Doxy.me VR vs. Telemental Health-Based Exposure Therapy
Phase: NA
Conditions: Arachnophobia, Cynophobia, Ophidiophobia
Sponsor: University of South Florida

 
 
 
 
PROTOCOL TITLE: 
Doxy.me VR vs. Telemental Health-Based Exposure Therapy 
PRINCIPAL INVESTIGATOR: 
Brian E. Bunnell 
Department of Psychiatry and Behavioral Neurosciences 
813-974-8607 
bbunnell@usf.edu 
VERSION NUMBER/DATE: 
V3. November 21, 2023 
 
REVISION HISTORY 
*This table should only be used during submission of a Modification application to the IRB.  
 
Revision 
# 
Version Date 
Summary of Changes 
Consent 
Change? 
1 
10.26.2023 
Added flyering on USF campus to recruitment 
methods 
 
2 
11.21.2023 
Changed compensation structure to 50 at 
baseline, 50 at midtreatment, and 50 at final 
session.  
Yes 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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Table of Contents 
1.0 
Study Summary ........................................................................................................ 3 
2.0 
Objectives ................................................................................................................ 4 
3.0 
Background .............................................................................................................. 4 
4.0 
Study Intervention .................................................................................................... 5 
5.0 
Procedures Involved ................................................................................................. 6 
6.0 
Data and Specimen Storage for Future Research .................................................. 11 
7.0 
Sharing of Results with Subjects ........................................................................... 11 
8.0 
Study Timelines ..................................................................................................... 11 
9.0 
Inclusion and Exclusion Criteria ............................................................................ 11 
10.0 Vulnerable Populations .......................................................................................... 12 
11.0 Local Number of Subjects ..................................................................................... 12 
12.0 Recruitment Methods ............................................................................................. 12 
13.0 Withdrawal of Subjects .......................................................................................... 13 
14.0 Risks to Subjects .................................................................................................... 14 
15.0 Potential Benefits to Subjects or Others ................................................................ 14 
16.0 Data Management and Confidentiality .................................................................. 15 
17.0 Provisions to Monitor the Data to Ensure the Safety of Subjects .......................... 16 
18.0 Provisions to Protect the Privacy Interests of Subjects .......................................... 17 
19.0 Compensation for Research-Related Injury ........................................................... 17 
20.0 Subject Costs and Compensation ........................................................................... 17 
21.0 Consent Process ..................................................................................................... 18 
22.0 Setting .................................................................................................................... 18 
23.0 References .............................................................................................................. 18 
 
 

 
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1.0 
Study Summary  
1.1  
Study Title 
Doxy.me VR vs. Telemental Health-Based Exposure 
Therapy 
Study Design 
Feasibility randomized controlled efficacy trial  
Primary 
Objective/Purpose 
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. 
Secondary 
Objective(s)/Purposes 
Preliminarily examine the efficacy of using Doxy.me VR vs. 
TMH in reducing phobia severity.  
Research 
Intervention(s)  
Exposure Therapy 
ClinicalTrials.gov 
NCT # 
Registration on clinicaltrials.gov is pending  
Study Population 
Adults (≥18 years old) with intense fear of dogs, snakes, 
and/or spiders. 
Sample Size 
30 
Study Duration for 
individual subjects 
In total, participants will spend approximately 38 hours over 
13 study visits (12 Therapy and 1 Baseline Assessment) 
engaging in study procedures over the course of three 
months. 
Study Specific 
Abbreviations/ 
Definitions  
telemedicine-based virtual reality clinic (Doxy.me VR); 
standard telemental health (TMH); Virtual Reality (VR); 
Cognitive Behavioral Therapy (CBT) 
 
 

 
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2.0 
Objectives 
2.1 Primary Objective: 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. 
 
Secondary Objective: Preliminarily examine the efficacy of using Doxy.me VR vs. TMH 
in reducing phobia severity.  
 
2.2 This is a feasibility trial and not powered for hypothesis testing. 
 
3.0 
Background 
3.1 Telemedicine revolutionized mental health services (i.e., telemental health) by 
bringing accessible and personalized treatment at a distance.(Bunnell, Barrera, et al., 
2020; Bunnell, Sprague, et al., 2020). Telemental health is equally to more effective than 
in-person care with higher patient satisfaction at reduced costs.(Adams et al., 2018; 
Flodgren et al., 2015; Hilty et al., 2013; Langarizadeh et al., 2017; Yuen et al., 2012) 
Further, telemedicine transcends socio-cultural (e.g., stigma) and geographic (e.g., 
transportation) barriers that have traditionally limited access and use of mental health 
services.(Baker et al., 2011; Rojas & Gagnon, 2008; Wootton et al., 2011) Telemedicine 
has become the standard of modern mental health care with 85% of all mental health 
services in the U.S. now delivered remotely, a trend that is fully expected to continue 
post-pandemic.(Doran & Lawson, 2021; Khan et al., 2020; Nguyen et al., 2020; Pierce et 
al., 2020) As telemedicine evolves, innovative solutions that enhance telemedicine utility 
and outcomes will be needed for providers to continue delivering state-of-the-art 
telemental health care.(Bunnell, Barrera, et al., 2020) 
 
