Phobic DisordersVARESAPNCT01361074
In Vivo Versus Augmented Reality Exposure for Small Animal Phobia
A study testing In Vivo Exposure for Animal Phobia following Öst´s guidelines and Augmented Reality Exposure for Animal Phobia following Öst´s guidelines in people with Phobic Disorders, run by Universitat Jaume I at 2 sites in Spain.
Trial summary
The aim of this study is to explore the differential efficacy of in vivo exposure versus augmented reality exposure in the treatment of specific phobia (small animals). The hypothesis is: There will not be significant statistical differences in the efficacy of in vivo exposure therapy versus augmented reality exposure… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Phobic Disorders
- What is being tested?
- In Vivo Exposure for Animal Phobia following Öst´s guidelines and Augmented Reality Exposure for Animal Phobia following Öst´s guidelines
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesSpain
- Study dates
- Jan 2011to Jan 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be between 18-65 years of age.
- To meet current DSM-IV-TR criteria for specific phobia (animal type)
- Have as the major presenting complaint anxiety in, and avoidance of, a large range of situations involving spiders or cockroaches.
- A minimum of 1 year duration of the phobia.
- To have scores over 4 in phobic avoidance (on a scale of 0 to 8).
- Express a willingness to participate in the study.
Who cannot join
- To be able to put a hand inside the container with a spider or cockroach during the behavioral test.
- Have other psychiatric problem in immediate need of treatment.
- Have psychotic or organic symptoms.
- Have heart or lung disease.
- Current alcohol or drug dependence or medication.
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
University Jaume I
Castellon, Castellon, 12006
University Jaume I
Castellon, Castellón, 12071
About this study
Official title: In Vivo Versus Augmented Reality Exposure for Small Animal Phobia Treatment: A Randomized Controlled Trial
The aim of this study is to explore the differential efficacy of in vivo exposure versus augmented reality exposure in the treatment of specific phobia (small animals).
The hypothesis is: There will not be significant statistical differences in the efficacy of in vivo exposure therapy versus augmented reality exposure in the treatment of specific phobia (small animals).
Read the detailed description
Among anxiety disorders, specific phobias are highly prevalent (around 7.2% and 11.3% in the general population). Cockroach or spider phobia is a type of specific phobia, animal type. The gold standard for the treatment of specific phobia (included small animal phobia) is in vivo exposure. Most phobia sufferers (60-80%) never seek treatment. Besides, not all patients benefit from in vivo exposure, given that an important amount of them do not accept the intervention or drop out (around 25%) when they are informed about the intervention procedure.
Information and Communication Technologies (ICT) like Virtual Reality (VR) and Augmented Reality (AR) are pioneer applications that can improve treatment adherence and acceptance. There exist some studies offering preliminary evidence of the efficacy of AR for the treatment of small animal phobia. However, there are not any controlled study exploring the differential efficacy of ICT-based exposure interventions versus in vivo exposure. In the present study the differential efficacy of AR exposure versus in vivo exposure for the treatment of small animal phobia is explored with a between subject randomized controlled trial. A pre-treatment assessment will be conducted in order to establish the diagnosis and evaluate the main outcome measures. All participants will receive an intensive exposure session following Öst guidelines, (in vivo exposure in one experimental condition and AR exposure in the other experimental condition). After the treatment a post-treatment assessment will be carried out as well as follow-up assessments at 3- and 12-month after treatment completion.
- Conditions
- Phobic Disorders
- Being tested
- In Vivo Exposure for Animal Phobia following Öst´s guidelines, Augmented Reality Exposure for Animal Phobia following Öst´s guidelines
- Keywords
- Virtual reality, Augmented reality, In vivo exposure, One session treatment, ICT, Efficacy, Specific phobia, Anxiety disorders
- Medical subject headings
- Phobic Disorders, Phobia, Specific, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In Vivo Exposure for Animal Phobia following Öst´s guidelinesBehavioural
Also called In vivo exposure in phobic disorders, In vivo exposure for small animal phobia
In vivo exposure is applied using "one-session treatment" guidelines (Öst, Salkovskis and Hellström, 1991). Exposure is conducted in a single extended session lasting up to 3 hours and implemented individually. The treatment includes participant modelling, in vivo exposure, reinforced practice and cognitive challenge. Treatment in a single session is just a starting point; it is recommended that the participants continue to be exposed to the phobic situations after therapy in their daily lives in order to fully surmount their problems. Participants are informed that the treatment required close collaboration between themselves and the therapist. The exposure session is completed in a gradual and planned way.
