Biofeedback, virtual reality and mobile phones in the treatment of generalized anxiety disorder (gad): A phase-2 controlled clinical trial

Generalized Anxiety Disorder (GAD) is a psychiatric disease characterized by long-lasting anxiety that is not focused on a specific object or situation. 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 difficult to learn. To overcome this limitation, the EU-funded INTREPID research project (IST-2002-507464) proposes improvement of exiting treatment for GAD through the use of a biofeedback-enhanced virtual reality (VR) system, used both for relaxation and controlled exposure. Furthermore, this experience is strengthened by the use of a mobile phone that allows patients to perform the virtual experience even in an outpatient setting. This approach was tested in a Phase II randomized controlled trial (NCT00602212), including three groups of four patients each, resulting in a total of 12 patients. The first group consisted of the VR and Mobile group (VRMB) including biofeedback, the second of the VR and Mobile group (VRM) without biofeedback, and the third the waiting list (WL) group. This study provides initial evidence for better efficacy of treatment for the VRMB group. Subjects belonging to this group reported a higher decrease in some of the anxiety psychometric questionnaires after the treatment than both VRM and WL groups, even if the VRM group, too, reported some significant improvements at the end of therapy. Moreover, qualitative reports concerning outpatient use of mobile phones suggests that it can solve a classical problem of VR therapies-the impossibility of using a VR system in the real life context of the patient.