- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06302868
Telemedicine-Based Virtual Reality Clinic for the Treatment of Phobias
April 23, 2026 updated by: University of South Florida
Doxy.me VR vs. Telemental Health-Based Exposure Therapy
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.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Tampa, Florida, United States, 33613
- University of South Florida
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Is an adult ≥ 18 years old
- Has a self-reported fear of dogs, snakes, and/or spiders
- 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
- Has access to the internet AND a computer OR smartphone with video conferencing capabilities
- 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:
- Is participating in ongoing mental health therapy from a non-study therapist
- Has had changes to psychotropic medication use within six weeks preceding enrollment in the trial
- 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
- Reports active auditory, visual, and/or tactile hallucinations via the Diagnostic Assessment Research Tool (DART) Psychosis Module screening question
- Reports having a diagnosis of photosensitive epilepsy by a medical doctor or a history of experiencing seizures that they believe were caused by photosensitivity
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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.
|
Participants will complete 12 60-minute exposure therapy sessions in a Virtual Reality Clinic using Virtual Reality stimuli and progress to in vivo exposures.
|
|
Active Comparator: 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.
|
Participants will complete 12 60-minute exposure therapy sessions using photos/videos and progress to in vivo exposures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Phobia Symptom Severity
Time Frame: Baseline, 6 Weeks Post-Baseline, and 3 Months Post-Baseline
|
The Severity Measure for Specific Phobia (SMSP) is a 10-item self-report questionnaire that assesses the severity of specific phobia symptoms relative to an individual's feared stimulus.
Total scores range from 0 to 4 with higher scores indicating higher phobia severity.
The SMSP has excellent internal consistency, reliability, and criterion and discriminant validity.
|
Baseline, 6 Weeks Post-Baseline, and 3 Months Post-Baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Specific Phobia Diagnosis
Time Frame: Baseline and 3 Months Post-Baseline
|
The Diagnostic Assessment Research Tool (DART) is a modular, semi-structured interview assessing criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
In this study, therapists administered the DART Specific Phobia Module (DART-SP), which classifies symptoms as Absent, Subthreshold, or Present.
The DART has demonstrated strong construct, discriminant, and convergent validity across its modules.
|
Baseline and 3 Months Post-Baseline
|
|
General Anxiety Severity
Time Frame: Baseline and 3 Months Post-Baseline
|
The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report measure that assesses the severity of general anxiety symptomatology.
Scores range from 0 to 21 with higher scores indicating higher anxiety severity.
The GAD-7 has demonstrated excellent internal consistency, reliability, and good convergent validity.
|
Baseline and 3 Months Post-Baseline
|
|
Depression Severity
Time Frame: Baseline and 3 Months Post-Baseline
|
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report measure that assesses the severity of depression symptomatology.
Scores range from 0 to 27 with higher scores indicating higher depression severity.
The PHQ-9 has demonstrated good convergent validity and specificity for depression diagnosis as well as excellent internal consistency and reliability.
|
Baseline and 3 Months Post-Baseline
|
|
Therapeutic Alliance
Time Frame: 6 Weeks Post-Baseline and 3 Months Post-Baseline
|
The Working Alliance Inventory-Self Report (WAI-SR) is a 12-item measure that assesses client-reported therapeutic alliance.
Total Scores range from 12 to 60 with higher scores suggesting better therapeutic alliance.
The WAI-SR includes 3 subscales: Goal (ie, the degree to which clients and therapists agree on goals of treatment), Task Agreement (ie, the degree to which clients and therapists agree on how to achieve those goals), and Bond (ie, the degree to which clients and therapists have developed a personal bond).
Subscale Scores range from 4 to 20, with higher scores suggesting better alliance within each domain.
The WAI-SR has demonstrated good convergent validity and excellent internal consistency and reliability.
|
6 Weeks Post-Baseline and 3 Months Post-Baseline
|
|
Treatment Satisfaction
Time Frame: 6 Weeks Post-Baseline and 3 Months Post-Baseline
|
The Client Satisfaction Questionnaire-8 (CSQ-8) is an 8-item client-rated questionnaire that assesses satisfaction with treatment.
Scores range from 8 to 32 with higher scores indicating increased satisfaction.
The CSQ-8 is correlated with clinical outcomes and post-treatment functioning and has demonstrated good construct validity and internal consistency and reliability.
|
6 Weeks Post-Baseline and 3 Months Post-Baseline
|
|
System Usability
Time Frame: 6 Weeks Post-Baseline and 3 Months Post-Baseline
|
The System Usability Scale (SUS) is a 10-item self-report questionnaire that assesses the usability of a particular software system, platform, or app.
Scores range from 0-100 with scores >68 indicating good usability, scores >80 indicating excellent usability, and scores < 60 suggesting potential usability issues.
The SUS has demonstrated good internal consistency and reliability.
|
6 Weeks Post-Baseline and 3 Months Post-Baseline
|
|
Telepresence
Time Frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Average across weeks reported.
|
The Single Item Presence Questionnaire (SIPQ) is a 1-item self-reported measure of telepresence that asks respondents, "to what extent did you feel present in the environment, as if you were really there?"
Ratings are provided on a scale of 0 "not at all present" to 10 "'totally present."
The SIPQ has demonstrated good to excellent validity, reliability, and sensitivity.
|
Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Average across weeks reported.
|
|
Cybersickness
Time Frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Average across weeks reported.
|
The Cybersickness in VR Questionnaire (CSQ-VR) is a 6-item self-report questionnaire that assesses nausea, vestibular, and oculomotor cybersickness experienced in VR.
This measure was completed by participants in the Doxy.me
VR condition after each therapy session that included VR-based exposures.
Total scores range from 6 to 27 with higher scores reflecting increased levels of cybersickness.
The CSQ-VR has demonstrated excellent internal consistency and convergent validity.
The CSQ-VR was completed by the Doxy.me
VR group only.
|
Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Average across weeks reported.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Brian E Bunnell, PhD, University of South Florida
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 25, 2023
Primary Completion (Actual)
July 26, 2024
Study Completion (Actual)
July 26, 2024
Study Registration Dates
First Submitted
January 12, 2024
First Submitted That Met QC Criteria
March 6, 2024
First Posted (Actual)
March 12, 2024
Study Record Updates
Last Update Posted (Actual)
May 18, 2026
Last Update Submitted That Met QC Criteria
April 23, 2026
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 006215
- R43MH129065 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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