Augmented Reality Exposure for Animal Phobia following Öst´s guidelinesBehavioural
Also called Augmented Reality Exposure in phobic disorders, Augmented Reality Exposure for small animal phobia
Augmented Reality (AR) is a variation of Virtual Reality in which the user sees the real world augmented by various virtual elements; it complements reality rather than replacing it completely (Azuma et al., 2001). The most significant aspect of AR is that the virtual elements add relevant and helpful information to the physical information available in the real world. The system includes the options of changing the number, movement and size of small animals. Preliminary data show the utility of the system for the treatment of insect phobia (Botella et al., 2005). AR exposure is applied in the same way than in vivo exposure, that is, in a gradual, planned and controlled way using "one-session treatment" guidelines (Öst, Salkovskis and Hellström, 1991). The therapist can see what the participant sees in AR on a monitor and observe the same stimuli.
| Study group | Role | What they receive |
|---|---|---|
| In Vivo Exposure | Experimental | Not described Receives: Behavioral: In Vivo Exposure for Animal Phobia following Öst´s guidelines |
| Augmented Reality Exposure | Experimental | Not described Receives: Behavioral: Augmented Reality Exposure for Animal Phobia following Öst´s guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Behavioral Avoidance Test (BAT, Öst, Salkovskis, and Hellström's, 1991) at pre, post intervention and 3 and 12-month follow-up periods
The BAT assesses the severity of the subjective fear, avoidance, and belief in the catastrophic thoughts of the participants on a scale of 0 to 10 before they entered in a room with a feared insect. A container with a live cockroach or spider in it was placed 5 meters from the entrance. Participants were asked to enter the room and approach the insect as closely as possible. They were told that they could terminate the behavioral test at any point. Their performances in the test were scored, taking into account their final proximity to the insect and was converted to a behavioral score.
Measured: At pre (baseline), post intervention and 3 and 12-month follow-up periods
Secondary outcomes (1)
Change in Spider Phobia Beliefs Questionnaire (SPBQ; adapted from Arntz, Lavy, Van der Berg, & Van Rijsoort, 1993) at pre, post intervention and 3 and 12-month follow-up periods
This is a self-report scale with two subscales: items 1-42 assess the strength of fearful beliefs about spiders; items 43-78 measure the strength of fearful beliefs about one's reaction to encountering spiders. Items are rated from 0 to 100. Good internal consistency for both subscales (α=.94) and acceptable test-retest reliability (r=.68 for the spider-related and r=.71 for the self-related one) have been reported. An adaptation of this questionnaire was made by our research team in order to assess fearful beliefs about cockroaches and has been used in other studies (Botella et al., 2008).
Measured: At pre (baseline), post intervention and 3 and 12-month follow-up periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2011 (estimated)
- Study startJan 2011
- Primary completionMay 2011
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Phobic DisordersStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Collaborators
- University of Valencia
- Responsible party
- Sponsor
- Investigators
- Cristina Botella, Full Professor, Study director, University Jaume I, Castellon, Spain.Cristina Botella, Full Professor, Study director, University Jaume I, Castellon, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01361074
- Sponsor's protocol ID
- UJaumeI01
- Acronym
- VARESAP
- Status last verified
- Sep 2013
- First submitted
- 26 Apr 2011
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Botella C, Breton-Lopez J, Quero S, Banos R, Garcia-Palacios A. Treating cockroach phobia with augmented reality. Behav Ther. 2010 Sep;41(3):401-13. doi: 10.1016/j.beth.2009.07.002. Epub 2010 Mar 20.
