Bringing Exposure Therapy to Real-Life Context With Augmented Reality

NCT03649347 | Terminated Results

• 1 other identifier: 1711000968
• 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 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.

Conditions

Phobias Snakes; Phobias Spiders

Keywords

Exposure therapy; Technology; Telemedicine

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• Behavioral Approach Test--Ability to Confront Phobia

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

Other Outcomes (2)

• Snake Phobia

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

• Spider Phobia--additional Measure

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

Study Arms (4)

AR Therapy Intervention for Spider Phobia

EXPERIMENTAL

AR Therapy Intervention participants first complete a behavioral approach test (BAT). They approach a live spider to get as close as they comfortably can. This BAT provides a baseline measure of the degree of fear of spiders; the BAT is not a form of exposure therapy. Participants then complete exposure therapy using an augmented reality (AR) headset. A therapist controls the AR paradigm, placing virtual spiders in a participant's real environment as a method of exposure therapy. Once a participant's anxiety is reduced to low, stable levels (as measured by the participant's subjective units of distress assessed at intervals during session), the participant then completes a second BAT to measure their degree of fear immediately following AR therapy. The difference between the first and second BAT are used to assess the efficacy of the AR exposure therapy treatment. One month later, the AR Therapy Intervention participants complete a third BAT to assess for treatment efficacy over time.

Behavioral: Augmented reality exposure therapy

No Treatment Control Group for Spider Phobia

NO INTERVENTION

The No Treatment Control group participants do not receive any AR exposure therapy for the duration of the study. These participants complete a behavioral approach test (BAT) at their first study visit, during which they approach a live spider as close as they comfortably can. This BAT provides a baseline measure of the degree of fear of spiders; the BAT is not a form of exposure therapy. One month later, the No Treatment Control group participants return for a second BAT to assess the degree to which their fear has changed as a function of time, in the context of NOT receiving any exposure therapy. After completion of the second BAT at this one-month follow-up visit, these participants are offered the opportunity for some form of exposure therapy following the conclusion of the study.

AR Therapy Intervention for Snake Phobia

EXPERIMENTAL

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

No Treatment Control Group for Snake Phobia

NO INTERVENTION

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).

Interventions

Augmented reality exposure therapy BEHAVIORAL

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

AR Therapy Intervention for Snake Phobia; AR Therapy Intervention for Spider Phobia

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Wayne State U Department of Psychiatry

Detroit, Michigan, 48197, United States

Location

MeSH Terms

Conditions

Arachnophobia

Results Point of Contact

• Title: Kathleen Gorski, Research Coordinator
• Organization: Stress, Trauma, and Anxiety Research Clinic (STARC) at Wayne State University

kathleen.gorski2@med.wayne.edu

313-577-9202

Study Officials

• Arash Javanbakht, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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 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

Study Record Dates

• First Submitted: April 21, 2018
• First Posted: August 28, 2018
• Study Start: August 30, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: April 19, 2022
• Results First Posted: March 7, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)