Istituto Auxologico Italiano
Milan, 20100, Italy
NCT Number: NCT00602212
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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Milan, 20100, Italy
The patients were randomly assigned to the following groups: (1) the VR and Mobile group (VRMB) including biofeedback - 7 subjects; (2) the VR and Mobile group (VRM) without biofeedback - 9 subjects; (3) the waiting list (WL) group - 8 subjects:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
VR relaxing environment and audio-visual mobile narratives will be used to teach patients how to relax themselves
Other names: relaxation, 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:
Other names: relaxation, virtual reality, biofeedback
Time frame: immediately before and after each treatment session. At follow up (6 and 12 months)
Time frame: during the treatment and during the follow up period
Istituto Auxologico Italiano
Other
The Potential of Virtual Reality as Anxiety Management Tool: a Randomised Controlled Study in a Sample of Patients Affected by Generalized Anxiety Disorder
Acronym: INTREPID
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