Management and Treatment of Stress-related Disorders (INTERSTRESS)
Condition: Psychological Stress
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      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. This is mediated by the person's appraisal of the significance of the stimulus, of
      the personal, social and cultural resources available and of the efficacy of the coping
      efforts.

      Extreme levels of stress can have a negative influence on one's professional life and can
      disrupt both the social and personal life of an individual. Stress can also cause different
      physiological and psychological disorders such as anxiety, chronic headaches, depression,
      withdrawal symptoms, nausea, phobias, blood pressure problems, heart impairments and others.

      Stress Management Therapy can help to overcome counter effects of stress. Usually various
      techniques are used including relaxation, interaction, biofeedback and Cognitive Behavior
      Therapy methods. According to the Cochrane Database of Systematic Reviews the best validated
      approach covering both stress management and stress treatment is the Cognitive Behavioral
      Therapy (CBT) approach.

      The trouble with stress is that it is very personal. Thus, stress-related 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 has to be the person's
      situated experience.

      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 physical and virtual world.

      From the clinical point of view the INTERSTRESS solution may offer the following innovations
      to current traditional protocols for stress management:

        -  Objective and quantitative assessment of user's stress level using biosensors and
           behavioral analysis;

        -  Provision of warnings and motivating feedbacks to improve self awareness, compliance and
           long term outcome;

        -  Decision Support System (DSS) for treatment planning through data fusion and detection
           algorithms.
    

Detailed description: 
      The present trial is based on a randomized controlled study. We will recruited at least 100
      participants, that will be split into two groups of at least 50 subjects who suffer from
      psychological stress: 1) the experimental group 2) the control group. Participants included
      in the experimental condition will receive a treatment based on cognitive behavioral
      techniques combined to virtual reality, biofeedback and mobile phone, while the control group
      will receive traditional stress management CBT-based training, without the use of new
      technologies. Psychometric and physiological outcomes will serve as quantitative dependent
      variables, while subjective reports of participants will be used as qualitative dependent
      variable.

      Different settings are planned for the training: Clinical, Home and Mobile Setting.

      Following, a description of the protocol in details, both for the experimental and the
      control group, in the three different settings.

      1) In the experimental condition, participants will first take part to an intake session with
      the introduction to the training (clinical setting) and to an assessment week to detect
      stressful situations in daily life through portable biosensors and a smart phone (home
      setting); then they will be exposed to an assessment session for detecting the
      psycho-physiological variations occurred during the different stressful environments exposure
      (clinical setting).

      Afterwards, participants will receive a training for psychological stress management based on
      cognitive behavioral techniques combined to virtual reality, biofeedback and mobile phone.
      The training will be structured into ten sessions (two per week, each one lasting about one
      hour), which will be divided into four parts:

        -  homework checking

        -  exposition to a stressful scenario and following cognitive restructuring with the
           clinician

        -  relaxation

        -  home assignment During the training, biosensors will be worn to monitor physiological
           parameters, to track the emotional/heath status and to directly influence experience in
           the virtual world.

      Relaxation will be induced through the immersion in different virtual environments (e.g.,
      lake) which will be customized with different pre-recorded audio narratives that describe the
      specific setting and that guide the execution of a series of relaxation exercises.
      Experimental group will be exposed both to relaxing VR environments and to VR biofeedback, in
      alternate way during sessions.

      18-months follow up is planned in order to verify the efficacy of the training over a
      long-term period.

      2) In the control condition, participants will receive a training based on a protocol with
      the same structure of the experimental group's one, without the use of new technologies and
      biofeedback.

      In particular, guided imagery will be employed as a stress exposition and for relaxation
      exercises. The smart phone for stress assessment will be replaced by a traditional diary,
      where to mark stressful event during the assessment week. In order to obtain comparable
      measures with the experimental group, participants in the control condition will be assessed
      during the training with the same questionnaires and their physiological measures will be
      recorded during each session. As to home setting, instead of Second Life participants will
      receive a book about psychological stress, with the same contents included in that virtual
      island.18-months follow up is planned in order to verify the efficacy of the training over a
      long-term period.
    

Intervention name(s): Coping skills and relaxation training with new technologies; Traditional coping skills and relaxation training
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Psychological stress