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

Federica Pallavicini,Luca Morganti,Pietro Cipresso,Brenda Wiederhold,Cinzia Vigna,Andrea Gaggioli,Giuseppe Riva,Simona Raspelli,Alessandra Grassi,Margherita Baruffi,Silvia Serino

doi:10.1186/1745-6215-14-191

Abstract

BackgroundPsychological 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/DesignThe 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.DiscussionWhat 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 registrationhttp://clinicaltrials.gov/ct2/show/NCT01683617

Highlights

Introduction of the trainingClinical interview (MINI)Give state-trait anxiety inventory (STAI) Y2 and satisfaction with life scale (SWLS)Questionnaire about participant’s expectations and motivationsExposition to a neutral virtual environmentExplanation of how to use the Personal digital assistants (PDA), Second Life and the Patient Management System (PMS) Session I
Stress-related disorders cannot be explained on the basis of the terrible things that happen to people
The INTERSTRESS project suggests the adoption of a new paradigm for e-health Interreality, which integrates contextualized assessment and treatment within a hybrid environment, bridging the physical and the virtual worlds [20,21,22,23,24]

Summary

Introduction

Introduction of the trainingClinical interview (MINI)Give STAI Y2 and SWLSQuestionnaire about participant’s expectations and motivationsExposition to a neutral virtual environmentExplanation of how to use the PDA, Second Life and the PMS Session I. 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. According to Cohen and colleagues [1], psychological stress occurs when an individual perceives that environmental demands tax or exceed his or her adaptive capacity In this view, stressful experiences are conceptualized as person-environment transactions, whose result is dependent on the impact of the external stimulus. Stress can cause different physiological and psychological disorders, such as anxiety, chronic headaches, depression, withdrawal symptoms, nausea, phobias, blood pressure problems, heart impairments and others [2,3,4,5]

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