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ArachnophobiaNCT06302868

Telemedicine-Based Virtual Reality Clinic for the Treatment of Phobias

A study testing Telemedicine Exposure Therapy Using Photos and Videos and Telemedicine-Based Virtual Reality Exposure Therapy in people with Arachnophobia and Cynophobia, run by University of South Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arachnophobia, Cynophobia, Ophidiophobia
What is being tested?
Telemedicine Exposure Therapy Using Photos and Videos and Telemedicine-Based Virtual Reality Exposure Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
1 siteUnited States
Study dates
25 Oct 2023to 26 Jul 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of South Florida

    Tampa, Florida, 33613

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Telemedicine Exposure Therapy Using Photos and Videos, Telemedicine-Based Virtual Reality Exposure Therapy
Keywords
phobia, phobias, snakes, dogs, spiders
Medical subject headings
Arachnophobia, Zoophobia, Phobic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Telemedicine Exposure Therapy Using Photos and VideosBehavioural

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

  • Telemedicine-Based Virtual Reality Exposure TherapyBehavioural

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

Study groups in NCT06302868
Study groupRoleWhat they receive
Telemedicine-based Virtual Reality Exposure TherapyActive comparatorThis 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.
Receives: Behavioral: Telemedicine-Based Virtual Reality Exposure Therapy
Standard Telemedicine Exposure TherapyActive comparatorThis 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.
Receives: Behavioral: Telemedicine Exposure Therapy Using Photos and Videos

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phobia Symptom Severity

    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.

    Measured: Baseline, 6 Weeks Post-Baseline, and 3 Months Post-Baseline

Secondary outcomes (8)
  1. Specific Phobia Diagnosis

    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.

    Measured: Baseline and 3 Months Post-Baseline

  2. General Anxiety Severity

    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.

    Measured: Baseline and 3 Months Post-Baseline

  3. Depression Severity

    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.

    Measured: Baseline and 3 Months Post-Baseline

  4. Therapeutic Alliance

    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.

    Measured: 6 Weeks Post-Baseline and 3 Months Post-Baseline

  5. Treatment Satisfaction

    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.

    Measured: 6 Weeks Post-Baseline and 3 Months Post-Baseline

  6. System Usability

    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.

    Measured: 6 Weeks Post-Baseline and 3 Months Post-Baseline

  7. Telepresence

    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.

    Measured: 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.

  8. Cybersickness

    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.

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2024
  2. Study start25 Oct 2023
  3. Primary completion26 Jul 2024
  4. Study completion26 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06302868
Sponsor's protocol ID
006215
Other IDs
R43MH129065
Status last verified
Dec 2025
First submitted
12 Jan 2024
Last updated
18 May 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bunnell BE, Schuler KR, Craggs JG, Welch BM, Ong T. Examining the Efficacy of a Telehealth-Based Virtual Reality Clinic in Treating Adults With Specific Phobia: Feasibility Randomized Controlled Trial. JMIR Form Res. 2026 Jun 15;10:e84670. doi: 10.2196/84670.

    PubMed 42296397
  • 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.

    PubMed 40209221

Questions about this trial

What is this clinical trial studying?

A study testing Telemedicine Exposure Therapy Using Photos and Videos and Telemedicine-Based Virtual Reality Exposure Therapy in people with Arachnophobia and Cynophobia, run by University of South Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phobia Symptom Severity (time frame: Baseline, 6 Weeks Post-Baseline, and 3 Months Post-Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06302868, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.

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