Bringing Exposure Therapy to Real-Life Context With Augmented Reality-Dogs (ARET)-Dogs

NCT05067491 | Active Not Recruiting

• 1 other identifier: 1711000968-Dog Phobia
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

In this patented project, U.S. Patent No. 10,839,707, the investigators will develop an augmented reality exposure therapy method for cynophobia, also known as dog phobia, to test in the clinic. The platform will include a software that allows the clinician (psychiatrist/therapist) to position virtual objects in the real environment of the patient with the above mentioned phobia while the patient is wearing the augmented reality (AR) device. Then the clinician will lead the patient through steps of exposure therapy to the feared object. The investigators will then measure the impact of treatment and compare to before treatment measures of fear of the phobic object. Exposure therapy is the most evidence-based treatment for specific phobias, social phobia, obsessive-compulsive disorder (OCD), and posttraumatic stress disorder (PTSD). The core principle is patient's exposure to the feared objects/situations guided by a clinician. For example, in cynophobia, patient is exposed to pictures of dogs printed or on a computer screen - or if available, view of a real dog in the office. Gradually, patient tolerates viewing/approaching the dog from a closer distance, and fear response extinguishes. The clinician has a crucial role in signaling safety to the patient, as well as providing support and coaching. This treatment is limited by multiple factors: 1) limited access to feared objects/situations in the clinic, 2) even when feared objects are available, they are not diverse (e.g. different types, sizes, and colors of dogs), which limits generalization of safety learning, 3) when available, clinician has very limited control over behaviors of the feared object, 4) safety learning is limited to the clinic office context, and contextualization of safety learning to real life experiences is left to the patient to do alone, which often does not happen. This is specifically important in conditions such as PTSD, where there is cumulative evidence for impaired contextualization as a key neurobiological underpinning. 5) Lack of geographical access to experts in exposure therapy, especially for PTSD, in rural areas.

Conditions

Specific Phobia, Animal

Keywords

Exposure therapy; Technology; Telemedicine; Cynophobia

Outcome Measures

Primary Outcomes (1)

• Behavioral Approach Test--Ability to confront phobia

  A measure of the closest distance the patient can have to the feared object. Scored from 0-12 based on distance away from feared object and interaction with feared object. The score is given based on participant interaction, therefore one value is chosen. Higher values closer to 12 show greater comfortability and ability to interact with the feared object.

  Change in score on Behavioral Approach Test from baseline to post treatment (immediately following the last exposure therapy session and at one-month follow-up)

Secondary Outcomes (1)

• Cynophobia (fear of dogs) as measured by the Dog Phobia Questionnaire (DPQ)

  Change in score on Dog Phobia Questionnaire from baseline to post treatment (immediately following the last exposure therapy session and at one-month follow-up)

Other Outcomes (2)

• Autonomic Arousal

  Change in score from baseline to post treatment (immediately following the last exposure therapy session and at one-month follow-up)

• Credibility and expectancy of treatment efficacy as measured by the Credibility/Expectancy Questionnaire

  Change in score from baseline to post treatment (immediately following the last exposure therapy session and at one-month follow-up)

Study Arms (2)

Intervention

EXPERIMENTAL

The experimental group will go through an exposure therapy session using an augmented reality headset device. The participant will work with the therapist, who will control the augmented reality paradigm and cater the exposure to the needs of the participant. The duration of the exposure will be as long as is needed to reduce anxiety regarding the feared object until self-reported subjective distress is low and stable.

Behavioral: Augmented reality exposure therapy

Non-intervention

NO INTERVENTION

The control group will not go through an exposure therapy session using an augmented reality headset device. This will be a no-intervention control group that can have some form of exposure therapy following the conclusion of the treatment/research period.

Interventions

Augmented reality exposure therapy BEHAVIORAL

Virtual objects will be placed in the patient's visual field, superimposed on their real environment for exposure therapy.

