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

• ClinicalTrials.gov Identifier: NCT03649347
• Recruitment Status: Terminated
• First Posted: August 28, 2018
• Results First Posted: March 7, 2022
• Last Update Posted: March 7, 2022
• Sponsor: Wayne State University
• Information provided by (Responsible Party): Arash Javanbakht, Wayne State University

Study Description

Brief Summary:

In this patented project, U.S. Patent No. 10,839,707, the investigators will develop an augmented reality exposure therapy method for arachnophobia, and fear of snakes, 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 phobias while the patient is wearing the augmented reality (AR) device. Then the clinician will lead the patient through steps of exposure therapy to the fear objects. 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 arachnophobia, patient is exposed to pictures of spiders printed or on a computer screen- or if available, view of a real tarantula in the office. Gradually, patient tolerates viewing/approaching the spider 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 and colors of spiders), which limits generalization of safety learning, 3) when available, clinician has very limited control over behaviors of the feared objects (e.g. spider/snake), 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.

Condition or disease	Intervention/treatment	Phase
Phobias Snakes; Phobias Spiders	Behavioral: Augmented reality exposure therapy	Not Applicable

Detailed Description:

Anxiety and stress-related disorders are very common. One in three people experience some form of anxiety disorder including phobias, PTSD, and OCD. These disorders chronically limit one's ability to function and enjoy life. In addition to the common prevalence, wars in Iraq and Afghanistan have left about 13% of the returning veterans with combat PTSD, and even more with partial symptoms. Lifetime prevalence of PTSD is as high as 10% in women. Economic burden of anxiety disorders is between 42 to 52 billion dollars, one third of the country's total mental health bill. Near 30% of this money is spent in treatment costs. Burden of lost workdays only for PTSD is $3 billion. OCD affects 2.3% of the U.S. adults, half have serious impairment. Social phobia is one of the most common anxiety disorders with a 12 months prevalence of 6.8% and lifetime prevalence of 12.1%

Exposure therapy is the most effective treatment for cue-related anxiety disorders such as specific phobias, social phobia, OCD, and PTSD. The core principle is exposure to the feared objects/situations guided by a clinician. For example, in arachnophobia (fear of spiders) patient is exposed to picture of a spider on a computer, or from distance in the office, and gradually, with help of the clinician, they tolerate view of the spider from a closer distance. Clinician has a crucial role as the social safety cue in this process.

Although exposure therapy is very effective in treatment of phobias, OCD, and PTSD, there are limitations. Access and adherence to, and efficacy of exposure therapy are limited to 50% by multiple factors: First, there is a national shortage of psychiatrists and psychotherapists; patients often have to be on waiting list for weeks to months, and in many geographical locations such services are extremely scarce or do not exist. More than 50% of clinicians are not trained in exposure therapy, and there is usually geographical barriers for access to skilled therapists. In general, more than half of the US counties are unable to recruit mental health providers. Very frequently patients only receive medication or supportive therapy for several years before they can see a specialist trained in exposure therapy. Certain conditions like social phobia or PTSD make it increasingly difficult to leave the house and go to the clinic. Second, the feared objects are not always available in office for exposure and exposure most of the times is limited to pictures, movie clips, imagination, narrative, or memories. Imaginary exposure commonly lacks the level of arousal that is required for development of new safety learning. Third, patients have to practice real-life exposure on their own. In vivo treatment is commonly limited: often patients do not create situations that elicit the optimal safety learning, do not know how to create exposure situations, or simply do not follow through because of high anxiety in the absence of someone to coach them. This gap between exposure in the office, and real-life exposure remains a significant roadblock in successful exposure therapy. Fourth, clinicians are usually unable to provide treatment across multiple physical, temporal and social contexts that can promote contextualization of safety learning. Exposure mostly happens in the physical, emotional, social, and temporal context of the office visits. A fifth limitation is that current exposure therapy methods, do not address overgeneralization of the fear response.

