Virtual Reality as Anxiety Management Tool for Generalized Anxiety Disorder

NCT00602212 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2011-09-09

No results posted yet for this study

Summary

Generalized Anxiety Disorder (GAD) is a psychiatric disease characterized by long-lasting anxiety that is not focused on a specific object or situation. According to the DSM-IV-TR the essential feature of GAD is at least six months of "excessive anxiety and worry" about a variety of events and situations. Anxiety and worry are often accompanied by a variety of physical symptoms like restlessness, being easily fatigued, difficulty concentrating, irritability, muscle tension and disturbed sleep. The high prevalence of GAD in the general population and the severe limitations it causes point out the necessity to find new strategies to treat it in a more efficient way. Within the treatment of GAD, physical (relaxation and controlled breathing), behavioral (visualization and controlled exposure) and cognitive control strategies (challenging negative thoughts) represent a key part of the treatment, even if they are hard to be learned. Given the features of this disease and its pervasive effect on patient's personal, occupational and affective life, we thought it could benefit from an ubiquitous treatment.We suggested, then, to improve the treatment of GAD through the use of a biofeedback enhanced virtual reality (VR) system used for relaxation, controlled exposure and SIT. The use of SIT in the context of GAD is motivated by the acknowledgment that sometimes stressors can't be avoided or altered and then patients can't apply strategies focused on finding solutions. In these instances, coping effort should be directed to emotionally palliative set of responses such as acceptance, reframing and perspective thinking. All these cognitive changes are facilitated if a concomitant relaxation is induced. The treatment involves two virtual reality components:

I) an immersive virtual reality system experienced in the therapist's office;

II) a mobile exposure system allowing patients to perform the virtual experience in an outpatient setting. The role of the mobile exposure system is the following:

* To present and structure emotionally relevant contents in an ubiquitous context.
* To verify the compliance of the patient and eventually alert patient/therapist;
* To track in real-time the emotional level of the patient and record it for later assessment by the therapist;
* To provide a feedback to the patient able to help him in coping with the contents;
* To automatically contact the therapist if the emotional level is higher than a preset cut-off value defined by the therapist.

Conditions

  • Generalized Anxiety Disorder

Interventions

BEHAVIORAL

relaxation with virtual reality (VR)

VR relaxing environment and audio-visual mobile narratives will be used to teach patients how to relax themselves

BEHAVIORAL

relaxation and biofeedback virtual reality

The patients experienced the same protocol described above, but with the biofeedback support. Specifically, in the sessions with the therapist, HR variations were used to modify specific features of the virtual environment:

Sponsors & Collaborators

  • Istituto Auxologico Italiano

    lead OTHER

Principal Investigators

  • Giuseppe Riva, Phd · Istituto Auxologico Italiano

  • Alessandra Gorini, PsyD · Istituto Auxologico Italiano

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2010-12-31
Completion
2011-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00602212 on ClinicalTrials.gov