Virtual Reality as Anxiety Management Tool for Generalized Anxiety Disorder (INTREPID)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Istituto Auxologico Italiano
ClinicalTrials.gov Identifier:
NCT00602212
First received: January 15, 2008
Last updated: September 8, 2011
Last verified: January 2008
  Purpose

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.

Condition Intervention
Generalized Anxiety Disorder
Behavioral: relaxation with virtual reality (VR)
Behavioral: relaxation and biofeedback virtual reality

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Istituto Auxologico Italiano:

Primary Outcome Measures:
  • level of anxiety measured by: psychometric questionnaires (PSWQ, BAI, Anti, CID, STAI) and psychophysiological measures ((skin conductance response (SCR), muscle tension, heart and respiratory rates) [ Time Frame: immediately before and after each treatment session. At follow up (6 and 12 months) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • subjective measures (diary) [ Time Frame: during the treatment and during the follow up period ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: February 2008
Study Completion Date: June 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: VR + Mobile Phone without Biofeedback
In this experimental condition patients received an eight-session VR-based treatment including relaxation and exposure
Behavioral: relaxation with virtual reality (VR)
VR relaxing environment and audio-visual mobile narratives will be used to teach patients how to relax themselves
Other Names:
  • relaxation
  • virtual reality
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:
Other Names:
  • relaxation
  • virtual reality
  • biofeedback
Experimental: VR + Mobile Phone with biofeedback
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:
Behavioral: relaxation with virtual reality (VR)
VR relaxing environment and audio-visual mobile narratives will be used to teach patients how to relax themselves
Other Names:
  • relaxation
  • virtual reality
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:
Other Names:
  • relaxation
  • virtual reality
  • biofeedback

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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Primary diagnosis of GAD
  2. Requesting treatment for their GAD
  3. Older than 17 and younger than 70; (4) no change in dose of psychotropic medications 1 month before inclusion

Exclusion Criteria:

  1. Depressive disorder preceding the current episode of GAD or requiring immediate treatment
  2. Behavior therapy received for their GAD
  3. Evidence of organic mental disorders accounting for the complaints, mental retardation, psychotic disorders, alcohol or drug dependence
  4. Migraine, headache, seizure disorder, and vestibular abnormalities since they represent significant contraindications for the use of VR.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00602212

Locations
Italy
Istituto Auxologico Italiano
Milano, Italy, 20100
Sponsors and Collaborators
Istituto Auxologico Italiano
Investigators
Study Director: Giuseppe Riva, Phd Istituto Auxologico Italiano
Principal Investigator: Alessandra Gorini, PsyD Istituto Auxologico Italiano
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Istituto Auxologico Italiano
ClinicalTrials.gov Identifier: NCT00602212     History of Changes
Other Study ID Numbers: 03E701, IST-2002-507464
Study First Received: January 15, 2008
Last Updated: September 8, 2011
Health Authority: Italy: Ministry of Health

Keywords provided by Istituto Auxologico Italiano:
generalized anxiety disorder (GAD)

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 23, 2014