<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01683617</url>
  </required_header>
  <id_info>
    <org_study_id>03E901</org_study_id>
    <secondary_id>FP7-247685</secondary_id>
    <nct_id>NCT01683617</nct_id>
  </id_info>
  <brief_title>Management and Treatment of Stress-related Disorders (INTERSTRESS)</brief_title>
  <acronym>INTERSTRESS</acronym>
  <official_title>INTERSTRESS - Interreality in the Management and Treatment of Stress-related Disorders</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istituto Auxologico Italiano</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Istituto Auxologico Italiano</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Psychological stress occurs when an individual perceives that environmental demands tax or&#xD;
      exceed his or her adaptive capacity. In this view, stressful experiences are conceptualized&#xD;
      as person-environment transactions, whose result is dependent on the impact of the external&#xD;
      stimulus. This is mediated by the person's appraisal of the significance of the stimulus, of&#xD;
      the personal, social and cultural resources available and of the efficacy of the coping&#xD;
      efforts.&#xD;
&#xD;
      Extreme levels of stress can have a negative influence on one's professional life and can&#xD;
      disrupt both the social and personal life of an individual. Stress can also cause different&#xD;
      physiological and psychological disorders such as anxiety, chronic headaches, depression,&#xD;
      withdrawal symptoms, nausea, phobias, blood pressure problems, heart impairments and others.&#xD;
&#xD;
      Stress Management Therapy can help to overcome counter effects of stress. Usually various&#xD;
      techniques are used including relaxation, interaction, biofeedback and Cognitive Behavior&#xD;
      Therapy methods. According to the Cochrane Database of Systematic Reviews the best validated&#xD;
      approach covering both stress management and stress treatment is the Cognitive Behavioral&#xD;
      Therapy (CBT) approach.&#xD;
&#xD;
      The trouble with stress is that it is very personal. Thus, stress-related disorders depend a&#xD;
      great deal on how the person experiencing a stressor is put together -psychologically and&#xD;
      physically. So the focus for assessment, prediction and treatment has to be the person's&#xD;
      situated experience.&#xD;
&#xD;
      To overcome the above limitations, the INTERSTRESS project suggests the adoption of a new&#xD;
      paradigm for e-health - Interreality - that integrates contextualized assessment and&#xD;
      treatment within a hybrid environment, bridging physical and virtual world.&#xD;
&#xD;
      From the clinical point of view the INTERSTRESS solution may offer the following innovations&#xD;
      to current traditional protocols for stress management:&#xD;
&#xD;
        -  Objective and quantitative assessment of user's stress level using biosensors and&#xD;
           behavioral analysis;&#xD;
&#xD;
        -  Provision of warnings and motivating feedbacks to improve self awareness, compliance and&#xD;
           long term outcome;&#xD;
&#xD;
        -  Decision Support System (DSS) for treatment planning through data fusion and detection&#xD;
           algorithms.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present trial is based on a randomized controlled study. We will recruited at least 100&#xD;
      participants, that will be split into two groups of at least 50 subjects who suffer from&#xD;
      psychological stress: 1) the experimental group 2) the control group. Participants included&#xD;
      in the experimental condition will receive a treatment based on cognitive behavioral&#xD;
      techniques combined to virtual reality, biofeedback and mobile phone, while the control group&#xD;
      will receive traditional stress management CBT-based training, without the use of new&#xD;
      technologies. Psychometric and physiological outcomes will serve as quantitative dependent&#xD;
      variables, while subjective reports of participants will be used as qualitative dependent&#xD;
      variable.&#xD;
&#xD;
      Different settings are planned for the training: Clinical, Home and Mobile Setting.&#xD;
&#xD;
      Following, a description of the protocol in details, both for the experimental and the&#xD;
      control group, in the three different settings.&#xD;
&#xD;
      1) In the experimental condition, participants will first take part to an intake session with&#xD;
