Examining a Telemedicine-Based Virtual Reality Clinic in Treating Adults With Specific Phobia: Protocol for a Feasibility Randomized Controlled Efficacy Trial.

BACKGROUND

Virtual reality (VR) has strong potential to enhance the effectiveness of telemental health care (TMH) by providing accessible, personalized treatment from home. While there is ample research supporting VR for in-person treatment, there is only preliminary data on the efficacy of telemedicine-based VR. Furthermore, the majority of VR apps used in therapy are not designed for mental health care. VR has the potential to enhance TMH through innovative technology solutions designed specifically for the enhancement of remotely delivered evidence-based practices. This feasibility randomized controlled efficacy trial aims to fill both of these gaps by piloting a novel telemedicine-based VR app (Doxy.me VR) equipped with animal phobia exposure stimuli.

OBJECTIVE

This is a feasibility randomized controlled efficacy trial comparing exposure therapy via a telemedicine-based VR clinic versus standard TMH with adults with an intense fear of dogs, snakes, or spiders. The primary objective is to assess the feasibility of a fully powered trial. The secondary objective is to conduct a preliminary examination of clinical outcomes (eg, specific phobia symptoms).

METHODS

This single-site trial will enroll a minimum of 30 and a maximum of 60 adults with self-reported fear of dogs, snakes, or spiders. Potential participants will be recruited through clinical trial and research recruitment websites and posting flyers. All self-report assessments and homework will be partially automated using REDCap (Research Electronic Data Capture; Vanderbilt University) forms and surveys, but the baseline assessment of phobia symptoms and exposure intervention will be administered by the study therapist.

RESULTS

The feasibility of the proposed trial methodology will be assessed using enrollment, retention, assessment completion, and treatment protocol fidelity benchmarks. Between-group differences in specific phobia, anxiety, and depression symptoms while covarying for pretreatment scores, will be conducted using repeated measures ANOVA along with differences in therapeutic alliance and presence. Data obtained from these analyses will inform power analyses for a fully powered efficacy trial. In total, 54 participants were randomized between October 25, 2023, and July 26, 2024 (Doxy.me VR n=28 and TMH n=26). Data analysis will be completed and submitted by the end of the second quarter of 2025.

CONCLUSIONS

This feasibility randomized controlled trial comparing Doxy.me VR versus TMH aims to enhance the delivery of evidence-based treatments via telemedicine and reduce barriers to remotely delivered exposure therapy. This feasibility trial will be followed by a fully powered efficacy trial on telemedicine-based VR for animal phobias.

TRIAL REGISTRATION

ClinicalTrials.gov NCT06302868; https://clinicaltrials.gov/study/NCT06302868.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/65770.