Generalized Anxiety DisorderINTREPIDNCT00602212
Virtual Reality as Anxiety Management Tool for Generalized Anxiety Disorder
A study testing relaxation with virtual reality (VR) and relaxation and biofeedback virtual reality in people with Generalized Anxiety Disorder, run by Istituto Auxologico Italiano at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- relaxation with virtual reality (VR) and relaxation and biofeedback virtual reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2008to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis of GAD
- Requesting treatment for their GAD
- Older than 17 and younger than 70; (4) no change in dose of psychotropic medications 1 month before inclusion
Who cannot join
- Depressive disorder preceding the current episode of GAD or requiring immediate treatment
- Behavior therapy received for their GAD
- Evidence of organic mental disorders accounting for the complaints, mental retardation, psychotic disorders, alcohol or drug dependence
- Migraine, headache, seizure disorder, and vestibular abnormalities since they represent significant contraindications for the use of VR.
Trial locations and contacts
1 site in 1 country.
About this study
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
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:
- an immersive virtual reality system experienced in the therapist's office;
Read more
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.
Read the 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:
- 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.
- 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:
- Campfire (sessions 1-2). HR controls the fire intensity: a reduction of the patient's physiological activation reduces fire intensity until it disappears;
- 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;
- 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;
- 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.
- 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.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- relaxation with virtual reality (VR), relaxation and biofeedback virtual reality
- Keywords
- generalized anxiety disorder (GAD)
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
relaxation with virtual reality (VR)Behavioural
Also called relaxation, virtual reality
VR relaxing environment and audio-visual mobile narratives will be used to teach patients how to relax themselves
relaxation and biofeedback virtual realityBehavioural
Also called relaxation, virtual reality, 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:
| Study group | Role | What they receive |
|---|---|---|
| VR + Mobile Phone without Biofeedback | Active comparator | In this experimental condition patients received an eight-session VR-based treatment including relaxation and exposure Receives: Behavioral: relaxation with virtual reality (VR); Behavioral: relaxation and biofeedback virtual reality |
| VR + Mobile Phone with biofeedback | Experimental | 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: Receives: Behavioral: relaxation with virtual reality (VR); Behavioral: relaxation and biofeedback virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: immediately before and after each treatment session. At follow up (6 and 12 months)
Secondary outcomes (1)
subjective measures (diary)
Measured: during the treatment and during the follow up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2008 (estimated)
- Study startFeb 2008
- Primary completionDec 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giuseppe Riva, Phd, Study director, Istituto Auxologico ItalianoAlessandra Gorini, PsyD, Principal investigator, Istituto Auxologico Italiano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00602212
- Sponsor's protocol ID
- 03E701
- Other IDs
- IST-2002-507464
- Acronym
- INTREPID
- Status last verified
- Jan 2008
- First submitted
- 15 Jan 2008
- Last updated
- 9 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Riva G, Gorini A, Gaggioli A. The Intrepid project - biosensor-enhanced virtual therapy for the treatment of generalized anxiety disorders. Stud Health Technol Inform. 2009;142:271-6.
PubMed 19377166Gorini A, Riva G. The potential of virtual reality as anxiety management tool: a randomized controlled study in a sample of patients affected by generalized anxiety disorder. Trials. 2008 May 5;9:25. doi: 10.1186/1745-6215-9-25.
PubMed 18457580Repetto C, Gorini A, Vigna C, Algeri D, Pallavicini F, Riva G. The use of biofeedback in clinical virtual reality: the INTREPID project. J Vis Exp. 2009 Nov 12;(33):1554. doi: 10.3791/1554.
PubMed 19915521Repetto C, Gorini A, Algeri D, Vigna C, Gaggioli A, Riva G. The use of biofeedback in clinical virtual reality: the intrepid project. Stud Health Technol Inform. 2009;144:128-32.
PubMed 19592748Gorini A, Pallavicini F, Algeri D, Repetto C, Gaggioli A, Riva G. Virtual reality in the treatment of generalized anxiety disorders. Stud Health Technol Inform. 2010;154:39-43.
PubMed 20543266
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00602212
- Acronym / sponsor ID
- INTREPID / 03E701
- Conditions
- Generalized Anxiety Disorder
- Keywords
- generalized anxiety disorder (GAD)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 28 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
- 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:
- Campfire (sessions 1-2). HR controls the fire intensity: a reduction of the patient's physiological activation reduces fire intensity until it disappears;
- 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;
- 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;
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VR + Mobile Phone without Biofeedback | Active comparator | Behavioral: relaxation with virtual reality (VR), Behavioral: relaxation and biofeedback virtual realityIn this experimental condition patients received an eight-session VR-based treatment including relaxation and exposure |
| VR + Mobile Phone with biofeedback | Experimental | Behavioral: relaxation with virtual reality (VR), Behavioral: relaxation and biofeedback virtual realityThe 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: |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary diagnosis of GAD
- Requesting treatment for their GAD
- Older than 17 and younger than 70; (4) no change in dose of psychotropic medications 1 month before inclusion
Key exclusion criteria (4 listed)
- Depressive disorder preceding the current episode of GAD or requiring immediate treatment
- Behavior therapy received for their GAD
- Evidence of organic mental disorders accounting for the complaints, mental retardation, psychotic disorders, alcohol or drug dependence
- Migraine, headache, seizure disorder, and vestibular abnormalities since they represent significant contraindications for the use of VR.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| relaxation with virtual reality (VR)Also: relaxation, virtual realityVR relaxing environment and audio-visual mobile narratives will be used to teach patients how to relax themselves | Behavioural | VR + Mobile Phone with biofeedback, VR + Mobile Phone without Biofeedback |
| relaxation and biofeedback virtual realityAlso: relaxation, virtual reality, biofeedbackThe 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: | Behavioural | VR + Mobile Phone with biofeedback, VR + Mobile Phone without Biofeedback |
Primary outcome
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)
1 secondary outcome
subjective measures (diary)
Time frame: during the treatment and during the follow up period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2011.
- Background: PubMed 19377166Riva G, Gorini A, Gaggioli A. The Intrepid project - biosensor-enhanced virtual therapy for the treatment of generalized anxiety disorders. Stud Health Technol Inform. 2009;142:271-6.
- Background: PubMed 18457580Gorini A, Riva G. The potential of virtual reality as anxiety management tool: a randomized controlled study in a sample of patients affected by generalized anxiety disorder. Trials. 2008 May 5;9:25. doi: 10.1186/1745-6215-9-25.
- Results publication: PubMed 19915521Repetto C, Gorini A, Vigna C, Algeri D, Pallavicini F, Riva G. The use of biofeedback in clinical virtual reality: the INTREPID project. J Vis Exp. 2009 Nov 12;(33):1554. doi: 10.3791/1554.
- Results publication: PubMed 19592748Repetto C, Gorini A, Algeri D, Vigna C, Gaggioli A, Riva G. The use of biofeedback in clinical virtual reality: the intrepid project. Stud Health Technol Inform. 2009;144:128-32.
- Derived from this study: PubMed 20543266Gorini A, Pallavicini F, Algeri D, Repetto C, Gaggioli A, Riva G. Virtual reality in the treatment of generalized anxiety disorders. Stud Health Technol Inform. 2010;154:39-43.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe Riva, Phd study director
Istituto Auxologico Italiano
Alessandra Gorini, PsyD principal investigator
Istituto Auxologico Italiano
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing relaxation with virtual reality (VR) and relaxation and biofeedback virtual reality in people with Generalized Anxiety Disorder, run by Istituto Auxologico Italiano at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00602212, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2011.