Cognitive Behavioral Immersion for Depression: Randomized Controlled Trial Comparing Virtual Reality and Flat-Screen Delivery.

Background: Depression is prevalent and debilitating. Although interventions exist, they are rarely delivered in accessible, scalable ways that retain their effectiveness. Cognitive behavioral immersion (CBI) is a coach-led cognitive behavioral skills program delivered in social virtual worlds that offers a potential solution. Objective: This parallel-group, web-based randomized controlled superiority trial compared CBI accessed via virtual reality headsets (CBI-VR) or flat-screen devices (CBI-FS) to a delayed access control. Methods: Inclusion criteria included a clinical level of depression symptoms, age ≥18 years, able and willing to give informed consent, access to a computer with an internet connection, and ability to speak and read English. Eligible participants were randomized using a random number generation script in a 1:1:1 ratio to conditions. CBI consisted of 8 weekly 1-hour groups led by coaches who taught cognitive behavioral skills. The intervention lasted 8 weeks; follow-up lasted 6 months. The primary outcome was depression symptoms; secondary outcomes were anxiety symptoms and quality of life. Recruitment and study procedures were conducted online. Outcomes were assessed through electronic self-report questionnaires. The study was unblinded. Hierarchical linear modeling was used to examine differences in rates of change among conditions. We explored the sense of presence as a potential mediator of intervention response. Results: Participants were recruited from February 2024 to January 2025; n=102 were randomized to each condition. Participants randomized to CBI-VR and CBI-FS attended an average of 5 intervention sessions. Primary analyses included all participants in the intent-to-treat sample that completed ≥2 outcome surveys to estimate within-person change (CBI-VR: n=98; CBI-FS: n=86; control: n=102). CBI-VR showed faster reductions in depressive and anxiety symptoms than either CBI-FS (depression: β=.21; 95% CI 0.02-0.40; P=.03 and anxiety: β=.20, 95% CI 0.03-0.38; P=.02) or the control (depression: β=.31, 95% CI 0.13-0.48; P<.001 and anxiety: β=.18, 95% CI 0.01-0.34; P=.03) across the 8-week intervention, with improvements largely maintained over the 6-month follow-up. CBI-VR also showed greater improvements in general quality of life (β=-1.02; 95% CI -1.63 to -0.40; P=.001) and psychological well-being (β=-1.01, 95% CI -1.44 to -0.59; P<.001) than the control from pre- to postintervention. The sense of physical presence in the environment was associated with CBI-VR's effects on depression symptoms (ab=-0.85, 95% CI -1.71 to -0.15). No adverse effects occurred in any group. Conclusions: This study evaluated the efficacy of an innovative coach-led cognitive behavioral skills group delivered via VR. To our knowledge, our trial is the first to demonstrate that CBI delivered via VR is effective. These findings extend prior work on digital cognitive behavioral therapy by supporting CBI-VR as an effective and viable intervention package for depression and anxiety symptoms. These findings may help inform future research on suitable technology that can help bridge mental health care gaps.