ClinicalTrials.gg
CompletedNCT06302868Updated May 18, 2026Results posted

Telemedicine-Based Virtual Reality Clinic for the Treatment of Phobias

An interventional study of Telemedicine Exposure Therapy Using Photos and Videos and Telemedicine-Based Virtual Reality Exposure Therapy in Arachnophobia, Cynophobia and Ophidiophobia, sponsored by University of South Florida. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-18.

Sponsored by University of South Florida · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
54
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Arachnophobia
  • Cynophobia
  • Ophidiophobia

Keywords

  • phobia
  • phobias
  • snakes
  • dogs
  • spiders
03

In context

Arachnophobia

26 studies on the registry are indexed under Arachnophobia; 2 are open to participants now.

This study's enrollment of 54 is close to the median of 60 across 26 interventional studies indexed under Arachnophobia.

Browse Arachnophobia studies →

Lead sponsor

University of South Florida is the lead sponsor of 340 studies on the registry; 65 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 having a diagnosis of photosensitive epilepsy by a medical doctor or a history of experiencing seizures that they believe were caused by photosensitivity
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
54 participants (actual)

Study arms

  • 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.

    Behavioral: Telemedicine-Based Virtual Reality Exposure Therapy

  • 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.

    Behavioral: Telemedicine Exposure Therapy Using Photos and Videos

Interventions

  • BehavioralTelemedicine Exposure Therapy Using Photos and Videos

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

  • BehavioralTelemedicine-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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: Baseline, 6 Weeks Post-Baseline, and 3 Months Post-Baseline

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    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.

  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.

    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.

07

Results

Posted May 18, 2026

Participant flow

Participant flow — Overall Study
MilestoneTelemedicine-based Virtual Reality Exposure TherapyStandard Telemedicine Exposure Therapy
Started2925
6 weeks post-baseline1415
Completed1414
Not completed1511
Withdrew: Lost to follow-up65
Withdrew: Withdrawal by subject96

Outcome measures

PrimaryPhobia 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.

Time frame:
Baseline, 6 Weeks Post-Baseline, and 3 Months Post-Baseline
Reported as:
Mean · units on a scale
Phobia Symptom Severity
units on a scaleTelemedicine-based Virtual Reality Exposure TherapyStandard Telemedicine Exposure Therapy
Baseline2.80 ± 0.803.18 ± 0.82
6 Weeks Post-Baseline1.51 ± 0.831.55 ± 0.89
3 Months Post-Baseline0.86 ± 0.680.56 ± 0.47
SecondarySpecific 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.

Time frame:
Baseline and 3 Months Post-Baseline
Reported as:
Count of participants · Participants
Specific Phobia Diagnosis
ParticipantsTelemedicine-based Virtual Reality Exposure TherapyStandard Telemedicine Exposure Therapy
Baseline — Specific Phobia Diagnosis Present2923
Baseline — Specific Phobia Diagnosis Subthreshold02
Baseline — Specific Phobia Diagnosis Absent00
3 Months Post-Baseline — Specific Phobia Diagnosis Present10
3 Months Post-Baseline — Specific Phobia Diagnosis Subthreshold23
3 Months Post-Baseline — Specific Phobia Diagnosis Absent78
SecondaryGeneral 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.

Time frame:
Baseline and 3 Months Post-Baseline
Reported as:
Mean · units on a scale
General Anxiety Severity
units on a scaleTelemedicine-based Virtual Reality Exposure TherapyStandard Telemedicine Exposure Therapy
Baseline6.03 ± 4.487.68 ± 6.95
3 Months Post-Baseline7.14 ± 5.633.71 ± 4.41
SecondaryDepression 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.

Time frame:
Baseline and 3 Months Post-Baseline
Reported as:
Mean · units on a scale
Depression Severity
units on a scaleTelemedicine-based Virtual Reality Exposure TherapyStandard Telemedicine Exposure Therapy
Baseline4.62 ± 4.257.60 ± 7.39
3 Months Post-Baseline7.43 ± 5.404.86 ± 7.59
SecondaryTherapeutic 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.

