A Randomized Controlled Efficacy Trial of a Telemedicine-based Virtual Reality Clinic for the Treatment of Phobias
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Telemedicine-Based Virtual Reality Exposure Therapy, Telemedicine-Based Exposure Therapy Using Photos and Videos.
- Who it may be relevant to
- Registry conditions: Specific Phobia, Animal. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Doxy.me VR vs. Telemental Health-Based Exposure Therapy: Phase II
Overview
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
- Behavioral 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: - Behavioral 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.
Primary outcome measures
- Phobia symptom severity [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)]
Secondary outcome measures (9)
- Specific Phobia Diagnosis [Time frame: Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)]
- General Anxiety [Time frame: Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)]
- Depression Severity [Time frame: Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)]
- Quality of Life Level [Time frame: Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)]
- Level of Telepresence [Time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7; Averaged across weeks]
- Cybersickness Severity [Time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7; Averaged across weeks]
- Level of Working (Therapeutic) Alliance [Time frame: 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)]
- Satisfaction with Therapy [Time frame: 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)]
- System Usability [Time frame: 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of South Florida — Tampa
Identifiers
NCT: NCT07558824 · 008130 · R44MH129065