Management and Treatment of Stress-related Disorders (INTERSTRESS)
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.
Behavioral: Coping skills and relaxation training with new technologies
Behavioral: Traditional coping skills and relaxation training
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||INTERSTRESS - Interreality in the Management and Treatment of Stress-related Disorders|
- Level of psychological stress measured by psychometric questionnaires (PSM, PSS, COPE, PSQI, SWLS, STAI) [ Time Frame: five weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
- psychophysiological measures (heart rate and heart rate variability indexes) [ Time Frame: 5 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
Experimental: A treatment based on CBT and new technologies
Individuals will receive a treatment based on cognitive behavioral therapy and new technologies (virtual reality, virtual reality combined to biofeedback and mobile phones). 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. During biofeedback exercises a wearable biosensor system will provide suggestions to the trainer based on the reactions of the participants, and the biosensor data will directly modify the virtual reality experience in real time.
|Behavioral: Coping skills and relaxation training with new technologies|
Active Comparator: Traditional treatment based on CBT
Participants will receive a treatment based on traditional cognitive behavioral therapy techniques for stress management, without the use of new technologies. Relaxation will be induced by guided imagery, through auditory narratives.
|Behavioral: Traditional coping skills and relaxation training|
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01683617
|Istituto Auxologico Italiano|
|Milano, MI, Italy, 20100|