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

This study has been completed.
Sponsor:
Collaborator:
University of Valencia
Information provided by (Responsible Party):
Universitat Jaume I
ClinicalTrials.gov Identifier:
NCT01361074
First received: April 26, 2011
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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).


Condition Intervention
Phobic Disorders
Behavioral: In Vivo Exposure for Animal Phobia following Öst´s guidelines
Behavioral: Augmented Reality Exposure for Animal Phobia following Öst´s guidelines

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: In Vivo Versus Augmented Reality Exposure for Small Animal Phobia Treatment: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Universitat Jaume I:

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 [ Time Frame: At pre (baseline), post intervention and 3 and 12-month follow-up periods ] [ Designated as safety issue: No ]
    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 [ Time Frame: At pre (baseline), post intervention and 3 and 12-month follow-up periods ] [ Designated as safety issue: No ]
    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).


Enrollment: 60
Study Start Date: January 2011
Study Completion Date: January 2013
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01361074

Locations
Spain
University Jaume I
Castellón, Spain, 12071
Sponsors and Collaborators
Universitat Jaume I
University of Valencia
Investigators
Study Director: Cristina Botella, Full Professor University Jaume I, Castellon, Spain.
Study Director: Cristina Botella, Full Professor University Jaume I, Castellon, Spain
  More Information

Additional Information:
Publications:

Responsible Party: Universitat Jaume I
ClinicalTrials.gov Identifier: NCT01361074     History of Changes
Other Study ID Numbers: UJaumeI01
Study First Received: April 26, 2011
Last Updated: September 17, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by Universitat Jaume I:
Virtual reality
Augmented reality
In vivo exposure
One session treatment
ICT
Efficacy
Specific phobia
Anxiety disorders

Additional relevant MeSH terms:
Phobic Disorders
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 21, 2014