Time frame:
6 Weeks Post-Baseline and 3 Months Post-Baseline
Reported as:
Mean · units on a scale
Therapeutic Alliance
units on a scaleTelemedicine-based Virtual Reality Exposure TherapyStandard Telemedicine Exposure Therapy
6 Weeks Post-Baseline Total Score55.64 ± 3.8257.67 ± 1.98
6 Weeks Post-Baseline Bond Subscale Score19.14 ± 1.8319.73 ± 0.59
6 Weeks Post-Baseline Task Subscale Score17.79 ± 1.2518.13 ± 1.55
6 Weeks Post-Baseline Goal Subscale Score18.71 ± 1.7719.80 ± 0.41
3 Months Post-Baseline Total Score56.93 ± 4.1457.21 ± 4.17
3 Months Post-Baseline Bond Subscale Score19.14 ± 2.0718.86 ± 2.24
3 Months Post-Baseline Task Subscale Score18.50 ± 1.7018.86 ± 1.35
3 Months Post-Baseline Goal Subscale Score19.29 ± 1.4319.50 ± 0.94
SecondaryTreatment 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.

Time frame:
6 Weeks Post-Baseline and 3 Months Post-Baseline
Reported as:
Mean · units on a scale
Treatment Satisfaction
units on a scaleTelemedicine-based Virtual Reality Exposure TherapyStandard Telemedicine Exposure Therapy
6 Weeks Post-Baseline Total Score30.36 ± 2.3431.47 ± 0.92
3 Months Post-Baseline31.43 ± 1.4031.07 ± 1.39
SecondarySystem 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.

Time frame:
6 Weeks Post-Baseline and 3 Months Post-Baseline
Reported as:
Mean · units on a scale
System Usability
units on a scaleTelemedicine-based Virtual Reality Exposure TherapyStandard Telemedicine Exposure Therapy
6 Weeks Post-Baseline Total Score76.43 ± 17.1790.33 ± 13.72
3 Months Post-Baseline80.89 ± 11.9988.39 ± 19.82
SecondaryTelepresence

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.

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.
Reported as:
Mean · units on a scale
Telepresence
units on a scaleTelemedicine-based Virtual Reality Exposure TherapyStandard Telemedicine Exposure Therapy
Telepresence8.38 ± 1.117.69 ± 2.04
SecondaryCybersickness

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.

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.
Reported as:
Mean · units on a scale
Cybersickness
units on a scaleTelemedicine-based Virtual Reality Exposure TherapyStandard Telemedicine Exposure Therapy
Cybersickness7.69 ± 2.04—

Adverse events

Collected over From enrollment until end of follow-up, up to 3 months post-baseline.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Telemedicine-based Virtual Reality Exposure Therapy0/29 (0%)0/29 (0%)0/29 (0%)
Standard Telemedicine Exposure Therapy0/25 (0%)0/25 (0%)0/25 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Telemedicine-based Virtual Reality Exposure TherapyStandard Telemedicine Exposure TherapyTotal
Mean46.10 ± 13.3542.20 ± 13.9845.69 ± 15.53
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Telemedicine-based Virtual Reality Exposure TherapyStandard Telemedicine Exposure TherapyTotal
Sex/Gender — Female231942
Sex/Gender — Male5611
Sex/Gender — Non-Binary/Gender Fluid101
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Telemedicine-based Virtual Reality Exposure TherapyStandard Telemedicine Exposure TherapyTotal
American Indian or Alaska Native000
Asian011
Native Hawaiian or Other Pacific Islander000
Black or African American8715
White181432
More than one race336
Unknown or Not Reported000
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Telemedicine-based Virtual Reality Exposure TherapyStandard Telemedicine Exposure TherapyTotal
Hispanic or Latino268
Not Hispanic or Latino271946
Unknown or Not Reported000
08

Study locations

1 site
  • University of South Florida
    Tampa, Florida 33613, United States
09

References and documents

Publications

  • 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 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06302868
Responsible party
Sponsor
First posted
Mar 12, 2024
Start date
Oct 25, 2023
Primary completion
Jul 26, 2024
Completion
Jul 26, 2024
Results posted
May 18, 2026
Last update
May 18, 2026

Study contacts

Brian E Bunnell, PhD
principal investigator · University of South Florida

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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