Psychiatry · Medical Literature
Examining the Efficacy of a Telehealth-Based Virtual Reality Clinic in Treating Adults With Specific Phobia: Feasibility Randomized Controlled Trial.
Abstract
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. 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). 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. 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. 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.
Clinical relevance
Is it feasible to conduct a fully powered randomized controlled trial comparing virtual reality exposure therapy (VRET) delivered via a multiuser, telehealth-based VR platform (Doxy.me VR) to standard telemental health care (TMH) for adults with specific phobia (fear of dogs, snakes, or spiders), and does VRET show preliminary evidence of clinical efficacy? __SNAPSHOT__ {"studyDesign":"Single-site, fully remote, parallel-group feasibility randomized controlled trial (feasibility RCT) with preliminary efficacy assessment","setting":"University of South Florida, Department of Psychiatry and Behavioral Neurosciences, Morsani College of Medicine; fully remote/telehealth setting (United States)","sampleSize":"n=54 randomized (intervention: ~27 VRET, control: ~27 standard TMH per 1:1 allocation; exact per-arm n not reported in abstract)","population":"Adults with clinically elevated fear of dogs, snakes, or spiders meeting criteria for specific phobia; recruited and treated entirely remotely. Comorbidities and demographic specifics not reported in abstract.","intervention":"Exposure therapy (12 weekly sessions over 3 months) delivered via Doxy.me VR — a synchronous, multiuser, telehealth-based virtual reality application that allows therapist and client to share a virtual environment in real time","comparator":"Standard telemental health care (TMH): exposure therapy delivered via conventional video telehealth (Doxy.me platform) over the same 12-session, 3-month protocol","primaryOutcome":"Feasibility of conducting a fully powered RCT, assessed by five pre-specified benchmarks: (1) enrolling ≥30 participants during months 1–9; (2) collecting ≥70% of midtreatment self-report data; (3) collecting ≥70% of posttreatment self-report data; (4) collecting ≥70% of weekly self-report data; (5) achieving treatment fidelity ≥80%. Secondary clinical outcome: specific phobia symptom severity measured by the Severity Measure for Specific Phobia (SMSP; 10-item, 0–4 scale, higher = greater severity).","followUp":"3 months (posttreatment); assessments at baseline, each session, midtreatment (after session 6, ~6 weeks), and posttreatment (3 months post-baseline)","fundingSource":"Partially industry-affiliated: three authors (Bunnell, Ong, Welch) are employees of Doxy.me Inc., the commercial company whose VR product was under investigation; additional institutional affiliation with University of South Florida. Independent grant funding source not reported in abstract."}
Key findings
The authors report that the study met its primary feasibility objective: telehealth-based multiuser synchronous VRET was declared feasible, and preliminary evidence of clinical efficacy was observed. Specific feasibility benchmark results (e.g., exact enrollment numbers reached, data completion percentages achieved, and fidelity scores) are not reported in the abstract. Fifty-four participants were randomized across the trial period (first enrollment: October 25, 2023; last session completed: July 26, 2024). The primary clinical outcome (SMSP) and between-group differences in therapeutic alliance (WAI-SR), client satisfaction (CSQ-8), system usability (SUS), presence (SIPQ), and cybersickness (CSQ-VR) were assessed preliminarily; specific between-group effect sizes, confidence intervals, p-values, and NNT/NNH are not reported in the abstract. Treatment fidelity was assessed by audio recording all sessions, with a randomly selected 20% rated for fidelity. No specific adverse event data are reported in the abstract beyond the monitoring of cybersickness as a secondary outcome. All quantitative outcome data are available only in the full text, which was not accessible for this summary.
Practice implications
This feasibility trial is the first published study to demonstrate that a therapist and patient can co-inhabit a shared multiuser VR environment synchronously via telehealth for the purpose of delivering structured exposure therapy. The study established proof-of-concept feasibility and generated preliminary—not confirmatory—efficacy signals for VRET via telehealth in animal-type specific phobia. The study did NOT establish superiority of VRET over standard TMH, did NOT enroll a sample powered for efficacy inference, and did NOT examine long-term outcomes beyond 3 months. The population was restricted to adults with fear of dogs, snakes, or spiders; findings cannot be generalized to other phobia subtypes (e.g., blood-injection-injury, situational, or natural environment), to more complex anxiety disorders, or to populations with significant psychiatric comorbidities. The results are not ready for direct clinical application but are highly relevant to clinicians and health systems considering telehealth-integrated VR delivery models. The identified procedural refinements are intended to directly inform a subsequent fully powered RCT. Importantly, because only the abstract was available for review, quantitative clinical outcome data and their interpretation are necessarily limited. __LIMITATIONS__ Feasibility design with n=54 is insufficiently powered to detect or rule out clinically meaningful between-group differences; all efficacy findings are preliminary and hypothesis-generating only.,Single-site, single-therapist or limited-therapist design reduces generalizability to real-world, multi-clinician settings.,Phobia stimuli restricted to dogs, snakes, and spiders; generalizability to other specific phobia subtypes or to generalized anxiety disorder is untested.,Significant conflict of interest: three of five authors are employees of Doxy.me Inc., the commercial developer of the VR product under investigation, introducing risk of bias in implementation, reporting, and interpretation.,No blinding of participants or therapists to arm assignment is possible given the nature of the intervention, risking performance and detection bias.,Absence of waitlist or no-treatment control arm means observed clinical improvement cannot be attributed specifically to VR augmentation versus the therapeutic relationship or natural symptom course.,Fully remote recruitment and delivery may enrich for a technologically literate, motivated population, limiting generalizability to patients with low digital literacy or limited technology access.,Cybersickness, a clinically meaningful technology-related adverse effect, was monitored but quantitative results are not available in the abstract.,No follow-up beyond 3 months; durability of phobia reduction, relapse rates, and long-term functional outcomes are unknown.,Abstract-only availability for this summary precludes full evaluation of statistical methods, attrition handling, and completeness of outcome reporting. __BOTTOM_LINE_CATEGORY__ promising_but_preliminary __BOTTOM_LINE__ This first-of-its-kind feasibility RCT demonstrates that synchronous, multiuser, telehealth-based VR exposure therapy for specific phobia is operationally feasible and shows preliminary clinical promise, but the sample is too small and the design too preliminary to support efficacy conclusions or changes in clinical practice. Clinicians should be aware that three of five authors are employed by the company whose product was tested, warranting cautious interpretation of favorable findings. The study's primary value lies in its role as a foundation for a fully powered confirmatory RCT, the design of which will be informed by lessons learned here.