Telemedicine-Based Virtual Reality Clinic for the Treatment of Phobias

NCT ID: NCT06302868

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-03

Study Completion Date

2024-08-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Arachnophobia Cynophobia Ophidiophobia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Telemedicine-based Virtual Reality Exposure Therapy

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.

Group Type ACTIVE_COMPARATOR

Telemedicine-Based Virtual Reality Exposure Therapy

Intervention Type BEHAVIORAL

Participants will complete 12 60-minute exposure therapy sessions in a Virtual Reality Clinic using Virtual Reality stimuli and progress to in vivo exposures.

Standard Telemedicine Exposure Therapy

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.

Group Type ACTIVE_COMPARATOR

Telemedicine Exposure Therapy Using Photos and Videos

Intervention Type BEHAVIORAL

Participants will complete 12 60-minute exposure therapy sessions using photos/videos and progress to in vivo exposures.

Interventions

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Telemedicine Exposure Therapy Using Photos and Videos

Participants will complete 12 60-minute exposure therapy sessions using photos/videos and progress to in vivo exposures.

Intervention Type BEHAVIORAL

Telemedicine-Based Virtual Reality Exposure Therapy

Participants will complete 12 60-minute exposure therapy sessions in a Virtual Reality Clinic using Virtual Reality stimuli and progress to in vivo exposures.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

University of South Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian E Bunnell, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

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University of South Florida

Tampa, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kaitlyn R Schuler, PhD

Role: CONTACT

813-396-9169

Facility Contacts

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Brian Bunnell, PhD

Role: primary

References

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Schuler KR, Ong T, Welch BM, Craggs JG, Bunnell BE. Examining a Telemedicine-Based Virtual Reality Clinic in Treating Adults With Specific Phobia: Protocol for a Feasibility Randomized Controlled Efficacy Trial. JMIR Res Protoc. 2025 Apr 10;14:e65770. doi: 10.2196/65770.

Reference Type DERIVED
PMID: 40209221 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R43MH129065

Identifier Type: NIH

Identifier Source: secondary_id

View Link

006215

Identifier Type: -

Identifier Source: org_study_id

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