NCT01361074

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2011

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 26, 2011

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

December 4, 2015

Status Verified

September 1, 2013

Enrollment Period

4 months

First QC Date

April 26, 2011

Last Update Submit

December 3, 2015

Conditions

Keywords

Virtual realityAugmented realityIn vivo exposureOne session treatmentICTEfficacySpecific phobiaAnxiety disorders

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • 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

    At pre (baseline), post intervention and 3 and 12-month follow-up periods

Study Arms (2)

In Vivo Exposure

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

Augmented Reality Exposure

EXPERIMENTAL
Behavioral: Augmented Reality Exposure for Animal Phobia following Öst´s guidelines

Interventions

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.

Also known as: In vivo exposure in phobic disorders, In vivo exposure for small animal phobia
In Vivo Exposure

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.

Also known as: Augmented Reality Exposure in phobic disorders, Augmented Reality Exposure for small animal phobia
Augmented Reality Exposure

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Jaume I

Castellon, Castellon, 12006, Spain

Location

University Jaume I

Castellon, Castellón, 12071, Spain

Location

Related Publications (10)

  • 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.

    PMID: 20569788BACKGROUND
  • 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.

    PMID: 10802831BACKGROUND
  • 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.

    PMID: 8629891BACKGROUND
  • 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.

    PMID: 17927544BACKGROUND
  • 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.

    PMID: 11710258BACKGROUND
  • 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.

    PMID: 526242BACKGROUND
  • 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.

    PMID: 15938656BACKGROUND
  • 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.

    PMID: 16315475BACKGROUND
  • Ost LG. One-session treatment for specific phobias. Behav Res Ther. 1989;27(1):1-7. doi: 10.1016/0005-7967(89)90113-7.

    PMID: 2914000BACKGROUND
  • 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.

    PMID: 3352391BACKGROUND

Related Links

MeSH Terms

Conditions

Phobic DisordersPhobia, SpecificAnxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Cristina Botella, Full Professor

    University Jaume I, Castellon, Spain.

    STUDY DIRECTOR
  • Cristina Botella, Full Professor

    University Jaume I, Castellon, Spain

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2011

First Posted

May 26, 2011

Study Start

January 1, 2011

Primary Completion

May 1, 2011

Study Completion

January 1, 2013

Last Updated

December 4, 2015

Record last verified: 2013-09

Locations