A Randomized Controlled Efficacy Trial of a Telemedicine-based Virtual Reality Clinic for the Treatment of Phobias
23 de abril de 2026 actualizado por: 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?
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Tipo de estudio
Intervencionista
Inscripción (Estimado)
240
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Maureen Jacobs Plaisimond
- Número de teléfono: 813-396-0060
- Correo electrónico: MCOM-VRStudy@usf.edu
Ubicaciones de estudio
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Florida
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Tampa, Florida, Estados Unidos, 33613
- University of South Florida
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Contacto:
- Maureen Jacobs Plaisimond
- Número de teléfono: 813-396-0060
- Correo electrónico: MCOM-VRStudy@usf.edu
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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.
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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: |
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Comparador activo: 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.
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Participants will complete 7 60-minute exposure therapy sessions using photos/videos and progress to in vivo exposures.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Phobia symptom severity
Periodo de tiempo: Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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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.
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Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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Dog Phobia Severity
Periodo de tiempo: Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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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.
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Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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Snake Phobia Severity
Periodo de tiempo: Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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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.
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Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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Spider Phobia Severity
Periodo de tiempo: Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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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.
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Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Specific Phobia Diagnosis
Periodo de tiempo: Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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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.
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Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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General Anxiety
Periodo de tiempo: Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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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.
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Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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Depression Severity
Periodo de tiempo: Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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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.
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Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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Quality of Life Level
Periodo de tiempo: Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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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.
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Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
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Level of Telepresence
Periodo de tiempo: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7; Averaged across weeks
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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.
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Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7; Averaged across weeks
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Cybersickness Severity
Periodo de tiempo: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7; Averaged across weeks
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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.
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Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7; Averaged across weeks
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Level of Working (Therapeutic) Alliance
Periodo de tiempo: 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)
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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.
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4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)
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Satisfaction with Therapy
Periodo de tiempo: 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)
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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.
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4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)
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System Usability
Periodo de tiempo: 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)
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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.
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4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Brian E. Bunnell, PhD, University of South Florida
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de abril de 2026
Finalización primaria (Estimado)
1 de diciembre de 2027
Finalización del estudio (Estimado)
1 de enero de 2028
Fechas de registro del estudio
Enviado por primera vez
23 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
23 de abril de 2026
Publicado por primera vez (Actual)
30 de abril de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de abril de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
23 de abril de 2026
Última verificación
1 de febrero de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 008130
- R44MH129065 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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