Ignite Creation Date:
2024-05-05 @ 7:07 PM
Last Modification Date:
2024-10-26 @ 9:43 AM
Study NCT ID:
NCT00602212
Status:
COMPLETED
Last Update Posted:
2011-09-09
First Post:
2008-01-15
Brief Title:
Virtual Reality as Anxiety Management Tool for Generalized Anxiety Disorder
Sponsor:
Istituto Auxologico Italiano
Organization:
Istituto Auxologico Italiano
Study Overview
Official Title:
The Potential of Virtual Reality as Anxiety Management Tool a Randomised Controlled Study in a Sample of Patients Affected by Generalized Anxiety Disorder
Status:
COMPLETED
Status Verified Date:
2008-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INTREPID
Brief 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 patients personal occupational and affective life we thought it could benefit from an ubiquitous treatmentWe 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 cant be avoided or altered and then patients cant 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 therapists 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 patienttherapist
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
I an immersive virtual reality system experienced in the therapists 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 patienttherapist
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 andor autogenic techniques All the environments were developed by the ESIEA INTREPID team JL Dautin J Ardouin F Crison and M Le Renard -wwwesieafr using the 3DVIA 41 Virtools toolkit by Dassault Systèmes - wwwvirtoolscomTo 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 patients physiological activation reduces fire intensity until it disappears
2 Beach sessions 3-4 HR controls the movement of the waves a reduction of the patients 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 patients 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 patients 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
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 andor autogenic techniques All the environments were developed by the ESIEA INTREPID team JL Dautin J Ardouin F Crison and M Le Renard -wwwesieafr using the 3DVIA 41 Virtools toolkit by Dassault Systèmes - wwwvirtoolscomTo 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 patients physiological activation reduces fire intensity until it disappears
2 Beach sessions 3-4 HR controls the movement of the waves a reduction of the patients 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 patients 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IST-2002-507464 | OTHER_GRANT | European Union - IST Programme - FP5 | None |