Abstract

Major depressive disorder (MDD) is a global concern with increasing prevalence. While many evidence-based psychotherapies (EBPs) have been identified to treat MDD, there are numerous barriers for patients to access these treatments. Virtual reality (VR) has been used as a treatment enhancement for a variety of mental health disorders, but few have examined its efficacy and use for MDD in clinical settings. Behavioral activation (BA) is a simple yet effective EBP for MDD that may have potential to be easily enhanced and adapted with VR. A previous report by our group explored the feasibility and acceptability of VR-enhanced behavioral activation (VR-BA) in a small clinical proof of concept pilot. The present study examines the clinical efficacy of a more immersive extended reality prototype (XR-BA) based on modifications from this early pilot testing. We report on the first clinical efficacy testing of XR-BA comparing it to traditional BA.Our main objective was to corroborate previous VR-BA feasibility and tolerability findings with a more immersive extended reality prototype using a commercially available Meta QUEST 2 VR headset. In addition, this study examined whether XR-BA was efficacious and non-inferior to traditional BA in treating MDD in a clinical telemedicine setting.A nonblinded between-subjects randomized controlled trial was conducted comparing XR-BA to traditional BA remotely via a Zoom platform between December 19, 2022 and July 24, 2023. The study utilized the same brief three week, four-session BA protocol described in our previous study and in previous efficacious brief BA interventions in the literature. The main difference between study arms was the requirement for the experimental XR-BA subjects to use a Quest 2 VR headset to engage in pleasant activities instead of in real life (IRL) activities for therapy homework. The primary outcome measured was the Patient Health Questionnaire-9 (PHQ-9). Independent samples t-tests and paired-samples t-tests were used to determine statistical significance and confirmed with Statistical Equation Modeling (SEM).Of 71 participants assessed for eligibility, 26 met study criteria and were randomized to receive either XR-BA (n=13) or traditional BA (n=13). The mean age of the 26 participants (6 male, 19 female, 1 non-binary/third gender) was 50.3 (SD = 17.3). No adverse events were reported in either group, and no significant difference in dropout rates or homework completion was observed. The XR-BA intervention was found to be statistically non-inferior to traditional BA, t(18.6) = -.28, p = .78. Both the XR-BA arm, t(9) = 2.5, p = .04, and the traditional BA arm, t(10) = 2.3, p = .04 experienced a statistically significant decrease in symptoms and clinical severity from the beginning of session 1 to the beginning of session 4.This study confirmed our previous findings that XR-BA is a feasible and acceptable enhancement of traditional BA for an outpatient MDD population. The findings, although limited, also provide evidence that XR-BA is not inferior to traditional BA. XR-enhanced BA may be worth pursuing as a modality for improving access and reducing barriers to mental health for those with MDD. In addition, our data indicates further exploration is warranted to test XR's ability to enhance the expectation/placebo effects of EBP's for MDD.ClinicalTrials.gov Identifier: NCT05525390.RR2-10.2196/35526.

View details for DOI 10.2196/52326

View details for PubMedID 38437873