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Bringing Exposure Therapy to Real-Life Context With Augmented Reality

Bringing Exposure Therapy for Animal Phobias to Real-Life Context With Augmented Reality

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03649347
Acronym
ARET
Enrollment
25
Registered
2018-08-28
Start date
2018-08-30
Completion date
2020-04-01
Last updated
2022-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Phobias Snakes, Phobias Spiders

Keywords

Exposure therapy, Technology, Telemedicine

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.

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.

Interventions

Exposure therapy via utilization of augmented reality. Virtual objects will be placed on the patient's real environment for exposure therapy.

Sponsors

Wayne State University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

15 AR Therapy Intervention for Spider Phobia vs 15 No Treatment Control Group for Spider Phobia; 30 intervention vs 30 non intervention control group for fear of snakes

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Spider PhobiaChange in score on Fear of Spiders questionnaire from baseline to post-treatment, at one month follow-upFear 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

MeasureTime frameDescription
Behavioral Approach Test--Ability to Confront PhobiaChange in score on Behavioral Approach Test from baseline to post-treatment, at one month follow-upA 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

MeasureTime frameDescription
Snake PhobiaChange 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.
Spider Phobia--additional MeasureChange in score on Spider Phobia questionnaire from baseline to post-treatment, at one month follow-upThe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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.
13
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).
12
AR Therapy Intervention for Fear of Snakes
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.
0
No Treatment Control Group for Fear of Snakes
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).
0
Total25

Baseline characteristics

CharacteristicAR Therapy Intervention for Spider PhobiaNo Treatment Control Group for Spider PhobiaAR Therapy Intervention for Fear of SnakesNo Treatment Control Group for Fear of SnakesTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
13 Participants12 Participants0 Participants0 Participants25 Participants
Age, Continuous23 years24 years23.5 years
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
United States
13 Participants12 Participants0 Participants0 Participants25 Participants
Sex/Gender, Customized
Sex
Did Not Report
1 Participants2 Participants0 Participants0 Participants3 Participants
Sex/Gender, Customized
Sex
Female
9 Participants7 Participants0 Participants0 Participants16 Participants
Sex/Gender, Customized
Sex
Male
3 Participants3 Participants0 Participants0 Participants6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 130 / 12
other
Total, other adverse events
0 / 130 / 12
serious
Total, serious adverse events
0 / 130 / 12

Outcome results

Primary

Spider Phobia

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.

Time frame: Change in score on Fear of Spiders questionnaire from baseline to post-treatment, at one month follow-up

Population: OF NOTE: No participants were recruited for snake phobia data collection due to the COVID-19 pandemic halting in-person research activities, therefore no data were collected for snake phobia.

ArmMeasureGroupValue (MEAN)Dispersion
AR Therapy Intervention for Spider PhobiaSpider PhobiaBaseline Score104 score on a scaleStandard Deviation 10.8
AR Therapy Intervention for Spider PhobiaSpider PhobiaPost Treatment Score43.2 score on a scaleStandard Deviation 22.5
No Treatment Control Group for Spider PhobiaSpider PhobiaPost Treatment Score102 score on a scaleStandard Deviation 18.4
No Treatment Control Group for Spider PhobiaSpider PhobiaBaseline Score111 score on a scaleStandard Deviation 11.7
Comparison: A repeated measures ANOVA was conducted to assess main effects of group (AR therapy intervention versus no treatment control), time (baseline, one week follow up, and one month follow up) as well as an interaction effect. The P-Value shown below is for the interaction effect. Post-hoc power analysis indicated actual power 99%, critical F=4.76.p-value: <0.001ANOVA
Secondary

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 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.

Time frame: Change in score on Behavioral Approach Test from baseline to post-treatment, at one month follow-up

Population: OF NOTE: No participants were recruited for snake phobia data collection due to the COVID-19 pandemic halting in-person research activities, therefore no data were collected for snake phobia.

ArmMeasureGroupValue (MEAN)Dispersion
AR Therapy Intervention for Spider PhobiaBehavioral Approach Test--Ability to Confront PhobiaBaseline Distance6.27 metersStandard Deviation 2.26
AR Therapy Intervention for Spider PhobiaBehavioral Approach Test--Ability to Confront PhobiaPost Treatment Distance0 metersStandard Deviation 0
No Treatment Control Group for Spider PhobiaBehavioral Approach Test--Ability to Confront PhobiaPost Treatment Distance6 metersStandard Deviation 3.03
No Treatment Control Group for Spider PhobiaBehavioral Approach Test--Ability to Confront PhobiaBaseline Distance7.5 metersStandard Deviation 5.16
Comparison: A repeated measures ANOVA was conducted to assess main effects of group (AR therapy intervention versus no treatment control), time (baseline, one week follow up, and one month follow up) as well as an interaction effect. The P-Value shown below is for the interaction effect. Post-hoc power analysis indicated actual power 96%, critical F=4.76.p-value: <0.001ANOVA
Other Pre-specified

Snake Phobia

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.

Time frame: Change in score on Snake Anxiety questionnaire from baseline to post treatment (immediately following the last exposure therapy session)

Population: OF NOTE: No participants were recruited for snake phobia data collection due to the COVID-19 pandemic halting in-person research activities, therefore no data were collected for snake phobia.

Other Pre-specified

Spider Phobia--additional Measure

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.

Time frame: Change in score on Spider Phobia questionnaire from baseline to post-treatment, at one month follow-up

Population: OF NOTE: No participants were recruited for snake phobia data collection due to the COVID-19 pandemic halting in-person research activities, therefore no data were collected for snake phobia.

ArmMeasureGroupValue (MEAN)Dispersion
AR Therapy Intervention for Spider PhobiaSpider Phobia--additional MeasureBaseline Score20.4 score on a scaleStandard Deviation 4.25
AR Therapy Intervention for Spider PhobiaSpider Phobia--additional MeasurePost Treatment Score11.1 score on a scaleStandard Deviation 5.69
No Treatment Control Group for Spider PhobiaSpider Phobia--additional MeasureBaseline Score25.7 score on a scaleStandard Deviation 3.23
No Treatment Control Group for Spider PhobiaSpider Phobia--additional MeasurePost Treatment Score24.9 score on a scaleStandard Deviation 3.14
Comparison: A repeated measures ANOVA was conducted to assess main effects of group (AR therapy intervention versus no treatment control), time (baseline, one week follow up, and one month follow up) as well as an interaction effect. The P-Value shown below is for the interaction effect. Post-hoc power analysis indicated actual power 99%, critical F=3.49.p-value: <0.005ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026