PubMed 20569788Essau CA, Conradt J, Petermann F. Frequency, comorbidity, and psychosocial impairment of specific phobia in adolescents. J Clin Child Psychol. 2000 Jun;29(2):221-31. doi: 10.1207/S15374424jccp2902_8.
PubMed 10802831Magee WJ, Eaton WW, Wittchen HU, McGonagle KA, Kessler RC. Agoraphobia, simple phobia, and social phobia in the National Comorbidity Survey. Arch Gen Psychiatry. 1996 Feb;53(2):159-68. doi: 10.1001/archpsyc.1996.01830020077009.
PubMed 8629891Garcia-Palacios A, Botella C, Hoffman H, Fabregat S. Comparing acceptance and refusal rates of virtual reality exposure vs. in vivo exposure by patients with specific phobias. Cyberpsychol Behav. 2007 Oct;10(5):722-4. doi: 10.1089/cpb.2007.9962.
PubMed 17927544Garcia-Palacios A, Hoffman HG, See SK, Tsai A, Botella C. Redefining therapeutic success with virtual reality exposure therapy. Cyberpsychol Behav. 2001 Jun;4(3):341-8. doi: 10.1089/109493101300210231.
PubMed 11710258Marks IM, Mathews AM. Brief standard self-rating for phobic patients. Behav Res Ther. 1979;17(3):263-7. doi: 10.1016/0005-7967(79)90041-x. No abstract available.
PubMed 526242Botella CM, Juan MC, Banos RM, Alcaniz M, Guillen V, Rey B. Mixing realities? An application of augmented reality for the treatment of cockroach phobia. Cyberpsychol Behav. 2005 Apr;8(2):162-71. doi: 10.1089/cpb.2005.8.162.
PubMed 15938656Juan MC, Alcaniz M, Monserrat C, Botella C, Banos RM, Guerrero B. Using augmented reality to treat phobias. IEEE Comput Graph Appl. 2005 Nov-Dec;25(6):31-7. doi: 10.1109/mcg.2005.143. No abstract available.
PubMed 16315475Ost LG. One-session treatment for specific phobias. Behav Res Ther. 1989;27(1):1-7. doi: 10.1016/0005-7967(89)90113-7.
PubMed 2914000Ost LG. [One-session treatment of specific phobias--a rapid and effective method]. Lakartidningen. 1988 Mar 30;85(13):1139-42. No abstract available. Swedish.
PubMed 3352391
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Versus Augmented Reality Exposure for Small Animal Phobia Treatment: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01361074
- Acronym / sponsor ID
- VARESAP / UJaumeI01
- Conditions
- Phobic Disorders
- Keywords
- Virtual reality, Augmented reality, In vivo exposure, One session treatment, ICT, Efficacy, Specific phobia, Anxiety disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Collaborators
- University of Valencia
- Study start
- Jan 2011
- Primary completion
- May 2011 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 26 May 2011 (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.
The aim of this study is to explore the differential efficacy of in vivo exposure versus augmented reality exposure in the treatment of specific phobia (small animals).
The hypothesis is: There will not be significant statistical differences in the efficacy of in vivo exposure therapy versus augmented reality exposure in the treatment of specific phobia (small animals).
Detailed description
Among anxiety disorders, specific phobias are highly prevalent (around 7.2% and 11.3% in the general population). Cockroach or spider phobia is a type of specific phobia, animal type. The gold standard for the treatment of specific phobia (included small animal phobia) is in vivo exposure. Most phobia sufferers (60-80%) never seek treatment. Besides, not all patients benefit from in vivo exposure, given that an important amount of them do not accept the intervention or drop out (around 25%) when they are informed about the intervention procedure.
