Examining the Efficacy of Extended Reality-Enhanced Behavioral Activation for Adults With Major Depressive Disorder: Randomized Controlled Trial.

backgroundMajor 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 to patients accessing them. Virtual reality (VR) has been used as a treatment enhancement for a variety of mental health disorders, but few studies have examined its clinical use in treating MDD. Behavioral activation (BA) is a simple yet effective and established first-line EBP for MDD that has the potential to be easily enhanced and adapted with VR technology. A previous report by our group explored the feasibility and acceptability of VR-enhanced BA in a small clinical proof-of-concept pilot. This study examines the clinical efficacy of a more immersive extended reality (XR)-enhanced BA (XR-BA) prototype. This is the first clinical efficacy test of an XR-BA protocol.

objectiveThis study examined whether XR-BA was feasible and efficacious in treating MDD in an ambulatory telemedicine clinic.

methodsA nonblinded between-subject randomized controlled trial compared XR-BA to traditional BA delivered via telehealth. The study used a previously established, brief 3-week, 4-session BA EBP intervention. The experimental XR-BA participants were directed to use a Meta Quest 2 (Reality Labs) VR headset to engage in simulated pleasant or mastery activities and were compared to a control arm, which used only real-life mastery or pleasant activities as between-session homework. The Patient Health Questionnaire (PHQ)-9 was the primary outcome measure. Independent-sample and paired-sample t tests (2-tailed) were used to determine statistical significance and confirmed using structural equation modeling.

resultsOverall, 26 participants with MDD were randomized to receive either XR-BA (n=13, 50%) or traditional BA (n=13, 50%). The mean age of the 26 participants (n=6, 23% male; n=19, 73% female; n=1, 4% nonbinary or third gender) was 50.3 (SD 17.3) years. No adverse events were reported in either group, and no substantial differences in dropout rates or homework completion were observed. XR-BA was found to be statistically noninferior to traditional BA (t

conclusionsThis study confirmed previous findings that XR-BA may be a feasible, non-inferior, and acceptable enhancement to traditional BA. Additionally, there was evidence that supports the potential of XR to enhance expectation or placebo effects. Further research is needed to examine the potential of XR to improve access, outcomes, and barriers to MDD care.

trial registrationClinicalTrials.gov NCT05525390; https://clinicaltrials.gov/study/NCT05525390.