Phobia AnimalNCT05333783
Augmented Reality Exposure Therapy for Cynophobia
A study testing Augmented Reality Exposure Therapy Based on ExposXR software in people with Phobia Animal, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
The feasibility study for the Augmented Reality Exposure Therapy for Cynophobia will be carried out for people with dog phobia. This feasibility study's sample will be adults living in Turkey. The informed consent form and demographic form will be sent to the participants who have given this approval. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Phobia Animal
- What is being tested?
- Augmented Reality Exposure Therapy Based on ExposXR software
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 May 2022to 29 Nov 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
- Clinician-confirmed Dog Phobia
- Scoring 10 or higher on the Specific Phobia Scale (Adult version)
Who cannot join
- Psychosis and/or Substance Use Disorder
- Epileptic Seizure History
- Uncorrected Visual Impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treating Cynophobia With Augmented Reality Exposure Therapy
The feasibility study for the Augmented Reality Exposure Therapy for Cynophobia will be carried out for people with dog phobia. This feasibility study's sample will be adults living in Turkey. The informed consent form and demographic form will be sent to the participants who have given this approval. Those who are eligible will be invited to diagnostic interviews. Those participants who meet the inclusion criteria will be included in the feasibility study. 22 participants are expected to participate in this study. The phobia severity will be measured three times: once before and twice after the intervention.
Read the detailed description
Specific phobia is an overwhelming fear of an object, place, situation, feeling or animal. For the treatment of specific phobias, exposure therapy is accepted as the most effective way to treat the patients and it is frequently used by psychiatrists and psychotherapists. To treat specific phobias using exposure therapy, the patients are exposed to their feared objects or situations in a safe and controlled environment while they are guided and accompanied by a therapist. It is not always possible to conduct in vivo treatment however, due to a number of reasons such as the feared objects being unavailable, cost-effectiveness, patients with extremely high anxiety etc. Results of the former studies revealed that specific phobias can be treated using Augmented Reality (AR) where patients are exposed to virtually created feared objects in real life context. There are limited studies that have been conducted to test the effectiveness of AR because it is a newly developed technology. Former studies used AR to treat phobia of smaller object such as fear of cockroaches, insects and spiders. The current study aims to test whether AR is a successful tool that can be utilized as a treatment option for people with specific disorders. More specifically, we aim to test the effectiveness of Augmented Reality Exposure Therapy (ARET) in the treatment of patients with cynophobia, i.e., fear of dogs.
- Conditions
- Phobia Animal
- Being tested
- Augmented Reality Exposure Therapy Based on ExposXR software
- Medical subject headings
- Zoophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented Reality Exposure Therapy Based on ExposXR softwareBehavioural
The ExposXR software is developed by The Stress Trauma Anxiety Research Clinic at Wayne State University, U.S.A. When it is used inside a Augmented Reality hardware such as Hololens, it renders artificial phobic objects into what the participants see. The treatment consist of a one-session treatment for cynophobia using Augmented Reality.
| Study group | Role | What they receive |
|---|---|---|
| Augmented Reality Exposure Therapy Based on ExposXR software | Experimental | The intervention arm will receive the assigned intervention in one session. Participants will be called for 2 times for post-assessment. Receives: Behavioral: Augmented Reality Exposure Therapy Based on ExposXR software |
| Treatment as Usual | No intervention | The control arm has no intervention. However, the participants are not given any instruction limiting their encounters with the phobic stimuli. The participants in the control arm will receive the intervention after the post-assessments are completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Behavioral Approach Task (BAT) scores over time.
Specific Phobia Scale is a 10-item questionnaire that measures the severity of a specific phobia. Scores range from 0 (none) to 4 (severe).
Measured: [Change from baseline (Before the intervention) to post assessment (1 week and 1 month after the pre-assessment) ]
Secondary outcomes (3)
Change of the Specific Phobia Scale (SPS) Turkish version scores over time.
Specific Phobia Scale is a 10-item questionnaire that measures the severity of a specific phobia. Scores range from 0 (none) to 4 (severe).
Measured: [Change from baseline (Before the intervention) to post assessment (1 week and 1 month after the pre-assessment) ]
Change of the Skin Conductance scores over time.
The skin conductance response, also known as the electrodermal response is the phenomenon that the skin momentarily becomes a better conductor of electricity when either external or internal stimuli occur that are physiologically arousing. Conductance is measured in μSiemens (μS) and is the inverse of electrical resistance.
Measured: [Change from baseline (Before the intervention) to post assessment (1 week and 1 month after the pre-assessment) ]
Change of the Subjective Unit of Distress scores over time.
Subjective unit of distress (SUD) is a self-report measurement technique used to measure the intensity of distress or nervousness in people with anxiety. The SUDs are rated on a scale from 0 to 100. Higher scores indicate higher distress.
Measured: [Change from baseline (Before the intervention) to post assessment (1 week and 1 month after the pre-assessment) ]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start13 May 2022
- Primary completion25 Jul 2022
- Study completion29 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Phobia AnimalStudies 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
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Collaborators
- Wayne State University
- Responsible party
- Sponsor
- Investigators
- Can Anarat, MA, Study chair, Koç UniversityEkin Cakir, PhD, Study chair, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333783
- Sponsor's protocol ID
- 2022.034.IRB3.006
- Status last verified
- Sep 2023
- First submitted
- 11 Mar 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Javanbakht A, Madaboosi S, Grasser LR. Real-life contextualization of exposure therapy using augmented reality: A pilot clinical trial of a novel treatment method. Ann Clin Psychiatry. 2021 Nov;33(4):220-231. doi: 10.12788/acp.0042.