Information and Communication Technologies (ICT) like Virtual Reality (VR) and Augmented Reality (AR) are pioneer applications that can improve treatment adherence and acceptance. There exist some studies offering preliminary evidence of the efficacy of AR for the treatment of small animal phobia. However, there are not any controlled study exploring the differential efficacy of ICT-based exposure interventions versus in vivo exposure. In the present study the differential efficacy of AR exposure versus in vivo exposure for the treatment of small animal phobia is explored with a between subject randomized controlled trial. A pre-treatment assessment will be conducted in order to establish the diagnosis and evaluate the main outcome measures. All participants will receive an intensive exposure session following Öst guidelines, (in vivo exposure in one experimental condition and AR exposure in the other experimental condition). After the treatment a post-treatment assessment will be carried out as well as follow-up assessments at 3- and 12-month after treatment completion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In Vivo Exposure | Experimental | Behavioral: In Vivo Exposure for Animal Phobia following Öst´s guidelines |
| Augmented Reality Exposure | Experimental | Behavioral: Augmented Reality Exposure for Animal Phobia following Öst´s guidelines |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be between 18-65 years of age.
- To meet current DSM-IV-TR criteria for specific phobia (animal type)
- Have as the major presenting complaint anxiety in, and avoidance of, a large range of situations involving spiders or cockroaches.
- A minimum of 1 year duration of the phobia.
- To have scores over 4 in phobic avoidance (on a scale of 0 to 8).
Key exclusion criteria (5 listed)
- To be able to put a hand inside the container with a spider or cockroach during the behavioral test.
- Have other psychiatric problem in immediate need of treatment.
- Have psychotic or organic symptoms.
- Have heart or lung disease.
- Current alcohol or drug dependence or medication.
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 |
|---|---|---|
| In Vivo Exposure for Animal Phobia following Öst´s guidelinesAlso: In vivo exposure in phobic disorders, In vivo exposure for small animal phobiaIn vivo exposure is applied using "one-session treatment" guidelines (Öst, Salkovskis and Hellström, 1991). Exposure is conducted in a single extended session lasting up to 3 hours and implemented individually. The treatment includes participant modelling, in vivo exposure, reinforced practice and cognitive challenge. Treatment in a single session is just a starting point; it is recommended that the participants continue to be exposed to the phobic situations after therapy in their daily lives in order to fully surmount their problems. Participants are informed that the treatment required close collaboration between themselves and the therapist. The exposure session is completed in a gradual and planned way. | Behavioural | In Vivo Exposure |
| Augmented Reality Exposure for Animal Phobia following Öst´s guidelinesAlso: Augmented Reality Exposure in phobic disorders, Augmented Reality Exposure for small animal phobiaAugmented Reality (AR) is a variation of Virtual Reality in which the user sees the real world augmented by various virtual elements; it complements reality rather than replacing it completely (Azuma et al., 2001). The most significant aspect of AR is that the virtual elements add relevant and helpful information to the physical information available in the real world. The system includes the options of changing the number, movement and size of small animals. Preliminary data show the utility of the system for the treatment of insect phobia (Botella et al., 2005). AR exposure is applied in the same way than in vivo exposure, that is, in a gradual, planned and controlled way using "one-session treatment" guidelines (Öst, Salkovskis and Hellström, 1991). The therapist can see what the participant sees in AR on a monitor and observe the same stimuli. | Behavioural | Augmented Reality Exposure |
Primary outcome
Change in Behavioral Avoidance Test (BAT, Öst, Salkovskis, and Hellström's, 1991) at pre, post intervention and 3 and 12-month follow-up periods
Time frame: At pre (baseline), post intervention and 3 and 12-month follow-up periods
The BAT assesses the severity of the subjective fear, avoidance, and belief in the catastrophic thoughts of the participants on a scale of 0 to 10 before they entered in a room with a feared insect. A container with a live cockroach or spider in it was placed 5 meters from the entrance. Participants were asked to enter the room and approach the insect as closely as possible. They were told that they could terminate the behavioral test at any point. Their performances in the test were scored, taking into account their final proximity to the insect and was converted to a behavioral score.
