NCT01683617

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 5, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 12, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 29, 2018

Status Verified

August 1, 2018

Enrollment Period

1.7 years

First QC Date

September 5, 2012

Last Update Submit

August 27, 2018

Conditions

Psychological Stress

Keywords

Psychological stress

Outcome Measures

Primary Outcomes (3)

  • 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).

    five weeks

  • quality of life questionnaire

    5 weeks

  • psychophysiological measures (heart rate and heart rate variability indexes)

    5 weeks

Study Arms (2)

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.

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.

Behavioral: Traditional coping skills and relaxation training

Interventions

Coping skills and relaxation training with new technologiesBEHAVIORAL
A treatment based on CBT and new technologies
Traditional coping skills and relaxation trainingBEHAVIORAL
Traditional treatment based on CBT

Eligibility Criteria

Age25 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto Auxologico Italiano

Milan, MI, 20100, Italy

Location

Related Publications (7)

  • 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: 22357020BACKGROUND

  • 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: 20543263BACKGROUND

  • 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: 21335786BACKGROUND

  • Riva G. Interreality: A New Paradigm for E-health. Stud Health Technol Inform. 2009;144:3-7.

    PMID: 19592718BACKGROUND

  • Gaggioli 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.

    PMID: 25004803DERIVED

  • Pallavicini 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.

    PMID: 23806013DERIVED

  • Pallavicini 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.

    PMID: 23398927DERIVED

Related Links

MeSH Terms

Conditions

Stress, Psychological

Interventions

Coping SkillsRelaxation Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesMind-Body TherapiesComplementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Scientific coordinator

Study Record Dates

First Submitted

September 5, 2012

First Posted

September 12, 2012

Study Start

May 1, 2012

Primary Completion

January 1, 2014

Study Completion

July 1, 2015

Last Updated

August 29, 2018

Record last verified: 2018-08

Locations

IT(1)