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In Vivo Versus Augmented Reality Exposure for Small Animal Phobia (VARESAP)

Primary Purpose

Phobic Disorders

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
In Vivo Exposure for Animal Phobia following Öst´s guidelines
Augmented Reality Exposure for Animal Phobia following Öst´s guidelines
Sponsored by
Universitat Jaume I
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Phobic Disorders focused on measuring Virtual reality, Augmented reality, In vivo exposure, One session treatment, ICT, Efficacy, Specific phobia, Anxiety disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Jaume I
  • University Jaume I

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

In Vivo Exposure

Augmented Reality Exposure

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
April 26, 2011
Last Updated
December 3, 2015
Sponsor
Universitat Jaume I
Collaborators
University of Valencia
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1. Study Identification

Unique Protocol Identification Number
NCT01361074
Brief Title
In Vivo Versus Augmented Reality Exposure for Small Animal Phobia
Acronym
VARESAP
Official Title
In Vivo Versus Augmented Reality Exposure for Small Animal Phobia Treatment: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitat Jaume I
Collaborators
University of Valencia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phobic Disorders
Keywords
Virtual reality, Augmented reality, In vivo exposure, One session treatment, ICT, Efficacy, Specific phobia, Anxiety disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
In Vivo Exposure
Arm Type
Experimental
Arm Title
Augmented Reality Exposure
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
In Vivo Exposure for Animal Phobia following Öst´s guidelines
Other Intervention Name(s)
In vivo exposure in phobic disorders, In vivo exposure for small animal phobia
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Augmented Reality Exposure for Animal Phobia following Öst´s guidelines
Other Intervention Name(s)
Augmented Reality Exposure in phobic disorders, Augmented Reality Exposure for small animal phobia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Behavioral Avoidance Test (BAT, Öst, Salkovskis, and Hellström's, 1991) at pre, post intervention and 3 and 12-month follow-up periods
Description
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.
Time Frame
At pre (baseline), post intervention and 3 and 12-month follow-up periods
Secondary Outcome Measure Information:
Title
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
Description
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).
Time Frame
At pre (baseline), post intervention and 3 and 12-month follow-up periods

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristina Botella, Full Professor
Organizational Affiliation
University Jaume I, Castellon, Spain.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Cristina Botella, Full Professor
Organizational Affiliation
University Jaume I, Castellon, Spain
Official's Role
Study Director
Facility Information:
Facility Name
University Jaume I
City
Castellon
ZIP/Postal Code
12006
Country
Spain
Facility Name
University Jaume I
City
Castellón
ZIP/Postal Code
12071
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
20569788
Citation
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.
Results Reference
background
PubMed Identifier
10802831
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. doi: 10.1207/S15374424jccp2902_8.
Results Reference
background
PubMed Identifier
8629891
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. doi: 10.1001/archpsyc.1996.01830020077009.
Results Reference
background
PubMed Identifier
17927544
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. doi: 10.1089/cpb.2007.9962.
Results Reference
background
PubMed Identifier
11710258
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. doi: 10.1089/109493101300210231.
Results Reference
background
PubMed Identifier
526242
Citation
Marks 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.
Results Reference
background
PubMed Identifier
15938656
Citation
Botella 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.
Results Reference
background
PubMed Identifier
16315475
Citation
Juan 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.
Results Reference
background
PubMed Identifier
2914000
Citation
Ost LG. One-session treatment for specific phobias. Behav Res Ther. 1989;27(1):1-7. doi: 10.1016/0005-7967(89)90113-7.
Results Reference
background
PubMed Identifier
3352391
Citation
Ost LG. [One-session treatment of specific phobias--a rapid and effective method]. Lakartidningen. 1988 Mar 30;85(13):1139-42. No abstract available. Swedish.
Results Reference
background
Links:
URL
http://www.labpsitec.uji.es/esp/index.php
Description
Information about our research group
URL
http://www.hitl.washington.edu/projects/magnet/
Description
International research group that focuses on virtual reality and analgesic effects

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In Vivo Versus Augmented Reality Exposure for Small Animal Phobia

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