A Randomized Controlled Efficacy Trial of a Telemedicine-based Virtual Reality Clinic for the Treatment of Phobias
23 de abril de 2026 atualizado 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?
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Tipo de estudo
Intervencional
Inscrição (Estimado)
240
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Maureen Jacobs Plaisimond
- Número de telefone: 813-396-0060
- E-mail: MCOM-VRStudy@usf.edu
Locais de estudo
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Florida
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Tampa, Florida, Estados Unidos, 33613
- University of South Florida
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Contato:
- Maureen Jacobs Plaisimond
- Número de telefone: 813-396-0060
- E-mail: MCOM-VRStudy@usf.edu
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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 Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Phobia symptom severity
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Specific Phobia Diagnosis
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Brian E. Bunnell, PhD, University of South Florida
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
1 de abril de 2026
Conclusão Primária (Estimado)
1 de dezembro de 2027
Conclusão do estudo (Estimado)
1 de janeiro de 2028
Datas de inscrição no estudo
Enviado pela primeira vez
23 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de abril de 2026
Primeira postagem (Real)
30 de abril de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
30 de abril de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
23 de abril de 2026
Última verificação
1 de fevereiro de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 008130
- R44MH129065 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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