Virtual reality (VR) uses interactive and immersive simulation to facilitate mental health 
therapies.(Maples-Keller et al., 2017) Stressors that are physical (e.g., phobias, trauma, 
addiction) or psychological (e.g., body image, mood, identity) can be realistically 
recreated in VR for safe, repeatable, and effective therapy.(Jerdan et al., 2018; Maples-
Keller et al., 2017; Srivastava et al., 2014) VR is engaging and improves treatment 
compliance and retention, making VR conducive to the vital practice of in- and between-
session mental health exercises.(Bell et al., 2020) There is abundant support for VR 
mental health therapy in on-site settings.(Park et al., 2019; Pimentel et al., 2021) 
However, VR mental health therapy via telemedicine is limited to preliminary efficacy 
studies.(Dilgul et al., 2021; Goldenhersch et al., 2020; Tamplin et al., 2020) There is 
strong potential to combine the accessibility of telemedicine and clinical utility of VR as 
the next evolution of telemental health care. 
 
With this goal, Doxy.me Inc. partnered with the University of South Florida to create 
Doxy.me VR is a standalone app currently available on Quest 2 headsets via invite only. 
The app is designed for a therapist to meet with a client in a private, comfortable VR 
clinic office. To join each other in VR, the therapist selects a room code and provides that 
code to their client, who joins by entering that code into the app. While joined in the 
same VR room, the therapist and client can interact by speaking with each other in 

 
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immersive VR. Therapists can also spawn a variety of small animals such as dogs, 
snakes, and spiders for use in treating specific phobias. Therapists can browse, select, 
maneuver, remove, and choose animations for the animals to exhibit once made visible to 
the client. 
 
 
 
 
 
Figure 1. Screenshots of Doxy.me Virtual Reality clinic with stimuli 
 
3.2 N/A 
 
4.0 
Study Intervention  
4.1 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. Exposure therapy is a gold standard treatment for 
phobias and other anxiety-related mental health disorders (Taylor, 2003). Exposure 
therapy is acceptable, efficient, and produces durable effects (Vinograd & Craske, 2020). 
By exposing an individual to their fear-related stimuli (e.g., dog) in a controlled setting 
(e.g., therapist’s office), the individual’s fear response diminishes as their anxiety reduces 
over prolonged and repeated exposure (e.g., the individual is no longer fearful around 
dogs). The most common approach to this process includes gradual exposure which 

 
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begins with less intense stimuli and increases in intensity over time. One way to do 
gradual exposure is multimedia stimuli (e.g., photos, videos) and then gradually moving 
towards exposure to real life stimuli (i.e., in-vivo exposure). Another way is using VR 
stimuli in which patients are immersed in a virtual environment and interact with virtual 
stimuli (i.e., in virtuo exposure). VR-based exposure therapy is a safe, accessible, and 
engaging alternative to in-vivo exposure therapy that can be less stressful and more 
conducive to treatment success (Horigome et al., 2020; Meyerbröker & Emmelkamp, 
2010; Parsons & Rizzo, 2008; Yoshinaga et al., 2020). 
 
The present study will use an exposure therapy protocol developed specifically for 
Virtual Reality (Stephane Bouchard et al., 2012; Côté & Bouchard, 2005; Michaliszyn et 
al., 2010; St-Jacques et al., 2010). Following the baseline assessment session (Study Visit 
1), the treatment is comprised of 12, ≤ 60-minute therapy sessions: one psychoeducation 
and treatment planning session, 10 exposure sessions, and one relapse prevention session 
(Study Visits 2-13). During the first therapy session, patients learn about the principles of 
Cognitive Behavioral Therapy (CBT), what causes anxiety and specific phobias, 
procedures for exposure, and complete a fear hierarchy, which is a list of situations 
ranked from least to most anxiety provoking. These lists will include a text-based list of 
various virtual/multimedia situations (i.e., static, and active states of different types of 
feared animals) and ‘in vivo’/live situations (e.g., petting a dog, touching a snake at a pet 
store). Therapy sessions 2-11 begin with a review of homework followed by a ~35-
minute virtual exposure session. Patients report their anxiety level using a 1-100% scale 
on a 5-minute interval throughout the exposure and remain in the exposure until they 
report a 50% reduction in their anxiety rating following the introduction of the stimulus. 
Upon completion of the exposure, the study therapist (i.e., a Postdoctoral Fellow and 
Clinical Psychologist) and patient process thoughts and feelings related to the exposure, 
reframe appraisals of their feared stimuli through cognitive restructuring, and practice 
breathing retraining and relaxation methods. The Doxy.me VR group will conduct their 
in-session exposures in the VR clinic and the TMH group will conduct their in-session 
exposures using multimedia on the Doxy.me platform (e.g., screen sharing videos and 
photos). This intervention requires daily homework practicing virtual exposures 
conducted in session and eventually progressing to in vivo exposures. Once patients have 
progressed through all virtual situations in their hierarchy and have completed their first 
in vivo exposure for homework, weekly therapy sessions will be devoting to processing 
between-session in vivo exposures and will last approximately 45 minutes. See Treatment 
Manual in Local Site Documents for a more detailed outline of the intervention. 
 
