPhone 4S); b) the shimmer, (University of Pisa).
Figure 4
Figure 4
Virtual reality stress scenario screenshot.
Figure 5
Figure 5
Virtual reality relaxing scenario screenshot.
Figure 6
Figure 6
Learning island screenshot.

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