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| ID | Type | Description | Link |
|---|---|---|---|
| R44MH129065 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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?
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemedicine-based Virtual Reality Exposure Therapy | Experimental | 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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| Standard Telemedicine-Based Exposure Therapy | Active Comparator | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine-Based Virtual Reality Exposure Therapy | Behavioral | 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: |
| Measure | Description | Time Frame |
|---|---|---|
| Phobia symptom severity | 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 | 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 | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Specific Phobia Diagnosis | 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) |
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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.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maureen Jacobs Plaisimond | Contact | 813-396-0060 | MCOM-VRStudy@usf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Brian E. Bunnell, PhD | University of South Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida | Tampa | Florida | 33613 | United States |
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| Telemedicine-Based Exposure Therapy Using Photos and Videos | Behavioral | Participants will complete 7 60-minute exposure therapy sessions using photos/videos and progress to in vivo exposures. |
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| General Anxiety | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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) |
| ID | Term |
|---|---|
| C562465 | Phobia, Specific |
| D010698 | Phobic Disorders |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D014743 | Videotape Recording |
| ID | Term |
|---|---|
| D013637 | Tape Recording |
| D001296 | Audiovisual Aids |
| D018961 | Educational Technology |
| D013672 | Technology |
| D013676 | Technology, Industry, and Agriculture |
| D013690 | Television |
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