5.0 
Procedures Involved 
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. Participants randomized to the Doxy.me group will be 
provided with Quest 2 VR headsets with the Doxy.me VR application pre-loaded to the 
device. This VR clinic is a standalone app currently available on Quest 2 headsets via 

 
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invite only. The app is designed for a therapist to meet with a client in a private, 
comfortable VR clinic office. To join each other in VR, the therapist selects a room code 
and provides that code to their client, who joins by entering that code into the app. While 
in the same VR room, the therapist and client can interact by speaking with each other in 
immersive VR. Therapists can also spawn a variety of small animals such as dogs, 
snakes, and spiders for use in treating specific phobias. Therapists can browse, select, 
maneuver, remove, and choose animations for the animals to exhibit once made visible to 
the client. 
 
Therapy sessions will be audio recorded and 20% will be observed by the PI to assess 
treatment fidelity. Primary clinical outcomes (i.e., phobia severity as measured by the 
SMSP) will be assessed at baseline and 3-months post-baseline. Intervention targets will 
include presence–assessed weekly via patient-report– and working alliance–assessed at 
mid- and post-treatment via study therapist- and patient-report. Benchmarks for 
feasibility will include enrolling up to 60 patients during months 1-9 of the trial (i.e., 
3/month), 70% patient retention at 3-month follow-up, 70% of weekly self-report 
collected, and ≥80% treatment fidelity. 
 
5.2 Please select the methods that will be employed in this study (select all that apply): 
☒ Audio/Video Recording 
☐ Psychophysiological Recording 
☒ Behavioral Interventions 
☐ Record Review - Educational 
☐ Behavioral Observations and Experimentations 
☐ Record Review - Employee 
☐ Deception 
☐ Record Review- Medical  
☐ Focus Groups 
☐ Record Review - Other 
☒ Interviews 
☐ Specimen Collection or Analysis 
☐ Investigational Device – Non-Significant Risk 
(e.g. Mobile Applications) 
☒ Surveys and/or Questionnaires 
☐Psychometric Testing 
☐ Other Social-Behavioral Procedures 
 
Recruitment 
Potential participants reached through Clinical Connection, Research Match, and 
Facebook ads (see Section 12.0 Recruitment Methods) will be provided with a link that 
will direct them to an Online Pre-Screening Questionnaire that will be administered via a 
REDCap survey (see Measures in Local Site Documents and Figure 2. Study Schema and 
Schedule of Events).  Potential participants meeting preliminary eligibility criteria will be 
presented with an invitation to schedule an initial consent and baseline assessment visit 
via Microsoft Bookings and will receive a calendar invitation and text/email reminders 24 
hours and 1 hour prior to the scheduled visit time. If potential participants do not meet 
eligibility criteria due to participating in ongoing mental health therapy from a non-study 
therapist or having had changes to psychotropic medication use within six weeks 
preceding enrollment in the trial, they will be presented with a message inviting them to 
revisit the pre-screening questionnaire at a later date if/when those conditions no longer 
apply. 
 

 
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Consent and Baseline Assessment 
The consent and baseline assessment visit will be conducted via video-conferencing 
platform and will not be audio or video recorded. During this visit study staff will (1) 
confirm the potential participant’s responses on the Online Pre-Screening Questionnaire, 
(2) provide detailed information about the study and obtain signed informed consent via 
REDCap e-Consent, (3) assist participants in completing baseline questionnaires via 
REDCap survey, (4) administer the Specific Phobia and Risk Assessment modules of the 
Diagnostic Assessment Research Tool (DART; See Measures document for specific 
items), and (5) make a final determination on the participant’s eligibility. Eligible 
participants will then be randomized using the REDCap Randomization Module and 
scheduled for their first treatment visit (see Measures in Local Site Documents and 
Figure 2. Study Schema and Schedule of Events). 
 
