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A Randomized Controlled Efficacy Trial of a Telemedicine-based Virtual Reality Clinic for the Treatment of Phobias

ConditionSpecific Phobia, Animal
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of South Florida

About this trial

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?

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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:

  • 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.

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Telemedicine-based Virtual Reality Exposure TherapyExperimental treatment 1 intervention
Group B: Standard Telemedicine-Based Exposure TherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
2

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.

Time frame
Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
3

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.

Time frame
Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
4

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.

Time frame
Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)

Secondary outcomes

1

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.

Time frame
Baseline, 4 Weeks Post-Baseline (Mid-Treatment), 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
2

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.

Time frame
Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
3

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.

Time frame
Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)
4

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.

Time frame
Baseline, 7 Weeks Post-Baseline (Post-Treatment), and 28 weeks Post-Baseline (3-Months Post-Treatment)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of South Florida

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: