Trial Outcomes & Findings for Telemedicine-Based Virtual Reality Clinic for the Treatment of Phobias (NCT NCT06302868)

NCT ID: NCT06302868

Last Updated: 2026-05-18

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

54 participants

Primary outcome timeframe

Baseline, 6 Weeks Post-Baseline, and 3 Months Post-Baseline

Results posted on

2026-05-18

Participant Flow

Participant milestones

Participant milestones
Measure
Telemedicine-based Virtual Reality Exposure Therapy
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.
Standard Telemedicine Exposure Therapy
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.
Overall Study
STARTED
29
25
Overall Study
6 Weeks Post-Baseline
14
15
Overall Study
COMPLETED
14
14
Overall Study
NOT COMPLETED
15
11

Reasons for withdrawal

Reasons for withdrawal
Measure
Telemedicine-based Virtual Reality Exposure Therapy
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.
Standard Telemedicine Exposure Therapy
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.
Overall Study
Lost to Follow-up
6
5
Overall Study
Withdrawal by Subject
9
6

Baseline Characteristics

Telemedicine-Based Virtual Reality Clinic for the Treatment of Phobias

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Telemedicine-based Virtual Reality Exposure Therapy
n=29 Participants
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.
Standard Telemedicine Exposure Therapy
n=25 Participants
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.
Total
n=54 Participants
Total of all reporting groups
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=11 Participants
0 Participants
n=9 Participants
0 Participants
n=20 Participants
Age, Continuous
46.10 Years
STANDARD_DEVIATION 13.35 • n=11 Participants
42.20 Years
STANDARD_DEVIATION 13.98 • n=9 Participants
45.69 Years
STANDARD_DEVIATION 15.53 • n=20 Participants
Sex/Gender, Customized
Sex/Gender · Female
23 Participants
n=11 Participants
19 Participants
n=9 Participants
42 Participants
n=20 Participants
Sex/Gender, Customized
Sex/Gender · Male
5 Participants
n=11 Participants
6 Participants
n=9 Participants
11 Participants
n=20 Participants
Sex/Gender, Customized
Sex/Gender · Non-Binary/Gender Fluid
1 Participants
n=11 Participants
0 Participants
n=9 Participants
1 Participants
n=20 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=11 Participants
0 Participants
n=9 Participants
0 Participants
n=20 Participants
Race (NIH/OMB)
Asian
0 Participants
n=11 Participants
1 Participants
n=9 Participants
1 Participants
n=20 Participants
Race (NIH/OMB)
Black or African American
8 Participants
n=11 Participants
7 Participants
n=9 Participants
15 Participants
n=20 Participants
Race (NIH/OMB)
White
18 Participants
n=11 Participants
14 Participants
n=9 Participants
32 Participants
n=20 Participants
Race (NIH/OMB)
More than one race
3 Participants
n=11 Participants
3 Participants
n=9 Participants
6 Participants
n=20 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=11 Participants
0 Participants
n=9 Participants
0 Participants
n=20 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=11 Participants
6 Participants
n=9 Participants
8 Participants
n=20 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
27 Participants
n=11 Participants
19 Participants
n=9 Participants
46 Participants
n=20 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=11 Participants
0 Participants
n=9 Participants
0 Participants
n=20 Participants

PRIMARY outcome

Timeframe: Baseline, 6 Weeks Post-Baseline, and 3 Months Post-Baseline

Population: The Overall Number of Participants Analyzed refers to the number of participants enrolled and randomized to each arm. The number of participants analyzed in rows differs from this number due to participants being lost to contact and withdrawn from the study.

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.

