Augmented Reality Exposure Therapy for Cynophobia

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: Completed
• Conditions: Phobia Animal
• Intervention / Treatment: Behavioral: Augmented Reality Exposure Therapy Based on ExposXR software

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: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ceren Acarturk, Assoc. Prof.; Phone Number: +90 (532) 256 38 46; Email: cacarturk@ku.edu.tr

Study Locations

• Turkey
  • Istanbul, Turkey
    • Koç University

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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).	[Change from baseline (Before the intervention) to post assessment (1 week and 1 month after the pre-assessment) ]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	[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.	[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.	[Change from baseline (Before the intervention) to post assessment (1 week and 1 month after the pre-assessment) ]

Collaborators and Investigators

• Sponsor: Koç University
• Collaborators: Wayne State University
• Investigators: Study Chair: Can Anarat, MA, Koç University; Study Chair: Ekin Cakir, PhD, Koç University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2022
• Primary Completion (Actual): July 25, 2022
• Study Completion (Actual): November 29, 2022

Study Registration Dates

• First Submitted: March 11, 2022
• First Submitted That Met QC Criteria: April 12, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID 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