Augmented Reality Exposure Therapy for Cynophobia

NCT ID: NCT05333783

Last Updated: 2023-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-13
• Study Completion Date: 2022-11-29

Brief 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. 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.

Conditions

Phobia Animal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Augmented Reality Exposure Therapy Based on ExposXR software

Intervention Type: BEHAVIORAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wayne State University

OTHER

Sponsor Role: collaborator

Koç University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Can Anarat, MA

Role: STUDY_CHAIR

Koç University

Ekin Cakir, PhD

Role: STUDY_CHAIR

Koç University

Locations

Koc University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 34672925 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2022.034.IRB3.006

Identifier Type: -

Identifier Source: org_study_id