Telemedicine-Based Virtual Reality Clinic for the Treatment of Phobias

NCT06302868 | Recruiting

• 2 other identifiers: 006215R43MH129065
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Arachnophobia; Cynophobia; Ophidiophobia

Keywords

phobia; phobias; snakes; dogs; spiders

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Telemedicine-based Virtual Reality Exposure Therapy

ACTIVE COMPARATOR

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.

Behavioral: Telemedicine-Based Virtual Reality Exposure Therapy

Standard Telemedicine Exposure Therapy

ACTIVE COMPARATOR

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.

Behavioral: Telemedicine Exposure Therapy Using Photos and Videos

Interventions

Telemedicine Exposure Therapy Using Photos and Videos BEHAVIORAL

Participants will complete 12 60-minute exposure therapy sessions using photos/videos and progress to in vivo exposures.

Standard Telemedicine Exposure Therapy

Telemedicine-Based Virtual Reality Exposure Therapy BEHAVIORAL

Participants will complete 12 60-minute exposure therapy sessions in a Virtual Reality Clinic using Virtual Reality stimuli and progress to in vivo exposures.

Telemedicine-based Virtual Reality Exposure Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• Is an adult ≥ 18 years old
• Has a self-reported fear of dogs, snakes, and/or spiders
• 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
• Has access to the internet AND a computer OR smartphone with video conferencing capabilities
• Will reside in the state of Florida for the duration of the study

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this study:
• Is participating in ongoing mental health therapy from a non-study therapist
• Has had changes to psychotropic medication use within six weeks preceding enrollment in the trial
• 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
• Reports active auditory, visual, and/or tactile hallucinations via the Diagnostic Assessment Research Tool (DART) Psychosis Module screening question
• Reports a history of epilepsy or seizures

Sponsors & Collaborators

• University of South Florida: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of South Florida

Tampa, Florida, 33613, United States

RECRUITING

Related Publications (1)

• Schuler KR, Ong T, Welch BM, Craggs JG, Bunnell BE. Examining a Telemedicine-Based Virtual Reality Clinic in Treating Adults With Specific Phobia: Protocol for a Feasibility Randomized Controlled Efficacy Trial. JMIR Res Protoc. 2025 Apr 10;14:e65770. doi: 10.2196/65770.

  PMID: 40209221 DERIVED

MeSH Terms

Conditions

Arachnophobia; Zoophobia; Phobic Disorders

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Brian E Bunnell, PhD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaitlyn R Schuler, PhD

CONTACT

813-396-9169; krschuler@usf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: March 12, 2024
• Study Start: October 3, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)