Ignite Creation Date:
2024-05-06 @ 12:53 AM
Last Modification Date:
2024-10-26 @ 10:56 AM
Study NCT ID:
NCT01683617
Status:
COMPLETED
Last Update Posted:
2018-08-29
First Post:
2012-09-05
Brief Title:
Management and Treatment of Stress-related Disorders INTERSTRESS
Sponsor:
Istituto Auxologico Italiano
Organization:
Istituto Auxologico Italiano
Study Overview
Official Title:
INTERSTRESS - Interreality in the Management and Treatment of Stress-related Disorders
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INTERSTRESS
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 persons 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 ones 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 persons 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 users 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
Extreme levels of stress can have a negative influence on ones 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 persons 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 users 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
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 emotionalheath status and to directly influence experience in the virtual world
Relaxation will be induced through the immersion in different virtual environments eg 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 groups 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 island18-months follow up is planned in order to verify the efficacy of the training over a long-term period
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 emotionalheath status and to directly influence experience in the virtual world
Relaxation will be induced through the immersion in different virtual environments eg 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 groups 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 island18-months follow up is planned in order to verify the efficacy of the training over a long-term period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FP7-247685 | OTHER_GRANT | European Union - Seventh Framework Programme FP7 | None |