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

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ClinicalTrials.gov Identifier: NCT03649347
Recruitment Status : Recruiting
First Posted : August 28, 2018
Last Update Posted : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
Arash Javanbakht, Wayne State University

Brief Summary:

In this patent pending project, the investigators will develop an augmented reality exposure therapy method for arachnophobia and fear of snake 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
Phobia Snakes Phobias Spiders Behavioral: Augmented reality exposure therapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 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 Small Animal Phobias (Spiders and Snakes) to Real-Life Context With Augmented Reality
Actual Study Start Date : August 30, 2018
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Phobias

Arm Intervention/treatment
Experimental: AR therapy intervention for spider phobia
The experimental group will go through a 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. Augmented reality exposure therapy
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 be offered the opportunity for some form of exposure therapy following the conclusion of the treatment/research period (1 months).
Experimental: AR therapy intervention for fear of snakes
The experimental group will go through a 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. Augmented reality exposure therapy
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 fear of snakes
This will be a waitlist control group that will be offered the opportunity for some form of exposure therapy following the conclusion of the treatment/research period (1 months).



Primary Outcome Measures :
  1. Spider Phobia [ Time Frame: Change in score on Fear of Spiders questionnaire from baseline to post treatment (immediately following the last exposure therapy session) ]

    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 (immediately following the last exposure therapy session) ]
    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.


Other Outcome Measures:
  1. Autonomic Arousal [ Time Frame: Change in score from baseline to post treatment (immediately following the last exposure therapy session) ]
    Galvanic skin response will be used to assess hyperarousal throughout the sessions. Galvanic skin response will be measured as the magnitude of the change from baseline to presentation of feared stimulus. Higher SCR is associated with greater autonomic arousal/fear of the object.

  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 (immediately following the last exposure therapy session) ]
    The Spider Phobia questionnaire is a 31 item questionnaire with yes or no responses. 9 items are reverse coded. This will serve as an additional measure of spider phobia to the primary outcome measure. All items are added together for a total score. Higher scores are indicative of more severe phobia.



Information from the National Library of Medicine

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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 small 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03649347


Contacts
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Contact: Arash Javanbakht, MD 313-577-0766 ajavanba@med.wayne.edu
Contact: Lana R Grasser, BSc 313-577-0301 lgrasser@med.wayne.edu

Locations
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United States, Michigan
Wayne State U Department of Psychiatry Recruiting
Detroit, Michigan, United States, 48197
Contact: Arash Javanbakht, MD    313-577-1396    ajavanba@med.wayne.edu   
Sponsors and Collaborators
Wayne State University
Investigators
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Principal Investigator: Arash Javanbakht, MD Wayne State University

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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    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Phobic Disorders
Anxiety Disorders
Mental Disorders