Animal PhobiaNCT04553120
Improving the Exposure Therapy Through Projection-based Augmented Reality for the Treatment of Cockroach Phobia
A study testing Alternating single stimulus and multiple stimuli in people with Animal Phobia, run by Universitat Jaume I at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Animal Phobia
- What is being tested?
- Alternating single stimulus and multiple stimuli
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSpain
- Study dates
- 30 Sep 2020to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving the Exposure Therapy Through Projection-based Augmented Reality for the Treatment of Cockroach Phobia: A Multiple-baseline Single Case Study
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.
Read the 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 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.
- Conditions
- Animal Phobia
- Being tested
- Alternating single stimulus and multiple stimuli
- Keywords
- Specific Phobia, Cockroach phobia, Exposure therapy, Augmented Reality, Projection-Based, Single case study
- Medical subject headings
- Zoophobia, Phobia, Specific
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alternating single stimulus and multiple stimuliBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Alternating treatments condition - 10 days wait | Experimental | 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. Receives: Behavioral: Alternating single stimulus and multiple stimuli |
| Alternating treatments condition - 9 days wait | Experimental | 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. Receives: Behavioral: Alternating single stimulus and multiple stimuli |
| Alternating treatments condition - 13 days wait | Experimental | 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. Receives: Behavioral: Alternating single stimulus and multiple stimuli |
| Alternating treatments condition - 12 days wait | Experimental | 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. Receives: Behavioral: Alternating single stimulus and multiple stimuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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)
Measured: 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.
Secondary outcomes (4)
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).
Measured: 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).
Measured: 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).
Measured: 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?"
Measured: Immediately after the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2020
- Study start30 Sep 2020
- Primary completion31 Dec 2020
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Animal PhobiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single case, multiple-baseline AB design
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Jaume I
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04553120
- Sponsor's protocol ID
- N1256
- Status last verified
- May 2024
- First submitted
- 1 Jul 2020
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 26072451Wrzesien, 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.
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.
PubMed 27042067
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Exposure Therapy Through Projection-based Augmented Reality for the Treatment of Cockroach Phobia: A Multiple-baseline Single Case Study
- ClinicalTrials.gov ID
- NCT04553120
- Acronym / sponsor ID
- N1256
- Conditions
- Animal Phobia
- Keywords
- Specific Phobia, Cockroach phobia, Exposure therapy, Augmented Reality, Projection-Based, Single case study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Universitat Jaume IUniversity, hospital or other
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 17 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Single case, multiple-baseline AB design
| Arm | Type | Receives |
|---|---|---|
| Alternating treatments condition - 10 days wait | Experimental | Behavioral: Alternating single stimulus and multiple stimuliThe 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. |
| Alternating treatments condition - 9 days wait | Experimental | Behavioral: Alternating single stimulus and multiple stimuliThe 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. |
| Alternating treatments condition - 13 days wait | Experimental | Behavioral: Alternating single stimulus and multiple stimuliThe 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. |
| Alternating treatments condition - 12 days wait | Experimental | Behavioral: Alternating single stimulus and multiple stimuliThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alternating single stimulus and multiple stimuliP-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). | Behavioural | Alternating treatments condition - 10 days wait, Alternating treatments condition - 12 days wait, Alternating treatments condition - 13 days wait, Alternating treatments condition - 9 days wait |
Primary outcome
Change in Behavioral Avoidance Test (BAT; adapted from Öst, Salkovskis, & Hellström's, 1991)
Time frame: At the beginning of the intervention and immediately after the treatment
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).
Change in fear, avoidance, belief in negative thoughts and coping ability with the feared stimulus levels.
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.
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)
4 secondary outcomes
Change in Fear of Cockroaches Questionnaire (adapted from Fear of Spiders Questionnaire; FSQ, Szymanski & O'Donohue, 1995)
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).
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)
Time frame: At the beginning of the intervention and immediately after the treatment
Preferences
Time frame: Immediately after the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Background: PubMed 26072451Shiban 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.
- BackgroundWrzesien, 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.
- Background: PubMed 27042067Botella 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alternating single stimulus and multiple stimuli in people with Animal Phobia, run by Universitat Jaume I at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Behavioral Avoidance Test (BAT; adapted from Öst, Salkovskis, & Hellström's, 1991) (time frame: At the beginning of the intervention and immediately after the treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04553120, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2024.