Treatment 
Participants will receive weekly ≤ 60-minute therapy sessions (see Section 4.0 Study 
Intervention). Therapy session visits will be scheduled using Microsoft Bookings and 
participants will receive a calendar invitation and email reminders 24 hours and 1 hour 
prior to the scheduled visit time (See Appointment invitations and reminders in Local 
Site Documents). All therapy sessions will be conducted via videoconferencing, with the 
Doxy.me VR group transitioning to the Doxy.me VR clinic for the exposure exercise 
portion of the session. Participants in this group will be mailed a Meta Quest 2 VR 
headset with the Doxy.me VR app pre-loaded on the device. This headset will be owned 
by the University of South Florida and will be required to be returned when participants 
complete the study. Postage will be covered by the study. All therapy sessions will 
include the assignment of homework, including reading an informational handout after 
therapy session 1 and exposure therapy assignments after therapy sessions 2-11. Daily 
exposure-based homework assignments will require participants to practice the same 
exposure exercises they completed during that week’s therapy session for a minimum of 
30 minutes, with the specific situation being assigned to participants by the study 
therapist (i.e., Postdoctoral Fellow). Participants will receive text/email reminders with 
links to REDCap surveys that will provide instructions for the homework assignment, 
including situation to be used in the exposure exercise, and ask participants to report the 
results of the homework exercise including anxiety levels during the exposure exercise 
(see Treatment Data Collection Forms in Local Site Documents). At the end of each 
therapy session the study therapist (i.e., Postdoctoral Fellow) will send participants a link 
via the videoconference platforms messaging feature to a REDCap survey with the 
weekly assessment, which participants will be asked to complete before the end of the 
therapy session (see Measures in Local Site Documents and Figure 2. Study Schema and 
Schedule of Events). Therapy sessions will be audio recorded and 20% of recordings will 
be observed by the PI to rate fidelity to the protocol. All therapy session notes will be  
completed and stored in REDCap and signed by both the therapist (i.e., Postdoctoral 
Fellow) and supervisor (PI).   
 
Assessment Strategy and Measures  
All trial assessments are listed in Table 1 and were chosen considering several factors 
including (1) sound psychometric properties, (2) ease of administration, (3) past use in 

 
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similar clinical trials, and (4) brevity. All questionnaires will be completed via REDCap 
survey with study staff present via videoconference to answer any questions (see 
Measures in Local Site Documents and Figure 2. Study Schema and Schedule of Events). 
 
 
Treatment Fidelity 
All treatment sessions will be recorded and 20% will be rated by the Supervisor (PI) 
using a Treatment Fidelity Checklist based on the treatment manual (see Treatment Data 
Collection Forms in Local Site Documents).  
 
Figure 2. Study Schema and Schedule of Events 
Pre-Screening 
-15 to Day 1 
15 min 
Pre-screen participants by inclusion and exclusion criteria; schedule Visit 1 
Assessment(s): Online Pre-Screening Questionnaire; SMSP-A 
 
↓ 
Visit 1/Day 1 
60 min 
Obtain informed consent; perform baseline assessment. 
Assessment(s): Demographics; SMSP-A; GAD-7; PHQ-9; DART SP; DART RA 
 
↓ 
 
Randomize 
 
↓ 
 
↓ 
 
Doxy.me VR 
n = 15 
 
TMH 
n = 15 
 
↓ 
 
↓ 
Visit 2/Day 7±3 
60 min 
Administer study intervention Session 1 
Assessment(s): SIPQ (Telemedicine Group); CSQ-VR and SIPQ (Doxy.me VR 
Group) 
 
↓ 
Visit 3/Day 14±3 
60 min 
Administer study intervention Session 2 
Assessment(s): SIPQ (Telemedicine Group); CSQ-VR and SIPQ (Doxy.me VR 
Group) 
 
↓ 
Table 1. Study Assessments 
Domain 
Informant Measure 
Demographics 
Patient 
Patient Demographics Questionnaire 
Anxiety Severity 
Patient 
General Anxiety Disorder-7 (GAD-7)(Johnson et al., 2019; Spitzer et al., 2006) 
Depression Severity 
Patient 
Patient Health Questionnaire-9 (PHQ-9)(Kroenke et al., 2011, 2009) 
Therapeutic Alliance 
Patient 
Provider 
Working Alliance Inventory- Short Revised (WAI-SR)(Hatcher & Gillaspy, 
2006) Working Alliance Inventory – Short Revised Therapist (WAI-SRT; 
(Hatcher & Gillaspy, 2006) 
Treatment Satisfaction 
Patient 
Client Satisfaction Questionnaire (CSQ-8)(Larsen et al., 1979) 
Specific Phobia Severity  
Patient  
Severity Measure for Specific Phobia-Adult (SMSP-A; (Craske et al., 2013);  
Specific Phobia Diagnosis 
 
Diagnostic Assessment Research Tool (DART;(Schneider et al., 2022) 
Presence  
Patient  
Single Item Presence Questionnaire (SIPQ; (S. Bouchard et al., 2005) 
Cybersickness 
Patient 
Cybersickness in Virtual Reality Questionnaire (CSQ-VR; (Kourtesis et al., 
2023) 
Usability  
Patient 
System Usability Scale (Peres et al., 2013) 

 
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Visit 4/Day 21±3 
60 min 
Administer study intervention Session 3 
Assessment(s): SIPQ (Telemedicine Group); CSQ-VR and SIPQ (Doxy.me VR 
Group) 
 
↓ 
Visit 5/Day 28±3 
60 min 
Administer study intervention Session 4 
Assessment(s): SIPQ (Telemedicine Group); CSQ-VR and SIPQ (Doxy.me VR 
Group) 
 
