Psychological StressINTERSTRESSNCT01683617
Management and Treatment of Stress-related Disorders (INTERSTRESS)
A study testing Coping skills and relaxation training with new technologies and Traditional coping skills and relaxation training in people with Psychological Stress, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years
- Conditions the study is for
- Psychological Stress
- What is being tested?
- Coping skills and relaxation training with new technologies and Traditional coping skills and relaxation training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- May 2012to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individual who suffer from psychological stress;
- Age between 25 and 60 years.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- 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.
- 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.
- Conditions
- Psychological Stress
- Being tested
- Coping skills and relaxation training with new technologies, Traditional coping skills and relaxation training
- Keywords
- Psychological stress
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coping skills and relaxation training with new technologiesBehavioural
Traditional coping skills and relaxation trainingBehavioural
| Study group | Role | What they receive |
|---|---|---|
| A treatment based on CBT and new technologies | Experimental | 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. Receives: Behavioral: Coping skills and relaxation training with new technologies |
| Traditional treatment based on CBT | Active comparator | 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. Receives: Behavioral: Traditional coping skills and relaxation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of psychological stress measured by psychometric questionnaires (PSM, PSS, COPE, PSQI, SWLS, STAI)
Treatment duration is 5 weeks. Outcome measures are assessed before and after treatment and at follow-up (18-month).
Measured: five weeks
quality of life questionnaire
Measured: 5 weeks
psychophysiological measures (heart rate and heart rate variability indexes)
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Psychological StressStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Riva, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683617
- Sponsor's protocol ID
- 03E901
- Other IDs
- FP7-247685
- Acronym
- INTERSTRESS
- Status last verified
- Aug 2018
- First submitted
- 5 Sep 2012
- Last updated
- 29 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22357020Riva 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.
PubMed 20543263Gaggioli 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.
PubMed 21335786Riva G. Interreality: A New Paradigm for E-health. Stud Health Technol Inform. 2009;144:3-7.
PubMed 19592718Gaggioli A, Pallavicini F, Morganti L, Serino S, Scaratti C, Briguglio M, Crifaci G, Vetrano N, Giulintano A, Bernava G, Tartarisco G, Pioggia G, Raspelli S, Cipresso P, Vigna C, Grassi A, Baruffi M, Wiederhold B, Riva G. Experiential virtual scenarios with real-time monitoring (interreality) for the management of psychological stress: a block randomized controlled trial. J Med Internet Res. 2014 Jul 8;16(7):e167. doi: 10.2196/jmir.3235.
PubMed 25004803Pallavicini F, Gaggioli A, Raspelli S, Cipresso P, Serino S, Vigna C, Grassi A, Morganti L, Baruffi M, Wiederhold B, Riva G. Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial. Trials. 2013 Jun 28;14:191. doi: 10.1186/1745-6215-14-191.
PubMed 23806013Pallavicini F, Cipresso P, Raspelli S, Grassi A, Serino S, Vigna C, Triberti S, Villamira M, Gaggioli A, Riva G. Is virtual reality always an effective stressors for exposure treatments? Some insights from a controlled trial. BMC Psychiatry. 2013 Feb 11;13:52. doi: 10.1186/1471-244X-13-52.
PubMed 23398927
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTERSTRESS - Interreality in the Management and Treatment of Stress-related Disorders
- ClinicalTrials.gov ID
- NCT01683617
- Acronym / sponsor ID
- INTERSTRESS / 03E901
- Conditions
- Psychological Stress
- Keywords
- Psychological stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 12 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A treatment based on CBT and new technologies | Experimental | Behavioral: Coping skills and relaxation training with new technologiesIndividuals 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. |
| Traditional treatment based on CBT | Active comparator | Behavioral: Traditional coping skills and relaxation trainingParticipants 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. |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Individual who suffer from psychological stress;
- Age between 25 and 60 years.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coping skills and relaxation training with new technologies | Behavioural | A treatment based on CBT and new technologies |
| Traditional coping skills and relaxation training | Behavioural | Traditional treatment based on CBT |
Primary outcome
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 questionnaire
Time frame: 5 weeks
psychophysiological measures (heart rate and heart rate variability indexes)
Time frame: 5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- Background: PubMed 22357020Riva 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.
- Background: PubMed 20543263Riva 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.
- Background: PubMed 21335786Gaggioli 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.
- Background: PubMed 19592718Riva G. Interreality: A New Paradigm for E-health. Stud Health Technol Inform. 2009;144:3-7.
- Derived from this study: PubMed 25004803Gaggioli A, Pallavicini F, Morganti L, Serino S, Scaratti C, Briguglio M, Crifaci G, Vetrano N, Giulintano A, Bernava G, Tartarisco G, Pioggia G, Raspelli S, Cipresso P, Vigna C, Grassi A, Baruffi M, Wiederhold B, Riva G. Experiential virtual scenarios with real-time monitoring (interreality) for the management of psychological stress: a block randomized controlled trial. J Med Internet Res. 2014 Jul 8;16(7):e167. doi: 10.2196/jmir.3235.
- Derived from this study: PubMed 23806013Pallavicini F, Gaggioli A, Raspelli S, Cipresso P, Serino S, Vigna C, Grassi A, Morganti L, Baruffi M, Wiederhold B, Riva G. Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial. Trials. 2013 Jun 28;14:191. doi: 10.1186/1745-6215-14-191.
- Derived from this study: PubMed 23398927Pallavicini F, Cipresso P, Raspelli S, Grassi A, Serino S, Vigna C, Triberti S, Villamira M, Gaggioli A, Riva G. Is virtual reality always an effective stressors for exposure treatments? Some insights from a controlled trial. BMC Psychiatry. 2013 Feb 11;13:52. doi: 10.1186/1471-244X-13-52.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coping skills and relaxation training with new technologies and Traditional coping skills and relaxation training in people with Psychological Stress, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of psychological stress measured by psychometric questionnaires (PSM, PSS, COPE, PSQI, SWLS, STAI) (time frame: five weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01683617, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.