Arachnophobia, Cynophobia, Ophidiophobia
Conditions
Keywords
phobia, phobias, snakes, dogs, spiders
Brief summary
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.
Detailed description
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.
Interventions
Participants will complete 12 60-minute exposure therapy sessions in a Virtual Reality Clinic using Virtual Reality stimuli and progress to in vivo exposures.
BEHAVIORALTelemedicine Exposure Therapy Using Photos and Videos
Participants will complete 12 60-minute exposure therapy sessions using photos/videos and progress to in vivo exposures.
Sponsors
University of South Florida
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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 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 having a diagnosis of photosensitive epilepsy by a medical doctor or a history of experiencing seizures that they believe were caused by photosensitivity
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phobia Symptom Severity | Baseline, 6 Weeks Post-Baseline, and 3 Months Post-Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specific Phobia Diagnosis | Baseline and 3 Months Post-Baseline | 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. |
| General Anxiety Severity | Baseline and 3 Months Post-Baseline | 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. |
| Depression Severity | Baseline and 3 Months Post-Baseline | 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. |
| Therapeutic Alliance | 6 Weeks Post-Baseline and 3 Months Post-Baseline | 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. |
| Treatment Satisfaction | 6 Weeks Post-Baseline and 3 Months Post-Baseline | 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. |
| System Usability | 6 Weeks Post-Baseline and 3 Months Post-Baseline | 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. |
| Telepresence | 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. | 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. |
| Cybersickness | 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. | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBrian E Bunnell, PhD
University of South Florida
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 45.69 Years STANDARD_DEVIATION 15.53 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 32 Participants |
| Sex/Gender, Customized Sex/Gender Female | 19 Participants |
| Sex/Gender, Customized Sex/Gender Male | 5 Participants |
| Sex/Gender, Customized Sex/Gender Non-Binary/Gender Fluid | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 25 |
| other Total, other adverse events | 0 / 29 | 0 / 25 |
| serious Total, serious adverse events | 0 / 29 | 0 / 25 |
Outcome results
None listed