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A Randomized Controlled Efficacy Trial of a Telemedicine-based Virtual Reality Clinic for the Treatment of Phobias

Doxy.me VR vs. Telemental Health-Based Exposure Therapy: Phase II

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07558824
Enrollment
240
Registered
2026-04-30
Start date
2026-04-01
Completion date
2028-01-01
Last updated
2026-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specific Phobia, Animal

Keywords

phobia, phobias, snakes, dogs, spiders

Brief summary

The goal of this clinical trial is to learn if a telemedicine-based virtual reality clinic (Doxy.me VR) works to treat dog, spider, and snake phobias in adults. The main questions it aims to answer are: Does Doxy.me VR decrease the severity of phobias better than traditional telemedicine-based treatment? Does this work because it feels more realistic than telemedicine alone?

Interventions

Participants will complete 7 60-minute exposure therapy sessions in a Virtual Reality Clinic using Virtual Reality stimuli and progress to in vivo exposures. Other Name:

BEHAVIORALTelemedicine-Based Exposure Therapy Using Photos and Videos

Participants will complete 7 60-minute exposure therapy sessions using photos/videos and progress to in vivo exposures.

Sponsors

University of South Florida
Lead SponsorOTHER
National Institute of Mental Health (NIMH)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Individuals will be eligible if they: (1) are an adult (≥18 years old); (2) have a self-reported fear of dogs, snakes, and/or spiders; (3) score 89 ≥ on the FSQ OR 24 ≥ on the SNAQ OR 147 ≥ on the DPQ; and (4) have access to the internet AND a computer OR smartphone with video conferencing capabilities.

Exclusion criteria

Individuals will be ineligible to participate if they: (1) are participating in ongoing mental health therapy from a non-study therapist; (2) changed psychiatric medication use within the past 6 weeks; (3) report active auditory, visual, and/or tactile hallucinations via the DART Psychosis Module screening question; (4) report active health conditions requiring upcoming planned or likely hospitalization or intensive treatment that will prevent them from participating; (5) report active legal proceedings that might lead to incarceration during the study period that would prevent them from participating; (6) report an unstable housing situation (eg., eviction or homelessness); (7) have experienced photosensitive seizures within the prior 6 months; (8) endorse more than 20% of symptom validity questions.

Design outcomes

Primary

MeasureTime frameDescription
Phobia symptom severityBaseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)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.
Dog Phobia SeverityBaseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)The Dog Phobia Questionnaire (DPQ) is a 27-item, self-report questionnaire assessing the severity of dog phobia symptoms. Scores range from 27 to 189 with higher scores indicating higher phobia severity.
Snake Phobia SeverityBaseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)The Snake Anxiety Questionnaire (SNAQ) is a 30-item self-report questionnaire assessing the severity of snake phobia symptoms. Scores range from 0 to 30 with higher scores indicating higher phobia severity.
Spider Phobia SeverityBaseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)The Fear of Spiders Questionnaire (FSQ) is an 18-item self-report questionnaire assessing the severity of spider phobia symptoms. Scores range from 18 to 126 with higher scores indicating higher phobia severity.

Secondary

MeasureTime frameDescription
Specific Phobia DiagnosisBaseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)The Diagnostic Assessment Research Tool (DART) is a modular semi structured interview corresponding with the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5). Study therapists administer the DART Specific Phobia Module, which provides designations of Absent, Subthreshold, and Present.
General AnxietyBaseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report measure of anxiety symptom severity. Scores range from 0 to 15 with higher scores indicating higher anxiety severity.
Depression SeverityBaseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)The Patient Health Questionnaire-8 (PHQ-8) is an 8-item self-report measure of depression symptom severity. Scores range from 0 to 27 with higher scores indicating higher depression severity.
Quality of Life LevelBaseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)The Quality of Life Scale (QOLS) is a 16-item self-report measure of quality of life. Scores range from 16 to 112 with higher scores indicating better quality of life.
Level of TelepresenceWeek 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7; Averaged across weeksThe iGroup Presence Questionnaire (iPQ) is a 14-item self-report questionnaire of telepresence. Scores on each subscale range from 0-6 with higher scores indicating more presence.
Cybersickness SeverityWeek 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7; Averaged across weeksThe Cybersickness in Virtual Reality Questionnaire (CSQ-VR) is an 6-item measure of nausea, vestibular, and oculomotor cybersickness experienced in virtual reality. Scores range from 6 to 27 with higher scores indicating higher levels of cybersickness.
Level of Working (Therapeutic) Alliance4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)The Working Alliance Inventory (WAI-SR) is a 12-item client-rated measure of therapeutic alliance. Total scores range from 1 to 5 with higher scores indicating a better therapeutic alliance.
Satisfaction with Therapy4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)The Satisfaction with Therapy and Therapist Scale-Revised (STTS-R) is a 13-item self-report questionnaire that assesses client satisfaction with treatment. Scores range from 0 to 60 with higher scores indicating higher satisfaction.
System Usability4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)The System Usability Scale (SUS) is a 10-item self-report measure of the usability of a particular software system, platform, or app. Scores range from 0-100 with higher scores indicating better usability.

Countries

United States

Contacts

CONTACTMaureen Jacobs Plaisimond
MCOM-VRStudy@usf.edu813-396-0060
PRINCIPAL_INVESTIGATORBrian E. Bunnell, PhD

University of South Florida

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 1, 2026