Management and Treatment of Stress-related Disorders (INTERSTRESS) (INTERSTRESS)

August 27, 2018 updated by: Giuseppe Riva, Istituto Auxologico Italiano

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • Milano, MI, Italy, 20100
        • Istituto Auxologico Italiano

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Individual who suffer from psychological stress;
  • Age between 25 and 60 years.

Exclusion Criteria:

  • DSM_IV-TR Axis I disorders;
  • history of neurological diseases, mental retardation, psychosis, alcohol or drug dependence;
  • psychotherapy received for their psychological stress;
  • pharmacotherapy received for their psychological stress;
  • migraine, headache, or vestibular abnormalities.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
five weeks
quality of life questionnaire
Time Frame: 5 weeks
5 weeks
psychophysiological measures (heart rate and heart rate variability indexes)
Time Frame: 5 weeks
5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Auxologico Italiano

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

September 5, 2012

First Submitted That Met QC Criteria

September 11, 2012

First Posted (Estimate)

September 12, 2012

Study Record Updates

Last Update Posted (Actual)

August 29, 2018

Last Update Submitted That Met QC Criteria

August 27, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03E901
  • FP7-247685 (Other Grant/Funding Number: European Union - Seventh Framework Programme (FP7))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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