An interventional study of Alternating single stimulus and multiple stimuli in Animal Phobia, sponsored by Universitat Jaume I. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-13.
Sponsored by Universitat Jaume I · Not applicable, Interventional, and Treatment
The aim of this study is to test the efficacy and efficiency of varying the phobic stimuli during the augmented reality (AR) exposure therapy using multiple stimuli versus one single stimulus through projection-based AR (P-ARET) 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 is associated to 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.
The study will follow the guidelines of a multiple-baseline single case design with alternating treatments. Participants (N = 4) who received a diagnosis of SP for cockroaches (DSM-5), will be randomly assigned to different baselines (ranging between 8 and 14 days) and all of them will receive the two experimental conditions: 1) AR exposure therapy with multiple stimuli and; 2) AR exposure therapy with a single stimulus. Five evaluation moments will be included: pre-intervention (baseline), post- intervention, and follow-up at the first month, 6 and 12 months.
85 studies on the registry are indexed under Phobia, Specific; 13 are open to participants now.
This study's enrollment of 4 is below 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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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.
The intervention will be based on exposure therapy to cockroaches using P-ARET. 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 restructuring, and reinforcement and relapse prevention.
Behavioral: Alternating single stimulus and multiple stimuli
The intervention will be based on exposure therapy to cockroaches using P-ARET. 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 restructuring, and reinforcement and relapse prevention.
Behavioral: Alternating single stimulus and multiple stimuli
The intervention will be based on exposure therapy to cockroaches using P-ARET. 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 restructuring, and reinforcement and relapse prevention.
Behavioral: Alternating single stimulus and multiple stimuli
The intervention will be based on exposure therapy to cockroaches using P-ARET. 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 restructuring, and reinforcement and relapse prevention.
Behavioral: Alternating single stimulus and multiple stimuli
P-ARET for cockroach phobia alternating between two interventions: exposure to a single stimulus (always using the same projected cockroach) and exposure to multiple stimuli (different cockroaches in terms of number, shape, colour and movement). It will be counterbalanced to start the same number of participants in each of the two modalities. The two conditions will be randomly applied for each participant, with the restriction of that each condition will be applied 3 times. There will be 6 weekly sessions of approximately 1 hour. The purpose of this exposure treatment is to confront patients to the phobic stimuli in a controlled manner, which favors the habituation process and allows them to accept that the negative consequences they fear do not actually occur. All exposure sessions should be recorded (patients will sign informed consent for recording prior to treatment initiation).
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 evaluated in a scale ranging from 0 (the participant does not enter the room) to 12 (interacts with the cockroach).
Time frame: At the beginning of the intervention and immediately after the treatment
Change in fear, avoidance, belief in negative thoughts and coping ability with the feared stimulus levels.
Item1: If you see a cockroach in front of you at this moment... To what extent would you be scared of it? Item 2: If you see a cockroach in front of you at this moment... to what extent would you avoid it?, Item 3: If you see a cockroach in front of you at this moment... To what extent would you believe that it is dangerous for you?, Item 4: To what extent you believe that you could cope with a cockroach of different size, colour and shape? Ranged from 0 (nothing) to 10 (very much)
Time frame: Once a day (from the start of the baseline until the end of the treatment) 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 1 (nothing) to 7 (very much).
Time frame: At the beginning of the intervention and immediately after the treatment
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).
Time frame: At the beginning of the intervention and immediately after 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 treatment condition) 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 evaluated in a scale ranging from 0 (the participant does not enter the room) to 12 (interacts with the cockroach).
Time frame: At the beginning of the intervention and immediately after the treatment
Preferences
Preferences about the treatment condition (MS versus SS) were assessed with a questionnaire composed of the following items: Item 1 "If you could choose between the two types of exposure sessions, which one would you choose?; Item 2 "Which of these two ways of applying the exposure session do you consider to be more effective in helping you overcome your problem?"; Item 3 "Which of these two ways of applying the exposure session do you consider more aversive?"; and Item 4 "Which of these two ways to apply the exposure session would you recommend to a friend who had the same problem?"
Time frame: Immediately after the treatment
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: At the beginning of the intervention and immediately after the treatment, 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: At the beginning of the intervention and immediately after 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: At the beginning of the intervention and immediately after the treatment
Plan to share: Undecided
Ran from Sep 2020 to primary completion in Dec 2020, 3 months.
Of 48 non-industry interventional studies with no phase under Phobia, Specific, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 42. This study's 3 months is below that.
Counting every sponsor, half of 49 studies reached it within 28 months; a quarter within 11 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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