Open Access Study protocol

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

Federica Pallavicini1*, Andrea Gaggioli1, Simona Raspelli1, Pietro Cipresso1, Silvia Serino1, Cinzia Vigna1, Alessandra Grassi2, Luca Morganti1, Margherita Baruffi1, Brenda Wiederhold3 and Giuseppe Riva12

Author Affiliations

1 Applied Technology for Neuro-Psychology Laboratory (IRCCS Istituto Auxologico Italiano), Via Pellizza da Volpedo, 41, Milan, Italy

2 Department of Psychology, Catholic University of Milan, Largo Gemelli, 1, Milan, Italy

3 Virtual Reality Medical Institute, 30 Clos Chapelle aux Champs, Bte. 1, 3030, Brussels, Belgium

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Trials 2013, 14:191  doi:10.1186/1745-6215-14-191

Published: 28 June 2013

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 webcite

Keywords:
Psychological Stress; Virtual Reality; Smartphone; Biofeedback