A Randomized Controlled Efficacy Trial of a Telemedicine-based Virtual Reality Clinic for the Treatment of Phobias
23 april 2026 uppdaterad av: 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?
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Studietyp
Interventionell
Inskrivning (Beräknad)
240
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Maureen Jacobs Plaisimond
- Telefonnummer: 813-396-0060
- E-post: MCOM-VRStudy@usf.edu
Studieorter
-
-
Florida
-
Tampa, Florida, Förenta staterna, 33613
- University of South Florida
-
Kontakt:
- Maureen Jacobs Plaisimond
- Telefonnummer: 813-396-0060
- E-post: MCOM-VRStudy@usf.edu
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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: |
|
Aktiv komparator: 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.
|
Participants will complete 7 60-minute exposure therapy sessions using photos/videos and progress to in vivo exposures.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Phobia symptom severity
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Specific Phobia Diagnosis
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Brian E. Bunnell, PhD, University of South Florida
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 april 2026
Primärt slutförande (Beräknad)
1 december 2027
Avslutad studie (Beräknad)
1 januari 2028
Studieregistreringsdatum
Först inskickad
23 april 2026
Först inskickad som uppfyllde QC-kriterierna
23 april 2026
Första postat (Faktisk)
30 april 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
30 april 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 april 2026
Senast verifierad
1 februari 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 008130
- R44MH129065 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .