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Completed

NCT Number: NCT06302868

Telemedicine-Based Virtual Reality Clinic for the Treatment of Phobias

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of South Florida

Tampa, Florida, 33613, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemedicine Exposure Therapy Using Photos and Videos

Behavioral

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

Telemedicine-Based Virtual Reality Exposure Therapy

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Doxy.me VR vs. Telemental Health-Based Exposure Therapy

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 12, 2024
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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