Outcome measures

Outcome measures
Measure
Telemedicine-based Virtual Reality Exposure Therapy
n=29 Participants
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.
Standard Telemedicine Exposure Therapy
n=25 Participants
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.
Phobia Symptom Severity
Baseline
2.80 units on a scale
Standard Deviation 0.80
3.18 units on a scale
Standard Deviation 0.82
Phobia Symptom Severity
6 Weeks Post-Baseline
1.51 units on a scale
Standard Deviation 0.83
1.55 units on a scale
Standard Deviation 0.89
Phobia Symptom Severity
3 Months Post-Baseline
0.86 units on a scale
Standard Deviation 0.68
0.56 units on a scale
Standard Deviation 0.47

SECONDARY outcome

Timeframe: Baseline and 3 Months Post-Baseline

Population: The Overall Number of Participants Analyzed refers to the number of participants enrolled and randomized to each arm. The number of participants analyzed in rows differs from this number due to participants being lost to contact, withdrawn from the study, and unable to complete the DART interview.

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.

Outcome measures

Outcome measures
Measure
Telemedicine-based Virtual Reality Exposure Therapy
n=29 Participants
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.
Standard Telemedicine Exposure Therapy
n=25 Participants
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.
Specific Phobia Diagnosis
Baseline · Specific Phobia Diagnosis Present
29 Participants
23 Participants
Specific Phobia Diagnosis
3 Months Post-Baseline · Specific Phobia Diagnosis Present
1 Participants
0 Participants
Specific Phobia Diagnosis
3 Months Post-Baseline · Specific Phobia Diagnosis Subthreshold
2 Participants
3 Participants
Specific Phobia Diagnosis
Baseline · Specific Phobia Diagnosis Subthreshold
0 Participants
2 Participants
Specific Phobia Diagnosis
Baseline · Specific Phobia Diagnosis Absent
0 Participants
0 Participants
Specific Phobia Diagnosis
3 Months Post-Baseline · Specific Phobia Diagnosis Absent
7 Participants
8 Participants

SECONDARY outcome

Timeframe: Baseline and 3 Months Post-Baseline

Population: The Overall Number of Participants Analyzed refers to the number of participants enrolled and randomized to each arm. The number of participants analyzed in rows differs from this number due to participants being lost to contact and withdrawn from the study.

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.

Outcome measures

Outcome measures
Measure
Telemedicine-based Virtual Reality Exposure Therapy
n=29 Participants
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.
Standard Telemedicine Exposure Therapy
n=25 Participants
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.
General Anxiety Severity
3 Months Post-Baseline
7.14 units on a scale
Standard Deviation 5.63
3.71 units on a scale
Standard Deviation 4.41
General Anxiety Severity
Baseline
6.03 units on a scale
Standard Deviation 4.48
7.68 units on a scale
Standard Deviation 6.95

SECONDARY outcome

Timeframe: Baseline and 3 Months Post-Baseline

Population: The Overall Number of Participants Analyzed refers to the number of participants enrolled and randomized to each arm. The number of participants analyzed in rows differs from this number due to participants being lost to contact and withdrawn from the study.

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.

Outcome measures

Outcome measures
Measure
Telemedicine-based Virtual Reality Exposure Therapy
n=29 Participants
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.
Standard Telemedicine Exposure Therapy
n=25 Participants
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.
Depression Severity
Baseline
4.62 units on a scale
Standard Deviation 4.25
7.60 units on a scale
Standard Deviation 7.39
Depression Severity
3 Months Post-Baseline
7.43 units on a scale
Standard Deviation 5.40
4.86 units on a scale
Standard Deviation 7.59

SECONDARY outcome

Timeframe: 6 Weeks Post-Baseline and 3 Months Post-Baseline

Population: The Overall Number of Participants Analyzed refers to the number of participants who completed this measure at 6 Weeks Post-Baseline in each arm. The number of participants analyzed in rows differs from this number due to participants being lost to contact and withdrawn from the study.

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.

