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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

April 26, 2011
September 17, 2013
January 2011
May 2011   (final data collection date for 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 ] [ 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.
Change in Behavioral Avoidance Test (BAT, Öst, Salkovskis, and Hellström's, 1991) at pre, post intervention and 1, 3, 6, and 12-month follow-up periods [ Time Frame: At pre (baseline), post intervention and 1, 3, 6, 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.
Complete list of historical versions of study NCT01361074 on ClinicalTrials.gov Archive Site
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).
Change in Spider Phobia Beliefs Questionnaire (SPBQ; adapted from Arntz, Lavy, Van der Berg, & Van Rijsoort, 1993) at pre, post intervention and 1, 3, 6, and 12-month follow-up periods [ Time Frame: At pre (baseline), post intervention and 1, 3, 6, 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).
Not Provided
Not Provided
 
In Vivo Versus Augmented Reality Exposure for Small Animal Phobia
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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Phobic Disorders
  • 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
  • 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
  • Experimental: In Vivo Exposure
    Intervention: Behavioral: In Vivo Exposure for Animal Phobia following Öst´s guidelines
  • Experimental: Augmented Reality Exposure
    Intervention: Behavioral: Augmented Reality Exposure for Animal Phobia following Öst´s guidelines

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
January 2013
May 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01361074
UJaumeI01
No
Universitat Jaume I
Universitat Jaume I
University of Valencia
Study Director: Cristina Botella, Full Professor University Jaume I, Castellon, Spain.
Study Director: Cristina Botella, Full Professor University Jaume I, Castellon, Spain
Universitat Jaume I
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP