Clinical Trial: Management and Treatment of Stress-related Disorders (INTERSTRESS)

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: INTERSTRESS - Interreality in the Management and Treatment of Stress-related Disorders

Brief 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 vi

Detailed Summary:

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:

  • Level of psychological stress measured by psychometric questionnaires (PSM, PSS, COPE, PSQI, SWLS, STAI) [ Time Frame: five weeks ]
    Treatment duration is 5 weeks. Outcome measures are assessed before and after treatment and at follow-up (18-month).
  • quality of life [ Time Frame: 5 weeks ]
  • psychophysiological measures (heart rate and heart rate variability indexes) [ Time Frame: 5 weeks ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Istituto Auxologico Italiano

Dates:
Date Received: September 5, 2012
Date Started: May 2012
Date Completion: July 2015
Last Updated: January 31, 2014
Last Verified: January 2014