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

December 3, 2015 updated by: Universitat Jaume I

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Castellon, Spain, 12006
        • University Jaume I
      • Castellón, Spain, 12071
        • University Jaume I

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: In Vivo Exposure
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.
Other Names:
  • In vivo exposure in phobic disorders
  • In vivo exposure for small animal phobia
Experimental: Augmented Reality Exposure
Behavioral: 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.
Other Names:
  • Augmented Reality Exposure in phobic disorders
  • Augmented Reality Exposure for small animal phobia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At pre (baseline), post intervention and 3 and 12-month follow-up periods

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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).
At pre (baseline), post intervention and 3 and 12-month follow-up periods

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitat Jaume I

Collaborators

University of Valencia

Investigators

  • Study Director: Cristina Botella, Full Professor, University Jaume I, Castellon, Spain.
  • Study Director: Cristina Botella, Full Professor, University Jaume I, Castellón, Spain

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

April 26, 2011

First Submitted That Met QC Criteria

May 25, 2011

First Posted (Estimate)

May 26, 2011

Study Record Updates

Last Update Posted (Estimate)

December 4, 2015

Last Update Submitted That Met QC Criteria

December 3, 2015

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UJaumeI01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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