↓ 
Visit 6/Day 35±3 
60 min 
Administer study intervention Session 5 
Assessment(s): SIPQ (Telemedicine Group); CSQ-VR and SIPQ (Doxy.me VR 
Group) 
 
↓ 
Visit 7/Day 42±3 
60 min + 20 min 
Administer study intervention Session 6; Conduct Mid-Treatment Assessment 
Assessment(s): SIPQ (Telemedicine Group); CSQ-VR and SIPQ (Doxy.me VR 
Group); SMSP-A; WAI-SR; WAI-SRT; CSQ-8; SUS (Both Groups) 
 
↓ 
Visit 8/Day 49±3 
60 min 
Administer study intervention Session 7 
Assessment(s): SIPQ (Telemedicine Group); CSQ-VR and SIPQ (Doxy.me VR 
Group) 
 
↓ 
Visit 9/Day 56±3 
60 min 
Administer study intervention Session 8 
Assessment(s): SIPQ (Telemedicine Group); CSQ-VR and SIPQ (Doxy.me VR 
Group) 
 
↓ 
Visit 10/Day 63±3 
60 min 
Administer study intervention Session 9 
Assessment(s): SIPQ (Telemedicine Group); CSQ-VR and SIPQ (Doxy.me VR 
Group) 
 
↓ 
Visit 11/Day 70±3 
60 min 
Administer study intervention Session 10 
Assessment(s): SIPQ (Telemedicine Group); CSQ-VR and SIPQ (Doxy.me VR 
Group) 
 
↓ 
Visit 12/Day 77±3 
60 min 
Administer study intervention Session 11 
Assessment(s): SIPQ (Telemedicine Group); CSQ-VR and SIPQ (Doxy.me VR 
Group) 
 
↓ 
Visit 13/Day 84±3 
60 min + 20min 
Administer study intervention Session 12; Post-Treatment Assessment 
Assessment(s): SMSP-A; GAD-7; PHQ-9; DART SP; WAI-SR; WAI-SRT; CSQ-8; 
SUS (Both groups) 
 
5.3 There are no procedures or interventions that are going to be conducted as part of this 
research project that would have been conducted even if the research was not occurring. 
We are conducting the procedures solely for research purposes. 
 
5.4 There are no additional foreseeable risks to the above procedures in need of further 
mitigation beyond those ordinarily incurred in working with this population. Standard 
operational procedures of the USF Department of Psychiatry and Behavioral 

 
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Neurosciences specify responsibilities for handling dangers to self and others, safety 
planning, and mandatory reporting responsibilities. 
 
5.5 N/A 
5.6 N/A 
5.7 N/A 
6.0 
Data and Specimen Storage for Future Research 
6.1 N/A 
6.2 N/A 
6.3 N/A 
 
7.0 
Sharing of Results with Subjects 
7.1 An individual participant’s assessment results from questionnaires and interviews will 
be shared with that individual participant verbally at the end of each visit during which 
the assessment occurred (i.e., baseline, mid-treatment, post-treatment). 
 
8.0 
Study Timelines 
8.1 The study timeline with estimated visits and their accompanying durations can be 
viewed in Figure 2. Study Schema and Schedule of Events. Participants will participate in 
a ≤60-minute initial consent and baseline assessment visit (Visit 1). They will then 
participate in 12 ≤60-minute therapy sessions (Visits 2-13) and up to 6, ~30-minute 
homework assignments per week over 12 weeks. Participants will also participate in 20-
minute mid- and post-treatment assessments, which will occur during Visits 7 and 13, 
respectively. In total, participants will spend approximately 38 hours over 13 study visits 
(i.e., Baseline + 12 Therapy Sessions) engaging in study procedures over the course of 
three months. 
 
9.0 
Inclusion and Exclusion Criteria 
9.1 In order to be eligible to participate in this study, an individual must meet all of the 
following criteria: 
1. Is an adult ≥ 18 years old 
2. Has a self-reported fear of dogs, snakes, and/or spiders 
3. Indicates Subthreshold or Present Specific Phobia symptoms as 
determined by the study therapist via administration of the Diagnostic 
Assessment Research Tool (DART) Specific Phobia Module 
4. Has access to the internet AND a computer OR smartphone with video 
conferencing capabilities 
5. Will reside in the state of Florida for the duration of the study 
 
9.2 An individual who meets any of the following criteria will be excluded from 
participation in this study: 
1. Is participating in ongoing mental health therapy from a non-study 
therapist 
2. Has had changes to psychotropic medication use within six weeks 
preceding enrollment in the trial 

 
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3. Reports active suicidal and/or homicidal intent or plan as determined by 
the study therapist via administration of the Diagnostic Assessment 
Research Tool (DART) Risk Assessment Module 
4. Reports active auditory, visual, and/or tactile hallucinations via the 
Diagnostic Assessment Research Tool (DART) Psychosis Module 
screening question 
5. Reports a history of epilepsy or seizures 
 
9.3 An individual who meets any of the following criteria will become ineligible to 
continue on the study after enrollment: 
 