Augmented Reality Augmented reality (AR) is the next wave of interactive human-computer technology that provides an opportunity of mixing virtually created objects with reality. Instead of creating a completely synthetic environment, AR adds virtually created objects to the real non-synthetic context. These elements become part of the real context, or cover some of its components. AR technology ultimately becomes less expensive than virtual reality (VR) technology because it does not require modeling the whole environment.

The investigators have developed a proof of concept prototype. The prototype that includes a scenario for treatment of fear of spiders (arachnophobia) and fear of snakes. Software platform connects the patient to a clinician who is located in the same or a different physical space, the patient wears the AR device, the clinician is able to see the patient's field of view, and positions a virtual spider/snake in the patient's environment, clinician determines direction/velocity of motions of the virtual spider/snake, clinician leads patient through the process of exposure therapy process until patient is desensitized to the view of the spider/snake. Exposure can then advance to higher number of spiders/snakes, or larger ones.

Subject Recruitment: Subject recruitment will happen at the Wayne State University (WSU) Department of Psychiatry and Behavioral Neurosciences (DPBN) psychiatry clinic, through flyers spread on the campus, and advertisement on Wayne State's student website. The investigators aim to pre-screen a minimum of 50 individuals. The actual number of participants to be enrolled is 50, and the investigators have a minimum pre-screening of 50 anticipating that some may not qualify.

Treatment will take place at the Stress, Trauma, and Anxiety Research Clinic at the WSU department of psychiatry in Detroit. Participants will do 1-4 sessions of augmented reality exposure therapy (ARET), each lasting 90 minutes. The first session will include a short refresher on principles of exposure therapy, and training the use of the AR equipment.

At any time the level of distress due to exposure is determined too high, both patient and the provider can abort the exposure. This will be done similarly to any other conventional exposure therapy method.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 25 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 15 Intervention vs 15 non intervention control group for spider phobia; 30 intervention vs 30 non intervention control group for fear of snakes
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Bringing Exposure Therapy for Animal Phobias to Real-Life Context With Augmented Reality
• Actual Study Start Date: August 30, 2018
• Actual Primary Completion Date: April 1, 2020
• Actual Study Completion Date: April 1, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: AR Therapy Intervention for Spider Phobia; Augmented reality (AR) exposure therapy involves placing virtual objects in the participant's real environment as a method of exposure therapy. The AR therapy intervention group will complete an exposure therapy session using an augmented reality headset. 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 exposure therapy session will be as long as needed to reduce anxiety to low and stable levels, as measured by the participant's subjective units of distress.	Behavioral: Augmented reality exposure therapy; Exposure therapy via utilization of augmented reality. Virtual objects will be placed on the patient's real environment for exposure therapy.
No Intervention: No Treatment Control Group for Spider Phobia; This will be a waitlist control group that will receive no treatment for the duration of the study, however they will be offered the opportunity for some form of exposure therapy following the conclusion of the study (1 month).
Experimental: AR Therapy Intervention for Snake Phobia; Augmented reality (AR) exposure therapy involves placing virtual objects in the participant's real environment as a method of exposure therapy. The AR therapy intervention group will complete an exposure therapy session using an augmented reality headset. 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 exposure therapy session will be as long as needed to reduce anxiety to low and stable levels, as measured by the participant's subjective units of distress.	Behavioral: Augmented reality exposure therapy; Exposure therapy via utilization of augmented reality. Virtual objects will be placed on the patient's real environment for exposure therapy.
No Intervention: No Treatment Control Group for Snake Phobia; This will be a waitlist control group that will receive no treatment for the duration of the study, however they will be offered the opportunity for some form of exposure therapy following the conclusion of the study (1 month).

Outcome Measures

Primary Outcome Measures :

1. Spider Phobia [ Time Frame: Change in score on Fear of Spiders questionnaire from baseline to post-treatment, at one month follow-up ]

   Fear of spiders / severity of phobia will be measured via the Fear of Spiders questionnaire in order to determine how treatment has impacted the fear.

