Specific Phobia Clinical Trial
Official title:
Effectiveness of a Projection-based Augmented Reality Exposure System in Treating Cockroach Phobia. A Randomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 96 |
Est. completion date | July 31, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Spain | Universitat Jaume I | Castellón De La Plana | Castellón |
Lead Sponsor | Collaborator |
---|---|
Universitat Jaume I |
Spain,
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.pon — View 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. — View 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.
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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Anxiety Disorders Interview Schedule for DSM-IV-TR (ADIS-IV) - Specific Phobia | Diagnostic interview for specific phobia based on DSM-IV-TR criteria. | Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months). | |
Other | Change in Disgust Propensity and Sensitivity Scale-Revised-12 (DPSS-R-12; Sandín et al., 2008) | This questionnaire includes two subscales that measure propensity to disgust and sensitivity to disgust. It contains 12 items ranged from 1 (never) to 5 (always). | Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months). | |
Other | Change in The Clinician Severity Scale (adapted from Di Nardo, Brown & Barlow, 1994) | This instrument assesses the severity of symptoms evaluated by the clinician and the scale ranged from 0 (absent) to 8 (very severe). | Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months). | |
Other | Change in Scale of expectation and satisfaction with the treatment (adapted from Borkovec y Nau, 1972) | This instrument contains 6 items ranged from 0 (nothing) to 10 (very much) assessing the patient's opinions about the treatment, focusing on their expectations and degree of satisfaction. | Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months). | |
Other | Change in Beck Depression Inventory 2nd edition (BDI-II; Beck, Steer, Brown, 1996; Spanish validation from Sanz, Navarro y Vázquez, 2003) | This instrument assesses the existence and severity of symptoms of depression following the DSM-IV criteria. The BDI-II is a self report instrument that contains 21 items ranged from 0 to 3. | Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months). | |
Other | Change in State-Trait Anxiety Inventory (adapted from Laux, Glanzmann, Schaffner, & Spielberger, 1981) | This instrument includes two scales designed to assess state and trait anxiety respectively. Each scale contains 20 items ranged from 0 (nothing/rarely) to 3 (very much/always). | Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months). | |
Primary | 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 | Change in attentional biases | An eye-tracking attentional task has been specifically designed for this project. This task evaluates the attentional bias toward cockroaches in terms of time, gaze direction and visual scanning pattern and can reveal changes in attentional bias after the treatment compared to the start | Baseline and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months) | |
Secondary | Change in Fear of Cockroaches Questionnaire (adapted from Fear of Spiders Questionnaire; FSQ, Szymanski & O'Donohue, 1995) | This questionnaire assesses the level of fear to cockroaches. It has 18 items evaluated in a scale ranging from 1 (nothing) to 7 (very much). | Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months). | |
Secondary | Change in Cockroach Phobia Beliefs Questionnaire (SBQ; adapted from Spider Phobia Beliefs Questionnaire; SBQ, Arntz, Lavy, van der Berg & van Rijssoort, 1993). | This questionnaire assesses two different constructs, namely catastrophic beliefs about cockroaches and beliefs about the patient's own ability to cope with a cockroach. It has 48 items evaluated in a scale ranging from 0 (I don´t believe so) to 100 (I´m convinced of it). | Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months). | |
Secondary | Change in Fear and Avoidance Scales (adapted from Marks & Mathews, 1979). | This instrument assesses the level of fear and avoidance to the feared stimulus (i. e., cockroaches), ranged from 0 (nothing) to 10 (very much). It evaluates target behavior, negative thoughts and modulators. | Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months). | |
Secondary | Change in Patient's Improvement Scale (adapted from the Clinical Global Impression scale; CGI, Guy, 1976). | This instrument evaluates the degree of improvement of the patient' symptoms after the treatment compared to the start. It is ranged from 1 (much worse) and 7 (much better). | Baseline (At the beginning of the intervention) and immediately after the intervention, also at follow-up assessment periods (1, 6 and 12 months). |
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