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

23 april 2026 bijgewerkt door: University of South Florida

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

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?

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

240

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • Florida
      • Tampa, Florida, Verenigde Staten, 33613
        • University of South Florida
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Gedragsmatig: Telemedicine-Based Virtual Reality Exposure Therapy

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:
Actieve vergelijker: Standard Telemedicine-Based 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.
Gedragsmatig: Telemedicine-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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Phobia symptom severity
Tijdsspanne: Baseline, 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.
Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
Dog Phobia Severity
Tijdsspanne: Baseline, 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.
Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
Snake Phobia Severity
Tijdsspanne: Baseline, 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.
Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
Spider Phobia Severity
Tijdsspanne: Baseline, 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.
Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Specific Phobia Diagnosis
Tijdsspanne: Baseline, 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.
Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
General Anxiety
Tijdsspanne: Baseline, 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.
Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
Depression Severity
Tijdsspanne: Baseline, 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.
Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
Quality of Life Level
Tijdsspanne: Baseline, 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.
Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
Level of Telepresence
Tijdsspanne: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7; Averaged across weeks
The 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.
Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7; Averaged across weeks
Cybersickness Severity
Tijdsspanne: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7; Averaged across weeks
The 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.
Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7; Averaged across weeks
Level of Working (Therapeutic) Alliance
Tijdsspanne: 4 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.
4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)
Satisfaction with Therapy
Tijdsspanne: 4 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.
4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)
System Usability
Tijdsspanne: 4 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.
4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of South Florida

Medewerkers

National Institute of Mental Health (NIMH)

Onderzoekers

  • Hoofdonderzoeker: Brian E. Bunnell, PhD, University of South Florida

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 april 2026

Primaire voltooiing (Geschat)

1 december 2027

Studie voltooiing (Geschat)

1 januari 2028

Studieregistratiedata

Eerst ingediend

23 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

23 april 2026

Eerst geplaatst (Werkelijk)

30 april 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

30 april 2026

Laatste update ingediend die voldeed aan QC-criteria

23 april 2026

Laatst geverifieerd

1 februari 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 008130
  • R44MH129065 (Subsidie/contract van de Amerikaanse NIH)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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