PubMed 34672925
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Cynophobia With Augmented Reality Exposure Therapy
- ClinicalTrials.gov ID
- NCT05333783
- Acronym / sponsor ID
- 2022.034.IRB3.006
- Conditions
- Phobia Animal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Collaborators
- Wayne State University
- Study start
- 13 May 2022 (actual)
- Primary completion
- 25 Jul 2022 (actual)
- Study completion
- 29 Nov 2022 (actual)
- First posted
- 19 Apr 2022 (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 feasibility study for the Augmented Reality Exposure Therapy for Cynophobia will be carried out for people with dog phobia. This feasibility study's sample will be adults living in Turkey. The informed consent form and demographic form will be sent to the participants who have given this approval. Those who are eligible will be invited to diagnostic interviews. Those participants who meet the inclusion criteria will be included in the feasibility study. 22 participants are expected to participate in this study. The phobia severity will be measured three times: once before and twice after the intervention.
Detailed description
Specific phobia is an overwhelming fear of an object, place, situation, feeling or animal. For the treatment of specific phobias, exposure therapy is accepted as the most effective way to treat the patients and it is frequently used by psychiatrists and psychotherapists. To treat specific phobias using exposure therapy, the patients are exposed to their feared objects or situations in a safe and controlled environment while they are guided and accompanied by a therapist. It is not always possible to conduct in vivo treatment however, due to a number of reasons such as the feared objects being unavailable, cost-effectiveness, patients with extremely high anxiety etc. Results of the former studies revealed that specific phobias can be treated using Augmented Reality (AR) where patients are exposed to virtually created feared objects in real life context. There are limited studies that have been conducted to test the effectiveness of AR because it is a newly developed technology. Former studies used AR to treat phobia of smaller object such as fear of cockroaches, insects and spiders. The current study aims to test whether AR is a successful tool that can be utilized as a treatment option for people with specific disorders. More specifically, we aim to test the effectiveness of Augmented Reality Exposure Therapy (ARET) in the treatment of patients with cynophobia, i.e., fear of dogs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Augmented Reality Exposure Therapy Based on ExposXR software | Experimental | Behavioral: Augmented Reality Exposure Therapy Based on ExposXR softwareThe intervention arm will receive the assigned intervention in one session. Participants will be called for 2 times for post-assessment. |
| Treatment as Usual | No intervention | –The control arm has no intervention. However, the participants are not given any instruction limiting their encounters with the phobic stimuli. The participants in the control arm will receive the intervention after the post-assessments are completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinician-confirmed Dog Phobia
- Scoring 10 or higher on the Specific Phobia Scale (Adult version)
Key exclusion criteria (3 listed)
- Psychosis and/or Substance Use Disorder
- Epileptic Seizure History
- Uncorrected Visual Impairment
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 |
|---|---|---|
| Augmented Reality Exposure Therapy Based on ExposXR softwareThe ExposXR software is developed by The Stress Trauma Anxiety Research Clinic at Wayne State University, U.S.A. When it is used inside a Augmented Reality hardware such as Hololens, it renders artificial phobic objects into what the participants see. The treatment consist of a one-session treatment for cynophobia using Augmented Reality. | Behavioural | Augmented Reality Exposure Therapy Based on ExposXR software |
Primary outcome
Change of the Behavioral Approach Task (BAT) scores over time.
Time frame: [Change from baseline (Before the intervention) to post assessment (1 week and 1 month after the pre-assessment) ]
Specific Phobia Scale is a 10-item questionnaire that measures the severity of a specific phobia. Scores range from 0 (none) to 4 (severe).
3 secondary outcomes
Change of the Specific Phobia Scale (SPS) Turkish version scores over time.
Time frame: [Change from baseline (Before the intervention) to post assessment (1 week and 1 month after the pre-assessment) ]
Change of the Skin Conductance scores over time.
Time frame: [Change from baseline (Before the intervention) to post assessment (1 week and 1 month after the pre-assessment) ]
Change of the Subjective Unit of Distress scores over time.
Time frame: [Change from baseline (Before the intervention) to post assessment (1 week and 1 month after the pre-assessment) ]
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 7 Sep 2023.
- Background: PubMed 34672925Javanbakht A, Madaboosi S, Grasser LR. Real-life contextualization of exposure therapy using augmented reality: A pilot clinical trial of a novel treatment method. Ann Clin Psychiatry. 2021 Nov;33(4):220-231. doi: 10.12788/acp.0042.
- Individual participant dataSharing planned: No
Related trials for Phobia Animal
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A Randomized Controlled Efficacy Trial of a Telemedicine-based Virtual Reality Clinic for the Treatment of Phobias
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Bringing Exposure Therapy to Real-Life Context With Augmented Reality-Dogs (ARET)-Dogs
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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.
Can Anarat, MA study chair
Koç University
Ekin Cakir, PhD study chair
Koç University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Reality Exposure Therapy Based on ExposXR software in people with Phobia Animal, run by Koç University at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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 7 Sep 2023. 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 Turkey (Türkiye). 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 of the Behavioral Approach Task (BAT) scores over time. (time frame: [Change from baseline (Before the intervention) to post assessment (1 week and 1 month after the pre-assessment) ]). 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 NCT05333783, which also lists 1 linked publication.
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 7 Sep 2023.