Telemedicine-Based Virtual Reality Clinic for the Treatment of Phobias

Arachnophobia Clinical Trial

Official title:

Doxy.me VR vs. Telemental Health-Based Exposure Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06302868
• Other study ID #: 006215
• Secondary ID: R43MH129065
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: March 2024
• Source: University of South Florida
• Contact: Kaitlyn R Schuler, PhD
• Phone: 813-396-9169
• Email: krschuler[@]usf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 a history of epilepsy or seizures

Related Conditions & MeSH terms

• Arachnophobia

Intervention

Behavioral:
• Telemedicine Exposure Therapy Using Photos and Videos
Participants will complete 12 60-minute exposure therapy sessions using photos/videos and progress to in vivo exposures.
• Telemedicine-Based Virtual Reality Exposure Therapy
Participants will complete 12 60-minute exposure therapy sessions in a Virtual Reality Clinic using Virtual Reality stimuli and progress to in vivo exposures.

Locations

Country	Name	City	State
United States	University of South Florida	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phobia symptom severity	The Severity Measure for Specific Phobia (SMSP) will be used to assess changes in phobia symptom severity at the 3 Month Follow-Up.; Each item on the measure is rated on a 5-point scale (0=Never; 1=Occasionally; 2=Half of the time; 3=Most of the time, and 4=All of the time). The total score can range from 0 to 40 with higher scores indicating greater severity of specific phobia. The clinician will use an average total score, which reduces the overall score to a 5-point scale, which allows the clinician to think of the severity of the individual's specific phobia in terms of none (0), mild (1), moderate (2), severe (3), or extreme (4).	3 Month Follow-Up