      the introduction to the training (clinical setting) and to an assessment week to detect&#xD;
      stressful situations in daily life through portable biosensors and a smart phone (home&#xD;
      setting); then they will be exposed to an assessment session for detecting the&#xD;
      psycho-physiological variations occurred during the different stressful environments exposure&#xD;
      (clinical setting).&#xD;
&#xD;
      Afterwards, participants will receive a training for psychological stress management based on&#xD;
      cognitive behavioral techniques combined to virtual reality, biofeedback and mobile phone.&#xD;
      The training will be structured into ten sessions (two per week, each one lasting about one&#xD;
      hour), which will be divided into four parts:&#xD;
&#xD;
        -  homework checking&#xD;
&#xD;
        -  exposition to a stressful scenario and following cognitive restructuring with the&#xD;
           clinician&#xD;
&#xD;
        -  relaxation&#xD;
&#xD;
        -  home assignment During the training, biosensors will be worn to monitor physiological&#xD;
           parameters, to track the emotional/heath status and to directly influence experience in&#xD;
           the virtual world.&#xD;
&#xD;
      Relaxation will be induced through the immersion in different virtual environments (e.g.,&#xD;
      lake) which will be customized with different pre-recorded audio narratives that describe the&#xD;
      specific setting and that guide the execution of a series of relaxation exercises.&#xD;
      Experimental group will be exposed both to relaxing VR environments and to VR biofeedback, in&#xD;
      alternate way during sessions.&#xD;
&#xD;
      18-months follow up is planned in order to verify the efficacy of the training over a&#xD;
      long-term period.&#xD;
&#xD;
      2) In the control condition, participants will receive a training based on a protocol with&#xD;
      the same structure of the experimental group's one, without the use of new technologies and&#xD;
      biofeedback.&#xD;
&#xD;
      In particular, guided imagery will be employed as a stress exposition and for relaxation&#xD;
      exercises. The smart phone for stress assessment will be replaced by a traditional diary,&#xD;
      where to mark stressful event during the assessment week. In order to obtain comparable&#xD;
      measures with the experimental group, participants in the control condition will be assessed&#xD;
      during the training with the same questionnaires and their physiological measures will be&#xD;
      recorded during each session. As to home setting, instead of Second Life participants will&#xD;
      receive a book about psychological stress, with the same contents included in that virtual&#xD;
      island.18-months follow up is planned in order to verify the efficacy of the training over a&#xD;
      long-term period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Level of psychological stress measured by psychometric questionnaires (PSM, PSS, COPE, PSQI, SWLS, STAI)</measure>
    <time_frame>five weeks</time_frame>
    <description>Treatment duration is 5 weeks. Outcome measures are assessed before and after treatment and at follow-up (18-month).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>quality of life questionnaire</measure>
    <time_frame>5 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>psychophysiological measures (heart rate and heart rate variability indexes)</measure>
    <time_frame>5 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Psychological Stress</condition>
  <arm_group>
    <arm_group_label>A treatment based on CBT and new technologies</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional treatment based on CBT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Coping skills and relaxation training with new technologies</intervention_name>
    <arm_group_label>A treatment based on CBT and new technologies</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Traditional coping skills and relaxation training</intervention_name>
    <arm_group_label>Traditional treatment based on CBT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Individual who suffer from psychological stress;&#xD;
&#xD;
          -  Age between 25 and 60 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  DSM_IV-TR Axis I disorders;&#xD;
&#xD;
          -  history of neurological diseases, mental retardation, psychosis, alcohol or drug&#xD;
             dependence;&#xD;
&#xD;
          -  psychotherapy received for their psychological stress;&#xD;
