Examining the Efficacy of a Telemedicine-Based Virtual Reality Clinic in Treating Adults with Specific Phobia: Protocol for A Feasibility Randomized Controlled Efficacy Trial (Preprint)

Abstract

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. Further, the majority of VR applications used in therapy are not designed for mental healthcare. 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 application (Doxy.me VR) equipped with animal phobia exposure stimuli.

This is a feasibility randomized controlled efficacy trial comparing exposure therapy via a telemedicine-based VR clinic versus standard TMH to adults with intense fear of dogs, snakes, and/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 (e.g., specific phobia symptoms).

This single-site trial will enroll a minimum of 30 and maximum of 60 adults with self-reported fear of dogs, snakes, and/or spiders. Potential participants will be recruited through online platforms and posting flyers. All procedures will be partially automated using REDCap forms and surveys, but the baseline assessment of phobia symptoms will be administered by the study therapist.

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 co-varying for pre-treatment scores, will be conducted using r-ANOVA along with differences in therapeutic alliance and presence. Data obtained from these analyses will inform power analyses for a fully powered efficacy trial.

This feasibility RCT comparing Doxy.me VR vs. 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.

This trial was registered on ClinicalTrials.gov [NCT06302868]