Telemedicine-Based Virtual Reality Clinic for the Treatment of Phobias

University of South Florida

Status: Enrolling

Conditions: Ophidiophobia; Arachnophobia; Cynophobia

Treatments: Behavioral: Telemedicine Exposure Therapy Using Photos and Videos; Behavioral: Telemedicine-Based Virtual Reality Exposure Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06302868

006215

R43MH129065 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to assess the feasibility of conducting a randomized controlled efficacy trial comparing the delivery of exposure therapy via a telemedicine-based virtual reality clinic (Doxy.me VR) vs. standard telemental health (TMH) to adults with intense fear of dogs, snakes, and/or spiders. The secondary purpose is to preliminarily examine the efficacy of using Doxy.me VR vs. TMH in reducing phobia severity.

Full description

This study aims to assess the feasibility of conducting a randomized controlled efficacy trial comparing the delivery of exposure therapy via a telemedicine-based virtual reality clinic (Doxy.me VR) vs. standard telemental health (TMH) to adults with intense fear of dogs, snakes, and/or spiders. This study will use feasibility randomized controlled efficacy trial design. This single-site trial will include up to 60 adults with self-reported fear of dogs, snakes, and/or spiders who will be randomly assigned via the REDCap Randomization Module using a 1:1 allocation ratio to receive 12 sessions of exposure therapy over the course of 3 months via standard telemental health (TMH; n=15) vs. Doxy.me VR (n=15), a telemedicine-based virtual reality clinic.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. Is an adult ≥ 18 years old
2. Has a self-reported fear of dogs, snakes, and/or spiders
3. Indicates Subthreshold or Present Specific Phobia symptoms as determined by the study therapist via administration of the Diagnostic Assessment Research Tool (DART) Specific Phobia Module
4. Has access to the internet AND a computer OR smartphone with video conferencing capabilities
5. Will reside in the state of Florida for the duration of the study

Exclusion criteria

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Is participating in ongoing mental health therapy from a non-study therapist
2. Has had changes to psychotropic medication use within six weeks preceding enrollment in the trial
3. Reports active suicidal and/or homicidal intent or plan as determined by the study therapist via administration of the Diagnostic Assessment Research Tool (DART) Risk Assessment Module
4. Reports active auditory, visual, and/or tactile hallucinations via the Diagnostic Assessment Research Tool (DART) Psychosis Module screening question
5. Reports a history of epilepsy or seizures

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Telemedicine-based Virtual Reality Exposure Therapy

Active Comparator group

Description:

This group will receive exposure therapy in a telemedicine-based Virtual Reality Clinic using virtual reality snakes, dogs, or spiders. The VR stimuli range from small to medium to large and have four activity levels: idle, calm, energetic, and aggressive.

Treatment:

Behavioral: Telemedicine-Based Virtual Reality Exposure Therapy

Standard Telemedicine Exposure Therapy

Active Comparator group

Description:

This group will receive exposure therapy via Doxy.me telemedicine platform using photos and videos of snakes, dogs, or spiders. The photo/video stimuli range from small to medium to large and have four activity levels: idle, calm, energetic, and aggressive.

Treatment:

Behavioral: Telemedicine Exposure Therapy Using Photos and Videos