Clinical trial NCT04563403: Improving the Efficacy of Exposure Therapy for the Treatment of Cockroach Phobia
Official title: Improving the Efficacy of Exposure Therapy Using Projection-Based Augmented Reality for the Treatment of Cockroach Phobia: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Specific Phobia, Animal
Keywords: Specific Phobia
Cockroach phobia
Exposure therapy
Projection-Based augmented reality therapy
Multiple Stimuli
Single Stimulus
Randomized Clinical Trial
Lead sponsor: Universitat Jaume I
Sponsor class: OTHER
First posted: 2020-09-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial with two treatment conditions
Primary purpose: TREATMENT

Brief summary: The aim of this study is to test the efficacy and efficiency of the Projection-Based augmented reality therapy under two conditions: multiple stimuli (different types of cockroaches) (P-ARET MS) versus single stimulus (one cockroach) (P-ARET SS) for the treatment of participants diagnosed with cockroach phobia.

Detailed description: Specific phobia (SP) refers to an extreme and persistent fear of a specific object or situation that is out of proportion to the actual danger or threat. SP is the most prevalent anxiety disorder with substantial impairment and comorbidity. Animal fear is one of the most prevalent subtypes of SP. In vivo exposure is the treatment of choice for this problem, but this technique presents limitations in its implementation related to the access and acceptability (i.e., low acceptance on the part of patients and therapists, high dropout rates, limited access to the treatment and, difficulties in its application in the clinical context). Augmented Reality (AR) offers some advantages in delivering the exposure technique: 1) Exposure to multiple virtual stimuli; 2) Going beyond reality; 3) Allowing complete control over the situation; 4) It allows privacy and confidentiality. Particularly, 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.

We pretend to go a step beyond and explore ways of optimizing exposure therapy based on the inhibitory learning approach. AR can maximize some strategies like "variability" (varying stimuli, durations, levels of intensity, or the order of the hierarchy items), greater control by the therapists or "exposure to multiple contexts" which can produce a positive effect in terms of fear renewal and generalization of the results. Therefore, the aim of this study is to test the efficacy and efficiency of varying the phobic stimuli during the ARET: using multiple stimuli (MS) (P-ARET MS) versus single stimulus (SS) (P-ARET SS) in participants with cockroach phobia.

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 = 80) who received a diagnosis of SP for cockroaches (DSM-5), will be randomized into two experimental conditions: 1) Projection-based augmented reality therapy (P-ARET) with Multiple Stimuli (MS) (P-ARET MS); 2) Projection-based augmented reality therapy (P-ARET) with Single Stimulus (SS) (P-ARET SS). Five evaluation moments will be included: pre-intervention, post- intervention, 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, and at 1, 6 and 12 months after the end of the treatment.
Secondary outcomes:
measure: Change in Behavioral Avoidance Test through AR (BAT; adapted from Öst, Salkovskis, & Hellström's, 1991).
timeFrame: Baseline ( At the beginning of the intervention) and immediately after the intervention, and at 1, 6 and 12 months after the end of the treatment.
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, and at 1, 6 and 12 months after the end of the treatment.
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, and at 1, 6 and 12 months after the end of the treatment.
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, and at 1, 6 and 12 months after the end of the treatment.
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, and at 1, 6 and 12 months after the end of the treatment.
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).
Other outcomes:
measure: Change in Anxiety Disorders Interview Schedule for DSM-IV-TR (ADIS-IV)
timeFrame: Baseline ( At the beginning of the intervention) and immediately after the intervention, and at 1, 6 and 12 months after the end of the treatment.
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, and at 1, 6 and 12 months after the end of the treatment.
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, and at 1, 6 and 12 months after the end of the treatment.
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, and at 1, 6 and 12 months after the end of the treatment.
Locations:
city: Castellón De La Plana
country: Spain
facility: Universitat Jaume I
state: Castellón
Study officials:
References:
citation: Shiban Y, Schelhorn I, Pauli P, Muhlberger A. Effect of combined multiple contexts and multiple stimuli exposure in spider phobia: A randomized clinical trial in virtual reality. Behav Res Ther. 2015 Aug;71:45-53. doi: 10.1016/j.brat.2015.05.014. Epub 2015 May 28.
citation: Botella C, Mira A, Moragrega I, Garcia-Palacios A, Breton-Lopez J, Castilla D, Riera Lopez Del Amo A, Soler C, Molinari G, Quero S, Guillen-Botella V, Miralles I, Nebot S, Serrano B, Majoe D, Alcaniz M, Banos RM. An Internet-based program for depression using activity and physiological sensors: efficacy, expectations, satisfaction, and ease of use. Neuropsychiatr Dis Treat. 2016 Feb 23;12:393-406. doi: 10.2147/NDT.S93315. eCollection 2016.