   The fear of spiders questionnaire is 18 items scored on a scale from 1-7, for a low score of 18 and a high score of 126. Total score is calculated by adding all items together. Higher scores are indicative of greater fear of spiders.

Secondary Outcome Measures :

1. Behavioral Approach Test--Ability to Confront Phobia [ Time Frame: Change in score on Behavioral Approach Test from baseline to post-treatment, at one month follow-up ]
   A measure of the closest distance the patient can have to the feared object. Scored from 0-12 based on distance away in meters 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.

Other Outcome Measures:

1. Galvanic Skin Response to Real and AR Spiders - Intervention Group ONLY [ Time Frame: GSR to a real tarantula during the BAT before AR treatment and GSR to AR spiders during the first five minutes of AR treatment ]
   Galvanic skin response (GSR) was used to assess hyperarousal to a real tarantula as well as to AR spiders, in the intervention group ONLY. This comparison was used to asses the validity of the AR stimuli by demonstrating the level of arousal to both the real feared object (live tarantula) and AR spiders. GSR was baseline corrected for each participant. Higher GSR is associated with greater autonomic arousal and indicates greater fear of the object (live or AR version).
2. Snake Phobia [ Time Frame: Change in score on Snake Anxiety questionnaire from baseline to post treatment (immediately following the last exposure therapy session) ]
   Fear of snakes will be measured via the snake anxiety questionnaire. The Snake Anxiety questionnaire is a 30 item true or false questionnaire. The number of true or false responses are summed. Higher number of true responses is indicative of greater phobia.
3. Spider Phobia--additional Measure [ Time Frame: Change in score on Spider Phobia questionnaire from baseline to post-treatment, at one month follow-up ]
   The Spider Phobia questionnaire is a 31 item questionnaire with yes or no responses. All items are added together for a total score. 9 items are reverse scored. The minimum score is 0 and the maximum score is 31. Higher scores are indicative of more severe phobia. This questionnaire will serve as an additional measure of spider phobia to the primary outcome measure.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Primary diagnosis of specific phobia of animals (i.e. spiders or snakes), according to diagnostic and statistical manual version 5 (DSM-V) criteria. Both genders, ages 18-45, who are able and willing to consent for involvement in the study.

Exclusion Criteria:

• Subjects who refuse or are unable to consent to participate in the study.
• Active abuse of substances or meet criteria for substance use disorder in the past 6 months
• Current or previous diagnosis of psychotic disorder, schizophrenia, obsessive-compulsive disorder, bipolar disorder, mental retardation, active abuse of substances or meet criteria for substance use disorder in the past six months substance use, or PTSD.
• Unstable behavior that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study, e.g. significant Axis II disorder or suicidal behavior.
• Visual or auditory disabilities limiting ability use of 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

Contacts and Locations

Locations

United States, Michigan

Wayne State U Department of Psychiatry

Detroit, Michigan, United States, 48197

Sponsors and Collaborators

Wayne State University

Investigators

• Principal Investigator: Arash Javanbakht, MD; Wayne State University

  Study Documents (Full-Text)

Documents provided by Arash Javanbakht, Wayne State University:

Study Protocol  [PDF] September 22, 2020

Statistical Analysis Plan  [PDF] September 22, 2020

More Information

• Responsible Party: Arash Javanbakht, Director of Stress, Trauma, and Anxiety Research Clinic, Wayne State University
• ClinicalTrials.gov Identifier: NCT03649347
• Other Study ID Numbers: 1711000968
• First Posted: August 28, 2018
• Results First Posted: March 7, 2022
• Last Update Posted: March 7, 2022
• Last Verified: December 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Arash Javanbakht, Wayne State University:

Exposure therapy; Technology; Telemedicine

Additional relevant MeSH terms:

Phobic Disorders; Anxiety Disorders; Mental Disorders