1. Begins participating in ongoing mental health therapy from a non-study 
therapist 
2. Has changes to psychotropic medication use 
3. Does not indicate Subthreshold or Present Specific Phobia symptoms as 
determined by the study therapist via administration of the Diagnostic 
Assessment Research Tool (DART) Specific Phobia Module 
4. Reports active suicidal and/or homicidal intent or plan as determined by 
the study therapist via administration of the Diagnostic Assessment 
Research Tool (DART) Risk Assessment Module 
5. Moves out of the State of Florida during the study period 
 
9.4 N/A 
 
10.0 Vulnerable Populations 
10.1 N/A 
 
11.0 Local Number of Subjects 
11.1 We aim to complete treatment with and obtain post-treatment assessment data from 
a total of 30 participants (15 in TMH and 15 in VR group). We will enroll up to 60 
participants in the trial as needed to account for screen fails, withdrawals, and drops. 
 
12.0 Recruitment Methods 
12.1 Potential participants will be identified through Clinical Connection, Research 
Match, Facebook ads, and distributing flyers on University of South Florida campus.  
 
Clinical Connection is a national clinical trial participant recruiter. Clinical Connection 
matches potential study participants with clinical trials in a 50-mile radius of their 
location. Study sites post listings for clinical trials and potential participants are notified 
that a new clinical trial has been posted if they are signed up for alerts. Study sites can 
also send direct emails to potential participants every 30 days. Interested potential 
participants review the clinical trial description and fill out a contact form. The study site 
receives an email with the potential participant’s contact information and reaches out to 
them directly. Clinical Connection also posts paid advertisements for clinical trials on 
popular search engines. The study team will contact Clinical Connection referrals within 

 
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one business day of submission to provide study information, assess eligibility, obtain 
signed informed consent from patients via REDCap e-Consent, and assist participant in 
completing baseline assessments.  IRB approval is required prior to launching the study 
on Clinical Connection. There are four documents in Local Site Documents related to 
Clinical Connection: Clinical Connection Advertisement Example, Clinical Connection 
Research Site Profile Example, Clinical Connection Research Site Profile Text, and 
Clinical Connection Advertisement Text. These documents provide examples of posted 
studies and the text we intend to use on the advertisements for this study.  
 
ResearchMatch connects volunteers with researchers. Volunteers and researchers 
register for the site, and researchers can contact deidentified volunteers with information 
about their study. Volunteers registered for the site will be contacted through direct 
message on ResearchMatch. If a ResearchMatch volunteer expresses interest, the study 
team will contact them within one business day to provide study information, assess 
eligibility, obtain signed informed consent from patients via REDCap e-Consent, and 
assist participant in completing baseline assessments. At present, there are 80 English-
speaking adults with a phobia diagnosis registered on Research Match.  
 
Facebook advertisements will target relevant Facebook users. Potential participants will 
complete a contact form. As with the previous two recruitment methods, potential 
participants will be contacted by the study team within one business day. 
 
Distributing Flyers on USF Campus will involve placing flyers at USF Counseling 
Center, USF Student Health Center, and areas throughout campus where students 
congregate.  
 
12.2  
☐ Email 
 ☐ Record Review 
☒ Flyer 
☐ SONA  
☐ Letter 
☒ ResearchMatch (must upload HRP-
500 template) 
☐ News Advertisement 
☒ Other: Clinical Connection 
☒ Online/Social Media Advertisement 
 
 
12.3 N/A 
 
13.0 
Withdrawal of Subjects 
13.1 Anticipated circumstances under which participants will be withdrawn from the 
research without their consent include the event that they: 
1. Begin participating in ongoing mental health therapy from a non-study 
therapist 
2. Have changes to psychotropic medication use 
3. Begin to report active suicidal and/or homicidal intent or plan 
4. Begin to report active auditory, visual, and/or tactile hallucinations 
5. Begin to report the occurrence of epilepsy or seizures 

 
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6. Moves out of the State of Florida during the study period 
 
13.2 If subjects completely withdraw from the research, study staff will attempt to 
provide them with a referral to a therapist in their area. If subjects partially withdraw 
from the research, study staff will attempt to administer mid- and post-treatment 
assessments. Subjects will be given the option to completely withdraw from the study 
including withdrawing previously collected data.  
 
14.0 Risks to Subjects 
14.1 Physical, psychological, social, cultural, financial, and legal risks, and risks to 
privacy and/or confidentiality associated with this research are minimal because the 
probability and magnitude of harm or discomfort anticipated in the proposed research are 
not greater, in and of themselves, than those ordinarily encountered in daily lives of the 
general population or during the performance of routine physical or psychological 
examinations or tests. 
  
