The purpose of this study is to assess the feasibility of conducting a randomized controlled efficacy trial comparing the delivery of exposure therapy via a telemedicine-based virtual reality clinic (Doxy.me VR) vs. standard telemental health (TMH) to adults with intense fear of dogs, snakes, and/or spiders. The secondary purpose is to preliminarily examine the efficacy of using Doxy.me VR vs. TMH in reducing phobia severity.
This study aims to assess the feasibility of conducting a randomized controlled efficacy trial comparing the delivery of exposure therapy via a telemedicine-based virtual reality clinic (Doxy.me VR) vs. standard telemental health (TMH) to adults with intense fear of dogs, snakes, and/or spiders. This study will use feasibility randomized controlled efficacy trial design. This single-site trial will include up to 60 adults with self-reported fear of dogs, snakes, and/or spiders who will be randomly assigned via the REDCap Randomization Module using a 1:1 allocation ratio to receive 12 sessions of exposure therapy over the course of 3 months via standard telemental health (TMH; n=15) vs. Doxy.me VR (n=15), a telemedicine-based virtual reality clinic.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
54
Participants will complete 12 60-minute exposure therapy sessions using photos/videos and progress to in vivo exposures.
Participants will complete 12 60-minute exposure therapy sessions in a Virtual Reality Clinic using Virtual Reality stimuli and progress to in vivo exposures.
University of South Florida
Tampa, Florida, United States
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. The SMSP has excellent internal consistency, reliability, and criterion and discriminant validity.
Time frame: Baseline, 6 Weeks Post-Baseline, and 3 Months Post-Baseline
Specific Phobia Diagnosis
The Diagnostic Assessment Research Tool (DART) is a modular, semi-structured interview assessing criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). In this study, therapists administered the DART Specific Phobia Module (DART-SP), which classifies symptoms as Absent, Subthreshold, or Present. The DART has demonstrated strong construct, discriminant, and convergent validity across its modules.
Time frame: Baseline and 3 Months Post-Baseline
General Anxiety Severity
The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item self-report measure that assesses the severity of general anxiety symptomatology. Scores range from 0 to 21 with higher scores indicating higher anxiety severity. The GAD-7 has demonstrated excellent internal consistency, reliability, and good convergent validity.
Time frame: Baseline and 3 Months Post-Baseline
Depression Severity
The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report measure that assesses the severity of depression symptomatology. Scores range from 0 to 27 with higher scores indicating higher depression severity. The PHQ-9 has demonstrated good convergent validity and specificity for depression diagnosis as well as excellent internal consistency and reliability.
Time frame: Baseline and 3 Months Post-Baseline
Therapeutic Alliance
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The Working Alliance Inventory-Self Report (WAI-SR) is a 12-item measure that assesses client-reported therapeutic alliance. Total Scores range from 12 to 60 with higher scores suggesting better therapeutic alliance. The WAI-SR includes 3 subscales: Goal (ie, the degree to which clients and therapists agree on goals of treatment), Task Agreement (ie, the degree to which clients and therapists agree on how to achieve those goals), and Bond (ie, the degree to which clients and therapists have developed a personal bond). Subscale Scores range from 4 to 20, with higher scores suggesting better alliance within each domain. The WAI-SR has demonstrated good convergent validity and excellent internal consistency and reliability.
Time frame: 6 Weeks Post-Baseline and 3 Months Post-Baseline
Treatment Satisfaction
The Client Satisfaction Questionnaire-8 (CSQ-8) is an 8-item client-rated questionnaire that assesses satisfaction with treatment. Scores range from 8 to 32 with higher scores indicating increased satisfaction. The CSQ-8 is correlated with clinical outcomes and post-treatment functioning and has demonstrated good construct validity and internal consistency and reliability.
Time frame: 6 Weeks Post-Baseline and 3 Months Post-Baseline
System Usability
The System Usability Scale (SUS) is a 10-item self-report questionnaire that assesses the usability of a particular software system, platform, or app. Scores range from 0-100 with scores \>68 indicating good usability, scores \>80 indicating excellent usability, and scores \< 60 suggesting potential usability issues. The SUS has demonstrated good internal consistency and reliability.
Time frame: 6 Weeks Post-Baseline and 3 Months Post-Baseline
Telepresence
The Single Item Presence Questionnaire (SIPQ) is a 1-item self-reported measure of telepresence that asks respondents, "to what extent did you feel present in the environment, as if you were really there?" Ratings are provided on a scale of 0 "not at all present" to 10 "'totally present." The SIPQ has demonstrated good to excellent validity, reliability, and sensitivity.
Time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Average across weeks reported.
Cybersickness
The Cybersickness in VR Questionnaire (CSQ-VR) is a 6-item self-report questionnaire that assesses nausea, vestibular, and oculomotor cybersickness experienced in VR. This measure was completed by participants in the Doxy.me VR condition after each therapy session that included VR-based exposures. Total scores range from 6 to 27 with higher scores reflecting increased levels of cybersickness. The CSQ-VR has demonstrated excellent internal consistency and convergent validity. The CSQ-VR was completed by the Doxy.me VR group only.
Time frame: Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12, Average across weeks reported.