Outcome measures

Outcome measures
Measure
Telemedicine-based Virtual Reality Exposure Therapy
n=14 Participants
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.
Standard Telemedicine Exposure Therapy
n=15 Participants
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.
Therapeutic Alliance
6 Weeks Post-Baseline Total Score
55.64 units on a scale
Standard Deviation 3.82
57.67 units on a scale
Standard Deviation 1.98
Therapeutic Alliance
6 Weeks Post-Baseline Bond Subscale Score
19.14 units on a scale
Standard Deviation 1.83
19.73 units on a scale
Standard Deviation 0.59
Therapeutic Alliance
6 Weeks Post-Baseline Task Subscale Score
17.79 units on a scale
Standard Deviation 1.25
18.13 units on a scale
Standard Deviation 1.55
Therapeutic Alliance
6 Weeks Post-Baseline Goal Subscale Score
18.71 units on a scale
Standard Deviation 1.77
19.80 units on a scale
Standard Deviation 0.41
Therapeutic Alliance
3 Months Post-Baseline Total Score
56.93 units on a scale
Standard Deviation 4.14
57.21 units on a scale
Standard Deviation 4.17
Therapeutic Alliance
3 Months Post-Baseline Bond Subscale Score
19.14 units on a scale
Standard Deviation 2.07
18.86 units on a scale
Standard Deviation 2.24
Therapeutic Alliance
3 Months Post-Baseline Task Subscale Score
18.50 units on a scale
Standard Deviation 1.70
18.86 units on a scale
Standard Deviation 1.35
Therapeutic Alliance
3 Months Post-Baseline Goal Subscale Score
19.29 units on a scale
Standard Deviation 1.43
19.50 units on a scale
Standard Deviation 0.94

SECONDARY outcome

Timeframe: 6 Weeks Post-Baseline and 3 Months Post-Baseline

Population: The Overall Number of Participants Analyzed refers to the number of participants enrolled and randomized to each arm. The number of participants analyzed in rows differs from this number due to participants being lost to contact and withdrawn from the study.

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.

Outcome measures

Outcome measures
Measure
Telemedicine-based Virtual Reality Exposure Therapy
n=14 Participants
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.
Standard Telemedicine Exposure Therapy
n=15 Participants
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.
Treatment Satisfaction
6 Weeks Post-Baseline Total Score
30.36 units on a scale
Standard Deviation 2.34
31.47 units on a scale
Standard Deviation 0.92
Treatment Satisfaction
3 Months Post-Baseline
31.43 units on a scale
Standard Deviation 1.40
31.07 units on a scale
Standard Deviation 1.39

SECONDARY outcome

Timeframe: 6 Weeks Post-Baseline and 3 Months Post-Baseline

Population: The Overall Number of Participants Analyzed refers to the number of participants enrolled and randomized to each arm. The number of participants analyzed in rows differs from this number due to participants being lost to contact and withdrawn from the study.

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.

Outcome measures

Outcome measures
Measure
Telemedicine-based Virtual Reality Exposure Therapy
n=14 Participants
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.
Standard Telemedicine Exposure Therapy
n=15 Participants
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.
System Usability
6 Weeks Post-Baseline Total Score
76.43 units on a scale
Standard Deviation 17.17
90.33 units on a scale
Standard Deviation 13.72
System Usability
3 Months Post-Baseline
80.89 units on a scale
Standard Deviation 11.99
88.39 units on a scale
Standard Deviation 19.82

SECONDARY outcome

Timeframe: 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.

Population: The number of participants here differs from the number of participants assigned to arms in the Participant Flow due to participants being lost to contact and withdrawn from the study.

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.

Outcome measures

Outcome measures
Measure
Telemedicine-based Virtual Reality Exposure Therapy
n=19 Participants
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.
Standard Telemedicine Exposure Therapy
n=18 Participants
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.
Telepresence
8.38 units on a scale
Standard Deviation 1.11
7.69 units on a scale
Standard Deviation 2.04

SECONDARY outcome

Timeframe: 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.

Population: This measure was completed only by participants in the Doxy.me VR group. The number of participants here differs from the number of participants assigned to arms in the Participant Flow due to participants being lost to contact and withdrawn from the study.

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.

Outcome measures

Outcome measures
Measure
Telemedicine-based Virtual Reality Exposure Therapy
n=18 Participants
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.
Standard Telemedicine Exposure Therapy
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.
Cybersickness
7.69 units on a scale
Standard Deviation 2.04

Adverse Events

Telemedicine-based Virtual Reality Exposure Therapy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Standard Telemedicine Exposure Therapy

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Brian Bunnell

University of South Florida

Phone: 8139748607

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place