Augmented Reality Exposure Therapy for Cynophobia

September 6, 2023 updated by: Koç University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
18

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Ceren Acarturk, Assoc. Prof.
  • Phone Number: +90 (532) 256 38 46
  • Email: cacarturk@ku.edu.tr

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Koc University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Clinician-confirmed Dog Phobia
  • Scoring 10 or higher on the Specific Phobia Scale (Adult version)

Exclusion Criteria:

  • Psychosis and/or Substance Use Disorder
  • Epileptic Seizure History
  • Uncorrected Visual Impairment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Augmented Reality Exposure Therapy Based on ExposXR software
The intervention arm will receive the assigned intervention in one session. Participants will be called for 2 times for post-assessment.
Behavioral: Augmented Reality Exposure Therapy Based on ExposXR software
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.
No Intervention: Treatment as Usual
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
[Change from baseline (Before the intervention) to post assessment (1 week and 1 month after the pre-assessment) ]

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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) ]
Specific Phobia Scale is a 10-item questionnaire that measures the severity of a specific phobia. Scores range from 0 (none) to 4 (severe).
[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) ]
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.
[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) ]
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.
[Change from baseline (Before the intervention) to post assessment (1 week and 1 month after the pre-assessment) ]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Koç University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Wayne State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Can Anarat, MA, Koc University
  • Study Chair: Ekin Cakir, PhD, Koc University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 13, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 25, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 29, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 11, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022.034.IRB3.006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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