These minimal risks include: 
1. Possible breach of participant privacy and/or confidentiality 
2. Possible breach of the security of participant online data 
3. Possible participant discomfort due to completing psychological questionnaires 
and assessments 
4. Possible participant discomfort due to having therapy sessions recorded 
5. Participant discomfort during exposure therapy exercises. This discomfort is 
temporary but necessary for treatment gains to occur. 
6. Possible participant discomfort or cybersickness as a result of using the VR 
system, the duration of which is typically 5-10 minutes, and which will be 
assessed following each VR-based exposure using the CSQ-VR. 
7. Possible disclosure of suicidality or homicidality requiring mandatory reporting if 
participants are at imminent risk of endangering themselves or others. Standard 
operational procedures of the USF Department of Psychiatry and Behavioral 
Neurosciences specify responsibilities for handling dangers to self and others, 
safety planning, and mandatory reporting responsibilities. 
 
14.2 N/A 
14.3 N/A 
 
15.0 Potential Benefits to Subjects or Others 
15.1 Potential direct benefits to participants include reductions in anxiety associated with 
feared stimuli.   
 
15.2 The general public and scientific community will benefit from the knowledge 
produced in this research. This includes preliminary knowledge about the comparative 
efficacy of a telemedicine-based VR clinic vs. Standard TMH in the treatment of specific 
phobias. 
 

 
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16.0 Data Management and Confidentiality 
16.1 We will assess feasibility of the proposed trial methodology using the following 
benchmarks: 30 participants will be enrolled in months 1-9 of trial, 70% of participants 
will be retained at three-month follow-up, 70% of weekly self-report assessments will be 
completed, and we will reach 80% or greater treatment fidelity.  
 
The small sample size prevents any conclusions about efficacy; however, Analysis of 
Covariance will be used to conduct a preliminary assessment of between-group 
differences in clinical outcomes while co-varying for pre-treatment scores. We also will 
conduct a preliminary examination of associations between study targets including 
therapeutic alliance and presence.  
 
16.2 D.  
We will use the following security measures to protect data sources: 
 
1. Data collected during the trial will be securely stored in a HIPAA compliant USF 
REDCap database, including informed consent documents, questionnaire data, 
and session notes.  
2. Consent forms and de-identified data will be downloaded and stored in a secure 
HIPAA compliant Box folder. 
3. All research data exported from REDCap will include ID numbers only. 
4. Audio recordings will be stored in a secure HIPAA compliant USF Box folder. 
5. Only IRB-approved and trained study personnel will have access to the REDCap 
project and box folder. 
6. Computers, programs, and box folders containing data will be password-protected 
to prohibit unauthorized access. 
7. The codes that link the name of the participant and the study ID will be kept 
confidential in REDCap along with other identifiers including first name, last 
name, full date of birth, address, email address, and cell phone number.  
8. We have obtained a Certificate of Confidentiality from the National Institutes of 
Health so that we cannot be forced to disclose information that may identify 
participants, even by a court subpoena, in any federal, state, or local civil, 
criminal, administrative, legislative, or other proceedings. 
 
16.3 We will use the following quality assurance measures for subject recruitment, 
enrollment, enrollment targets, and for the validity and integrity of the data: 
1. study staff will complete and maintain up-to-date CITI and GCP training 
2. study staff will be trained and supervised weekly by the PI 
3. Standard Operating Procedures (SOPs) and study checklists will be used to train 
study staff and ensure fidelity to the study protocol  
4. informed consent will be obtained and documented by study staff to provide an 
audit trail  
9. any contact with study participants or potential study participants will be 
documented to provide an audit trail 
10. participant screening, recruitment, enrollment and enrollment targets, and data 
collection will be tracked to provide weekly updates to the PI 

 
Page 16 of 22 
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11. assessment data will be entered directly by participants into REDCap 
12. automated validity checks will be in place for any data collection 
13. data checks for ranges, cross-validity, and completion will be completed proximal 
to data collection 
14. collection of any study data will be documented by study staff to provide an audit 
trail 
15. the USF Conflict of Interest (COI) Office will maintain and monitor study 
progress according to ongoing conflict of interest management plans to ensure 
compliance with all requirements 
 
16.4 Identifiable information in this study will include patient names, dates of birth, 
phone numbers, email addresses, and physical addresses. Analyzed data will not include 
participant’s identifiable information and will only be shared with the public in aggregate 
form. Human subjects research records, including the original signed and dated consent 
documents, will be stored for at least 5 years after study completion. Signed and dated 
HIPAA authorizations and consent documents that include HIPAA authorizations will be 
stored for at least 5 years after study completion. After this time data will be deleted from 
REDCap. Patient assessment results and session notes will be shared with their healthcare 
provider upon submission of a signed release of information form, as stated in the 
informed consent document.  
 
16.5 If you will review/access and/or collect/obtain Protected Health Information (PHI) 
during recruitment or the main study, select all that apply: 
 
No Protected Health Information will be obtained during recruitment or the main study. 
As stated above, all identifiable information will be provided by the participant within the 
context of the study. No medical or insurance records will be accessed.  
 
16.6 Members of this research team are dedicated to the timely dissemination of study 
products and results. This includes the data used to inform Doxy.me VR features and 
exercises and resulting publications from analyses. We will prepare both brief and 
comprehensive reports for NIH, which will be circulated for review and comment 
to our colleagues in the field and the NIH. We will provide relevant information to senior 
leaders, supervisors, and providers at community health clinics and academic clinics 
located locally, regionally, and nationally. Results will be shared via professional, peer-
review, and lay publications, as well as presentations and forums, websites, 
newsletters, among others. 
 
