Virtual Reality as Anxiety Management Tool for Generalized Anxiety Disorder
Condition: Generalized Anxiety Disorder
MeSH terms: Anxiety Disorders
Study type: Interventional

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.
    

Detailed description: 
      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:

        1. Virtual Reality + Mobile Phone without Biofeedback Condition (VRM). In this experimental
           condition patients received an eight-session VR-based treatment including relaxation and
           exposure. In sessions 1 to 6, the patient explored a beautiful VR tropical island
           (experienced with a head-mounted display and head-tracking) following a predefined path
           leading to different relaxing areas: Campfire, Beach and Waterfall. In these areas the
           patients started to relax by observing the flickering campfire, watching waves lapping
           gently on a shore, or looking to the waterfall and fish pond. Each experience was
           supported by an audio narrative based on progressive muscle relaxation and/or autogenic
           techniques. All the environments were developed by the ESIEA INTREPID team (J.L. Dautin,
           J. Ardouin, F. Crison and M. Le Renard -www.esiea.fr) using the 3DVIA 4.1 Virtools
           toolkit by Dassault Systèmes - www.virtools.com.To improve the efficacy of the training
           and to increase the effects of relaxation, patients experienced at home, using a mobile
           phone, on a non-navigable version of the same virtual reality environment experienced
           during the therapy. The patient was asked to train relaxation abilities at least once a
           day for the entire duration of the treatment following the treatment plan provided by
           the therapist. In session 7 and 8 the patients explored again the island reaching a
           Gazebo in which they are exposed to pre-selected words or images related to their
           personal stressful events. The patients were then asked to use the learned relaxation
           techniques to cope with them.

        2. Virtual Reality + Mobile Phone with Biofeedback Condition (VRMB). The patients
           experienced the same protocol described above, but with the biofeedback support (see
           Figure 2). Specifically, in the sessions with the therapist, HR variations were used to
           modify specific features of the virtual environment:

             1. Campfire (sessions 1-2). HR controls the fire intensity: a reduction of the
                patient's physiological activation reduces fire intensity until it disappears;

             2. Beach (sessions 3-4). HR controls the movement of the waves: a reduction of the
                patient's physiological activation reduces the movement of the waves until the
                ocean becomes completely calm;

             3. Waterfall (sessions 5-6): HR controls the movement of the water: a reduction of the
                patient's physiological activation reduces the movement of the water until the
                water flow becomes completely still;

             4. Gazebo (sessions 7-8): HR controls the size of a stressful image or video: a
                reduction of the patient's physiological activation reduces the size of the
                stimulus until it disappears. This exercise is designed following the procedure of
                SIT.

        3. Waiting List Condition (WL). This was a control condition, in which patients were
           included in a waiting list and not received any kind of relaxation training.
    

Intervention name(s): relaxation with virtual reality (VR); relaxation and biofeedback virtual reality
Intervention type(s): Behavioral; Behavioral
Intervention description(s): VR relaxing environment and audio-visual mobile narratives will be used to teach patients how to relax themselves; 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 intervention name(s): relaxation; virtual reality; relaxation; virtual reality; biofeedback
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: generalized anxiety disorder (GAD)