In Vivo Versus Augmented Reality Exposure for Small Animal Phobia

Phobic Disorders Clinical Trial

— VARESAP  

Official title:

In Vivo Versus Augmented Reality Exposure for Small Animal Phobia Treatment: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01361074
• Other study ID #: UJaumeI01
• Status: Completed
• Phase: N/A
• First received: April 26, 2011
• Last updated: December 3, 2015
• Start date: January 2011
• Est. completion date: January 2013

Study information

• Verified date: September 2013
• Source: Universitat Jaume I
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical 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 in the treatment of specific phobia (small animals).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2013
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Phobic Disorders

Intervention

Behavioral:
• In Vivo Exposure for Animal Phobia following Öst´s guidelines
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 guidelines
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.

Locations

Country	Name	City	State
Spain	University Jaume I	Castellon
Spain	University Jaume I	Castellón

Sponsors (2)

Lead Sponsor	Collaborator
Universitat Jaume I	University of Valencia

Country where clinical trial is conducted

Spain, 

References & Publications (10)

Botella C, Bretón-López J, Quero S, Baños R, García-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. — View Citation

Botella CM, Juan MC, Baños RM, Alcañiz M, Guillén V, Rey B. Mixing realities? An application of augmented reality for the treatment of cockroach phobia. Cyberpsychol Behav. 2005 Apr;8(2):162-71. — View Citation

Essau 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. — View Citation

Garcia-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. — View Citation

Garcia-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. — View Citation

Juan MC, Alcañiz M, Monserrat C, Botella C, Baños RM, Guerrero B. Using augmented reality to treat phobias. IEEE Comput Graph Appl. 2005 Nov-Dec;25(6):31-7. — View Citation

Magee 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. — View Citation

Marks IM, Mathews AM. Brief standard self-rating for phobic patients. Behav Res Ther. 1979;17(3):263-7. — View Citation

Ost LG. [One-session treatment of specific phobias--a rapid and effective method]. Lakartidningen. 1988 Mar 30;85(13):1139-42. Swedish. — View Citation

Ost LG. One-session treatment for specific phobias. Behav Res Ther. 1989;27(1):1-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	At pre (baseline), post intervention and 3 and 12-month follow-up periods	No
Secondary	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 (a=.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).	At pre (baseline), post intervention and 3 and 12-month follow-up periods	No

External Links

•   Information about our research group
•   International research group that focuses on the treatment of psychological disorders
•   International research group that focuses on virtual reality and analgesic effects
•   International research group with interest in information technology for the treatment of patients