Examining the Efficacy of a Telehealth-Based Virtual Reality Clinic in Treating Adults With Specific Phobia: Feasibility Randomized Controlled Trial.

Background: Virtual reality (VR) has the potential to enhance telemental health care (TMH) by enabling accessible, engaging, and personalized treatment from home. Although VR is well-supported for in-person treatment, evidence for telehealth-based VR is limited. Moreover, no prior research has demonstrated the feasibility of therapists and clients conducting therapy sessions remotely within a shared (ie, multiuser) VR experience. Objective: The primary objective of this study was to evaluate the feasibility of conducting a randomized controlled efficacy trial (RCT) comparing exposure therapy delivered via Doxy.me VR (Doxy.me Inc)-a multiuser, telehealth-based VR app-to standard TMH in adults with clinically elevated fear of dogs, snakes, or spiders. A secondary objective was to preliminarily examine clinical (ie, specific phobia symptom severity) and treatment-related outcomes (ie, therapeutic alliance, client satisfaction, system usability, presence, cybersickness, and treatment fidelity). Methods: This study used a single-site, fully remote, parallel, feasibility RCT design. Participants were randomly assigned using a 1:1 ratio to receive 12 weekly exposure therapy sessions over 3 months, delivered via either standard TMH or Doxy.me VR. Assessments were conducted at baseline, each session, midtreatment, and posttreatment. All therapy sessions were audio recorded, 20% of which were randomly selected and rated for treatment fidelity. Feasibility benchmarks during the 12-month trial included: (1) enrolling 30 participants during Months 1-9 of the trial; (2) collecting 70% of midtreatment self-report data; (3) collecting 70% of posttreatment self-report data; (4) collecting 70% of weekly self-report data; and (5) achieving treatment fidelity ≥80%. Between-group differences in clinical treatment-related outcomes also were examined preliminarily. Results: A total of 54 participants were enrolled between October 25, 2023 and July 26, 2024, and randomly assigned to the Doxy.me VR (n=29) and TMH (n=25) conditions, exceeding our recruitment target by 180%. Among the 30 participants targeted for completion, data were obtained from 29 (96.7%) at midtreatment and 28 (93.3%) at posttreatment. Participants completed 86.5% (180/208) of weekly self-report assessments. Treatment fidelity was 90% based on ratings of 41 session recordings. There were no significant between-group differences in clinical outcomes (all P>.05) or most treatment-related outcomes. However, client satisfaction improved significantly more for the Doxy.me VR condition compared to TMH (P=.04). Power analyses indicated that a sample of 160 participants would ensure adequate power for a fully powered trial. Conclusions: Telehealth-based, multiuser, synchronous VRET is feasible and shows preliminary evidence of efficacy. These findings are promising, and opportunities to improve procedures identified in this feasibility trial will directly inform the protocol for a fully powered RCT evaluating telehealth-based VR and its potential to improve treatment of mental health disorders.