17.0 Provisions to Monitor the Data to Ensure the Safety of Subjects 
☐ Obtaining Signed Authorization 
☐ Waiver of HIPAA Authorization for 
Recruitment/Screening Purposes Only 
☐ Obtaining Online or Verbal Authorization 
(Alteration of HIPAA Authorization) 
☐ Waiver of HIPAA Authorization for 
Entire Study 
☐ Data Use Agreement 
☐ Business Associate Agreement 

 
Page 17 of 22 
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17.1 
Some questions asked during assessments and exposure exercises may cause 
participants distress, but this distress is expected to be similar to what participants would 
experience with routine care for specific fears/Phobias. The study therapist (i.e., 
Postdoctoral Fellow) will ensure that any questions causing distress are discussed with 
participants and will provide them with techniques to reduce distress. A temporary 
increase in the severity of anxiety is expected at the beginning of exposure therapy, along 
with a gradual decline in severity over the course of treatment. If participants are 
distressed and unable to participate in the study following baseline assessments, or at the 
end of the study participants feel that they are in need of further treatment, the study 
therapist (i.e., Postdoctoral Fellow) will provide a referral to therapist(s) in the 
participants local area. This will be provided verbally to participants and the study 
therapist (i.e., Postdoctoral Fellow) will follow up in one week via telephone to inquire as 
to the state of the referral and provide further assistance as necessary. 
 
17.2 N/A 
 
18.0 Provisions to Protect the Privacy Interests of Subjects 
18.1 The research will be conducted via telephone, online, video conferencing, and 
virtual reality by IRB approved study staff located in a closed private clinic office in the 
University of South Florida Department of Psychiatry and Behavioral Neurosciences. 
 
18.2 Study participants will provide informed consent. We will not access any previously 
existing records. 
 
19.0 Compensation for Research-Related Injury 
19.1 N/A 
 
20.0 Subject Costs and Compensation 
20.1 Patients who participate in this study will have internet and smartphone access, so 
we anticipate that they will have data and text message plans that will allow them to 
participate without any additional costs. However, there is the small risk that some 
participants may exceed their monthly data or text message limits during this study 
resulting in additional costs, for which they will be responsible. This risk will be 
discussed during the informed consent process. 
 
20.2 If you will provide compensation to subjects, select all that apply: 
 
Participants will receive a $50 eGift card for completing the baseline assessment, $50 
eGift card for completing the 6th therapy session, and a $50 e-gift card for completing the 
☐ No Compensation 
☐ Tokens (pens, food items, etc.) 
☒ Financial Compensation (cash, gift cards) 
☐ Other  
☐ Course Credit (i.e. extra credit, SONA 
points) 
 

 
Page 18 of 22 
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3-month follow-up assessment. There will be no partial compensation for partially 
completing either assessment.  
 
21.0 Consent Process 
21.1 
 
21.2 Study staff will obtain signed informed consent from participants via REDCap e-
Consent during the ≤60-minute videoconference-based consent and baseline assessment 
visit. A link to the REDCap e-Consent form will be sent to participants through the 
videoconferencing platform’s messaging feature. Participants will be able to review the 
consent form on the REDCap page and sign the form with their curser to signify their 
consent to participate. Study staff administering the consent process will also sign the 
REDCap consent form at that time. Participants will have the opportunity to download 
the signed consent from after both parties have signed. We will ensure that participants 
understand all aspects of the study and consent form, and adequate time will be provided 
for questions relating to treatment, use of VR, audio recording sessions, and assessments. 
We will use an Informed Consent Checklist to document this process (see Informed 
Consent Checklist in Local Site Documents).  
21.3 N/A 
21.4 N/A  
21.5 N/A 
21.6 N/A 
 
22.0 Setting 
22.1 The research will be conducted via telephone, online, video conferencing, and 
virtual reality from the University of South Florida Department of Psychiatry and 
Behavioral Neurosciences.  
 
23.0 References 
23.1 
☐ Obtaining Signed Consent (Subject or 
Legally Authorized Representative) 
☐ Obtaining Consent Online (Waiver of 
Written Documentation of Consent ) 
☐ Obtaining Signed Parental Permission 
☐ Obtaining Verbal Consent (Waiver of 
Written Documentation of Consent) 
☐ Obtaining Signed Assent for Children 
or Adults Unable to Consent 
☐ Waiving Consent and/or Parental Permission 
(Waiver of Consent Process) 
☐ Obtaining Verbal Assent for Children 
or Adults Unable to Consent 
☐ Waiving Assent/Assent is Not Appropriate 
☒ Obtaining eConsent Signatures 
(Subject or Legally Authorized 
Representative) 
☐ Obtaining eConsent Parental Permission  
 
☐ Obtaining eConsent Assent for 
Children 
 

 
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