Also known as: Exposure therapy via utilization of augmented reality

Intervention

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Primary diagnosis of dog phobia, according to Diagnostic and Statistical Manual-5 (DSM-5) criteria
• Willing and able to consent for involvement in the study

You may not qualify if:

• People who refuse or are unable to consent to participate in the study
• Current or previous diagnosis of psychotic disorder, schizophrenia, bipolar disorder, PTSD, mental retardation, active abuse of substances or meet criteria for substance use disorder in the past six months
• Unstable behavior that, in the opinion of the investigator, would place the participant at increased risk or preclude the participant's full compliance with or completion of the study, e.g., significant Axis II disorder or suicidal behavior
• Visual or auditory disabilities limiting ability to use the AR goggles
• Current use of antidepressant medications, mood stabilizers, or benzodiazepines
• History of seizures or a condition that would increase likelihood for seizures
• Serious medical or neurological illness
• Wards of the court

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Wayne State University Department of Psychiatry and Behavioral Neurosciences

Detroit, Michigan, 48201, United States

Location

Related Publications (7)

• Botella C, Perez-Ara MA, Breton-Lopez J, Quero S, Garcia-Palacios A, Banos RM. In Vivo versus Augmented Reality Exposure in the Treatment of Small Animal Phobia: A Randomized Controlled Trial. PLoS One. 2016 Feb 17;11(2):e0148237. doi: 10.1371/journal.pone.0148237. eCollection 2016.

  PMID: 26886423 BACKGROUND

• Wrzesien M, Burkhardt JM, Alcaniz Raya M, Botella C, Breton Lopez JM. Analysis of distributed-collaborative activity during augmented reality exposure therapy for cockroach phobia. Stud Health Technol Inform. 2010;154:134-9.

  PMID: 20543285 BACKGROUND

• Foa EB, McLean CP. The Efficacy of Exposure Therapy for Anxiety-Related Disorders and Its Underlying Mechanisms: The Case of OCD and PTSD. Annu Rev Clin Psychol. 2016;12:1-28. doi: 10.1146/annurev-clinpsy-021815-093533. Epub 2015 Nov 11.

  PMID: 26565122 BACKGROUND

• Tarrier N, Pilgrim H, Sommerfield C, Faragher B, Reynolds M, Graham E, Barrowclough C. A randomized trial of cognitive therapy and imaginal exposure in the treatment of chronic posttraumatic stress disorder. J Consult Clin Psychol. 1999 Feb;67(1):13-8. doi: 10.1037//0022-006x.67.1.13.

  PMID: 10028204 BACKGROUND

• Tsai CF, Yeh SC, Huang Y, Wu Z, Cui J, Zheng L. The Effect of Augmented Reality and Virtual Reality on Inducing Anxiety for Exposure Therapy: A Comparison Using Heart Rate Variability. J Healthc Eng. 2018 Nov 25;2018:6357351. doi: 10.1155/2018/6357351. eCollection 2018.

  PMID: 30595830 BACKGROUND

• Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.

  PMID: 11132119 BACKGROUND

• Vorstenbosch V, Antony MM, Koerner N, Boivin MK. Assessing dog fear: evaluating the psychometric properties of the Dog Phobia Questionnaire. J Behav Ther Exp Psychiatry. 2012 Jun;43(2):780-6. doi: 10.1016/j.jbtep.2011.10.006. Epub 2011 Oct 28.

  PMID: 22104660 BACKGROUND

MeSH Terms

Conditions

Phobia, Specific; Zoophobia

Study Officials

• Arash Javanbakht, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Stress, Trauma, and Anxiety Research Clinic

Model Details: 15 Intervention vs 15 non-intervention control group for cynophobia (fear of dogs)

Study Record Dates

• First Submitted: September 21, 2021
• First Posted: October 5, 2021
• Study Start: September 15, 2022
• Primary Completion: August 31, 2025
• Study Completion: August 31, 2025
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)