&#xD;
          -  pharmacotherapy received for their psychological stress;&#xD;
&#xD;
          -  migraine, headache, or vestibular abnormalities.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Istituto Auxologico Italiano</name>
      <address>
        <city>Milano</city>
        <state>MI</state>
        <zip>20100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <link>
    <url>https://cordis.europa.eu/project/rcn/102143_en.html</url>
    <description>Related Info</description>
  </link>
  <reference>
    <citation>Riva G, Vigna C, Grassi A, Raspelli S, Cipresso P, Pallavicini F, Serino S, Gaggioli A. Learning Island: the development of a virtual reality system for the experiential training of stress management. Stud Health Technol Inform. 2012;173:369-71.</citation>
    <PMID>22357020</PMID>
  </reference>
  <reference>
    <citation>Riva G, Raspelli S, Pallavicini F, Grassi A, Algeri D, Wiederhold BK, Gaggioli A. Interreality in the management of psychological stress: a clinical scenario. Stud Health Technol Inform. 2010;154:20-5.</citation>
    <PMID>20543263</PMID>
  </reference>
  <reference>
    <citation>Gaggioli A, Raspelli S, Grassi A, Pallavicini F, Cipresso P, Wiederhold BK, Riva G. Ubiquitous health in practice: the interreality paradigm. Stud Health Technol Inform. 2011;163:185-91.</citation>
    <PMID>21335786</PMID>
  </reference>
  <reference>
    <citation>Riva G. Interreality: A New Paradigm for E-health. Stud Health Technol Inform. 2009;144:3-7.</citation>
    <PMID>19592718</PMID>
  </reference>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>September 5, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>August 27, 2018</last_update_submitted>
  <last_update_submitted_qc>August 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istituto Auxologico Italiano</investigator_affiliation>
    <investigator_full_name>Giuseppe Riva</investigator_full_name>
    <investigator_title>Scientific coordinator</investigator_title>
  </responsible_party>
  <keyword>Psychological stress</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01683617
org study id: 03E901
secondary id: FP7-247685
nct id: NCT01683617
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Level of psychological stress measured by psychometric questionnaires (PSM, PSS, COPE, PSQI, SWLS, STAI)
time frame: five weeks
description: Treatment duration is 5 weeks. Outcome measures are assessed before and after treatment and at follow-up (18-month).
measure: quality of life questionnaire
time frame: 5 weeks
measure: psychophysiological measures (heart rate and heart rate variability indexes)
time frame: 5 weeks
arm group label: A treatment based on CBT and new technologies
arm group type: Experimental
description: 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.
arm group label: Traditional treatment based on CBT
arm group type: Active Comparator
description: 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.
intervention type: Behavioral
intervention name: Coping skills and relaxation training with new technologies
arm group label: A treatment based on CBT and new technologies
intervention type: Behavioral
intervention name: Traditional coping skills and relaxation training
arm group label: Traditional treatment based on CBT
criteria: 
gender: All
minimum age: 25 Years
maximum age: 60 Years
healthy volunteers: No
facility: 
country: Italy
url: https://cordis.europa.eu/project/rcn/102143_en.html
description: Related Info
citation: Riva G, Vigna C, Grassi A, Raspelli S, Cipresso P, Pallavicini F, Serino S, Gaggioli A. Learning Island: the development of a virtual reality system for the experiential training of stress management. Stud Health Technol Inform. 2012;173:369-71.
PMID: 22357020
citation: Riva G, Raspelli S, Pallavicini F, Grassi A, Algeri D, Wiederhold BK, Gaggioli A. Interreality in the management of psychological stress: a clinical scenario. Stud Health Technol Inform. 2010;154:20-5.
PMID: 20543263
citation: Gaggioli A, Raspelli S, Grassi A, Pallavicini F, Cipresso P, Wiederhold BK, Riva G. Ubiquitous health in practice: the interreality paradigm. Stud Health Technol Inform. 2011;163:185-91.
PMID: 21335786
citation: Riva G. Interreality: A New Paradigm for E-health. Stud Health Technol Inform. 2009;144:3-7.
PMID: 19592718
responsible party type: Principal Investigator
investigator affiliation: Istituto Auxologico Italiano
investigator full name: Giuseppe Riva
investigator title: Scientific coordinator
mesh term: Stress, Psychological