Clinical trial NCT04563390: Effectiveness of a Projection-based Augmented Reality Exposure System in Treating Cockroach Phobia.
Official title: Effectiveness of a Projection-based Augmented Reality Exposure System in Treating Cockroach Phobia. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Specific Phobia
Keywords: Specific phobia
Cockroach phobia
Exposure therapy
In vivo exposure
Projection-Based augmented reality therapy
Randomized Controlled Trial
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial with two treatment conditions and one WL control condition.
Primary purpose: TREATMENT

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.

Detailed description: The measurement of attentional biases as a clinical evaluation tool in anxiety disorders is presented as a valuable instrument capable of evaluating changes in the automatic cognitive processes that are involved in their maintenance. However, the variability between the different methodologies used for its measurement has produced a lack of empirical consistency that supports the use of this tool with a clinical purpose. The appearance and implementation of eye tracking technology in experimental studies has made it possible to overcome this problem. Despite this, to our knowledge, there are still no studies that implement this technology in the clinical field as a tool for evaluating therapeutic effectiveness.

Specific phobia is the anxiety disorder with the highest prevalence and, specifically the animal subtype, is one of the most prevalent (3.8%), producing a significant interference and high comorbidity. Despite that in vivo exposure therapy is the treatment of choice for specific phobia, the high dropout rates and difficulties in its application pose major limitations for its therapeutic implementation. The emergence of technologies such as augmented reality (AR) has made it possible to overcome these barriers, offering new ways of applying exposure therapy. AR technology offers the capacity to interact with the stimulus in the real world, facilitating the therapeutic process and the generalization of its results. Some studies have tested the effectivity and efficacy of the AR technology in small animals exposure treatment revealing promising results. However, these studies used a version of AR that requires the use of a device placed on the participant's head (HDM-Head Mounted Display) which can cause dizziness and back pain in some participants and limits the therapist-patient communication. An improved version of the AR system based on projection helps to solve this problem, allowing a more natural interaction with the stimulus and the therapist and greater comfort. The preliminary efficacy of this system has been tested in a case study but, so far, there is no RCT evaluating the efficacy of this AR system. Therefore, in this work two objectives are pursued, firstly, to test and validate a projection-based AR system in the phobia of cockroaches treatment and, secondly, to evaluate the clinical potential of the eye-tracking technology as a specific measure to assess changes in cognitive processes.

The Randomized Clinical Trial (RCT) will be conducted following the Consolidated Standards of Reporting Trials (CONSORT: http://www.consort-statement.org) and the SPIRIT guidelines (Standard Protocol Items: Recommendations for Intervention Trials). Participants (N=96) will be randomized into three groups (after receiving a SP diagnosis - DSM-5): 1) Projection-based augmented reality therapy (P-ARET); 2) In vivo Exposure therapy (IVET); and 3) a waiting list control group (WL). Participants in the WL will be randomly assigned to one of the two treatment conditions after spending time on the waiting list (1 week) for ethical reasons. Outcome measures will be assessed at baseline, post-treatment and 1-, 6-, and 12-month follow-ups.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Change in Behavioral Avoidance Test (BAT; adapted from Öst, Salkovskis, & Hellström's, 1991)
timeFrame: 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:
measure: Change in attentional biases
timeFrame: Baseline and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months)
measure: Change in Fear of Cockroaches Questionnaire (adapted from Fear of Spiders Questionnaire; FSQ, Szymanski & O'Donohue, 1995)
timeFrame: Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).
measure: Change in Cockroach Phobia Beliefs Questionnaire (SBQ; adapted from Spider Phobia Beliefs Questionnaire; SBQ, Arntz, Lavy, van der Berg & van Rijssoort, 1993).
timeFrame: Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).
measure: Change in Fear and Avoidance Scales (adapted from Marks & Mathews, 1979).
timeFrame: Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).
measure: Change in Patient's Improvement Scale (adapted from the Clinical Global Impression scale; CGI, Guy, 1976).
timeFrame: 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:
measure: Change in Anxiety Disorders Interview Schedule for DSM-IV-TR (ADIS-IV) - Specific Phobia
timeFrame: Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).
measure: Change in Disgust Propensity and Sensitivity Scale-Revised-12 (DPSS-R-12; Sandín et al., 2008)
timeFrame: Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).
measure: Change in The Clinician Severity Scale (adapted from Di Nardo, Brown & Barlow, 1994)
timeFrame: Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).
measure: Change in Scale of expectation and satisfaction with the treatment (adapted from Borkovec y Nau, 1972)
timeFrame: Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).
measure: Change in Beck Depression Inventory 2nd edition (BDI-II; Beck, Steer, Brown, 1996; Spanish validation from Sanz, Navarro y Vázquez, 2003)
timeFrame: Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).
measure: Change in State-Trait Anxiety Inventory (adapted from Laux, Glanzmann, Schaffner, & Spielberger, 1981)
timeFrame: Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months).
Locations:
city: Castellón De La Plana
country: Spain
facility: Universitat Jaume I
state: Castellón
Study officials:
affiliation: Universitat Jaume I
name: Soledad Quero, Psychology
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.