Effectiveness of a Projection-based Augmented Reality Exposure System in Treating Cockroach Phobia.

NCT04563390 | Recruiting

• 1 other identifier: TERA-P EY CP
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The main aim of this study is to validate and test the clinical effectiveness of the projection-based augmented reality system in cockroach phobia exposure therapy through an RCT that includes three conditions: (i) projection-based augmented reality therapy, (ii) usual treatment (in vivo exposure), (iii) waiting list control. In addition, it is intended to analyze the potential of the eye-tracking technology as a tool for evaluating the clinical effectiveness in cockroach phobia treatment.

Conditions

Specific Phobia

Keywords

Specific phobia; Cockroach phobia; Exposure therapy; In vivo exposure; Projection-Based augmented reality therapy; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Change in Behavioral Avoidance Test (BAT; adapted from Öst, Salkovskis, & Hellström's, 1991)

  Patients will be confronted to a real cockroach and they will be encouraged to get closer and interact with the stimulus as much as they can. The anxiety level (0-10), distance and level of interaction with the animal will be registered and evaluated on a scale ranging from 0 (the participant does not enter the room) to 12 (the participant interacts with the cockroach).

  Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).

Secondary Outcomes (5)

• Change in attentional biases

  Baseline and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months)

• Change in Fear of Cockroaches Questionnaire (adapted from Fear of Spiders Questionnaire; FSQ, Szymanski & O'Donohue, 1995)

  Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).

• Change in Cockroach Phobia Beliefs Questionnaire (SBQ; adapted from Spider Phobia Beliefs Questionnaire; SBQ, Arntz, Lavy, van der Berg & van Rijssoort, 1993).

  Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).

• Change in Fear and Avoidance Scales (adapted from Marks & Mathews, 1979).

  Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).

• Change in Patient's Improvement Scale (adapted from the Clinical Global Impression scale; CGI, Guy, 1976).

  Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).

Other Outcomes (6)

• Change in Anxiety Disorders Interview Schedule for DSM-IV-TR (ADIS-IV) - Specific Phobia

  Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).

• Change in Disgust Propensity and Sensitivity Scale-Revised-12 (DPSS-R-12; Sandín et al., 2008)

  Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).

• Change in The Clinician Severity Scale (adapted from Di Nardo, Brown & Barlow, 1994)

  Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).

Study Arms (3)

Projection-based augmented reality exposure therapy

EXPERIMENTAL

Intervention group that receives the projection-based augmented reality to carry out the exposure therapy for cockroach phobia.

Behavioral: Projection-based augmented reality exposure therapy (P-ARET).

In vivo exposure

EXPERIMENTAL

Intervention group that receives traditional in vivo exposure therapy for cockroach phobia.

Behavioral: In vivo exposure therapy

WL Control

NO INTERVENTION

Waiting list control group.

Interventions

Projection-based augmented reality exposure therapy (P-ARET). BEHAVIORAL

The intervention will be based on exposure therapy to cockroaches using P-ARET. The treatment will follow the guidelines of the "one-session treatment" (OST). Main components: Psychoeducation, Exposure to the feared object (cockroach), modeling (the therapist will interact with the phobic stimulus first and if possible, the patient will follow the same steps), cognitive challenge, and reinforcement and relapse prevention.

Projection-based augmented reality exposure therapy

In vivo exposure therapy BEHAVIORAL

The intervention will be based on traditional in vivo exposure therapy to real cockroaches. The treatment will follow the guidelines of the "one-session treatment" (OST). Main components: Psychoeducation, Exposure to the feared object (cockroach), modeling (the therapist will interact with the phobic stimulus first and if possible, the patient will follow the same steps), cognitive challenge, and reinforcement and relapse prevention.

In vivo exposure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being at least 18 years old
• Meeting DSM-5 diagnostic criteria for SP (animal subtype) to cockroaches
• Having a minimum of six-month duration of the phobia
• Sign an informed consent
• Presenting a score of at least 4 on the fear and avoidance scales of the diagnostic interview applied

You may not qualify if:

• Presence of another severe mental disorder that requires immediate attention
• Having current alcohol or drug dependence or abuse, psychosis or severe organic illness
• Currently being treated in a similar treatment program
• Being capable of inserting their hands in a plastic container with a cockroach (during the behavioral test)
• Receiving other psychological treatment during the study for cockroach phobia
• Start receiving pharmacological treatment during the study (or in case of being already taking them, change the drug or dose)

Sponsors & Collaborators

• Universitat Jaume I: lead

Study Sites (1)

Universitat Jaume I

Castellon, Castellón, 12071, Spain

RECRUITING

Related Publications (5)

• Wrzesien, M., Botella, C., Bretón-López, J., del Río González, E., Burkhardt, J. M., Alcañiz, M., & Pérez-Ara, M. Á. (2015). Treating small animal phobias using a projective-augmented reality system: A single-case study. Computers in Human Behavior, 49, 343-353.

  BACKGROUND

• Tobon, J. I., Ouimet, A. J., & Dozois, D. J. (2011). Attentional bias in anxiety disorders following cognitive behavioral treatment. Journal of Cognitive Psychotherapy, 25(2), 114-129.

  BACKGROUND

• Botella C, Perez-Ara MA, Breton-Lopez J, Quero S, Garcia-Palacios A, Banos RM. In Vivo versus Augmented Reality Exposure in the Treatment of Small Animal Phobia: A Randomized Controlled Trial. PLoS One. 2016 Feb 17;11(2):e0148237. doi: 10.1371/journal.pone.0148237. eCollection 2016.

  PMID: 26886423 RESULT

• Thorpe SJ, Salkovskis PM. The effect of one-session treatment for spider phobia on attentional bias and beliefs. Br J Clin Psychol. 1997 May;36(2):225-41. doi: 10.1111/j.2044-8260.1997.tb01409.x.

  PMID: 9167863 RESULT

• Grimaldos J, Breton-Lopez J, Palau-Batet M, Diaz-Sanahuja L, Quero S. Effectiveness of a projection-based augmented reality exposure system in treating cockroach phobia: study protocol of a randomised controlled trial. BMJ Open. 2023 May 19;13(5):e069025. doi: 10.1136/bmjopen-2022-069025.

  PMID: 37208132 DERIVED

MeSH Terms

Conditions

Phobia, Specific

Study Officials

• Soledad Quero, Psychology

  Universitat Jaume I

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Soledad Quero, Psychology

CONTACT

96 438 76 41; squero@uji.es

Jorge Grimaldos, Psychology

CONTACT

96 438 76 45; grimaldo@uji.es

Study Design

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

Model Details: Randomized Controlled Trial with two treatment conditions and one WL control condition.

Study Record Dates

• First Submitted: September 16, 2020
• First Posted: September 24, 2020
• Study Start: November 1, 2020
• Primary Completion: December 31, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: May 17, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

ES (1)