An interventional study of Projection-based augmented reality therapy (P-ARET) in Specific Phobia, Animal, sponsored by Universitat Jaume I. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-10.
Sponsored by Universitat Jaume I · Not applicable, Interventional, and Treatment
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.
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.
85 studies on the registry are indexed under Phobia, Specific; 13 are open to participants now.
This study's planned enrollment of 80 is close to the median of 74 across 81 interventional studies indexed under Phobia, Specific.
Browse Phobia, Specific studies →Universitat Jaume I is the lead sponsor of 80 studies on the registry; 19 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Projection-based augmented reality therapy (P-ARET) with Multiple Stimuli (MS) (P-ARET MS). Intervention group that receives P-ARET treatment varying the stimuli available in the system (different cockroaches in colour, size, etc).
Behavioral: Projection-based augmented reality therapy (P-ARET)
Projection-based augmented reality therapy (P-ARET) with Single Stimuli (SS) (P-ARET SS). Intervention group that receives P-ARET treatment using a single stimulus (one cockroach).
Behavioral: Projection-based augmented reality therapy (P-ARET)
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.
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 in a scale ranging from 0 (the participant does not enter the room) to 12 (the participant interacts with the cockroach).
Time frame: 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.
Change in Behavioral Avoidance Test through AR (BAT; adapted from Öst, Salkovskis, & Hellström's, 1991).
Patients will be confronted to a novel projected cockroach (not used before in any of the two treatment conditions) 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 in a scale ranging from 0 (the participant does not enter the room) to 12 (the participant interacts with the cockroach).
Time frame: 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.
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 0 ("I strongly disagree") to 7 ("I strongly agree") ).
Time frame: 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.
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 78 items evaluated in a scale ranging from 0 (I don´t believe so) to 100 (I´m convinced of it).
Time frame: 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.
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.
Time frame: 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.
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's symptoms after the treatment compared to the start. It is ranged from 1 (much worse) and 7 (much better).
Time frame: 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.
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
Time frame: 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 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).
Time frame: 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 Anxiety Disorders Interview Schedule for DSM-IV-TR (ADIS-IV)
Specific Phobia Diagnostic interview for specific phobia based on DSM-IV-TR criteria.
Time frame: 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.
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).
Time frame: 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.
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).
Time frame: 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.
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.
Time frame: 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.
Plan to share: Yes — According to the preservation of the privacy of the participants, the data from the clinical trial will be available upon reasonable request,
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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