1 secondary outcome
Change in Spider Phobia Beliefs Questionnaire (SPBQ; adapted from Arntz, Lavy, Van der Berg, & Van Rijsoort, 1993) at pre, post intervention and 3 and 12-month follow-up periods
Time frame: At pre (baseline), post intervention and 3 and 12-month follow-up periods
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 4 Dec 2015.
- Background: PubMed 20569788Botella C, Breton-Lopez J, Quero S, Banos R, Garcia-Palacios A. Treating cockroach phobia with augmented reality. Behav Ther. 2010 Sep;41(3):401-13. doi: 10.1016/j.beth.2009.07.002. Epub 2010 Mar 20.
- Background: PubMed 10802831Essau CA, Conradt J, Petermann F. Frequency, comorbidity, and psychosocial impairment of specific phobia in adolescents. J Clin Child Psychol. 2000 Jun;29(2):221-31. doi: 10.1207/S15374424jccp2902_8.
- Background: PubMed 8629891Magee WJ, Eaton WW, Wittchen HU, McGonagle KA, Kessler RC. Agoraphobia, simple phobia, and social phobia in the National Comorbidity Survey. Arch Gen Psychiatry. 1996 Feb;53(2):159-68. doi: 10.1001/archpsyc.1996.01830020077009.
- Background: PubMed 17927544Garcia-Palacios A, Botella C, Hoffman H, Fabregat S. Comparing acceptance and refusal rates of virtual reality exposure vs. in vivo exposure by patients with specific phobias. Cyberpsychol Behav. 2007 Oct;10(5):722-4. doi: 10.1089/cpb.2007.9962.
- Background: PubMed 11710258Garcia-Palacios A, Hoffman HG, See SK, Tsai A, Botella C. Redefining therapeutic success with virtual reality exposure therapy. Cyberpsychol Behav. 2001 Jun;4(3):341-8. doi: 10.1089/109493101300210231.
- Background: PubMed 526242Marks IM, Mathews AM. Brief standard self-rating for phobic patients. Behav Res Ther. 1979;17(3):263-7. doi: 10.1016/0005-7967(79)90041-x. No abstract available.
- Background: PubMed 15938656Botella CM, Juan MC, Banos RM, Alcaniz M, Guillen V, Rey B. Mixing realities? An application of augmented reality for the treatment of cockroach phobia. Cyberpsychol Behav. 2005 Apr;8(2):162-71. doi: 10.1089/cpb.2005.8.162.
- Background: PubMed 16315475Juan MC, Alcaniz M, Monserrat C, Botella C, Banos RM, Guerrero B. Using augmented reality to treat phobias. IEEE Comput Graph Appl. 2005 Nov-Dec;25(6):31-7. doi: 10.1109/mcg.2005.143. No abstract available.
- Background: PubMed 2914000Ost LG. One-session treatment for specific phobias. Behav Res Ther. 1989;27(1):1-7. doi: 10.1016/0005-7967(89)90113-7.
- Background: PubMed 3352391Ost LG. [One-session treatment of specific phobias--a rapid and effective method]. Lakartidningen. 1988 Mar 30;85(13):1139-42. No abstract available. Swedish.
- Information about our research groupLink provided by the sponsor.
- International research group that focuses on virtual reality and analgesic effectsLink provided by the sponsor.
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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.
Cristina Botella, Full Professor study director
University Jaume I, Castellon, Spain.
Cristina Botella, Full Professor study director
University Jaume I, Castellon, Spain
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In Vivo Exposure for Animal Phobia following Öst´s guidelines and Augmented Reality Exposure for Animal Phobia following Öst´s guidelines in people with Phobic Disorders, run by Universitat Jaume I at 2 sites in Spain.
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 6 inclusion and 5 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 4 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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?
Change in Behavioral Avoidance Test (BAT, Öst, Salkovskis, and Hellström's, 1991) at pre, post intervention and 3 and 12-month follow-up periods (time frame: At pre (baseline), post intervention and 3 and 12-month follow-up periods). 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 NCT01361074, which also lists 10 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 4 Dec 2015.